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- The trial met its primary endpoint and key secondary endpoints, with a favorable safety profile

-  Batoclimab is one of the most advanced FcRn inhibitors being developed in Greater China for the treatment of myasthenia gravis

HanAll Biopharma Co., Ltd. (KRX: 009420. KS) announced that its licensed partner Harbour BioMed in Greater China reported positive top-line results from its pivotal Phase 3 clinical trial of batoclimab in generalized myasthenia gravis (gMG) patients. This marks the first positive Phase 3 trial outcome for batoclimab worldwide.

The study met its primary endpoint as well as key secondary endpoints, and batoclimab was found to be well-tolerated with no new safety signals identified. Batoclimab is the first anti-FcRn treatment confirmed efficacious and safe in Chinese gMG population.

This multicenter, randomized, double-blind, placebo-controlled Phase 3 study enrolled 132 adult patients with gMG in China. Patients were randomized to receive batoclimab or placebo as subcutaneous injections by cycle. Each cycle consisted of a treatment period that includes six weekly injections, followed by four weeks of observation period.

“We are thrilled with the outstanding results from the study, which were the first Phase 3 data of our anti-FcRn asset batoclimab. We look forward to continuing our successful partnership with Harbour BioMed and CSPC for patients with gMG in China," said Sean Jeong, M.D., CEO of HanAll Biopharma.

Harbour BioMed and CSPC plan to submit a Biologics License Application to the National Medical Products Administration (NMPA) for batoclimab based on the study results.

Harbour BioMed became HanAll’s licensed partner to develop batoclimab in China in September 2017, and entered into a sub-license agreement with CSPC for batoclimab in October 2022.

Batoclimab is a fully human, subcutaneously administered antibody originated from HanAll, which selectively binds to and inhibits the neonatal Fc receptor (FcRn). It has demonstrated high potential as a new treatment option for gMG patients in China from the Phase 2 study, and received Breakthrough Therapy Designation from the NMPA in 2021.

About HanAll Biopharma

HanAll Biopharma (KRX: 009420.KS) is a global biopharmaceutical company founded in 1973, with a mission of making meaningful contributions to patients’ lives by introducing innovative, impactful therapies to address severe unmet medical needs. HanAll has been operating a portfolio of pharmaceutical products in areas ranging from endocrine, circulatory, and urologic diseases for more than 49 years. 

HanAll has also expanded its focus to ophthalmology, immunology, oncology and neurology to discover and develop innovative medicines for patients with diseases for which there are no effective treatments. Its lead pipeline asset, HL161 (INN: batoclimab), an anti-FcRn antibody, is being developed in Phase 3 and Phase 2 trials across the world for the treatment of rare autoimmune disorders including myasthenia gravis, thyroid eye disease, warm autoimmune hymolytic anemia, neuromyelitis optica, and immune thrombocytopenia. Another main asset, HL036 (INN: tanfanercept), an anti-TNF alpha biologic, is being evaluated in Phase 3 clinical trials in the US and China for the treatment of dry eye disease. For further information connect with us on linkedin. For any media inquiries, please contact HanAll PR/IR (pr@hanall.com, ir@hanall.com).  

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