Nature Publishes Preclinical Characterization and Primate Efficacy Data on Junshi Biosciences' COVID-19 Neutralizing Antibodies

Wednesday, 27 May 2020, 10:41 HKT/SGT

- CB6 demonstrated prophylactic and treatment effects in rhesus monkeys
- Clinical testing expected to begin in second quarter in collaboration with Eli Lilly and Company

SHANGHAI, CHINA, May 27, 2020 - (ACN Newswire) - Junshi Biosciences (HKEX: 1877) a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, today announced the publication of research results from the company's efforts to generate therapeutic COVID-19 neutralizing antibodies. The paper, titled "A human neutralizing MAb targeting the receptor binding site of SARS-CoV-2" (Shi et al. Nature), was published today in the journal Nature. Junshi and partner Eli Lilly and Company (NYSE: LLY) intend to file an IND and initiate clinical trials in the U.S. and China in the second quarter of 2020.

The article reports the identification and characterization of two specific human monoclonal antibodies (CA1 and CB6) isolated from a recovered COVID-19 patient. While both antibodies demonstrated substantial neutralization activity in vitro against SARS-CoV-2, CB6 exhibited superior neutralizing activities. CB6 reduced virus levels by about 3 logs in rhesus monkeys when administered one day after infection. When given one day before viral challenge, CB6 was able to keep viral load at no more than 103 RNA copies/ml, demonstrating strong prophylactic protection. Structural studies showed that CB6 recognizes epitopes in SARS-CoV-2 receptor binding domain that overlap with angiotensin converting enzyme 2 (ACE2)-binding sites, thereby directly obstructing virus/receptor interactions. The Fc portion of CB6 was modified to lower the risk of Fc mediated acute lung injury.

"We have successfully leveraged the Company's years of expertise with our fully integrated R&D antibody technology platform, conducting multiple parallel development tracks of candidate antibodies that were subsequently tested in vivo infection model by the Institute of Microbiology, Chinese Academy of Sciences," said Hui Feng, Ph.D., Junshi Biosciences' Chief Operating Officer. "One of these candidates, described in the Nature paper, demonstrated strong neutralizing activity against COVID-19. We expect to file an IND for this candidate in the second quarter in collaboration with our partner, Lilly. As part of our effort to contribute in the fight against this global pandemic, our Company has increased its research and development efforts, leveraging our strengths in the field of antibody discovery."

"Lilly is proud to have partnered with Junshi Biosciences to develop CB6 as a potential treatment for COVID-19. The fact that CB6 can protect rhesus monkeys from COVID-19 infection suggests a potential for prophylactic use in humans," said Daniel Skovronsky, M.D., Ph.D., Lilly's chief scientific officer and president of Lilly Research Laboratories. "We are moving as quickly as possible to test such a protective effect in patients at risk for COVID-19."

The paper can be accessed on the journal's website here.
https://www.nature.com/articles/s41586-020-2380-z

About Junshi Biosciences
Established in 2012, Junshi Biosciences is committed to developing first-in-class and best-in-class drugs through original innovation and becoming a pioneer in the area of translational medicine to provide patients with effective and affordable treatment options. On December 24, 2018, Junshi Biosciences was listed on the Main Board of the Stock Exchange of Hong Kong with the stock code: 1877.HK. The Company has established a diversified R&D pipeline comprising 21 drug candidates with therapeutic areas covering cancer, metabolic diseases, autoimmune diseases, neurologic diseases, and Infectious disease. Product types include monoclonal antibodies, fusion proteins, antibody-drug conjugates, and small molecule drugs. With a combined 33,000L fermentation capacity in two GMP-facilities at Shanghai and Suzhou, Junshi has established the manufacturing infrastructure to support commercialization and provide our partners and patients with high-quality products through a global supply chain network. For more information, please visit: http://junshipharma.com/en/Index.html

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