U.S. Government to Purchase Minimum of 100,000 Doses of Etesevimab and Bamlanivimab Neutralizing Antibody Therapy
February 26 2021 - 12:35PM
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. government has agreed to purchase a
minimum of 100,000 doses of 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).
Etesevimab and bamlanivimab together recently received emergency
use authorization for the treatment of recently diagnosed, mild to
moderate COVID-19 in patients who are at high risk of progressing
to severe COVID-19 and/or hospitalization. Additionally, the
National Institutes of Health (NIH) recently updated the COVID-19
Treatment Guidelines to recommend the use of bamlanivimab plus
etesevimab for the treatment of outpatients with mild to moderate
COVID-19 who are at high risk of clinical progression.
The agreement is for $210 million and doses will
be delivered through March 31, 2021. The U.S. government will have
the option to purchase up to an additional 1,100,000 doses through
November 25, 2021, under the same terms as the base agreement and
subject to agreement from Lilly, product availability and the
medical need in the U.S. The government has said it will provide
neutralizing antibodies at no out-of-pocket cost to patients,
although healthcare facilities may charge a fee for the product's
administration. The federal government directs the distribution of
etesevimab and bamlanivimab together.
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 bamlanivimabBamlanivimab
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, and 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. A Phase 3 study of bamlanivimab
alone or bamlanivimab and etesevimab together 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 Junshi BiosciencesFounded
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 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 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 (etesevimab), China’s first neutralizing fully human
monoclonal antibody against SARS-CoV-2. JS016 administered with
bamlanivimab has received Emergency Use Authorization (EUA) by US
FDA in Feb 2021 for the treatment of recently diagnosed, mild to
moderate COVID-19 in patients who are at 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.
About Eli Lilly and
CompanyLilly 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
Contact InformationIR
Team:Junshi
Biosciencesinfo@junshipharma.com+ 86 021-2250 0300
Solebury TroutBob
Aibai@soleburytrout.com+ 1 646-389-6658
PR Team:Junshi
BiosciencesZhi Lizhi_li@junshipharma.com+ 86 021-6105
8800
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