News Release

While we are disappointed with the outcome of today’s ODAC as it relates to the investigational product sintilimab, we appreciated the opportunity to publicly discuss the application and broader issues related to single-country clinical trials. We had hoped that sintilimab could have played a positive role for patients and the U.S. healthcare system through an aggressive pricing strategy. We acknowledge that the landscape has changed dramatically on a number of fronts since the ORIENT-11 study was conducted and the sintilimab application was initiated. Lilly wholeheartedly agrees with the importance of ethics in clinical trial conduct and clinical trial diversity. We have long-standing initiatives in place to advance diversity and inclusion in Lilly-conducted clinical trials. Along with Innovent, we will continue to work with the FDA as it completes its review of the sintilimab application.

Lilly remains committed to bringing forward medicines with the potential to meaningfully improve treatment paradigms for patients with cancer.

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