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Innovent Gains Licensing Rights to Eli Lilly's Retsevmo, Cyramza in China

NEW YORK – Innovent Biologics and Eli Lilly on Monday expanded their partnership in China, giving Innovent sole rights to commercialize RET inhibitor Retsevmo (selpercatinib) and VEGFR2 inhibitor Cyramza (ramucirumab).

Innovent, based in Suzhou, China, also gained the right of first negotiation for potential future commercialization of Lilly's pirtobrutinib, a BTK inhibitor being studied in blood cancers, in mainland China.

Last year, Lilly submitted new drug applications in China for several Retsevmo indications including metastatic RET fusion-positive non-small cell lung cancer, adult and pediatric advanced or metastatic RET-mutant medullary thyroid cancer, and adult and pediatric patients with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory. China's National Medical Products Administration granted priority review for these applications.

This month, Cyramza was approved in China for second-line treatment of advanced gastroesophageal junction. In 2021, Lilly also submitted for approval of Cyramza as second-line treatment for advanced hepatocellular carcinoma, which is still under review.

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 to Lilly.

Pirtobrutinib is currently being studied in a Phase I/II trial in patients with chronic lymphocytic leukemia, small lymphocytic lymphoma, and mantle cell lymphoma.

The two companies began their collaboration in 2019 to jointly develop and commercialize PD-1 inhibitor Tyvyt (sintilimab). Tyvyt is approved in China for unresectable locally advanced or metastatic squamous NSCLC, relapsed or refractory classical Hodgkin lymphoma, and as a first-line treatment of nonsquamous NSCLC.

"Lilly and Innovent have jointly launched and marketed Tyvyt and Halpryza (rituximab biosimilar) successfully in China," Innovent Chairman and CEO Michael Yu said in a statement. "The addition of Cyramza and Retsevmo, two potential differentiated products, will potentially further expand our oncology portfolio to seven commercialized products by this year, enabling us to provide integrated patient solutions with strong portfolio synergies while enhancing our franchise in large cancer indications including NSCLC, GC and HCC, and potentially in hematological malignancies as well."