Haisco Pharmaceutical Group (002653.SZ): Innovative Drug HSK39297 Tablets Included in Breakthrough Therapy Drug Program

Stock News10-13

Haisco Pharmaceutical Group Co.,Ltd. (002653.SZ) announced that the company was notified on October 13, 2025, that HSK39297 tablets have been officially included in the "Breakthrough Therapy Drug List" by the Center for Drug Evaluation (CDE) of the National Medical Products Administration. This inclusion will significantly accelerate the drug development process in this therapeutic area and bring new hope for the treatment of kidney/urological diseases in China.

HSK39297 is an oral, potent, and highly selective complement factor B small molecule inhibitor independently developed by the company. It is clinically intended for the treatment of complement-mediated hemolytic diseases and complement-mediated primary or secondary glomerular diseases.

Currently, HSK39297 tablets are undergoing Phase II clinical studies in patients with primary IgA nephropathy and have completed the 12-week core treatment period. Clinical results demonstrate that the preset endpoints were achieved. HSK39297 tablets showed significant reduction in proteinuria levels compared to the placebo group after 12 weeks of continuous treatment, with good overall safety and tolerability profile. These results establish a solid foundation for its inclusion in the breakthrough therapy program and progression to Phase III pivotal clinical research.

Meanwhile, the company is advancing Phase III clinical research of HSK39297 tablets for paroxysmal nocturnal hemoglobinuria.

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