Sanofi China’s relationship and cooperation with cemiplimab

The cooperation between Sanofi (Sanofi China) and cemiplimab (Cemiplimab, trade name Libtayo®) is mainly carried out through a joint R&D and commercialization agreement with the US Regeneron (Regeneron) in the field of immuno-oncology. The agreement was originally signed in 2015 to jointly promote the development and marketing of Cemiplimab, with Sanofi responsible for operations outside the United States and Regeneron primarily responsible for the U.S. market.

During the cooperation, Sanofi actively participated in the clinical advancement and approval process of Cemiplimab for various cancer indications. In 2018, Sanofi and Regeneron jointly increased investment to promote the expansion of indications of the drug in cutaneous squamous cell carcinoma (CSCC), non-small cell lung cancer (NSCLC) and other fields, and launched multiple key clinical trial projects, showing strong strategic intent. Recently, in 2024, Libtayo jointly promoted by them was approved in the EU for the treatment of basal cell carcinoma (BCC) and first-line NSCLC, further demonstrating the results of cooperation.

However, starting from2022, the cooperation model between Sanofi and Regeneron will undergo major adjustments. The two parties signed an agreement under which Sanofi will transfer all of its global rights and interests in Cemiplimab to Regeneron. In return, Regeneron will pay an upfront payment of approximately $900 million, and will pay Sanofi royalties and subsequent milestone payments of 11% of global net sales. The reorganization means that Regeneron will obtain exclusive global development, production and sales rights for the product, while Sanofi will continue to participate in the form of financial benefits.

For Sanofi China, this change means that the future promotion and localization services of Cemiplimab will rely on Regeneron’s global strategy and supply chain. Although Sanofi has withdrawn from its shareholding and operating decisions, it can still benefit from royalties and continue to use its marketing network in China to help patients obtain medication opportunities. On the whole, from early joint development to late-stage rights transfer, the cooperation between Sanofi and Regeneron reflects the professional collaborative path of large pharmaceutical companies sharing risks and benefits in the field of innovative immunotherapy.

Reference materials:https://www.libtayohcp.com/