Suzhou, Jiangsu headquartered Innovent has ‘strong clinical development capabilities and a broad commercial footprint in China’. The two companies will accelerate the development and commercialization of two Sanofi key clinical stage oncology assets: Phase III SAR408701 (tusamitamab ravtansine; anti-CEACAM5 antibody-drug conjugate) and Phase II SAR444245 (non-alpha IL-2), combining with sintilimab, the leading checkpoint inhibitor in China.
In addition to the collaboration and license agreement, Sanofi will invest €300m ($307m) in Innovent through subscription of new common shares.
Sanofi’s sales in China reached €2.7bn ($2.8bn) in 2021, enjoying growth of 7.9%. Growth in Q4 was driven by Dupixent, Plavix and vaccine sales. However, the country represents a small slice of the company’s €37bn ($38.9bn) annual sales globally, which are focused in the US and Europe.
John Reed, M.D., Ph.D. Global Head of Research and Development at Sanofi, said: “This strategic collaboration with Innovent will not only accelerate the development, market access and future commercialization of two of our key oncology medicines in selected combinations with sintilimab, but also bolster our overall presence in oncology in China. We look forward to a successful partnership with Innovent, one of the most innovative companies in China, and to leveraging their development capabilities and market leadership in the country.”
In addition to the strategic multi-product collaboration and license agreement, Sanofi, subject to conditions precedent including regulatory approval and customary closing conditions, will invest in new common shares issued by Innovent for €300m. Subject to mutual agreement of both parties in the future, Sanofi will have the right to acquire additional Innovent new common shares for €300m.
SAR408701 (tusamitamab ravtansine) is a potential first-in-class antibody-drug conjugate (ADC) targeting CEACAM5 (carcinoembryonic antigen-related cell adhesion molecule 5), a cell-surface glycoprotein that is highly expressed in non-small cell lung cancer (NSCLC), gastric cancer and other cancers. SAR408701 is currently in a Phase 3 study for 2L NSCLC globally including China, and global Phase 2 studies in additional indications including 1L NSCLC, gastric cancers and other solid tumors.
According to the agreement, Innovent will be responsible for developing and exclusively commercializing tusamitamab in multiple oncology-based indications in China. Sanofi will be entitled to receive up to €80 million development milestone payment and royalties on the net sales of the product in China upon approval.
SAR444245 is a potential first-in-class reprogrammed, site-directed, single PEGylated, recombinant human IL-2 (rIL-2) variant with extended half-life that specifically binds to the low-affinity IL-2 receptor but lacks binding affinity for the αlpha chain of the high-affinity IL-2 receptor. SAR444245(IL-2) is currently under global Phase 2 studies for skin cancers, gastrointestinal cancer, NSCLC / mesothelioma, head and neck tumors, and lymphoma.
Innovent and Sanofi will jointly explore the development of SAR444245 in China in various cancer types, where Innovent will lead the clinical development. Sanofi remains the sole Marketing Authorization holder for both assets and will be fully responsible for SAR245 commercialization. Innovent will be entitled to receive up to €60 million development milestone payments and royalties on the net sales of the product in China upon approval.
Sintilimab, marketed as TYVYT (sintilimab injection) in China, is a PD-1 immunoglobulin G4 monoclonal antibody jointly developed by Innovent and Eli Lilly and Company and which has been approved for six indications in the country. Innovent is currently conducting more than 20 clinical studies of sintilimab to evaluate its safety and efficacy in a wide variety of cancer indications.