CSPHF - Week In Review: U.S. FDA Rejects Innovent/Lilly PD-1 NDA Based On China-Only Trial Subjects

• A US FDA oncology advisory panel rejected the NDA submitted by Innovent and Lilly for their partnered anti-PD-1 antibody, voting 14-1 against approval.
• Hangzhou's Huadong Medicine acquired Asia-Pacific (ex-Japan) rights to a bi-functional immunotherapy from Akso Biopharma of Menlo Park, CA, in a $75 million agreement.
• Suzhou CStone Pharma was approved to market Tibsovo (ivosidenib tablets) in China for adult patients with relapsed/refractory acute myeloid leukemia who have a susceptible IDH1 mutation.
• Ascletis, a Hangzhou pharma, announced the US FDA has approved the company's IND for its self-developed oral PD-L1 small molecule inhibitor.

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