Group 1 - The core point of the article is that the company has received FDA approval for the IND application of its self-developed biosimilar HLX17, which is a monoclonal antibody targeting PD-1, for use in various resected solid tumor patients [1] - HLX17 has potential indications including melanoma, non-small cell lung cancer, esophageal cancer, head and neck squamous cell carcinoma, colorectal cancer, hepatocellular carcinoma, cholangiocarcinoma, triple-negative breast cancer, microsatellite instability-high or mismatch repair-deficient tumors, and gastric cancer [1] - The mechanism of action involves blocking the interaction between PD-1 and its ligands PD-L1 and PD-L2, thereby enhancing the immune response against tumor cells [1] Group 2 - According to IQVIA MIDASTM data, the global sales of pembrolizumab (the original drug) are projected to be approximately $32.056 billion in 2024 [2]
复宏汉霖：帕博利珠单抗生物类似药HLX17(重组抗PD-1人源化单克隆抗体注射液)在多种已切除实体瘤患者中的临床试验申请获美国食品药品管理局批准