ENVIDA Conditional Approval Converted to Regular Approval Supplementary Application Accepted by NMPA Officially

The domestic production drug supplementary application of Envida (generic name: Envorlimab Injection) has been officially accepted by the National Medical Products Administration (NMPA) and the acceptance number is CYSB2600056. The application specification is 200mg (1.0ml) per bottle. This application was submitted by Sichuan Silu Kangrui Pharmaceutical Co., Ltd., a company under 3D MEDICINES. The application materials were received and accepted for review on February 2, 2026. Envida (generic name: Envorlimab Injection, original research code: KN035) is a recombinant humanized anti-programmed death ligand 1 (PD-L1) monovalent antibody Fc fusion protein. Envida was independently developed by Corning Jerry Biological Pharmaceuticals Ltd. (09966) and its affiliates (both independent third parties) and has been in cooperation with the company since 2016. On March 30, 2020, Jiangsu Corning Jerry Biological Pharmaceuticals Co., Ltd. (a wholly-owned subsidiary of Corning Jerry), Silu Di Pharmaceuticals and Jiangsu SIMCERE PHARMA Co., Ltd. (a subsidiary of SIMCERE PHARMA Group Co., Ltd.) entered into a cooperation agreement. According to this agreement, Jiangsu Xiansheng was granted the exclusive marketing rights for Envida in mainland China for oncology indications and priority rights to license or transfer externally. In January 2024, the company entered into a license agreement with Corning Jerry and Glenmark Specialty S.A. (Glenmark), whereby Silu Di Pharmaceuticals and Corning Jerry agreed to grant Glenmark exclusive license and sublicensing rights for Envida oncology indications, including development and commercialization in the field of oncology in India, Asia Pacific (excluding Singapore, Thailand, and Malaysia), Middle East and Africa, Russia, CIS countries, and Latin America. In addition, as the world's first subcutaneous injection PD-L1 inhibitor, it was approved by the National Medical Products Administration in November 2021 for the treatment of adult patients with unresectable or metastatic microsatellite-high (MSI-H) or mismatch repair-deficient (dMMR) advanced solid tumors.