The China NMPA Approves Selpercatinib for the Treatment of Patients with RET-driven Lung and Thyroid Cancers

Innovent Biologics, Inc. a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune, ophthalmology and other major diseases, is pleased to see that the National Medical Products Administration (NMPA) of China has approved the New Drug Application (NDA) for selpercatinib (40mg & 80mg capsules) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, adult and pediatric patients 12 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation who require systemic therapy, and adult and pediatric patients 12 years of age and older with advanced or metastatic thyroid cancer (TC) with a RET gene fusion who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).

Selpercatinib is a selective and potent RET kinase inhibitor that was discovered and developed by Eli Lilly and Company. In March 2022, Innovent and Lilly expanded their strategic partnership in oncology, which includes an agreement for Innovent to obtain the sole commercialization rights of selpercatinib once approved in China, positioning Innovent to be fully responsible for the pricing, importation, marketing, distribution and detailing of this product. With this further expanded oncology product portfolio, Innovent intends to use its experienced oncology commercial team to leverage its broad commercial coverage in hospitals and pharmacies at various tiers and to provide integrated patient solutions with strong synergies to cancer patients in China.

Selpercatinib was globally the first RET inhibitor granted accelerated approval by the FDA in May 2020, under the brand name Retevmo. In November 2021, the NDA for selpercatinib was accepted by the Center for Drug Evaluation (CDE) of NMPA in China and was granted priority review to expedite the review process. The NDA approval was based on data from the global LIBRETTO-001 study and data from the Chinese patient population in the LIBRETTO-321 study.

Selpercatinib was evaluated in the Phase I/II LIBRETTO-001 study, the largest clinical trial ever reported in patients with RET-driven cancers. The major efficacy outcome measures were confirmed overall response rate (ORR) and duration of response (DoR). The updated results of patients with NSCLC and medullary thyroid cancer were presented at the European Lung Cancer Congress (ELCC) 2022 and the European Society for Medical Oncology (ESMO) Congress 2022, respectively.