Core Viewpoint - Corning Jereh Pharmaceutical-B (09966.HK) has announced that the National Medical Products Administration of China has officially accepted the New Drug Application (NDA) for KN035 (Envafolimab injection) in combination with GEMOX for the first-line treatment of unresectable or metastatic biliary tract cancer (BTC) [1] Group 1 - The acceptance of the NDA is based on the results of a Phase III clinical trial (KN035-CN-005), which is a randomized, parallel-controlled, multi-center study designed for advanced first-line BTC patients in China [1] - The trial aims to evaluate the efficacy and safety of KN035 in combination with the GEMOX regimen compared to the GEMOX regimen alone [1] Group 2 - KN035 (Envafolimab injection) is a recombinant humanized anti-PD-L1 single-domain antibody Fc fusion protein, developed independently by the company in collaboration with Suzhou Innovent Biologics since 2016 [2] - In March 2020, a cooperation agreement was established between the company's wholly-owned subsidiary Jiangsu Corning Jereh Biopharmaceutical Co., Ltd., Jiangsu Xiansheng Pharmaceutical Co., Ltd., and Suzhou Innovent Biologics, granting Jiangsu Xiansheng exclusive marketing rights for KN035 in oncology indications in mainland China [2] - In January 2024, a licensing agreement was signed with Suzhou Innovent Biologics and Glenmark Specialty S.A., granting Glenmark exclusive licensing and sublicensing rights for KN035 in oncology indications across various regions including India, the Asia-Pacific (excluding Singapore, Thailand, and Malaysia), the Middle East and Africa, Russia, CIS countries, and Latin America [2] Group 3 - KN035 is the world's first subcutaneous PD-L1 inhibitor, which was approved by the National Medical Products Administration 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]
康宁杰瑞制药-B(09966.HK)：KN035一线治疗BTC的NDA已获国家药监局受理