CAMBRIDGE, Mass., ROTTERDAM, Netherlands and SUZHOU,
China, June 26,
2024 /PRNewswire/ -- Harbour BioMed (the "Company";
HKEX: 02142), a global biopharmaceutical company committed to the
discovery, development, and commercialization of novel antibody
therapeutics focusing on oncology and immunology, announces that it
has resubmitted the Biologics License Application (BLA) of
batoclimab (HBM9161) to the National Medical Products
Administration (NMPA) of China for
the treatment of generalized myasthenia gravis (gMG).
Following the clinical trial protocol, the Company completed the
extension period for the Phase III clinical trial to collect
additional long-term safety data without enrolling new patients. As
a result, the Company voluntarily included this additional safety
data and resubmitted the BLA for batoclimab (HBM9161) as
planned.
"We are delighted to resubmit the BLA to the NMPA as scheduled
and will continuously communicate closely with the NMPA to advance
the review process of this innovative therapy. Based on the results
of the Phase III clinical trial, which demonstrated the efficacy of
batoclimab in both primary and secondary endpoints, we believe this
innovative therapy will further enhance the treatment of
generalized myasthenia gravis and benefit more patients," said Dr.
Jingsong Wang, Founder, Chairman and
CEO of Harbour BioMed.
Batoclimab received the "Breakthrough Therapy Certificate" from
the NMPA in 2021 and achieved a positive outcome in the
proof-of-concept study for treating Chinese gMG patients in
July 2021. The positive topline
results of its Phase III clinical trial were announced in
March 2023.
In October 2022, the Company
entered into an agreement with NBP Pharma, a wholly owned
subsidiary of the CSPC Group, to co-develop batoclimab in
Greater China. Under this
agreement, the Company is responsible for developing and conducting
the full clinical trial of batoclimab for gMG in China and will receive tiered royalties based
on annual net sales of batoclimab in Greater China.
About Generalized Myasthenia Gravis (gMG)
Myasthenia gravis (MG) is an acquired autoimmune disease
mediated by antibodies such as anti-acetylcholine receptor (AChR)
immunoglobulin G (IgG) and anti-muscle-specific tyrosine kinase
(Anti-MuSK) IgG, which involves the postsynaptic membrane of the
neuromuscular junction, causes impaired transmission at the
neuromuscular junction, and presents with skeletal muscle
contraction weakness. Patients often have ocular muscle
manifestations such as eyelid ptosis and diplopia, and most
patients will show symptoms other than ocular muscles and develop
generalized myasthenia gravis (gMG) which significantly affects
their working status and quality of life, and some patients even
develop myasthenic crisis which will be life-threatening in severe
cases.
Current main treatments for MG include cholinesterase inhibitors
and glucocorticoids and other immunosuppressive drugs, but the
efficacy and safety cannot meet the clinical needs of many
patients. Targeting reduction of pathogenic IgG autoantibodies is
one of the best solutions in MG treatment in terms of the
pathophysiological mechanism, such as plasmapheresis and
intravenous immunoglobulin, however, there still remains a
significant unmet need for these treatment options, including the
accessibility, safety and economic cost.
About Batoclimab (HBM9161)
Batoclimab (HBM9161), a fully human anti-FcRn mAb, blocks
FcRn-IgG interactions, accelerating the degradation of
autoantibodies and leads to the treatment of pathogenic
IgG-mediated autoimmune diseases. Phase III study in myasthenia
gravis received positive results showing that batoclimab can
quickly, significantly, and safely alleviate patients' symptoms and
improve quality of life.
About Harbour BioMed
Harbour BioMed (HKEX: 02142) is a global biopharmaceutical
company committed to the discovery, development, and
commercialization of novel antibody therapeutics focusing on
immunology and oncology. The Company is building its robust
portfolio and differentiated pipeline through internal R&D
capability, collaborations with co-discovery and co-development
partners, and select acquisitions.
The proprietary antibody technology platforms Harbour
Mice® generates fully human monoclonal antibodies
in two heavy and two light chains (H2L2) format, as well as heavy
chain only (HCAb) format. Building upon the HCAb antibodies, the
HCAb-based immune cell engagers (HBICE®) bispecific
antibody technology is capable of delivering tumor-killing effects
unachievable by traditional combination therapies. Integrating
Harbour Mice®, and HBICE® with a single B
cell cloning platform, our antibody discovery engine is highly
unique and efficient for the development of next-generation
therapeutic antibodies. For further information, please refer to
www.harbourbiomed.com.
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SOURCE Harbour BioMed