Innovent, Lilly Expand Oncology Partnership in China

Innovent Biologics, Inc., biopharma company that develops, manufactures, and commercializes medicines for the treatment of cancer, metabolic, autoimmune, and other major diseases, and Eli Lilly and Company have expanded their commercialization partnership in China.

Per the deal, Innovent will obtain the sole commercialization rights to import, market, promote, distribute and detail Lilly’s branded forms of ramucirumab (Cyramza) and selpercatinib (Retsevmo) once approved in China, along with a right of first negotiation granted to Innovent for potential future commercialization of Pirtobrutinib—an investigational, oral, highly selective, non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor that is currently being studied for the treatment of patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and mantle cell lymphoma (MCL).

According to Lilly, Cyramza was the first 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).

Retsevmo 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), adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy, and adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who need systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). In China, the new drug application (NDA) for Retsevmo for the above indications was accepted by China’s National Medical Products Administration (NMPA) and granted priority review in August 2021.

The agreement also states that, 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 plans to commercialize Cyramza and Retsevmo in China.