3D MEDICINES (01244) announced that the supplemental application for Envida® (generic name: Envafolimab Injection) to convert its conditional approval to full approval for the domestically produced drug has been formally accepted by the National Medical Products Administration (NMPA). The acceptance number is CYSB2600056, and the application specification is 200mg(1.0ml)/vial. This application was submitted by the company's Sichuan 3D Medicines Co., Ltd. The application materials were received and accepted for review on February 2, 2026. Envida® (generic name: Envafolimab Injection, original R&D code: KN035) is a recombinant humanized anti-programmed death-ligand 1 (PD-L1) single-domain antibody Fc fusion protein. Envida® was independently developed by Alphamab Oncology's exempted limited company and its subsidiaries (all being independent third parties), and has been co-developed with the company since 2016. On March 30, 2020, Jiangsu Alphamab Biopharmaceuticals Co., Ltd. (a wholly-owned subsidiary of Alphamab Oncology), 3D MEDICINES, and Jiangsu Simcere Pharmaceutical Co., Ltd. (a subsidiary of Simcere Pharmaceutical Group Limited) entered into a cooperation agreement. Under this agreement, Jiangsu Simcere was granted the exclusive marketing rights for Envida®'s oncology indications within mainland China, as well as a right of first refusal in the event of an out-license or transfer. In January 2024, the company entered into a license agreement with Alphamab Oncology and Glenmark Specialty S.A., whereby 3D MEDICINES and Alphamab Oncology agreed to grant Glenmark an exclusive license and sub-license for Envida®'s oncology indications to develop and commercialize Envida® for all fields of use in oncology in India, Asia Pacific (excluding Singapore, Thailand, and Malaysia), the Middle East and Africa, Russia, CIS countries, and Latin America. Furthermore, as the world's first subcutaneously injected PD-L1 inhibitor, it received marketing 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.