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Harbour BioMed, HanAll Biopharma’s Chinese
partner, announced on the 22nd that it is currently conducting Phase 1b/2a
clinical trials in China to verify the efficacy and safety of Batoclimab
subcutaneous injection in acute neuromyelitis optica spectrum disorder(NMOSD)
patients and has begun the first patient administrations for the trial.
Batoclimab is the international
non-proprietary name(INN) of the HL161 novel antibody drug(Harbour BioMed Code
Name: HBM9161; Immunovant Code Name: IMVT-1401), which is being globally
developed by HanAll Biopharma jointly with Harbour BioMed of China and
Immunovant of the U.S.
With no established treatment available, a
high-dose steroid is generally used in the treatment of NMOSD. For patients
with severe NMOSD, immunoglobulin, a blood component, is intravenously injected(IVIG),
or plasmapheresis, which filters out autoantibodies from the patient’s blood to
inject it back into the patient, is administered. Batoclimab is a subcutaneous
injection product that is convenient to administer. It is drawing anticipation
as a new drug to effectively remove the AQP autoantibody, the cause of the
disease.
Harbour BioMed anticipates the release of
Batoclimab in the Chinese market ahead of the competing products. In addition
to NMOSD, it plans to concurrently conduct clinical trials for immune
thrombocytopenic purpura(ITP), thyroid eye disease(TED), and myasthenia gravis(MG).
Separately from the clinical trials in
China, Immunovant, HanAll Biopharma’s global partner, announced positive Phase
2a clinical trial results for Batoclimab for TED at the end of March. It is
also conducting Phase 2 clinical trials in the U.S. and Europe in relation to
MG and warm antibody autoimmune hemolytic anemia(WAIHA).