HarbourBioMed, the Chinese licensing partner of Hanall Biopharma (009420.KS), has won local marketing approval for batoclimab, a treatment for autoimmune diseases. It is the first regulatory approval for either of the two autoimmune therapies — batoclimab and imeroprubart — that Hanall developed and is advancing through clinical trials and commercialization with global partners.
China's National Medical Products Administration (NMPA) approved the biologics license application for batoclimab subcutaneous injection on the 23rd. The approval covers a 170-milligram subcutaneous formulation for adult patients with generalized myasthenia gravis who test positive for anti-acetylcholine receptor antibodies.
The approval was based on results from a Phase 3 trial conducted at 27 hospitals in China. In the trial, 58.2% of patients receiving batoclimab saw their MG-ADL score, which measures the ability to perform daily activities, fall by at least three points from baseline during the first treatment cycle, with the improvement sustained for four weeks or longer. That compared with 31.3% in the placebo group, a statistically significant difference that met the primary endpoint. Patients on batoclimab also showed rapid symptom improvement starting from the second week of dosing.
Secondary endpoints also showed statistically significant improvement over placebo. Among patients treated with batoclimab, 64.2% showed sustained improvement in their Quantitative Myasthenia Gravis score, while 25.4% reached minimal symptom expression — an MG-ADL score of 0 or 1 — at least once. In the second treatment cycle, 62.7% of patients achieved sustained improvement in MG-ADL scores. Batoclimab was well tolerated, with mild to moderate peripheral edema the most frequently reported adverse event.
NBP Pharma, a subsidiary of CSPC Pharmaceutical Group, will handle sales and marketing of batoclimab in Greater China, including mainland China, Hong Kong, Macau and Taiwan. HarbourBioMed signed a sublicensing agreement with NBP Pharma in October 2022 transferring Greater China rights to the drug. Hanall Biopharma will receive milestone payments tied to the approval as well as sales royalties linked to annual net sales.
China's myasthenia gravis treatment market is projected to grow to $62.1 million (about 82.3 billion won) in 2033 from $30.3 million (about 40.1 billion won) in 2025, according to market researcher Grand View Research.