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-1BLAZE-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-4BLAZE-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 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 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
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 Information
IR 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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