SHANGHAI and INDIANAPOLIS, May 4,
2020 /PRNewswire/ -- Junshi Biosciences (HKEX: 1877) and Eli
Lilly and Company (NYSE: LLY) announced today they have entered
into an agreement to co-develop therapeutic antibodies for the
potential prevention and treatment of COVID-19, the disease caused
by the SARS-CoV-2 novel coronavirus.
At the beginning of the COVID-19 outbreak, Junshi Biosciences—a
China-based biopharmaceutical
company specializing in discovery, development and
commercialization of novel therapies—launched one of the industry's
first R&D efforts aimed at discovering therapies to combat
COVID-19. Multiple neutralizing antibodies have been engineered,
with the lead asset poised to enter clinical testing in the second
quarter.
"Since the outbreak of COVID-19, we have been working diligently
to join the fight against the pandemic. Entering into this
agreement with Lilly empowers us to accelerate the clinical
development of Junshi SARS-CoV-2 antibodies globally," said
Ning Li, M.D., Ph.D., Junshi
Biosciences' chief executive officer. "At the same time, by
leveraging Lilly's global presence and capabilities, we have the
potential to reach broader COVID-19 patient populations in a wider
range of countries and regions."
"As the number of global cases continues to grow, there is an
urgent need to study multiple complementary approaches to address
this disease," said Daniel
Skovronsky, M.D., Ph.D., Lilly's chief scientific officer
and president of Lilly Research Laboratories. "The data generated
by Junshi Biosciences suggest the lead antibody may have
appropriate properties to support testing its therapeutic use in
patients as well as exploring its potential for preventing
infection in at-risk individuals. We look forward to partnering
with Junshi Biosciences to quickly begin testing this potential new
therapy in clinical trials."
Lilly will receive an exclusive license to conduct clinical
development, manufacturing and distribution of products outside of
Greater China. Junshi Biosciences
will maintain all rights in Greater
China.
About Junshi SARS-CoV-2 Antibodies
JS016 is a recombinant fully human monoclonal neutralizing antibody
that is specific to the SARS-CoV-2 surface spike protein receptor
binding domain and can effectively block the binding of viruses to
host cell surface receptor ACE2. The project is jointly developed
by Junshi Biosciences and Institute of Microbiology, Chinese
Academy of Science.
At the beginning of the COVID-19 outbreak, Junshi Biosciences
rapidly launched the research and development program of
neutralizing antibodies to combat COVID-19. Within two months, the
company has completed IND enabling pre-clinical studies, the
process development and production for GLP toxicity study and GMP
production of clinical material by leveraging the company's
platform technology. Junshi Biosciences and Lilly aim to submit an
IND application and initiate clinical studies in the United States in the second quarter of the
year. Meanwhile, the company is communicating actively with the
Center for Drug Evaluation of the National Medical Products
Administration to initiate the IND application submission in
China as soon as possible.
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
About Eli Lilly and Company
Lilly is a global health
care 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 lilly.com and lilly.com/newsroom.
C-LLY
Lilly Cautionary Statement Regarding Forward-Looking
Statements
This press release contains forward-looking statements (as that
term is defined in the Private Securities Litigation Reform Act of
1995) about the benefits of an agreement between Lilly and Junshi
Biosciences and reflects Lilly's current beliefs. However, as with
any such undertaking, there are substantial risks and uncertainties
in the process of drug development and commercialization. Among
other things, there can be no guarantee that Lilly will realize the
expected benefits of the collaboration, or that the collaboration
will yield commercially successful products. For a further
discussion of these and other risks and uncertainties that could
cause actual results to differ from Lilly's expectations, please
see Lilly's most recent Forms 10-K and 10-Q filed with the U.S.
Securities and Exchange Commission. Lilly undertakes no duty to
update forward-looking statements.
Refer
to:
|
Nicole Hebert;
Nicole_Hebert@lilly.com; (317)
701-9984 (Lilly Media)
|
|
Kevin Hern;
hern_kevin_r@lilly.com; (317)
277-1838 (Lilly Investors)
|
|
Zhi Li;
zhi_li@junshipharma.com; phone (8621) 61058800 (Junshi
Media)
|
|
Inger Chen;
inger_chen@junshipharma.com; phone
(8621) 61058800 (Junshi Investors)
|
View original content to download
multimedia:http://www.prnewswire.com/news-releases/lilly-and-junshi-biosciences-to-co-develop-antibody-therapies-for-the-prevention-and-treatment-of-covid-19-301051788.html
SOURCE Eli Lilly and Company