Junshi Biosciences Receives NMPA Approval of sNDA for Toripalimab in Combination with Paclitaxel and Cisplatin in First-Line Treatment of Advanced or Distant Metastatic Esophageal Squamous Cell Carcinoma

–5th approved indication by NMPA significantly expands eligible patient population

SHANGHAI, China, May 16, 2022 (GLOBE NEWSWIRE) — Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences,” HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced today that the China National Medical Products Administration (NMPA) has approved the supplemental new drug application (sNDA) for toripalimab in combination with paclitaxel and cisplatin in the first-line treatment of patients with unresectable locally advanced/recurrent or distant metastatic esophageal squamous cell carcinoma (ESCC). The sNDA was accepted by the NMPA in July 2021. This is the fifth indication approved for toripalimab in China and will benefit Chinese patients with advanced ESCC.

The approval of the sNDA is based on results from the JUPITER-06 study (NCT03829969), a randomized, double-blind, placebo-controlled, multi-center Phase III clinical study. JUPITER-06 compared the efficacy and safety of toripalimab in combination with TP chemotherapy (paclitaxel + cisplatin) and placebo in combination with TP chemotherapy in the first-line treatment of patients with advanced or metastatic ESCC. The study results showed that, compared with chemotherapy alone, toripalimab in combination with TP chemotherapy demonstrated a statistically significant increase in survival benefits, with median overall survival (mOS) significantly extended to 17 months, progression-free survival (PFS) to 5.7 months, disease progression or mortality risk reduced by 42% (HR=0.58, P<0.0001), and patients benefiting regardless of their PD-L1 expression. In terms of safety, no new safety signal was found when adding toripalimab to the chemotherapy treatment. The results of JUPITER-06 were published in Cancer Cell.

“China is one of the countries with the highest incidence of esophageal cancer,” said Professor Ruihua Xu from Sun Yat-sen University Cancer Center, the principal investigator of JUPITER-06. “However, due to the differences between Eastern and Western patients in terms of cause of the disease and pathological characteristics, clinical evidence for innovative treatments specifically targeting the main subtypes of ESCC in China is relatively lacking. JUPITER-06 has demonstrated that a PD-1 inhibitor independently developed in China, combined with a TP chemotherapy regime, is more suitable for Chinese clinical practice. The results, to our surprise, were overwhelmingly positive. PFS and OS improved so significantly that patients broke the record in the survival of advanced ESCC in first-line treatment. This ‘China Protocol’ is a major contribution to the international field of immunotherapy.”

“The symptoms of early esophageal cancer patients are insidious and difficult to be detected. Many patients are already at advanced stages when they are diagnosed initially. However, chemotherapy, the standard first-line treatment for advanced ESCC, has a poor prognosis,” said Dr. Jianjun Zou, Global Research and Development President at Junshi Biosciences. “Through our combined efforts with JUPITER-06 investigators and participating patients, the study confirmed that toripalimab combined with chemotherapy significantly increases treatment efficacy. We look forward to bringing the better treatment option to these patients in China and will also actively communicate with regulatory agencies in other countries to make this innovative therapy beneficial to patients all over the world.”

“We are excited that the approval of the new indication of first-line treatment of advanced ESCC for toripalimab allows us to bring our immuno-oncology therapy to more patients, including those with low PD-L1 expressing tumors for whom available checkpoint inhibitors appear to be less effective,” said Dr. Patricia Keegan, Chief Medical Officer of Junshi Biosciences. “We will continue to focus on exploring the potential of I-O drugs in treating tumors with unmet medical needs.”

About Esophageal Cancer
Esophageal cancer is one of the most common malignant tumors in alimentary tract. According to data released by GLOBOCAN 2020, in 2020, 320,000 new esophageal cancer cases and 300,000 deaths due to esophageal cancer occurred in China, both accounting for more than half of the global total. The incidence and death rates of esophageal cancer ranked fifth and fourth among all domestic malignant tumors respectively. ESCC and esophageal adenocarcinoma are the two main histological subtypes of esophageal cancer. ESCC is the main subtype in China, accounting for approximately 90% of all esophageal cancer cases. For patients with advanced ESCC, the current standard first-line treatment is often the platinum-based chemotherapy, but the clinical benefit is limited, and the 5-year overall survival rate remains less than 20%. Therefore, there is an urgent unmet need for new drugs and treatments to extend the survival of patients.

About Toripalimab
Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 promotes the immune system’s ability to attack and kill tumor cells.

More than thirty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally by Junshi Biosciences, including in China, the United States, Southeast Asia, and European countries. Ongoing or completed pivotal clinical trials evaluating the safety and efficacy of toripalimab cover a broad range of tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin.

In China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI®). Currently, there are five approved indications for toripalimab in China:

  1. unresectable or metastatic melanoma after failure of standard systemic therapy;
  2. recurrent or metastatic nasopharyngeal carcinoma NPC after failure of at least two lines of prior systemic therapy;
  3. locally advanced or metastatic urothelial carcinoma that failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy;
  4. in combination with cisplatin and gemcitabine as the first-line treatment for patients with locally recurrent or metastatic NPC;
  5. in combination with paclitaxel and cisplatin as the first-line treatment of patients with unresectable locally advanced/recurrent or distant metastatic ESCC.

The first three indications have been included in the National Reimbursement Drug List (“NRDL”) (2021 Edition). Toripalimab is the only anti-PD-1 monoclonal antibody included in the NRDL for melanoma and NPC.

In addition, a sNDA Application for toripalimab is currently under review by the NMPA in China:

  • in combination with chemotherapy as the first-line treatment of patients with advanced or metastatic NSCLC without EGFR or ALK mutations.

In the United States, the FDA granted Breakthrough Therapy designation for toripalimab in combination with chemotherapy for the first-line treatment of recurrent or metastatic NPC as well as for toripalimab monotherapy in the second or third-line treatment of recurrent or metastatic NPC. Junshi Biosciences and Coherus plan to resubmit a Biologics License Application (BLA) for toripalimab for advanced NPC by mid-summer 2022. Additionally, the FDA has granted Fast Track designation for toripalimab for the treatment of mucosal melanoma and Orphan Drug Designation for the treatment of esophageal cancer, NPC, mucosal melanoma, soft tissue sarcoma, and SCLC. In 2021, Coherus in-licensed rights to develop and commercialize toripalimab in the United States and Canada. Junshi Biosciences and Coherus plan to file additional toripalimab BLAs with the FDA over the next several years for multiple other cancer types.

About Junshi Biosciences
Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative therapeutics. The company has established a diversified R & D pipeline comprising over 50 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for anti-PD-1 monoclonal antibody in China. Its first-in-human anti-BTLA monoclonal antibody for tumors was the first in the world to be approved for clinical trials by the FDA and NMPA and has since entered Phase Ib/II trials in both China and the US. Its anti-PCSK9 monoclonal antibody was the first in China to be approved for clinical trials by the NMPA.

In the face of the pandemic, Junshi Biosciences’ response was strong and immediate, joining forces with Chinese and international scientific research institutions and enterprises to develop an arsenal of drug candidates to combat COVID-19, taking the initiative to shoulder the social responsibility of Chinese pharmaceutical companies by prioritizing and accelerating COVID-19 R&D. Among the many drug candidates is JS016 (etesevimab), China’s first neutralizing fully human monoclonal antibody against SARS-CoV-2 and the result of the combined efforts of Junshi Biosciences, the Institute of Microbiology of the Chinese Academy of Science and Lilly. JS016 administered with bamlanivimab has been granted Emergency Use Authorizations (“EUA”) in over 15 countries and regions worldwide. Meanwhile, VV116, a new oral nucleoside analog anti-SARS-CoV-2 drug designed to hinder virus replication, is in global Phase III clinical trials. The JS016 and VV116 programs are a part of the company’s continuous innovation for disease control and prevention of the global pandemic.

Junshi Biosciences has more than 2,800 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing and Guangzhou). For more information, please visit: http://junshipharma.com.

Junshi Biosciences Contact Information
IR Team:
Junshi Biosciences
info@junshipharma.com
+ 86 021-2250 0300

Goby Global
Bob Ai
bai@gobyglobal.com
+ 1 646-389-6658

PR Team:
Junshi Biosciences
Zhi Li
zhi_li@junshipharma.com
+ 86 021-6105 8800

CPO Fintech Platform Topwatch Achieves Significant Milestones

Blockchain authentication enabled from Topwatch with ORIGYN Luxury partnership. Topwatch to exceed R 1 billion in revenue for 2022. Total accumulated Assets Under Management (AUM) exceeds R 3 billion ($202 m). Twelve year anniversary since first transaction in 2010.

Every Watch has a story – Topwatch.com

Every Watch has a story – Topwatch.com

CAPE TOWN, South Africa, May 16, 2022 (GLOBE NEWSWIRE) — Blockchain authentication – South Africa’s leading pre-owned luxury watch specialists, Topwatch, in collaboration with ORIGYN Luxury, now issue digital authentication certificates as Utility NFTs, secured on the blockchain, with every luxury product sold in-store and online. Thanks to unique biometric technology, not only do these certificates provide guaranteed authenticity, but offer a host of options such as insurance and traceability.

The partnership with ORIGYN Luxury addresses the issue of genuine luxury goods being swapped for counterfeits by constantly monitoring authenticity throughout a product’s lifespan. Together with ORIGYN Luxury, Topwatch is now able to authenticate luxury watches using advanced computer vision, machine learning and decentralised technology that assigns a unique biometric fingerprint to each watch as a result of the process. Once this one-of-a-kind biometric fingerprint has been created, an NFT containing all this information is minted.

Although the majority of luxury watches are sold through a network of carefully selected and authorised retailers, there are still counterfeits that plague the industry. It’s estimated that counterfeits cost the Swiss watch industry $2 billion per year, with over 40 million counterfeit watches believed to be produced and sold each year.

Topwatch founder and CEO Johan Dreyer says, “We’ve been actively combating the copied goods market without formal support for many years now. Finally, we have support in a pioneer in arguably one of the most needed segments of the luxury goods market. Joining forces with ORIGYN Luxury means we can now offer state-of-the-art products and services to enhance the customer’s journey in trusting CPO.”

End-consumers expect full transparency and proof of authenticity, and with Topwatch’s introduction of Authenticity Biometric Certificates, now they can have it.

“We’ve been in the watch industry for a long time, and we value the age-old traditions and pedigree that it brings with it. Being able to merge that with cutting-edge technology like the advancement of NFTs and blockchain, for global transparency, is a hugely significant innovation and one that we as Topwatch are proud to witness and to be a part of. Now our customers can buy a luxury watch and prove 100% authenticity by simply presenting their NFT. It’s a world first, and we’re also proud to be an early adopter of this technology,” says  Johan Dreyer.

Topwatch to exceed R1 billion in revenue for 2022 – Topwatch formally announces the company is on track to achieve R 1 billion in revenue for 2022. Boasting an impressive 60% market share in South Africa and increasing its market share globally, the independently owned certified pre-owned watch specialist is set for aggressive expansion, employing best practice technology and trading principles, backed by more than a decade of credible data.

Total AUM – Speaking to the business’s total accumulated Assets Under Management (AUM), which exceeds R 3 billion, Johan Dreyer says, “Investment in the high-end watch segment has become a priority asset class within diversified portfolios. With the increase in value and collectability of watches, a detailed understanding of the market has become a significant driving force which is being led by reputable and competent specialists with certified Assets Under Management (AUM).”

“The imminent underlying value resides in access to qualified information. This refers to knowing your customer, what watches they own (model specific) and at what price they should sell them for. This is where Topwatch takes the lead,” says Johan Dreyer.

Driven by advanced technology and algorithms, Topwatch has credible access to detailed information on a global scale thanks to an internally developed and highly sophisticated pricing and data capturing system.

Twelve-Year Anniversary – As access to premium watches becomes more limited, Topwatch prides itself on adapting and driving advancement in the pre-owned luxury watch market over the last 12 years, offering ownership to a wide range of luxury watches at minimal risk. Innovation, sophisticated technology, world-class customer service, authenticity via ORIGYN Luxury NFTs and unparalleled credibility lie at the core of the Topwatch ethos and will continue to do so for many more decades to come.

About Topwatch

Topwatch is a globally recognised and trusted CPO fintech platform, offering an expertly curated inventory of owned luxury watches. With over a decade of experience in buying, selling, and trading high-end timepieces backed by actual transactional pricing and a models database, Topwatch guarantees authenticity through careful validation and inspection of each timepiece, providing customers with additional peace-of-mind thanks to a 24-month warranty and optional buy-back scheme. To continually improve and innovate the luxury pre-owned watch market, Topwatch remains at the forefront of technology and market engagement.

For more information, please visit www.topwatch.com
Contact: Johan Dreyer | 021 872 0332 or 082 858 9343 | johan@topwatch.com | @topwatch.global

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BluChip Launches an Innovative NFT Marketplace Uniquely Tethering the Value of Museum Artwork to NFTs

BluChip Pioneers the “Swappable” BluChip NFT Marketplace

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PALM SPRINGS, Calif., May 16, 2022 (GLOBE NEWSWIRE) — BluChip today introduced its unique platform enabling the purchase of non-fungible tokens (NFTs) that are tethered to an original fine art painting or sculpture. With this ability, NFTs now have actual physical value specific to world-class artwork, making them more valuable than ever, while elevating the NFT marketplace as an attractive option for serious art collectors, investors and savvy traders. This innovative BluChip NFT Marketplace allows art collectors, cryptocurrency investors, digital asset speculators and others to access valuable NFT assets that can uniquely be swapped at any time for the actual artwork the NFT represents — all via a powerful, immutable Smart Contract on the blockchain.

Auctions for various BluChip NFTs will take place at https://bluchipnft.co beginning on May 23, 2022. BluChip’s unique Smart Contract technology enables bidders to bid on swappable NFTs that only the winning bidder can exchange to own a highly valuable, very sought-after masterpiece. With a digital token that ties BluChip’s NFTs to the genuine artwork, the NFT can simply be swapped out to receive the actual real-life museum-quality masterwork. However, unlike a traditional art sale, one does not need to have a place to relocate their masterpiece until one is ready to swap their BluChip NFT for the fine art.

Notably, the BluChip NFT Marketplace features some of the most exciting collectible artists, in which their artwork is rarely found for purchase. The presence of names such as Andy Warhol, Keith Haring and Banksy are certain to capture the attention of art aficionados, and it’s expected that many of them will be first-time NFT buyers.

Following are just a few examples of the many high-dollar-value NFTs that are available for auction, including their auction estimates.

First Auction:
Andy Warhol / Robert Longo – Four Serigraphs……………$100,000.00
Keith Haring – Three Subway Drawings………………….…….$150,000.00 EA
STIK – Love 143…………………………………………………………….$200,000.00

Second Auction:
Joan Mitchell – Untitled pastel………………………………………$150,000.00
Bill Traylor – Rabbit Hunt……………………..……………………….$350,000.00
Gertrude Abercrombie – Moon Doors…………………….…….$450,000.00

Third Auction:
Joan Miro – Dedication piece…………………….…………………$200,000.00
Franz Kline – Collage (Two)…………………….…………………….$250,000.00 EA
Rammellzee – Future Bot……………………………………………..$150,000.00

Note: Opening bids are always 55% of the auction estimate prices.

Coming Soon … Other Masterworks by:
Banksy, King Robbo, Invader, Blek Le Rat, Pavel Pukhov, Basquiat, Mark Rothko, David Park, Elmer Bischoff, and Richard Diebenkorn.

The NFT art market has recently exploded on the scene as the latest, investment-grade digital asset. As many forms of intellectual property migrate to the blockchain, the benefits can be innumerable. These one-of-a-kind digital assets can exist with proven scarcity, ownership and smart contract intelligence. Parasitic extractions along the value chain are eliminated. Instead, direct-to-market ownership, trading and tracking will enable marketplaces to flourish without needing any intermediaries, counterparty risk or the costs associated with having traditional IP management.

The NFT art market has proven to be an outstanding part of the digital asset marketplace. The single biggest challenge thus far has been bridging digital blockchain assets with physical assets. There is just no way to actually put a physical painting on the blockchain. Enter the new era of swappable BluChip NFTs, which provide a token that holds a unique claim on a physical asset in exchange for the digital asset. Cryptographically enforced, these swappable BluChip NFTs hold exclusive claim to actual museum-quality BluChip artwork.

A double entry accounting concept is created, whereby the digital asset and physical asset each can hold a unique value to the market. These two assets – one digital, one physical – are inextricably linked via Solana, which is a decentralized blockchain that tracks digital assets with Smart Contract governance and provable ownership. The buyer of exclusive BluChip NFTs will hold the exclusive rights to control the original artwork and speculate on the digital asset token representing that artwork. The owner of a BluChip NFT controls which side of the transaction suits them best; the digital token or the physical artwork because it is swappable without counterparty risk.

This innovation solves a major issue that has impeded the adoption of NFTs for many qualified investors, collectors and financially savvy traders. By bridging this gap between two established asset classes, BluChip NFT auctions brings a unique opportunity to acquire assets that connect with highly sought-after BluChip artwork rarely owned outside of museums. By providing the BluChip art market with swappable BluChip NFTs connected to genuine pieces of BluChip artworks, the demand and liquidity for BluChip art will increase and gain efficiency to find the strongest stakeholders in the market.

The History of Swappable NFTs

G. Thomas Kerr is the president of ArtCoins International, and the visionary behind its new BluChip division of swappable NFTs. Kerr has been in the cryptocurrency market and has a deep appreciation for the arts, but also has a finance and tech background.

“I was interested in finding a way to link the two asset classes together: fine art and digital assets, the swappable NFT does just that by enabling the marketplace to decide value and provide better price discovery for each asset class,” Kerr noted in his presentation to stakeholders. As such, ArtCoins International has partnered with the Musee d’ Art Moderne to auction over 100 great Masterworks, including masterpieces by Banksy, Basquiat, Rothko, and Haring to mint as swappable NFTs — all select works from its exclusive private museum collection.

This proven history of art acquisitions and high-end fine art sales led Kerr to consider the latest technology’s role in helping to create a new generation of art fans. “With so many people that have already gotten interested in NFTs, it simply made sense to tie digital masterpieces to their physical origins,” added Kerr. “BluChip’s goal is to make real-life fine art more accessible, and swappable NFTs are expected to become a big piece this new digital art renaissance.”

One-of-a-Kind Digital Assets

Another value-add of NFTs is their level of exclusivity. Some artists will create a limited-edition series that contains multiple versions of the same thing. But for the most part, NFTs aren’t duplicated, which really drives up consumer interest in buying them. However, some people have been hesitant to use their cryptocurrency on products that have no physical representation. When traditional NFTs are purchased, a digital asset only is provided, with ownership over it, but that doesn’t stop anyone else in the world from copying it and sharing it.

One of the biggest advantages is having a digital token that can be exchanged for a real, one-of-a-kind piece of art. Your BluChip NFT’s value of the fine art isn’t attached to the Solana blockchain or cryptocurrency, so even if your digital art were to lose market demand, the digital token can be traded back to BluChip’s wallet to redeem the actual physical piece of art. Therefore, if one purchased Banksy’s Mighty Mouse, possession of the physical piece can be taken at any time, which protects your investment no matter what happens in the NFT digital marketplace, you get the genuine artwork to keep.

Here, two auctions are already planned to include very rare original stencil masterworks by Bansky. His career has captivated people worldwide. Recent auction sale of the “Shredded Banksy” exceeded $25 million at Sotheby’s. His artwork has shown an appreciable value over the years, and there is no sign of this trend stopping. Hence, this makes BluChip NFTs a smart investment for art collectors. After all, there will be no other way to purchase an original Banksy of Mighty Mouse or Wicked Trumpet Player.

About BluChip

BluChip’s website will launch on May 16, 2022, and can be accessed at www.BluChipNFT.co. BluChip plans to be the world’s foremost website for purchasing NFTs of masterworks that are backed by a digital token.

To take advantage of the opportunity to win an auctioned NFT of museum quality artwork, be sure to visit BluChip’s website during the first few days. Some of the many pieces that will be included in their initial offerings include Warhol, Haring and Stik, so don’t miss it!

BluChip’s unique platform enables people to purchase NFTs that are tethered to the original painting or sculpture. In fact, if you decide that the actual artwork would be more useful to you than the non-fungible token, you simply have to swap it in to receive a masterpiece. Even better, this program makes certain that you can choose which side of the deal you want to be on. Start collecting art today by using BluChip’s NFT Marketplace website! Bid to win the fine art you will always love to own.

Media contact:
Chris Clemens
Clemens & Co.
Chris@clemenspr.com
(760) 578-8700

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Crowdz Secures $10M Strategic Investment, Led by Citi and Global Cleantech Capital

The investment will enable Crowdz to expand its ability to bring accessible working capital to small businesses.

Crowdz Blockchain Technology

Crowdz Blockchain Technology

CAMPBELL, Calif., May 16, 2022 (GLOBE NEWSWIRE) — Small and mid-sized enterprise (SME) finance platform Crowdz has secured $10 million in investment, led by Citi and Global Cleantech Capital, with participation from Bold Capital Partners, TFX Capital, and Augment Ventures.

Citi’s investment was led by the Spread Products Investment Technologies (SPRINT) team, the strategic investing arm of the bank’s industry-leading Global Spread Products division. Existing investor Global Cleantech Capital, a Netherlands-based growth venture capital firm, joined Citi in leading the round. Existing investors Bold Capital Partners, TFX Ventures, and Augment Ventures also participated, bringing Crowdz’s total capital raised to $25.5 million.

The capital will be used to fund Crowdz’s global expansion to meet its target of providing 25,000 SMEs with over $1B in working capital in 2023.

The current state of the supply chain cycle for SMEs is overwhelmingly defined by fragmentation and delays, inefficiencies which cost them over $3 trillion annually. Crowdz integrates with SMEs’ accounting, payment processing, and banking systems to allow SMEs to get paid early at competitive rates.

The innovative platform includes proprietary risk scoring that gives banks, financial institutions, and DeFi lenders access to attractive risk-adjusted, diversified returns, while helping to plug the SME finance gap.

Crowdz and Citi plan to collaborate to give small and medium enterprises (SMEs) rapid and efficient access to the working capital needed to keep their businesses running. In addition, Citi and Crowdz intend to grow recurring revenue finance as an asset class, with a particular focus on SaaS businesses, and expand its ability to help SMEs unlock cash flow through receivable financing. Citi has a longstanding commitment to expanding access to capital and inclusive financial services. Through its $200 million Impact Fund, Citi deploys its own capital to make equity investments in “double bottom line” US-based private sector companies that are applying innovative solutions to help address some of society’s most pressing challenges.

Through their investment, Citi joins a growing list of high-profile corporate entities partnered with Crowdz, including Meta (formerly Facebook) and EG Funds Management. Meta has committed $100 million to financing diverse-owned businesses in the U.S. EG Funds, an Australian fund manager with $5.1 billion under management, is currently setting up a white label in the Asia Pacific. Additionally, a number of clients utilize a white-labelled iteration of the Crowdz platform to provide access to working capital for SMEs that impact and power everyday communities, from family-owned businesses to up-and-coming startups across the U.S. and Europe.

Payson E. Johnston, CEO and co-founder of Crowdz, said: “Crowdz’s planned collaboration with Citi, paired with this investment from our partners, including Global Cleantech Capital, signifies a new phase of growth for the company, which will allow us to expand working capital access for SMEs. We share Citi’s view of recurring revenue as having the potential to become a new asset class, and Crowdz’s technology—including a global receivables marketplace with risk scoring, white label for enterprises and banks, and creation of digital assets—will help enable additional investment in this area.”  

Katya Chupryna, Director, Citi SPRINT, said: “While we have been extremely impressed with Crowdz’s traction in the traditional invoice receivables financing space, we are particularly excited about the burgeoning asset class of SaaS receivables. Only a small fraction of the $170 billion in yearly SaaS revenues are currently represented in financial products, indicating a massive opportunity for expansion. Through accretive synergies between Crowdz’s innovative technological solutions and Citi, the leading global bank, we see the potential to meaningfully develop SaaS receivables as an asset class.”

Sandeep Arora, Citi Institutional Clients Group’s Head of Digital and Chief Investment Officer, added: “Citi and Crowdz are both focused on creating new opportunities for SME clients and improving client experiences. Crowdz has built an impressive digital approach to provide efficient access to working capital. Digitization creates momentum, new opportunities for clients, and ultimately, the best user experiences. We’re excited to join this journey with Crowdz and support their continued growth.”

For more information, visit www.crowdz.io or read the full story on TechCrunch.

About Crowdz:

Crowdz is modernizing invoice financing and invoicing practices, particularly for small and midsize businesses, to revolutionize the $9 trillion worldwide receivables market.

The platform offers an alternative financing solution for small businesses that often struggle to obtain traditional bank financing. Its technology enables small businesses to sell invoices to funders for financing, reducing cash flow bottlenecks and giving small businesses working capital to survive and thrive.

Crowdz is headed by its co-founder and CEO, Payson E. Johnston, who served for 18 years as global B2B supply-chain Senior Manager for Cisco. Crowdz has raised $25.5 million in equity from investors including Bold Capital Partners, Barclays Bank, EGX, Augment Ventures, Global Cleantech Capital, Kx, TFX Capital, and Techstars Ventures. Crowdz’s technologies are covered by three patents and multiple pending patents.

About Citi
Citi, the leading global bank, has approximately 200 million customer accounts and does business in more than 160 countries and jurisdictions. Citi provides consumers, corporations, governments and institutions with a broad range of financial products and services, including consumer banking and credit, corporate and investment banking, securities brokerage, transaction services, and wealth management.

Additional information may be found at www.citigroup.com | Twitter: @Citi | YouTube: www.youtube.com/citi | Blog: http://blog.citigroup.com | Facebook: www.facebook.com/citi | LinkedIn: www.linkedin.com/company/citi.

About Global Cleantech Capital (GCC)
Global Cleantech Capital (GCC) is a growth equity firm based in Amsterdam, investing to scale exceptional companies into new market leaders in the clean energy, mobility, smart cities, and fintech sectors in Europe and North America. Investing over $900 million, the GCC team has a track record of delivering attractive returns paired with ESG impact. GCC is domiciled in the Netherlands and registered with the Dutch Authority for the Financial Markets (AFM). For more information, please visit our website at www.gccfund.com.

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Media Contact:
Stacey Kirsch, Media Relations Officer
Phone: 310-488-4639
Email: pr@crowdz.io

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Philips showcases ultra-low contrast PCI solutions at EuroPCR 2022

May 16, 2022

  • Co-registration of real-time intravascular ultrasound and/or iFR physiological assessment data onto motion-compensated angiograms aids percutaneous coronary intervention (PCI) procedure planning, quantitative lesion measurement, stent choice and sizing, and therapy assessment
  • Reduced need for contrast media enables broader access to PCI for patients at risk of acute kidney injury
  • Ultra-low contrast PCI procedures discussed in Philips-sponsored symposium at EuroPCR 2022

Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, is showcasing innovations at EuroPCR (May 17-20, Paris, France) that can enable interventionists to perform ultra-low contrast percutaneous coronary intervention (ULC-PCI) procedures with greater confidence and clarity. Philips’ ULC-PCI solutions co-register instantaneous blood flow measurements and/or intravascular ultrasound (IVUS) images onto real-time fluoroscopy to help interventionists diagnose, decide, guide, treat and confirm the success of PCI, with the potential to limit the use of iodinated contrast media.

Seamlessly integrating into Philips’ Image Guided Therapy System – Azurion – the company’s unique ULC-PCI solutions provide physicians with tools to help reduce the use of contrast media throughout PCI procedures.

The ability to perform PCI procedures using a very small amount of contrast media enables PCI to be offered to more patient groups, notably patients presenting with both coronary artery disease (CAD) and chronic kidney disease (CKD), who are at high risk of suffering contrast-induced nephropathy (CIN) [1] – a life-threatening form of hospital-acquired acute kidney injury (AKI) caused by contrast media toxicity. A 2020 study in the USA concluded that AKI after a PCI procedure resulted in an average increase in length of hospital stay of 3.6 days and an additional healthcare cost of 9,448 USD per patient [2].

“Innovation in catheter-based interventions to treat narrowed heart arteries – so-called percutaneous coronary interventions – continuous to contribute to improving the quality of life and prognosis for millions of patients around the world,” said Javier Escaned, MD, PhD, Head of the Interventional Cardiology Section at Hospital Clinico San Carlos, Madrid, Spain. “As a result, more complex patients can now undergo PCI, including those with advanced age and frailty, chronic renal failure, and associated heart conditions. In many of these patients, where the injection of radiological contrast used to guide the PCI can have deleterious effects, technologies developed by Philips that enable physicians to dramatically decrease contrast administration during the procedure is contributing to both the safety and quality of PCI.”

Dynamic Coronary Roadmap
During a conventional PCI procedure, contrast media is injected into the patient’s coronary arteries to acquire an angiogram, with additional fluoroscopy used during the procedure to help interventionists navigate their guide wires and catheters. To maintain visibility of the arteries, this guidance typically requires repeated contrast media injections, increasing the toxic load on the patient’s kidneys. Philips’ Dynamic Coronary Roadmap software removes the need for additional contrast media injection by overlaying the preoperative angiogram onto real-time motion-compensated 2D fluoroscopic imaging to provide interventionists with continuous visual feedback on the positioning of guide wires and catheters. In many cases, no additional contrast media injection is required for wire navigation.

While Philips’ Dynamic Coronary Roadmap software helps interventionists navigate guide wires and catheters to the site of a lesion, the company’s IntraSight Series 7 precision guidance system streamlines lesion assessment, simplifies vessel sizing, and enables precise therapy delivery.

iFR Co-registration
As an alternative or adjunct to IVUS co-registration, spatially accurate instantaneous wave-free ratio (iFR) pullback measurements can be co-registered onto the angiogram, adding valuable physiological data to the anatomical imaging. Unlike fractional flow reserve (FFR) measurements, iFR measurements do not require the use of hyperemic drug injection and can be used to assess both the degree and length of vessel stenosis and the effectiveness of therapy using a simple pressure wire pullback technique.

IVUS Co-registration
IntraSight Series 7’s IVUS co-registration facility merges real-time intravenous ultrasound and angiogram images, with information on the precise location of the ultrasound images derived during manual pull-back of the ultrasound catheter under continuous fluoroscopy. As a result, interventionists can simultaneously view reconstructed cross-sectional ultrasound images of the vessel lumen, including their precise position on the angiogram. This level of precision significantly reduces the risk of a ‘geographic miss’, which has been estimated to occur in over 60% of PCIs [3]. IntraSight Series 7’s Angio+ quantitative coronary analysis software automatically calculates lumen dimensions and stenosis in real time, helping accurate assessment of the required stent size.

Tri-registration
IntraSight Series 7’s Tri-registration function aids stent selection by co-registering IVUS and iFR information with the angiogram to help choose a stent that optimally supports meeting a procedure’s objectives. Coupled with IntraSight Series 7’s enhanced live stent visualization capabilities, which help to immediately verify correct stent positioning and deployment, the ability to enhance stent choice and size means more right-first-time procedures and better patient outcomes.

Ultra-Low Contrast PCI at EuroPCR
Professor Javier Escaned, together with other key thought leaders in the field of UCL-PCI, will discuss how to decrease operator dependence on vessel opacification during PCI in a Philips-sponsored symposium at EuroPCR 2022 on Tuesday, May 17, from 17:15 to 18:15 (CET). For more information and registration, click here.

[1] Dangas G, et al. Contrast-Induced nephropathy after percutaneous coronary interventions in relation to chronic kidney disease and hemodynamic variables. AJC 2005. https://doi.org/10.1016/j.amjcard.2004.08.056.
[2] Amin P, et al. Incremental cost of Acute Kidney Injury after Percutaneous Coronary Intervention in the United States. AM J Cardiol. 2020 Jan1;125(1):29-331.
[3] Costa et al. Impact of Stent Deployment Procedural Factors on Long-term Effectiveness and Safety of Sirolimus-Eluting Stents (Final results of the Multicenter Prospective STLLR Trial), Am J Cardiol 2008 Jun 15; 101(12):1704-11.

For further information, please contact:

Joost Maltha
Philips Global Press Office
Tel: +31 6 10 55 8116
Email: joost.maltha@philips.com

Fabienne van der Feer
Philips Image Guided Therapy
Tel: + 31 622 698 001
E-mail: fabienne.van.der.feer@philips.com

About Royal Philips
Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people’s health and well-being, and enabling better outcomes across the health continuum – from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Philips generated 2021 sales of EUR 17.2 billion and employs approximately 79,000 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.

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VistaJet unveils the world’s highest ‘Viewing Room in the Sky’ with Frieze

VistaJet for Art

VistaJet announces its global partnership with Frieze Art Fairs

VistaJet announces its global partnership with Frieze Art Fairs

New York, May 16, 2022: Ahead of the upcoming 2022 edition of Frieze New York, VistaJet, the first and only global business aviation company, announces its new global partnership with Frieze Art Fairs.

With over 80% of VistaJet’s Members sharing a passion for art, today marks the beginning of a series of incredible opportunities for VistaJet Members to connect with art in the most exclusive ways.

The World’s Highest Viewing Room in the Sky
Frieze New York is set to bring together over 65 of the world’s major galleries to exhibit ambitious solo, group, and themed presentations from groundbreaking artists. As a world-first, VistaJet Program Members can get first look at the Frieze Viewing Room — five days prior to the opening of the art fair at The Shed in New York — from 40,000 feet in the sky, anywhere in the world.

Accessible across a fleet of iconic silver and red aircraft, Members will be able to enter the Viewing Room from the comfort of their seat, unlocking the most cutting-edge and immersive technology to preview, select and acquire art from the world’s leading galleries.

To accompany Members throughout their exclusive art journey, a Frieze curator will also be available to virtually chaperon them into their initial exploration, featuring highlights from the show and unmissable pieces.

VIP Access to All Fairs
To welcome VistaJet global guests, Members can request VIP access* to the leading international Frieze Fairs, including New York (May 18-22), Seoul (September 2-5), London (October 12-16), and Los Angeles (dates to be announced).

Exclusive Members-Only Events
In collaboration with Frieze, VistaJet will be hosting a number of art activation events throughout the year, enabling its passionate Members to connect in person with like-minded artists, collectors, curators, and art patrons from around the world.

Megan Leckie, Global Head of VIP at Frieze said: Frieze is delighted to announce its new VIP partnership with VistaJet and open the door to its Members. Debuting on the occasion of Frieze New York 2022, the collaboration will bring the best in contemporary art to VistaJet audiences across the globe, creating yet another incredible way to connect with art.”

Thomas Flohr, Founder and Chairman at VistaJet added: We believe this partnership will allow our Members to pursue their passion for art in the simplest way – anytime and anywhere. Frieze Fairs are ultimately about connecting world-leading international galleries with the most renowned global collectors, and we are excited to create yet another innovative service for our clients through our partners in excellence.

For more information please visit: vistajet.com/art

*subject to availability

Information
VistaJet | press@vistajet.com

About VistaJet 

VistaJet is the first and only global business aviation company. On its fleet of over 80 silver and red business jets, VistaJet has flown corporations, governments and private clients to 187 countries, covering 96% of the world.
Founded in 2004, the company pioneered an innovative business model where customers have access to an entire fleet whilst paying only for the hours they fly, free of the responsibilities and asset risks linked to aircraft ownership. VistaJet’s signature Program membership offers customers a bespoke subscription of flight hours on its fleet of mid and long-range jets, to fly them anytime, anywhere.
VistaJet is part of Vista Global Holding — the world’s first private aviation ecosystem, integrating a unique portfolio of companies offering asset-light solutions to cover all key aspects of business aviation.
More VistaJet information and news at vistajet.com

VistaJet Limited is a European air carrier that operates 9H registered aircraft under its Maltese Air Operator Certificate No. MT-17 and is incorporated in Malta under Company Number C 55231. VistaJet US Inc. is an Air Charter Broker that does not operate aircraft. VistaJet and its subsidiaries are not U.S. direct carriers. VistaJet-owned and U.S. registered aircraft are operated by properly licensed U.S. air carriers, including XOJET Aviation LLC. 

About Frieze 

Frieze is the world’s leading platform for modern and contemporary art for scholars, connoisseurs, collectors, and the general public alike. Bringing together the world’s leading galleries to showcase ambitious solo, group and themed presentations by pioneering artists offers the opportunity to not only discover up-and-coming talent, but also engage with some of art history’s most important figures. Celebrating the creative spirit of each of the cities they show in, the fairs will see a strong representation from a plethora of unique galleries and spaces.

Frieze comprises three magazines – frieze, Frieze Masters Magazine and Frieze Week – and five international art fairs – Frieze London, Frieze Masters, Frieze New York, Frieze Los Angeles and Frieze Seoul (launching September 2022). Additionally, in October 2021, Frieze launched No.9 Cork Street, a hub for visiting international galleries in the heart of Mayfair, London. Frieze is part of the IMG network

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New release of Philips EchoNavigator helps interventional teams treat structural heart disease with greater ease and efficiency

May 16, 2022

  • EchoNavigator 4.0 empowers heart teams with greater control of live fusion imaging plus new anatomical modeling and transseptal puncture guidance during minimally-invasive procedures
  • Seamless integration and communication between Philips Ultrasound System EPIQ CVxi and Philips Image Guided Therapy System Azurion supports efficient fusion-imaging workflow for minimally-invasive treatment of structural heart disease

Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced at EuroPCR (17 – 20 May 2022, Paris, France) the international launch of EchoNavigator 4.0 [1], the new release of its advanced image-guided therapy solution for the treatment of structural heart disease. EchoNavigator 4.0 gives users of Philips’ EPIQ CVXi interventional cardiology ultrasound system greater control of live fusion-imaging on the company’s Image Guided Therapy System – Azurion – platform.

By integrating real-time transesophageal echocardiography (TEE), which places the ultrasound transducer close to the heart, and X-ray fluoroscopy, EchoNavigator 4.0 helps interventional teams to decide, guide, treat, and confirm complex structural heart disease therapy, such as heart valve repair or replacement. The solution also includes extended anatomical intelligence models, transseptal puncture guidance to help access the left atrium and mitral valve from the right atrium, and new 3D live image fusion capabilities, including Philips’ TrueVue photo-realistic rendering and GlassVue volumetric imaging modes. It also features automatic selection of an appropriate set of multiplanar reconstruction planes (sections taken from the 3D echo heart model), with presets for common views of the aortic and mitral valves and left atrial appendage.

“The latest EchoNavigator release gives us unique peri-interventional possibilities by offering a comprehensive set of automated views based on advanced 3D heart models in combination with live fusion imaging,” said Dr. Patric Biaggi, Head of Cardiac Imaging at Heart Clinic Hirslanden in Zurich, Switzerland. “This allows us to treat our patients with greater confidence and precision during every stage of the procedure.”

Largely due to lifestyle choices and the aging population, structural heart disease is now commonplace in older individuals. In the USA, for example, as many as 1 in 10 people over the age of 75-years are affected by a condition known as mitral regurgitation [2], which means the mitral valve in their heart does not close properly, adversely affecting the amount of oxygenated blood that can be pumped round their body. Worldwide, around 156 million people are estimated to suffer from the condition [3]. Fortunately, in many cases treating structural heart disease can now be performed via image-guided, minimally-invasive, catheter-based procedures that impose far less trauma than open-heart surgery.

Improved communication and teamwork
Philips EchoNavigator helps improve communication and teamwork between echocardiographers and interventionists during image-guided therapy by automatically fusing together echocardiography ultrasound and X-ray images, while also enhancing understanding of the relationship between X-ray and ultrasound in an intuitive way that helps interventional teams to complete procedures with greater safety, confidence, and clarity.

“Cardiology teams across the world are facing increasing numbers of complex structural heart disease cases and are seeking new ways to deliver effective high-quality care despite staffing shortages,” said Karim Boussebaa, General Manager of Image Guided Therapy Systems at Philips. “By helping echocardiographers and interventionists to work together in even more highly coordinated ways, this new release of EchoNavigator is an important step forward in boosting patient throughput, making more efficient use of time and resources, and achieving positive cardiovascular care outcomes.”

Greater control for echocardiographers
EchoNavigator 4.0 puts greater control of imaging in the hands of the echocardiographer via the EPIQ ultrasound platform’s touch screen, including the ability to fuse and annotate echocardiography and X-ray fluoroscopy images. Anatomical features can be identified either manually or automatically, with anatomical markers and annotations applied to one modality automatically transposed to the other. Live fusion images, markers, and annotations are immediately visible to interventional cardiologists via the Azurion platform’s FlexVision Pro monitor to help guide catheterization and therapy device deployment.

Extended automatic modeling and transseptal puncture guidance
Additional context and guidance are provided by EchoNavigator’s automated 3D anatomical modeling capabilities. These include models for the mitral valve and its leaflets, and transseptal area models to help identify the optimum zone in the wall separating the right and left atrium where the septum can be punctured to catheterize the left atrium and mitral valve. These 3D modeling capabilities also allow EchoNavigator 4.0 to automatically select an optimal set of multiplanar reconstruction planes, with presets for optimally viewing the aortic and mitral valves and left atrial appendage.

Enhanced fusion imaging with Cardiac TrueVue and TrueVue Glass rendering
EchoNavigator 4.0’s fusion imaging capabilities have been further enhanced by the ability to fuse live X-ray fluoroscopy images with live TrueVue and TrueVue Glass rendered echocardiography images to more easily visualize positioning and device-tissue interactions. Philips TrueVue 3D echo rendering improves visualization of anatomical structures and devices, while TrueVue Glass with Color allows interventionists to view the location of regurgitant blood flow across a heart valve.

With its long history of leadership in cardiology innovation, informed by continuous collaboration with leading clinical partners, Philips is uniquely positioned to deliver integrated solutions that span the care pathway to help solve cardiology’s daily challenges and provide better heart care with greater efficiency.

[1] Philips EchoNavigator 4.0 is not yet available in all markets, e.g not available in USA or China.
[2] Lloyd-Jones D, Adams RJ, et al. Heart disease and stroke statistics–2010 update: a report from the American Heart Association https://pubmed.ncbi.nlm.nih.gov/20019324/.
[3] Dziadzko V, Clavel MA, Dziadzko M, et al. Outcome and undertreatment of mitral regurgitation: a community cohort study. Lancet. 2018;391(10124):960-969. doi:10.1016/S0140-6736(18)30473-2 https://pubmed.ncbi.nlm.nih.gov/29536860/.

For further information, please contact:

Joost Maltha
Philips Global Press Office
Tel: +31 6 10 55 8116
Email: joost.maltha@philips.com

Fabienne van der Feer
Philips Image Guided Therapy
Tel: + 31 622 698 001
E-mail: fabienne.van.der.feer@philips.com

About Royal Philips
Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people’s health and well-being, and enabling better outcomes across the health continuum – from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Philips generated 2021 sales of EUR 17.2 billion and employs approximately 79,000 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.

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Zenas BioPharma Submits Investigational New Drug Application in China for ZB001 for the Treatment of Thyroid Eye Disease

WALTHAM, Mass. and SHANGHAI, China, May 15, 2022 (GLOBE NEWSWIRE) — Zenas BioPharma, a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies for patients in need around the world, today announced the submission of an investigational new drug (IND) application to the China National Medical Products Administration (NMPA) for the initiation of a Phase 1/2 clinical study of ZB001 for the treatment of Thyroid Eye Disease (TED). This study is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ZB001.

“The ZB001 IND submission to the NMPA marks a significant milestone for Zenas,” said Hua Mu, MD, PhD, Chief Executive Officer at Zenas. “There are currently no approved therapies for TED patients in China. Treatment options are limited and often involve high doses of steroids associated with serious side effects or surgical intervention. ZB001 has the potential to change the treatment paradigm for TED patients in China.”

ZB001 is a differentiated humanized monoclonal antibody targeting insulin-like growth factor 1 receptor (IGF-1R) for the treatment of TED. TED is a debilitating autoimmune disease that causes inflammation and fibrosis within the orbit of the eye, which can cause double vision, pain, and potential blindness. Patients with severe disease often require multiple remedial surgeries to the orbit, eye muscles and eyelids.

Zenas BioPharma licensed the exclusive rights to develop, manufacture and commercialize ZB001 (Viridian VRDN-001) and other compounds targeting IGF-1R in non-oncology indications in the greater area of China from Viridian Therapeutics, Inc. (Viridian) in October 2020. In October 2021, Viridian submitted an IND for VRDN-001 to the U.S. Food and Drug Administration and in December 2021 initiated a Phase 1/2 clinical trial to evaluate proof of concept in TED patients in North America.

About Zenas BioPharma

Zenas BioPharma is a global biopharmaceutical company based in the USA and China committed to becoming a leader in the development and commercialization of immune-based therapies for patients in the US, China and around the world. Zenas is rapidly advancing a deep pipeline of innovative therapeutics that continues to grow through our successful business development strategy. Our experienced leadership team and network of business partners drive operational excellence to deliver potentially transformative therapies to improve the lives of those facing autoimmune and rare diseases. For more information about Zenas BioPharma, please visit www.zenasbio.com and follow us on Twitter at @ZenasBioPharma and LinkedIn.

Investor and Media Contact:
Joe Farmer
Zenas BioPharma
IR@zenasbio.com

Zenas BioPharma ส่งการขึ้นทะเบียนยาที่มีความเป็นไปได้ว่าจะเป็นยาใหม่ (Investigational New Drug) ในประเทศจีนสำหรับยา ZB001 ซึ่งใช้สำหรับการรักษาโรคไทรอยด์ขึ้นตา

วอลแทม แมสซาชูเซตส์ และเซี่ยงไฮ้ ประเทศจีน , May 16, 2022 (GLOBE NEWSWIRE) —  Zenas BioPharma ซึ่งเป็นบริษัทชีวเภสัชภัณฑ์ระดับโลกมุ่งมั่นที่จะเป็นผู้นำในการพัฒนาและจำหน่ายการรักษาด้วยภูมิคุ้มกันบำบัดสำหรับผู้ป่วยที่ต้องการความช่วยเหลือทั่วโลก ในวันนี้ได้ประกาศส่งการขึ้นทะเบียนยาที่มีความเป็นไปได้ว่าจะเป็นยาใหม่ (Investigational New Drug หรือ IND) ต่อสำนักงานคณะกรรมการผลิตภัณฑ์การแพทย์แห่งชาติจีน (NMPA) เพื่อเริ่มต้นการศึกษาทางคลินิกระยะที่ 1/2 ของ ZB001 ซึ่งใช้สำหรับการรักษาโรคไทรอยด์ขึ้นตา (TED) การศึกษานี้ออกแบบมาเพื่อประเมินความปลอดภัย ความทนต่อยา เภสัชจลนศาสตร์ และประสิทธิภาพเบื้องต้นของ ZB001

Hua Mu กรรมการผู้จัดการ (MD) ปรัชญาดุษฎีบัณฑิต (PhD) ประธานเจ้าหน้าที่บริหารของ Zenas กล่าว “การส่ง IND ของ ZB001 ไปยัง NMPA นี้นับว่าเป็นก้าวสำคัญของ Zenas เลยล่ะครับ” “ในขณะนี้ยังไม่มีการรักษาสำหรับผู้ป่วย TED ที่ได้รับการอนุมัติในประเทศจีน ทางเลือกในการรักษามีจำกัด และมักต้องใช้สเตียรอยด์ในปริมาณสูงร่วมกับผลข้างเคียงที่ร้ายแรงหรือการผ่าตัด โดย ZB001 นี้จะมีศักยภาพที่จะเปลี่ยนกระบวนทัศน์การรักษาสำหรับผู้ป่วย TED ในประเทศจีนได้”

ZB001 เป็นโมโนโคลนอลแอนติบอดีที่มีลักษณะของมนุษย์ที่แตกต่างกัน ซึ่งกำหนดเป้าหมายไปที่ตัวรับฮอร์โมนโปรตีน polypeptide ที่เกิดขึ้นตามธรรมชาติซึ่งคล้ายกับอินซูลินที่ผลิตโดยตับ (Insulin-like growth factor 1 receptor หรือ IGF-1R) สำหรับการบำบัด TED TED เป็นโรคภูมิต้านทานเนื้อเยื่อของตนเอง (autoimmune disease) ที่ทำให้ร่างกายอ่อนแอ ซึ่งทำให้เกิดการอักเสบและพังผืดภายในกระดูก (orbit) ของดวงตา ซึ่งอาจทำให้เกิดการเห็นภาพซ้อน ความเจ็บปวด และอาจทำให้ตาบอดได้ ผู้ป่วยโรคร้ายแรงมักต้องได้รับการผ่าตัดแก้ไขหลายครั้งที่บริเวณกระดูกตา (orbit) กล้ามเนื้อตา และเปลือกตา

Zenas BioPharma ได้รับสิทธิ์แต่เพียงผู้เดียวในการพัฒนา ผลิต และจำหน่าย ZB001 และสารประกอบอื่น ๆ ที่กำหนดเป้าหมายไปที่ IGF-1R ในการบ่งชี้ที่ไม่เกี่ยวกับวิทยาเนื้องอก (non-oncology) ในจีนแผ่นดินใหญ่จาก Viridian Therapeutics, Inc. (Viridian) ในเดือนตุลาคม 2020 ในเดือนพฤศจิกายน 2021 Viridian ได้ยื่น IND สำหรับ ZB001 (เรียกว่า VRDN-001 โดย Viridian) ต่อสำนักงานคณะกรรมการอาหารและยาแห่งสหรัฐอเมริกา และในเดือนธันวาคม 2021 ก็ได้เริ่มการทดลองทางคลินิกระยะที่ 1/2 เพื่อประเมินการทดสอบความเป็นไปได้ในผู้ป่วย TED ในสหรัฐอเมริกา

เกี่ยวกับ Zenas BioPharma

Zenas BioPharma เป็นบริษัทชีวเภสัชภัณฑ์ระดับโลกที่ตั้งอยู่ในสหรัฐอเมริกาและจีน ซึ่งมุ่งมั่นที่จะเป็นผู้นำในการพัฒนาและจำหน่ายการรักษาด้วยภูมิคุ้มกันบำบัดสำหรับผู้ป่วยในสหรัฐอเมริกา จีน และทั่วโลก Zenas กำลังพัฒนานวัตกรรมการรักษาเชิงลึกอย่างรวดเร็ว ซึ่งยังคงเติบโตอย่างต่อเนื่องผ่านกลยุทธ์การพัฒนาธุรกิจที่ประสบความสำเร็จของเรา ทีมผู้นำที่มีประสบการณ์และเครือข่ายพันธมิตรทางธุรกิจของเราขับเคลื่อนความเป็นเลิศในการดำเนินงานเพื่อนำเสนอการบำบัดต่าง ๆ ที่มีความเป็นไปได้ที่จะก่อให้เกิดการปลี่ยนแปลงได้ เพื่อที่จะปรับปรุงชีวิตของผู้ที่เผชิญกับโรคภูมิต้านทานเนื้อเยื่อของตนเองและโรคที่พบได้ยากต่าง ๆ สำหรับข้อมูลเพิ่มเติมเกี่ยวกับ Zenas BioPharma กรุณาเยี่ยมชม www.zenasbio.com และติดตามเราบน ทวิตเตอร์ ได้ที่ @ZenasBioPharma และ ลิงกต์อิน

ติดต่อนักลงทุนและสื่อ:

Joe Farmer
Zenas BioPharma
IR@zenasbio.com

‘Cucul’ Competition Enlivens Aidilfitri

The culture of installing 'cucul' or colourful lights in every residence during the Hari Raya Aidilfitri celebration is still practised, especially in Temburong District. Last night, the Kampung Rataie Mosque Takmir Committee organised a prize presentation ceremony for the cucul competition.

Eleven houses participated in the competition and six selected houses won the competition. The cucul installed enlivened the Aidilfitri, in addition to beautifying the atmosphere at night. The prizes were presented by Awang Eldi bin Haji Suhaili, Mosque Affairs Officer. The ceremony took place at the Kampung Rataie National Housing Scheme Mosque.

Source: Radio Television Brunei

Register of Children in Need for Protection Launching Ceremony

25 active cases were recorded in the National Framework on Child Protection, NFCP since its launch in December 2020. NFCP is a national guide aimed to further develop the existing child protection ecosystem from 2020 to 2024. Yesterday afternoon, the Ministry of Culture, Youth and Sports through the Department of Community Development, JAPEM held a Launching Ceremony of the Register of Children and Youth in Need of Protection, RCYPNP. The event took place at Jerudong Sports Complex.

The launch was officiated by Yang Berhormat Retired Major General Dato Paduka Seri Awang Haji Aminuddin Ihsan bin Pehin Orang Kaya Saiful Mulok Dato Seri Paduka Haji Abidin, Minister of Culture, Youth and Sports. Earlier, Hajah Nor Ashikin Binti Haji Johari, Permanent Secretary for Community and Culture at the Ministry of Culture, Youth and Sports in a speech said that the RCYPNP, is one of main cores of the NFCP monitoring mechanism, that refers to the need for a centralised databank to aid the government in the formulation, monitoring, and evaluation of policies, programmes and projects in the area of child protection more efficiently.

Source: Radio Television Brunei

Working Visits to Primary Schools

Datin Seri Paduka Doctor Hajah Romaizah binti Haji Muhd Salleh, Deputy Minister of Education made working visits to another three government primary schools in Brunei Muara District.

The working visits focused on Tanah Jambu Primary School, Mentiri Primary School and Dato Mohd Yassin Primary School, Mentiri. During the visits, the delegation had the opportunity to take a closer look at the implementation of back to school activities under the "Siuknya Ke Sekolah" Programme.

Source: Radio Television Brunei