Innovent Biologics, Inc., a biopharmaceutical company that develops, manufactures and commercializes treatments for cancer, metabolic, autoimmune and other major diseases, and Eli Lilly and Co., expanded their strategic commercialization partnership in China.

Under the agreement, Innovent obtains the sole commercialization rights to import, market, promote, distribute Cyramza (ramucirumab) and Retsevmo (selpercatinib) once approved in China, and Innovent has the right of first negotiation for potential future commercialization of Pirtobrutinib in Mainland China.

Cyramza was the first U.S. FDA approved treatment for patients with advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma with disease progression on or after prior chemotherapy and the first FDA approved biomarker-driven therapy in patients with advanced hepatocellular carcinoma (HCC). In China, Cyramza (ramucirumab) in combination with paclitaxel was recently approved by NMPA for second-line treatment in patients with advanced or metastatic GEJ adenocarcinoma, making it the first and only drug approved for the second-line treatment of advanced gastric cancer in China. 

Retsevmo (selpercatinib) is a highly selective and potent rearranged during transfection (RET) inhibitor. It was approved by FDA, under the brand name Retevmo, as the first therapy specifically indicated for the treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC), and in patients with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy, and advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and  who are radioactive iodine-refractory. In China, the NDA for Retsevmo (selpercatinib) for the above indications was accepted by NMPA and granted priority review in August 2021.

In addition, Lilly has granted a right of first negotiation to Innovent for the potential future commercialization of pirtobrutinib in China. Pirtobrutinib is an investigational, oral, highly selective, non-covalent (reversible) Bruton’s tyrosine kinase (BTK) inhibitor being studied for the treatment of patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and mantle cell lymphoma (MCL).

Under the terms of the agreement, upon regulatory approvals of Cyramza in the hepatocellular carcinoma indication and Retsevmo in the non-small lung cancer indication, Innovent will make payments of $45 million in total and then intends to commercialize Cyramza and Retsevmo in China.