Etesevimab (JS016) Administered with Bamlanivimab Receives FDA Emergency Use Authorization for COVID-19

• Etesevimab and bamlanivimab administered together is authorized for treatment of recently diagnosed, mild to moderate COVID-19 in patients who are high risk for progression to severe COVID-19
• More than 250,000 doses manufactured throughout Q1 2021; up to 1 million doses by mid-2021
• FDA authorizes shortened infusion time for this neutralizing antibody therapy authorized for emergency use
  

SHANGHAI, China, Feb. 10, 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 U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for investigational etesevimab (JS016 or LY-CoV016) 1400 mg and bamlanivimab (LY-CoV555) 700 mg together, according to the company’s global partner Eli Lilly and Company (NYSE: LLY). This therapy is authorized for the treatment of mild to moderate COVID-19 in patients aged 12 and older who are at high risk for progressing to severe COVID-19 and/or hospitalization. Etesevimab and bamlanivimab should be administered together via a single intravenous infusion as soon as possible after a positive COVID-19 test and within 10 days of symptom onset.

In addition, the FDA has authorized infusion times for bamlanivimab alone and bamlanivimab and etesevimab together to be as short as 16 or 21 minutes, respectively – a significant reduction from the previously authorized time of 60 minutes. This change has been made in response to feedback received from front-line nurses and doctors administering these infusions and is aimed at reducing the burden on the healthcare system.

The EUA is based on Phase 3 data from the BLAZE-1 trial, announced on January 26, 2021, which demonstrated that etesevimab and bamlanivimab together reduced the risk of COVID-19 hospitalizations and death by 70 percent. These data replicate earlier results, published in The Journal of the American Medical Association (IF=45.54), in a much larger group of patients. The most common adverse event more often reported for patients receiving etesevimab and bamlanivimab together versus placebo was nausea on the day of infusion.

While Phase 2 and Phase 3 trials evaluated a range of doses of bamlanivimab alone and etesevimab and bamlanivimab together, data demonstrated consistent and similar clinical effects among all doses studied. Additionally, initial results from an ongoing Phase 2 study provided viral load and pharmacodynamic/pharmacokinetic data which demonstrated etesevimab 1400 mg and bamlanivimab 700 mg together produced similar effects to those observed in the Phase 3 trial with etesevimab 2800 and bamlanivimab 2800 together. Together, these data provide confidence in the authorized dose, which expands available supply to help more patients without sacrificing potential efficacy.

The FDA grants EUA to provide availability of a medicine that may help diagnose, treat or prevent a life-threatening disease when no adequate and approved alternatives are available. This administration of etesevimab and bamlanivimab together is authorized only for the duration of the declaration, unless the authorization is terminated or revoked sooner. The authorization is temporary and does not replace the formal review and approval process. The administration of etesevimab and bamlanivimab together remains investigational and has not been approved under a Biologics License Application (BLA). Evaluation of its safety and efficacy is ongoing in clinical trials. Data from these studies will be used to support a future BLA submission for the treatment.

Bamlanivimab alone is authorized in numerous countries, while bamlanivimab and etesevimab together is currently authorized in the U.S. and Italy. Lilly will continue working with global regulators to make these therapies available around the world. In an effort to help as many patients as possible, Lilly will continue to accelerate manufacturing of etesevimab for use around the world. Lilly, in collaboration with Amgen, plans to manufacture up to 1 million doses of etesevimab for administration with bamlanivimab by mid-2021. There are 100,000 doses ready immediately and an additional 150,000 doses will be available throughout the first quarter. Lilly anticipates procurement and allocation of etesevimab and bamlanivimab together will mirror the process followed for bamlanivimab alone – making the therapy available directly to governments for allocation based on unmet needs. Global allocation will aim to ensure access for patients with high unmet need, no matter where they live.

Dr. Ning LI, CEO of Junshi Biosciences said: "Since the outbreak of the pandemic, Junshi Biosciences and the IMCAS have been dedicated to the co-development of neutralizing antibodies. Now, with Lilly, our global partner’s participation, the innovative therapy is authorized for use in the U.S. and Italy, while unremitting endeavors to meet the extensive anti-COVID-19 needs are made by the local and overseas medical industry. The data of etesevimab and bamlanivimab together provides strong evidence for the safety and efficacy of JS016, thus giving us confidence to proceed with the clinical trial of JS016, which is ongoing in several countries and regions, including Mainland China, Hong Kong, the Philippines, etc."

About etesevimab(JS016)
Etesevimab (JS016 or LY-CoV016) 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 Junshi Biosciences after it was jointly developed by Junshi Biosciences and the Institute of Microbiology, Chinese Academy of Science (IMCAS). Junshi Biosciences leads development in Greater China, while Lilly leads development in the rest of the world.

Lilly has successfully completed a Phase 1 study (NCT04441931) of etesevimab in healthy U.S. volunteers to evaluate the safety, tolerability, pharmacokinetics and immunogenicity. A Phase 2/3 study in people recently diagnosed with COVID-19 in the ambulatory setting (BLAZE-1, NCT04427501) is ongoing. Junshi Biosciences has completed a similar Phase 1 study in healthy volunteers in China and has initiated Phase 1b/2 trials in COVID-19 patients globally.

About bamlanivimab(LY-CoV555)
Bamlanivimab (LY-CoV555) is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. It is designed to block viral attachment and entry into human cells, thus neutralizing the virus, potentially treating COVID-19. Bamlanivimab emerged from the collaboration between Lilly and AbCellera to create antibody therapies for the prevention and treatment of COVID-19. Lilly scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera and the scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center. It was identified from a blood sample taken from one of the first U.S. patients who recovered from COVID-19.

Lilly has successfully completed a Phase 1 study of bamlanivimab in hospitalized patients with COVID-19 (NCT04411628). A Phase 2/3 study in people recently diagnosed with COVID-19 in the ambulatory setting (BLAZE-1, NCT04427501) is ongoing. A Phase 3 study of bamlanivimab for the prevention of COVID-19 in residents and staff at long-term care facilities (BLAZE-2, NCT04497987) is also ongoing. In addition, bamlanivimab is being tested in the National Institutes of Health-led ACTIV-2 study in ambulatory COVID-19 patients.

About BLAZE-1
BLAZE-1 (NCT04427501) is a randomized, double-blind, placebo-controlled Phase 2/3 study designed to assess the efficacy and safety of bamlanivimab alone or together with etesevimab for the treatment of symptomatic COVID-19 in the outpatient setting. To be eligible, patients were required to have mild or moderate symptoms of COVID-19 as well as a positive SARS-CoV-2 test based on a sample collected no more than three days prior to drug infusion.

In the Phase 2 portion of BLAZE-1, cohorts of mild to moderate, recently diagnosed COVID-19 patients, were randomized to one of three doses of bamlanivimab (700 mg, 2800 mg, and 7000 mg), etesevimab 2800 mg plus bamlanivimab 2800 mg, or placebo. Results from the Phase 2 cohorts of BLAZE-1 were published in the New England Journal of Medicine and The Journal of the American Medical Association.

In the Phase 3 portion of BLAZE-1, the combination therapy arms enrolled mild to moderate, recently diagnosed COVID-19 patients who are at high risk for progressing to severe COVID-19 and/or hospitalization, studying etesevimab 2800 mg plus bamlanivimab 2800 mg versus placebo. The primary outcome measure for the Phase 3 portion of the BLAZE-1 trial was the percentage of participants who experience COVID-related hospitalizations or death from any cause by day 29. The key secondary endpoints were change from baseline to day 7 in SARS-CoV-2 viral load, persistently high SARS-CoV-2 viral load on day 7, time to sustained symptom resolution, and COVID-related hospitalization, ER visit or death from any cause from baseline by day 29. Additional endpoints include change from baseline in viral load at other time points, symptom improvement, symptom resolution, as well as safety.

The study is ongoing with additional treatment arms. Across all treatment arms, the trial will enroll up to 3,300 participants.

About BLAZE-4
BLAZE-4 (NCT04634409) is a randomized, double-blind, placebo-controlled trial designed to assess the efficacy and safety of bamlanivimab alone, and bamlanivimab and etesevimab together, at various doses, versus placebo for the treatment of symptomatic COVID-19 in the outpatient setting. Across all treatment arms, the trial will enroll an estimated 1,000 participants in the United States and Puerto Rico.

The primary outcome measure is percentage of participants who have a viral load greater than 5.27 at day 7. Additional endpoints include change from baseline to Day 7 in SARS-CoV-2 viral load, percentage of participants who experience COVID-related hospitalization, ER visit or death from baseline through Day 29, as well as safety.

About Junshi Biosciences
Founded in December 2012, Junshi Biosciences (HK: 1877; SH: 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 27 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 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 Chinese Academy of Science and Eli Lilly to co-develop JS016, China’s first neutralizing fully human monoclonal antibody against SARS-CoV-2, which has entered clinical trials and is now 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.

About Eli Lilly and Company
Lilly is a global healthcare leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at?www.lilly.com?and?www.lilly.com/news.?P-LLY

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