[Edaily Reporter NA EUN-KYUNG ] “Batoclimab,” a treatment for autoimmune diseases developed by HANALL BIOPHARMA CO.,LTD(009420), has received new drug approval in China. This comes approximately nine years after the company licensed the technology to Chinese biotech firm Harbour BioMed in 2017. Although development was halted in the U.S. due to clinical trial failures, the drug has now entered the commercialization phase in China.

HANALL BIOPHARMA CO.,LTD announced on the 23rd that China’s National Medical Products Administration (NMPA) has approved the marketing authorization for the subcutaneous injection formulation of batoclimab. The approval applies to adult patients with general myasthenia gravis (gMG) who test positive for anti-acetylcholine receptor (AChR) antibodies. Generalized myasthenia gravis is an autoimmune disease in which the immune system interferes with signal transmission between nerves and muscles, causing muscles to tire easily and lose strength. Batoclimab is an antibody therapy that inhibits the neonatal Fc receptor (FcRn) to promote the degradation of pathogenic autoantibodies that cause the disease.

This approval was based on the results of a Phase 3 clinical trial conducted at 27 medical institutions in China. In the batoclimab treatment group, 58.2% of patients experienced a reduction of 3 points or more in their MG-ADL score—which assesses the ability to perform activities of daily living—during the first treatment cycle, and this improvement was maintained for at least 4 weeks. In contrast, only 31.3% of patients in the placebo group showed such improvement, indicating a statistically significant difference.

The MG-ADL is a metric that assesses the severity of symptoms experienced in daily life, such as speaking, chewing, swallowing, and breathing; a lower score indicates milder symptoms. In the batoclimab group, symptom improvement was observed starting in week 2 of treatment. The proportion of patients who showed sustained improvement in the QMG score—which assesses muscle strength and muscle fatigue—was 64.2% in the batoclimab group and 40.6% in the placebo group.

In September 2017, HANALL BIOPHARMA CO.,LTD licensed the development and commercialization rights for batoclimab and the dry eye treatment “Tanpanercept” in Greater China to Harbor Biomed for a total of $81 million (approximately 91 billion won at the time). In December of the same year, the company transferred the rights to batoclimab for regions including North America and Europe to Royvant Sciences.

However, development in the U.S. hit a snag. Last April, ImmunoVant, a subsidiary of Royvant, halted further development of batoclimab after failing to meet the primary endpoints in two Phase 3 clinical trials for thyroid-associated ophthalmopathy. Instead, the company is focusing on the development of the next-generation FcRn antibody “Imeropruvate (IMVT-1402).”

In China, however, the drug demonstrated efficacy in a Phase 3 clinical trial for generalized myasthenia gravis, marking the first marketing approval among the FcRn antibody candidates that HANALL BIOPHARMA CO.,LTD has licensed out. Sales in Greater China will be handled by NBP Pharma, a subsidiary of CSPC Pharmaceutical Group, which signed a technology re-licensing agreement with Harbor BioMed in 2022. HANALL BIOPHARMA CO.,LTD is set to receive milestone payments from Harbor BioMed in connection with this approval, as well as tiered royalties linked to future annual net sales in Greater China.