CSPC PHARMA (01093.HK): Batoclimab injection wins China approval
- The product was licensed from HBM (Shanghai) by CSPC NBP Pharmaceutical and is approved for use with standard drugs in adults with AChR antibody-positive gMG.
- The pivotal phase III study ran at 27 Chinese sites, with 58.2% of batoclimab patients meeting the primary endpoint versus 31.3% on placebo (P=0.001).
- Efficacy was observed from week two, and secondary endpoints including sustained QMG improvement also showed statistically significant gains.
NewTimeSpace News: On 23 October 2026, CSPC Pharmaceutical Group Limited (stock code: 01093) said the National Medical Products Administration granted a drug registration certificate for batoclimab injection for subcutaneous use, licensed from HBM (Shanghai) by subsidiary CSPC NBP Pharmaceutical. It is approved with standard drugs in adults with anti-acetylcholine receptor (AChR) antibody-positive generalised myasthenia gravis (gMG).
A fully human monoclonal antibody targeting the neonatal Fc receptor (FcRn), it blocks FcRn-mediated recycling of immunoglobulin G and speeds the breakdown of pathogenic IgG autoantibodies, and is the first anti-FcRn therapy to complete gMG development in China. Approval rests on a phase III study at 27 Chinese sites, where 58.2% of patients on subcutaneous batoclimab met the primary endpoint versus 31.3% on placebo (P=0.001), defined as a sustained MG-ADL gain of at least three points for four weeks, with efficacy from week two.
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