HanAll Biopharma Autoimmune Disease Treatment Enters Phase 3 Clinical Trial for Myasthenia Gravis in China
New Drug Application for Myasthenia Gravis Phase 3 Expected to be Submitted to NMPA Next Year
[Asia Economy Reporter Kim Ji-hee] HanAll Biopharma announced on the 28th that the first patient dosing for the Phase 3 clinical trial of the autoimmune disease treatment new drug ‘HL161 (generic name Batoclimab)’ for myasthenia gravis has begun in China.
The clinical trial of HL161 in China is being conducted by its partner, Harbor Biomed. This trial is HL161’s first Phase 3 and the final hurdle for approval within China. Harbor Biomed plans to complete the Phase 3 clinical trial for myasthenia gravis by next year and submit a new drug application (BLA) to the National Medical Products Administration (NMPA) of China.
Harbor Biomed previously announced results from the Phase 2 clinical trial for myasthenia gravis conducted in China last July, showing that HL161 demonstrated statistically significant improvement in the primary endpoint, which is the ability of myasthenia gravis patients to perform daily activities, compared to placebo. The drug also showed excellent safety and tolerability.
According to Morgan Stanley in the United States, the myasthenia gravis market in China is rapidly growing and is expected to reach 1.2677 trillion KRW by 2030. Notably, there is currently no clear treatment for this disease.
Jing Song Wang, CEO of Harbor Biomed, stated, “For decades, there has been no effective treatment for myasthenia gravis in China. With this first patient dosing, Harbor Biomed has taken a step closer to its vision of providing patients with the highly effective Batoclimab, and we expect to produce good results from the clinical trial soon.”
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Harbor Biomed obtained commercialization rights for HL161 in China through a licensing agreement with HanAll in 2017. According to this agreement, Harbor Biomed must pay HanAll milestone payments at each clinical and approval stage, and after commercialization, royalties based on sales revenue.
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