3D Medicines Inc. (思路迪医药股份有限公司, Stock Code: 1244) announced that the National Medical Products Administration (NMPA) has officially accepted the supplemental application for 恩維達® (Envafolimab) to transition its status from conditional approval to regular approval. The accepted specification is 200mg (1.0ml) per vial, with the acceptance number CYSB2600056. The application was submitted by 3D Medicines (Sichuan) Co., Ltd., and the relevant materials were formally accepted for review on February 2, 2026.

Envafolimab (code: KN035) is a recombinant single domain antibody against PD-L1 fused with human Fc, co-developed since 2016 by Alphamab Oncology (Stock Code: 9966) and 3D Medicines. It has been conditionally approved in China since November 2021 as the first subcutaneous PD-L1 inhibitor for adult patients with advanced solid tumors displaying microsatellite instability-high (MSI-H) phenotype/mismatch-repair deficiency (dMMR).

In accordance with prior agreements, Jiangsu Simcere Pharmaceutical Co., Ltd. has exclusive marketing rights for oncology indications of Envafolimab in mainland China, while Glenmark Specialty S.A. has been granted an exclusive license to develop and commercialize Envafolimab in various international territories.

A cautionary statement accompanying this announcement notes that the potential for successful development and marketing of Envafolimab for indications beyond advanced MSI-H/dMMR solid tumors remains subject to further regulatory and clinical developments. The official announcement was issued on February 9, 2026.