Group 1 - The core point of the news is that Sihuan Pharmaceutical (01244) has received acceptance from the National Medical Products Administration (NMPA) for the regular approval of Envita (generic name: Envafolimab injection), which was previously conditionally approved [1] - The application was submitted by Sichuan Sihuan Kangrui Pharmaceutical Co., Ltd., and the submission materials were completed and accepted on February 2, 2026 [1] Group 2 - Envita (generic name: Envafolimab injection) is a recombinant humanized anti-PD-L1 single-domain antibody Fc fusion protein developed by Kangning Jereh Biopharmaceutical (09966) and its subsidiaries, in collaboration with Sihuan Pharmaceutical since 2016 [2] - A cooperation agreement was signed on March 30, 2020, granting Jiangsu Xiansheng exclusive marketing rights for Envita in mainland China for oncology indications [2] - In January 2024, Sihuan Pharmaceutical entered into a licensing agreement with Kangning Jereh and Glenmark Specialty S.A., granting exclusive licensing rights for Envita in oncology indications across various regions including India, the Asia-Pacific (excluding Singapore, Thailand, and Malaysia), the Middle East, Africa, Russia, CIS countries, and Latin America [2] - Envita is the world's first subcutaneous PD-L1 inhibitor, which was approved by the NMPA in November 2021 for the treatment of adult patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) advanced solid tumors [2]
思路迪医药股份：恩维达 附条件批准转常规批准补充申请获NMPA正式受理