On August 21, 2022 BroadenBio reported the company received the official letter of acceptance (Study May Proceed Letter) from the U.S. Food and Drug Administration (FDA) to proceed with a Phase 1 clinical trial of Class I investigational new drug BB102 for advanced solid tumors (Press release, BroadenBio, AUG 21, 2022, View Source [SID1234640201]). The project has previously been approved for clinical study by the Center of Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in July 2022, and a first-in-human Phase 1 clinical trial for patients with advanced solid tumors will soon be initiated in China.

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BB102 is an innovative small molecule kinase inhibitor discovered and being developed by BroadenBio for the treatment of advanced solid tumors driven by abnormal oncogenic genes. Besides its novel mechanism of action, high selectivity, good safety, and over advantages, BB102 shows promising efficacy to mutation-driven tumors, and is expected to benefit more cancer patients.