Hengrui Pharmaceuticals (01276.HK): SHR-4375 Injection Granted FDA Orphan Drug Designation

NewTimeSpace News: On July 27, 2026, Hengrui Pharmaceuticals (01276.HK) issued an announcement stating that its product SHR-4375 Injection has been awarded Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for treating pancreatic cancer.

Per the announcement, SHR-4375 is a tissue factor (TF)-targeted ADC independently developed by Hengrui Pharmaceuticals. Its domestic clinical trials have advanced to Phase II, with total cumulative R&D investment reaching approximately RMB 58.7 million. Following this orphan drug designation, Hengrui Pharmaceuticals will be eligible for policy incentives including tax credits for clinical trial expenses, waiver of New Drug Application (NDA) fees, and 7 years of marketing exclusivity upon approval.

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