HanAll Biopharma's Batoclimab receives China approval for gMG treatment

HanAll Biopharma has announced that its FcRn antibody drug candidate, Batoclimab, has received marketing authorization from China's National Medical Products Administration (NMPA). The approval is for the subcutaneous injection of Batoclimab (170mg) to treat adult patients with anti-acetylcholine receptor (Anti-AChR) antibody-positive generalized myasthenia gravis (gMG).

The decision follows Phase 3 clinical trials conducted across 27 hospitals in China. In these trials, 58.2% of the Batoclimab group showed a reduction of 3 or more points in the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale during the first treatment cycle, compared to 31.3% in the placebo group. Clinical improvements were observed as early as two weeks after administration.

Batoclimab's global partner, Harbour BioMed, secured the approval. Marketing and sales in Greater China, including mainland China, Hong Kong, Macau, and Taiwan, will be managed by NBP Pharma, a subsidiary of CSPC Pharmaceutical Group. HanAll Biopharma expects to receive milestone payments and tiered royalties based on annual net sales in the region.