Haisco gets approval for myasthenia gravis drug trial

Haisco Pharmaceutical Group announced today that it has received a "Drug Clinical Trial Approval Notice" from the National Medical Products Administration. This approval allows the company to proceed with clinical trials for a new indication of its innovative drug, HSK39297 tablets, specifically for generalized myasthenia gravis (GMG). The application was filed in August 2025.

HSK39297 tablets are an independently developed, small-molecule drug. Pre-clinical research indicates a clear target, confirmed efficacy, and good safety profile, positioning it as a promising treatment for GMG. This condition, a rare autoimmune disease affecting neuromuscular transmission, currently has limited effective treatment options, particularly for systemic involvement.

The company highlighted the significant unmet clinical need for better and safer therapeutic options for GMG patients. Haisco will provide timely updates on the project's progress, reminding investors of the inherent risks associated with innovative drug development due to its long, multi-stage, and high-risk nature.