 |
- 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
SEOUL, South Korea, March 6, 2023 /PRNewswire/ — 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).
Disclaimer statement
The contents of this announcement include statements that are, or may be deemed to be, "forward-looking statements." These forward-looking statements can be identified by the use of forward-looking terminology, including the terms "believes," "estimates," "anticipates," "expects," "intends," "may," "will," or "should" and include statements HANALL (the company, we) makes concerning its 2023 business and financial outlook and related plans; the therapeutic potential of its product candidates; the intended results of its strategy and the company, and its collaboration partners’, advancement of, and anticipated clinical development, data readouts and regulatory milestones and plans, including the timing of planned clinical trials and expected data readouts; the design of future clinical trials and the timing and outcome of regulatory filings and regulatory approvals. By their nature, forward-looking statements involve risks and uncertainties, and readers are cautioned that any such forward-looking statements are not guarantees of future performance. The company’s actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors our expectations regarding its the inherent uncertainties associated with competitive developments, preclinical and clinical trial and product development activities and regulatory approval requirements; our reliance on collaborations with third parties; estimating the commercial potential of our product candidates; our ability to obtain and maintain protection of intellectual property for its technologies and drugs; our limited operating history; and our ability to obtain additional funding for operations and to complete the development and commercialization of its product candidates. A further list and description of these risks, uncertainties and other risks can be found in Korea Stock Exchange (KRX) filings and reports, including in our most recent annual report as well as subsequent filings and reports filed by the company with the KRX. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. We undertake no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by Korean law and regulations.