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The registered clinical trial plan for the externally authorized drug CRB-701 (SYS6002) of the subsidiary of CSPC Pharmaceutical Innovation (300765.SZ) was approved by the US FDA
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Zhitong Finance App News, Shiyao Innovation (300765.SZ) issued an announcement. The company recently received a notice from Corbus Pharmaceuticals, Inc. (hereinafter referred to as “Corbus”). The company's holding subsidiary, Shiyao Group Jushi Biopharmaceutical Co., Ltd. authorized it to develop CRB-701 (SYS6002) and was approved by the US Food and Drug Administration (“US FDA”) to launch a registered clinical trial (trial code) for second-line oropharyngeal squamous cell carcinoma (OPSCC) indications: TEMPO-1).

CRB-701 (SYS6002) is a next-generation antibody-drug conjugate (ADC) targeting Nectin-4. Nectin-4 is a clinically proven tumor-related antigen that can be clearly expressed in urothelial carcinoma, and is also highly expressed in various tumors such as cervical cancer and head and neck squamous cell carcinoma (HNSCC). Previously, the US FDA had granted the drug two fast-track qualifications for CRB-701 (SYS6002) for the treatment of head and neck squamous cell carcinoma and cervical cancer, respectively.

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