Cspc Innovation Subsidiary's Licensed Drug CRB-701 (SYS6002) Gets FDA Nod for Phase 3 Trial in Second-Line Oropharyngeal Cancer

Stock News07-29

Cspc Innovation Pharmaceutical Co., Ltd. (300765.SZ) announced that it has received notification from Corbus Pharmaceuticals, Inc. regarding a key regulatory milestone.

The company’s controlling subsidiary, CSPC Pharmaceutical Group Limited's Jubio Biotechnology Co., Ltd., has developed and licensed the drug CRB-701 (SYS6002). The U.S. Food and Drug Administration has approved the initiation of a registrational clinical trial for this drug, designated as TEMPO-1, targeting second-line oropharyngeal squamous cell carcinoma.

CRB-701 is a next-generation antibody-drug conjugate that targets Nectin-4. This tumor-associated antigen has been clinically validated and is clearly expressed in urothelial carcinoma, while also showing high expression levels in other cancers, including cervical cancer and head and neck squamous cell carcinoma.

Previously, the FDA granted two Fast Track designations for CRB-701 to treat head and neck squamous cell carcinoma and cervical cancer.

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