君赛生物赴港IPO：聚焦实体瘤“免化疗”突破，GC101冲刺国内首个TIL疗法获批席位

Core Viewpoint - Junshi Biosciences has submitted its IPO application to the Hong Kong Stock Exchange, aiming to enter the biotech sector with its innovative TIL therapies, GC101 and GC203, which show promising clinical results in treating solid tumors [1][2]. Company Overview - Junshi Biosciences, established six years ago, focuses on innovative cell therapies and drug development for solid tumors [1]. - The company has developed GC101, the first TIL therapy that does not require high-intensity chemotherapy or IL-2 administration, and GC203, the first non-viral vector gene-modified TIL therapy [1][4]. Clinical Data - GC101 has shown an objective response rate (ORR) of 41.7% in patients with metastatic non-small cell lung cancer and 30% in patients with advanced melanoma [1][3]. - The therapy is currently undergoing critical clinical trials, with plans to submit a Biologics License Application (BLA) by 2026 [3]. Financial Performance - The company reported cumulative losses exceeding 350 million yuan from 2023 to mid-2025, with cash and cash equivalents at only 63.63 million yuan as of June 30, 2025 [1][5]. - R&D expenses have been increasing, with 57.62 million yuan in 2023, projected to rise to 90.99 million yuan in 2024 [5]. Market Potential - The global TIL therapy market is expected to reach $4.5 billion by 2035, with China's market projected to grow at a compound annual growth rate (CAGR) of 40% from 2030 to 2035 [4]. - Junshi's products are positioned to capitalize on this growth trend, especially with the anticipated lower treatment costs compared to imported therapies [3][4]. Competitive Landscape - The company faces competition from over ten similar TIL therapies currently in development, including IOVANCE's approved product in the U.S. [6]. - Junshi must continue to build advantages in clinical progress, efficacy data, and cost control to stand out in a rapidly evolving market [6]. Regulatory Environment - Positive signals from industry policies, such as breakthrough therapy designations and conditional approval processes, are expected to accelerate the approval of innovative cell therapies [6].