Recently, Simcere Pharmaceutical Group (2096.HK)’s innovative oncology subsidiary, Simcere Zaiming, announced that the New Drug Application (NDA) for the subcutaneous PD-L1 antibody Envafolimab®—developed in collaboration with 3D Medicines Inc. (01244.HK) and Alphamab Oncology (9966.HK)—in combination with the gemcitabine and oxaliplatin (GEMOX) regimen as a first-line treatment for unresectable or metastatic biliary tract cancer has been accepted for review by the China National Medical Products Administration (NMPA). Envafolimab® is expected to become China’s first domestically developed PD-L1 antibody for first-line treatment of advanced biliary tract cancer, offering patients a new therapeutic option.
Biliary tract cancer, often referred to as the “king of cancer” comprises three major subtypes: intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer. It is a highly aggressive malignancy with a poor prognosis. The average 5-year survival rate is only 5%–15% and is even lower for patients with advanced disease, underscoring a significant unmet clinical need.
Envafolimab® is the world’s first subcutaneous injectable PD-L1 antibody. It exerts its anti-tumor activity by blocking the PD-1/PD-L1 interaction, thereby activating anti-tumor immune responses. With a molecular weight approximately half that of conventional antibodies, Envafolimab® demonstrates enhanced tissue penetration and reaches tumor sites via the lymphatic system. It also offers notable advantages in convenience and safety, eliminating the need for intravenous infusion and allowing administration in as little as 30 seconds. These features may be particularly beneficial for patients who are frail, elderly, or have experienced adverse reactions to intravenous infusions.
Envafolimab® was first approved in China on November 24, 2021, for the treatment of adult patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) advanced solid tumors. To date, it has been used to treat nearly 80,000 patients nationwide and has been incorporated into more than ten authoritative Chinese and international clinical guidelines and consensus documents, including those issued by CSCO and NCCN.
The randomized, parallel-controlled, multicenter Phase III clinical trial (KN035-CN-005) of Envafolimab® for Chinese patients with first-line advanced biliary tract cancer has been completed. In addition, Phase III studies evaluating Envafolimab® as neoadjuvant and adjuvant therapy for non-small cell lung cancer are progressing rapidly, with the aim of expanding its indications. Envafolimab® has received Breakthrough Therapy Designation from the NMPA for the treatment of unresectable or metastatic solid tumors with high tumor mutational burden (TMB-H) and has been granted three Orphan Drug Designations by the U.S. Food and Drug Administration for indications including advanced cholangiocarcinoma.