Haisco Pharmaceutical advances pipeline with breakthrough designation, three IND approvals

Haisco Pharmaceutical Group announced that its innovative drug, HSK39297 tablets, has been granted breakthrough therapy designation by China's National Medical Products Administration (NMPA) for treating primary IgA nephropathy. This designation will accelerate the drug's development and prioritize its review for market approval. HSK39297, an oral complement factor B inhibitor, is currently in Phase II clinical trials and is also progressing to Phase III for paroxysmal nocturnal hemoglobinuria.

In related developments, Haisco Pharmaceutical also received Investigational New Drug (IND) approval for three additional innovative drug candidates through its subsidiary, Shanghai Haishengnuo Pharmaceutical Technology Co., Ltd. HSK50042 tablets, a small molecule inhibitor for respiratory system diseases, and HSK45019 tablets, a small molecule inhibitor for inflammatory bowel disease, both received IND approval. Both are classified as Class 1 chemical drugs.

Additionally, HSK55718 for injection, a non-opioid small molecule analgesic for acute pain, also secured IND approval. These approvals underscore Haisco Pharmaceutical's robust research and development pipeline across various therapeutic areas.