August 29, 2021

Distribution of Etesevimab/JS016 in the US Reopened

SHANGHAI, China, Aug. 29, 2021 (GLOBE NEWSWIRE) — 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 United States Food and Drug Administration (the “FDA”), alongside the Office of the Assistant Secretary for Preparedness and Response, has resumed the shipment and distribution of etesevimab and bamlanivimab administered together (the “Therapy”), according to the company’s global partner Eli Lilly and Company (NYSE: LLY). Direct ordering will be available to authorized states in the U.S. effective immediately.

The decision to resume distribution aligns with the FDA’s issuance of an updated fact sheet (the “Fact Sheet”) and a revised letter of authorization for etesevimab and bamlanivimab together. These include a revised limitation of authorized use, only allowing use in the states, territories, and U.S. jurisdictions with a low prevalence of variants that are resistant to treatment with the antibodies.

The Delta variant (the “Delta”) currently accounts for nearly 96 percent of all identified COVID-19 cases in the U.S. As shown in revisions to the Fact Sheet, pseudovirus and authentic virus studies demonstrate that etesevimab and bamlanivimab together retained neutralization activity against the Alpha variant and the Delta.

Over the last several months, prevalence of variants varies by state, region and even country and can change rapidly. As variants continue to evolve and their patterns of transmission and prevalence shift, Eli Lilly and Company (“Lilly”), a partner of the Company, will continue to work with governments and regulators worldwide to ensure the Therapy is available to appropriate patients.

About Etesevimab (JS016/LY-CoV016)
Etesevimab is a recombinant fully human monoclonal neutralizing antibody, which specifically binds to the SARS-CoV-2 surface spike protein receptor binding domain with high affinity and can block the binding of the virus to the ACE2 host cell surface receptor. Point mutations were introduced into the native human IgG1 antibody to mitigate effector function. Lilly licensed etesevimab from the Company after it was jointly developed by the Company and the Institute of Microbiology of Chinese Academy of Science. The Company leads development in Greater China (including mainland China, the Hong Kong Special Administrative Region, the Macau Special Administrative Region and the Taiwan region), while Lilly leads development in the rest of the world.

About Junshi Biosciences
Founded in December 2012, Junshi Biosciences 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 28 innovative drug candidates and 2 biosimilars, 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 an anti-PD-1 monoclonal antibody in China. Its first-in-human anti-BTLA antibody for solid tumors was the first in the world to be approved for clinical trials by the FDA and NMPA and its anti-PCSK9 monoclonal antibody was the first in China to be approved for clinical trials by the NMPA. In early 2020, Junshi Biosciences joined forces with the Institute of Microbiology of the Chinese Academy of Sciences and Eli Lilly to co-develop JS016 (etesevimab), China’s first neutralizing fully human monoclonal antibody against SARS-CoV-2. JS016 administered with bamlanivimab has received Emergency Use Authorization (EUA) from the US FDA in February 2021 for the treatment of recently diagnosed, mild to moderate COVID-19 in patients who are at a high risk of progressing to severe COVID-19 and/or hospitalization. The JS016 program is a part of our continuous innovation for disease control and prevention of the global pandemic. Junshi Biosciences has over 2,000 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing and Guangzhou). For more information, please visit: http://junshipharma.com.

Contact Information

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

Solebury Trout
Bob Ai
bai@soleburytrout.com
+1 646-389-6658

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

August 29, 2021August 30, 2021

Cable Theft Suspects Apprehended

3 locals were apprehended under the suspicion of cable theft owned by UNN. The incident took place on the 28th of August 2021 at Kampung Sibulu in Temburong District.

At the scene, the Royal Brunei Police Force through the Bangar Police Station found several copper wires believed to be cuttings of stolen wire cables and drug paraphernalia. A number of equipment and tools for theft were seized as evidence. The suspects, 2 men, aged 33 and 36, as well as a 24-year-old woman, were brought to the Bangar Police Station for investigation before they were handed over to the Narcotics Control Bureau for further investigation.

Source: Radio Television Brunei

August 29, 2021August 30, 2021

Online Music Lessons

Following the COVID-19 situation in the country, music schools in the country also utilise online learning sessions as part of precautionary measures to curb COVID-19 in the country. This includes Harmony Music School and Expression Music Academy.

According to a piano teacher, Jan Bernado Delos Santos, currently he can only teach 5 students a day via online. Meanwhile, Sheila Calzado, a music and vocal teacher at Expression Music Academy said teaching online music lessons is a challenge of its own.

A number of students thought that they prefer to learn music with their teacher face to face. But with the current situation, online learning is the best way to assist the government in curbing COVID-19.

Source: Radio Television Brunei

August 29, 2021August 30, 2021

Online Muallaf Guidance Class

As the country is facing the COVID-19 outbreak, various online learning initiatives have been actively implemented. The Belait District Dakwah Unit of the Islamic Da’wah Centre also did not miss the opportunity to conduct muallaf guidance classes via online.

32 new converts are taking part in the online classes which are held every Sunday. This enables them to continue their learning for 2 hours under the guidance of two teaching staff.

Source: Radio Television Brunei

August 29, 2021August 30, 2021

Short Local Documentary uses Kedayan Dialect

The public may be already familiar with documentaries published in various languages such as Malay Language, English and others. However, this particular short local documentary ‘Semut’ uses the Kedayan dialect.

A career as a teacher does not deter Muhammad Alwie bin Muhammad Salleh, also known as Alwie Salleh to produce a number of short videos that are entertaining yet informative. The ‘Semut’ video is brief, yet the use of Kedayan dialect enables the audience to easily understand and follow its storyline.

Staying at home does not mean not doing anything. For Alwie Salleh, this opportunity is used wisely to research on different types of insects.

By staying at home, Alwi Salleh has produced 5 episodes of the ‘Semut’ documentary. The public can follow his example of utilising time wisely while staying at home, and be a responsible citizen in together protecting ourselves and the community.

Source: Radio Television Brunei

August 29, 2021August 30, 2021

Donations to Assist in Curbing COVID-19

The Ministry of Health continues to receive donations from various parties in the country to assist in the efforts to curb COVID-19 transmission in the country.

Donations were contributed by Jetsen Sdn Bhd and Bobby Electrical Company Sdn Bhd;

Royal Brunei Airlines as well as from Charlotte;

Court Pioneer Company and Triple Star Enterprise.

Members of the public who wish to make donations can contact the ministry’s Emergency Operation Centre at 729 5712 during office hours.

Source: Radio Television Brunei

August 29, 2021August 30, 2021

More Vaccines Research is Needed

The efficacy period of the COVID-19 vaccine was among the questions raised during the question and answer session. According to the Minister of Health, it is still too early to be evaluated as it depends on the person’s antibody to fight the virus.

According to the Minister of Health, more studies are needed from other countries’ experience on the matter and how to tackle the issue after a year, whether a new vaccine or booster shot is needed. Currently a third dose of the COVID-19 vaccine is not required. Instead, completing the 2 dose vaccination is a priority.

Touching on the Moderna vaccine contamination in a certain country, the Ministry of Health has contacted the supplier and stated that the vaccines available in the country have no relation to the issue. However, the Ministry of Health will continue to monitor the situation and prioritise safety.

Meanwhile, the Minister at the Prime Minister’s Office and Second Minister of Finance and Economy explained on the matter of loss of jobs. Yang Berhormat said that JobCentre Brunei is ready to assist those who wish to seek new employment by providing over 300 new jobs.

Source: Radio Television Brunei

August 29, 2021August 30, 2021

10,826 Vaccines Administered, Highest Daily Record

The National Vaccination Programme for COVID-19 recorded the highest number of vaccines administered on 28th August, since the start of the programme. The Minister of Health stated that 10,826 people have received the COVID-19 vaccine injection, and to date, 19.4 per cent of the country’s citizens and residents have completed two doses of the COVID-19 vaccine injection.

The Minister of Health called on the country’s citizens and residents to jointly respond to the Government’s efforts to achieve at least 70 per cent of the population to get two doses of the COVID-19 vaccine injection for the well-being of all. Meanwhile, to increase the swab test capacity for SARS-CoV-2, another drive thru swab centre will start operating on the 30th of August 2021. The swab centre located at Pusat Insani, Seria will operate as per the procedures at the BRIDEX drive-thru swab centre. The service is only for individuals who have valid BruHIMS number. Only 2 individuals are allowed to get the swab test in a vehicle, namely the driver and a passenger, and only passengers aged 12 and above are allowed to get the swab test. Only one booking is needed for each vehicle through the QueUp app. Services at the centre are open to the public regardless of their BruHealth colour code. However, holders of the purple BruHealth code are advised to come between 5 in the afternoon to 7 in the evening only. The service at the swab centre is not for any individual who requires a swab test for outbound or pre-departure swab purposes. Swab tests for outbound or pre-departure swab purposes can be obtained at other swab centres as usual. The Pusat Insani, Seria drive-thru swab centre will operate every Monday to Thursday and Saturday from 8 in the morning to 8 in the evening.

Source: Radio Television Brunei