3D MEDICINES(01244): The results of a Phase III study of Enveda combined with GEMOX as first-line treatment for advanced bile duct cancer will be officially released at the 2026 ASCO Annual Meeting.

3D MEDICINES (01244) announced that a key clinical research result of the innovative immune new drug Envita (envolimab injection) has been successfully released at the 2026 American Society of Clinical Oncology (ASCO) annual meeting. Envita is the world's first subcutaneous injection PD-L1 inhibitor on the market, jointly developed by the company and Canjin Jerui Biopharmaceuticals (9966.HK). It is the world's first single-domain antibody for the treatment of tumors, with convenient administration and excellent safety. It has been approved for sale in China for four years, with cumulative sales exceeding 2 billion yuan. The rights in the United States, Japan, and Europe are actively being negotiated. Late-stage bile duct cancer has a poor prognosis, limited clinical treatment options, and huge unmet clinical needs. The publication of the data from this Phase III study will further validate the clinical value of this product in the field of liver and bile tumors, and further expand the market indication for sale in China. The study is a prospective, randomized, positive drug parallel-controlled, open-label multicenter Phase III pivotal trial, focusing on first-line treatment of late-stage bile duct cancer patients in China. Its aim is to evaluate the efficacy and safety of envelimab in combination with gemcitabine + oxaliplatin (GEMOX) regimen compared to the simple GEMOX regimen as a first-line treatment for BTC. This is a large-scale register clinical trial to achieve the expected survival benefit advantage of the first-line treatment of BTC with the global first subcutaneous PD-L1 monoclonal antibody + GEMOX target-free combination regimen. It will directly provide high-level evidence-based medicine for the clinical practice guidelines in China, help improve the strategy of immune combination therapy for Chinese BTC, and have significant scientific and clinical value.