Group 1 - The core point of the news is that Sihuan Pharmaceutical Holdings Group Ltd. has received acceptance from the National Medical Products Administration (NMPA) for the regular approval of Envita (generic name: Envafolimab injection) as a domestically produced drug supplement application [1][2] - The application was submitted by Sichuan Sihuan Kangrui Pharmaceutical Co., Ltd., a subsidiary of the company, and the acceptance number is CYSB2600056, with the application specification being 200mg (1.0ml) per bottle [1] - The application materials were completed and accepted for review 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 independently by Kanglong Chemical and its subsidiaries, in collaboration with the company since 2016 [2] - A cooperation agreement was signed on March 30, 2020, between Jiangsu Kanglong Chemical, Sihuan Pharmaceutical, and Jiangsu Xiansheng Pharmaceutical, granting Jiangsu Xiansheng exclusive marketing rights for Envita in mainland China for oncology indications [2] - In January 2024, the company entered into a licensing agreement with Kanglong Chemical and Glenmark Specialty S.A., granting Glenmark exclusive licensing and sublicensing rights for Envita in oncology indications across various regions, including India, the Asia-Pacific region (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(01244)：恩维达®附条件批准转常规批准补充申请获NMPA正式受理