君赛生物：聚焦实体瘤“免清淋”突破，GC101预计2026年提交上市申请

Core Viewpoint - Junshi Biosciences has submitted its prospectus to the Hong Kong Stock Exchange, aiming to list on the biotech board under Chapter 18A, focusing on innovative cell therapies and drug development for solid tumors [1][3]. Group 1: Product Development - Junshi Biosciences is developing GC101, the world's first TIL therapy that does not require high-intensity lymphodepletion chemotherapy or IL-2 administration, and GC203, the first non-viral vector gene-modified TIL cell drug [1][3]. - Clinical data shows that GC101 has an objective response rate (ORR) of 41.7% in patients with metastatic non-small cell lung cancer (NSCLC) who failed standard treatment, and a 30% ORR in patients with advanced melanoma [1][3]. - GC101 is expected to be the first TIL therapy approved for market in China, with plans to submit a Biologics License Application (BLA) in 2026 [2][4]. Group 2: Clinical Trials and Efficacy - In a study of 12 patients with metastatic NSCLC, GC101 demonstrated a 66.7% overall survival rate at 12 months, with a median follow-up of 13 months [2][4]. - The clinical trial for GC101 in melanoma is currently in a critical Phase II trial, while the NSCLC pipeline is in Phase Ib [2][4]. - GC101 has shown potential in treating various other malignancies, including cervical cancer, cholangiocarcinoma, colorectal cancer, breast cancer, head and neck squamous cell carcinoma, sarcoma, and gallbladder cancer [2][4]. Group 3: Financial Overview - The company's R&D expenses were 57.62 million yuan in 2023, projected to increase to 90.99 million yuan in 2024, with 52.8 million yuan spent in the first half of 2025 [5]. - The R&D costs related to core products account for 46% of the total expenses [5].