Harbour BioMed Wins China Approval for Batoclimab

Cambridge, Massachusetts, USA; Rotterdam, Netherlands; and Shanghai, China, October 22, 2026

Phase 3 Trial Demonstrates Sustained Symptom Improvement

The approval was supported by results showing a statistically significant improvement in daily functioning among patients receiving batoclimab compared with those receiving placebo. During the first treatment cycle, 58.2% of patients treated with batoclimab achieved sustained improvement on the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale, compared with 31.3% in the placebo group. Sustained improvement was defined as a reduction of at least three points from baseline that continued for four weeks or longer. The difference was statistically significant, with a reported P-value of 0.001. Treatment effects were observed as early as the second week of therapy, suggesting the potential for relatively early symptom improvement. Additional outcomes also favored batoclimab, including sustained improvement on the Quantitative Myasthenia Gravis (QMG) scale, which was reported in 64.2% of treated patients compared with 40.6% of placebo recipients. The company also reported greater improvements in other measures of symptom control and minimal symptom expression. These findings support the treatment’s potential role in addressing the daily functional challenges associated with gMG.

Targeted FcRn Mechanism and Subcutaneous Administration

Batoclimab is a fully human monoclonal antibody targeting FcRn, a receptor involved in recycling IgG antibodies and prolonging their presence in circulation. By blocking this recycling pathway, batoclimab is designed to accelerate the breakdown of circulating IgG, including the autoantibodies that contribute to autoimmune disease. In generalized myasthenia gravis, antibodies can interfere with communication between nerves and muscles, leading to weakness that may affect speaking, swallowing, mobility and other everyday activities. Batoclimab’s targeted mechanism aims to reduce this antibody burden and improve disease symptoms. Its subcutaneous formulation is another important feature, as injections under the skin can offer a different treatment experience from therapies requiring intravenous administration in a healthcare facility. The company describes a regimen of 680 mg once weekly for six consecutive administrations, followed by a four-week observation period, forming a nine-week treatment cycle. The approved indication specifically covers adults with gMG who are anti-AChR antibody positive.

Safety Findings and Commercialization Plans

In the pivotal study, batoclimab was generally well tolerated, although treatment-related safety considerations remain important for patients and clinicians. Peripheral edema was the most frequently reported adverse event, occurring in 38.8% of patients receiving batoclimab compared with 4.6% in the placebo group; reported cases were mild to moderate. Plasma albumin levels decreased during treatment and returned spontaneously after treatment discontinuation, according to the company. These findings highlight the importance of appropriate clinical monitoring and individualized treatment decisions. Commercialization across Greater China—including mainland China, Hong Kong, Macau and Taiwan—is expected to be handled by NBP Pharma, a subsidiary of CSPC Pharmaceutical Group, under a licensing agreement established in October 2022. Harbour BioMed is eligible to receive tiered royalties based on annual net sales in the region. The approval marks a significant development for Harbour BioMed’s antibody-based therapeutic portfolio and China’s gMG treatment landscape. Continued real-world experience and post-approval safety monitoring will help clarify the medicine’s role in routine clinical practice.

Source: Harbour BioMed press release