Sanofi and Innovent Biologics (Innovent) have announced they will work together to bring innovative medicines to patients in China with complex cancers.
Innovent is a biopharmaceutical company with proven clinical development capabilities and a broad commercial footprint in China. It has teamed up with Sanofi in a commitment to accelerate the development and commercialisation of two key Sanofi clinical stage oncology assets.
These include its phase 3 SAR408701 (tusamitamab ravtansine, anti-CEACAM5 antibody-drug conjugate) and its phase 2 SAR444245 (non-alpha IL-2), combining with Tyvyt (sintilimab), the leading checkpoint inhibitor in China.
John Reed, global head of research and development at Sanofi, said: “This strategic collaboration with Innovent will not only accelerate the development, market access and future commercialisation of two of our key oncology medicines in selected combinations with sintilimab, but also bolster our overall presence in oncology in China.”
SAR408701 is a potential first-in-class antibody-drug conjugate (ADC) targeting 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.
SAR444245 is a potential first-in-class reprogrammed, site-directed, single PEGylated, recombinant human IL-2 (rIL-2) variant that is currently under global phase 2 studies for skin cancers, gastrointestinal cancer, lymphoma, NSCLC and mesothelioma, head and neck tumours.
Tyvyt (sintilimab injection) is a PD-1 immunoglobulin G4 monoclonal antibody jointly developed by Innovent and Eli Lilly, with Innovent currently overseeing more than 20 clinical studies to evaluate the drug’s safety and effectiveness in a wide variety of cancer indications.
In China, Tyvyt has been approved for six indications, including relapsed or refractory classic Hodgkin’s lymphoma, first-line treatment of non-squamous NSCLC, first-line treatment of squamous NSCLC, first-line treatment of hepatocellular carcinoma, first-line treatment of oesophageal squamous cell carcinoma, and first-line treatment of gastric or gastroesophageal junction adenocarcinoma.
In addition to the collaboration and licence agreement, Sanofi will invest an additional €300m in Innovent through the subscription of new common shares.
According to the agreement, Innovent will be responsible for developing and exclusively commercialising tusamitamab in multiple oncology-based indications in China. Sanofi will be entitled to receive up to €80m in development milestone payments and royalties on the net sales of the product in China upon approval.
Sanofi remains the sole marketing authorisation holder for both assets and will oversee SAR245 commercialisation. Innovent will be entitled to receive up to €60m development milestone payments and royalties on the net sales of the product in China, subject to approval.