思路迪医药股份(01244.HK)：恩维达附条件批准转常规批准补充申请获国家药品监督管理局正式受理

Core Viewpoint - The company has received conditional approval for its drug Envita (generic name: Enviroli monoclonal antibody injection) to transition to regular approval, with the application officially accepted by the National Medical Products Administration (NMPA) of China [1] Group 1 - The application for Envita was submitted by Sichuan Silu Kangrui Pharmaceutical Co., Ltd., a subsidiary of the company, and the submission materials were completed and accepted on February 2, 2026 [1] - Envita is a recombinant humanized anti-PD-L1 single-domain antibody Fc fusion protein, developed by CanSino Biologics and has been in collaboration with the company since 2016 [2] - A cooperation agreement was established in March 2020 between Jiangsu CanSino Biologics, the company, and Jiangsu Xiansheng Pharmaceutical, granting exclusive marketing rights for Envita in mainland China for oncology indications to Jiangsu Xiansheng [2] Group 2 - In January 2024, the company entered into a licensing agreement with CanSino and Glenmark Specialty S.A., granting exclusive licensing and re-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 [3] - Envita is the world's first subcutaneous PD-L1 inhibitor, which received approval from 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 [3]