Yunnan Baiyao: INB301 Receives FDA Clearance for Clinical Trials in the U.S.
On June 3, Yunnan Baiyao announced that its Investigational New Drug (IND) application for INB301 Injection has received clearance from the U.S. Food and Drug Administration (FDA) to conduct clinical trials, with the proposed indication being cancer cachexia. According to the announcement, this is the first therapeutic biologic innovative drug developed by Yunnan Baiyao. On April 27, 2026, Yunnan Baiyao submitted the IND application for INB301 to the U.S. FDA. On June 2, 2026, INB301 received clinical trial clearance.
Previously, the IND application for INB301 was formally accepted by China’s NMPA on February 24, 2026, was included in the 30-day fast-track review and approval channel for innovative drugs, and subsequently received clinical trial approval on March 30, 2026.
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