HanAll Biopharma-Licensed Drug Batoclimab Receives Marketing Approval in China

Efficacy Demonstrated in China Phase 3 Trial
First Approval for an FcRn Antibody Drug Developed by HanAll
Expected to Receive a Regulatory Approval Milestone and Sales Royalties

Batoclimab, a novel antibody drug targeting the neonatal Fc receptor (FcRn) that HanAll Biopharma licensed out, has received marketing approval in China. It is the first drug approval among batoclimab and imeroprubart, which HanAll Biopharma developed and is advancing through clinical development and commercialization with global partners.

Harbor BioMed, HanAll Biopharma's partner in China, announced on October 23 that China's National Medical Products Administration (NMPA) had approved the biologics license application (BLA) for batoclimab for subcutaneous injection. The approval covers a 170 mg (1 mL/vial) subcutaneous (SC) formulation for adults with anti-acetylcholine receptor antibody (Anti-AChR)-positive generalized myasthenia gravis (gMG).

The approval was based on the results of a Phase 3 clinical trial conducted at 27 hospitals in China. The trial found that 58.2% of patients in the batoclimab group had a reduction of at least 3 points from baseline in their Myasthenia Gravis Activities of Daily Living (MG-ADL) score during the first treatment cycle, with the improvement lasting at least 4 weeks. This was a statistically significant difference compared with the placebo group (31.3%) (p=0.001), meeting the trial's primary endpoint.

Statistically significant improvements versus placebo were also seen in secondary endpoints, including the proportion of patients with sustained improvement in their Quantitative Myasthenia Gravis (QMG) score. The most frequently reported adverse event was mild to moderate peripheral edema.

Under a sublicense agreement signed in October 2022 between Harbor BioMed and NBP Pharma, a subsidiary of CSPC Pharmaceutical Group, NBP Pharma will handle marketing and sales of batoclimab in Greater China (mainland China, Hong Kong, Macau and Taiwan).

HanAll Biopharma expects to receive regulatory approval milestones from its licensing partner Harbor BioMed, as well as tiered royalties based on annual net sales of batoclimab in Greater China.

This content was produced with the assistance of AI translation services.