{"url":"https://newsforagent.com/news/2026-10-23/harbour-biomed-batoclimab-china-approval","markdown_url":"https://newsforagent.com/news/2026-10-23/harbour-biomed-batoclimab-china-approval.md","title":"Harbour BioMed Wins China Approval for Batoclimab SC","headline":"Harbour BioMed's Batoclimab SC Cleared by China's NMPA for Generalized Myasthenia Gravis","description":"China's NMPA approved Harbour BioMed's batoclimab SC for generalized myasthenia gravis after a Phase 3 trial met its primary endpoint in 58.2% of patients.","section":"Regulation & Approvals","published_at":"2026-10-23T00:55:58+00:00","modified_at":"2026-10-23T00:55:58+00:00","author":"News Desk","key_takeaways":["China's NMPA approved batoclimab SC, 170 mg (1 mL)/vial, for adults with anti-AChR antibody positive generalized myasthenia gravis.","In a pivotal Phase 3 study at 27 centers in China, 58.2% of batoclimab SC patients achieved sustained MG-ADL improvement versus 31.3% on placebo (P=0.001).","NBP Pharma, a subsidiary of CSPC Pharmaceutical Group, will commercialize batoclimab in Greater China under a 2022 license agreement."],"companies":[{"name":"Harbour Biomed","is_primary":true,"profile_url":null,"website":"https://www.harbourbiomed.com"}],"source":{"publisher":"PR Newswire","title":"Harbour BioMed Receives China NMPA Approval of Batoclimab Injection (Subcutaneous Injection) for the Treatment of Generalized Myasthenia Gravis","url":"https://www.prnewswire.com/news-releases/harbour-biomed-receives-china-nmpa-approval-of-batoclimab-injection-subcutaneous-injection-for-the-treatment-of-generalized-myasthenia-gravis-302917545.html"},"other_sources":[{"publisher":"news.cision.com","url":"https://news.cision.com/hansa-biopharma-ab/r/hansa-biopharma-announces-submission-of-ind-application-to-us-fda-for-hnsa-5487-in-gbs,c4412488"},{"publisher":"GlobeNewswire","url":"https://www.globenewswire.com/news-release/2026/10/19/3383356/0/en/clene-announces-new-drug-application-submission-to-fda-for-cnm-au8-for-the-treatment-of-als.html"}],"tags":["Regulation & Approvals","Harbour Biomed"],"body_markdown":"China's National Medical Products Administration approved batoclimab injection (subcutaneous injection), 170 mg (1 mL)/vial, for adults with anti-acetylcholine receptor antibody positive generalized myasthenia gravis, Harbour BioMed said in a [PR Newswire](https://www.prnewswire.com/news-releases/harbour-biomed-receives-china-nmpa-approval-of-batoclimab-injection-subcutaneous-injection-for-the-treatment-of-generalized-myasthenia-gravis-302917545.html) announcement on October 22, 2026. The company said the approval covers a Biologics License Application supported by a pivotal Phase 3 study run at 27 centers in China.\n\n## How the Batoclimab Phase 3 Study Performed\n\nThe main study population was patients positive for acetylcholine receptor antibodies or muscle-specific tyrosine kinase antibodies. The primary endpoint measured the proportion of patients with sustained improvement on the Myasthenia Gravis Activities of Daily Living Scale during the first treatment cycle, defined as a reduction of at least 3 points from baseline lasting at least 4 weeks. Batoclimab SC reached that endpoint in 58.2% of patients, against 31.3% in the placebo group, with a P value of 0.001. Treatment effect appeared as early as the second week.\n\nSecondary endpoints also favored batoclimab SC, including sustained Quantitative Myasthenia Gravis improvement in 64.2% versus 40.6% (P=0.008) and minimal symptom expression at any visit in 25.4% versus 4.7% (P=0.004). Peripheral edema was the most frequently reported adverse event in the treatment group, at 38.8% versus 4.6% for placebo, and all cases were mild to moderate.\n\n\"The approval of batoclimab SC is a proud moment for everyone at Harbour BioMed,\" said Dr. Jingsong Wang, Founder, Chairman and Chief Executive Officer. Professor Chongbo Zhao, MD, Principal Investigator of the pivotal Phase 3 study and Professor of Neurology at Huashan Hospital of Fudan University, said batoclimab SC is the first FcRn-targeted therapy to complete its entire clinical development in China.\n\n## Harbour BioMed's Run-Up to the Approval\n\nHarbour BioMed reported interim results for the six months ended June 30, 2026, with revenue of US$122.5 million, up 20.9% year-over-year, and profit of US$64.9 million, according to PR Newswire APAC. On August 18, 2026, the company announced NMPA approval of an Investigational New Drug application for HBM7004, a bispecific antibody for advanced solid tumors, PR Newswire reported. Harbour BioMed and Sinopharm entered a strategic collaboration on July 27, 2026 to establish an innovation R&D consortium, PR Newswire reported.\n\n## Other Neurology Filings in October 2026\n\nHansa Biopharma submitted an Investigational New Drug application to the US FDA for HNSA-5487, an IgG-cleaving enzyme for Guillain-Barré syndrome, on October 20, 2026, [news.cision.com](https://news.cision.com/hansa-biopharma-ab/r/hansa-biopharma-announces-submission-of-ind-application-to-us-fda-for-hnsa-5487-in-gbs,c4412488) reported. Clene Inc. Submitted a New Drug Application to the FDA on October 19, 2026 seeking accelerated approval of CNM-Au8 for ALS, [GlobeNewswire](https://www.globenewswire.com/news-release/2026/10/19/3383356/0/en/clene-announces-new-drug-application-submission-to-fda-for-cnm-au8-for-the-treatment-of-als.html) reported.\n\n## Commercialization and Dosing\n\nUnder a license agreement between Harbour BioMed and NBP Pharma dated October 2022, NBP Pharma, a subsidiary of CSPC Pharmaceutical Group, will commercialize batoclimab in Mainland China, Hong Kong, Macau and Taiwan. Harbour BioMed will receive tiered royalties on annual net sales in Greater China. The recommended regimen is 680 mg once weekly, with a 4-week observation after 6 consecutive administrations, making each cycle 9 weeks. The marketing authorization holder is Dragon Merit Holdings Limited, a CSPC Pharmaceutical Group subsidiary. Harbour BioMed describes itself on its [website](https://www.harbourbiomed.com) as a global biopharmaceutical company developing antibody therapeutics in immunology and oncology.\n","publisher":{"name":"News for Agent","url":"https://newsforagent.com"}}