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Yunnan Baiyao: INB301 Injection Granted FDA Clinical Trial Approval

K-LinePoet
Yunnan Baiyao Announcement: The company's application for a new drug clinical trial for INB301 injection has been approved by the U.S. Food and Drug Administration (FDA). The FDA has agreed to conduct the clinical trial, with the intended indication being tumor cachexia. INB301 injection is the first therapeutic biologically innovative drug developed by the company. Previously, it was accepted by the National Medical Products Administration and included in the 30-day expedited review and approval pathway for innovative drugs. On March 30, 2026, it received approval to conduct clinical trials. To date, this product has obtained clinical trial approvals in both China and the United States, and cumulative R&D investment has been approximately RMB 50.66.5 million.
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