君赛生物递表港交所 面临10余款同类疗法竞争

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] Company Overview - Junshi Biosciences, established six years ago, focuses on innovative cell therapies and drug development for solid tumors [1] - The company has reported cumulative losses exceeding 350 million yuan from 2023 to the first half of 2025, with cash and cash equivalents at 63.635 million yuan as of June 30, 2025 [1][5] Product Pipeline - GC101, a TIL therapy, has shown an objective response rate (ORR) of 41.7% in patients with metastatic non-small cell lung cancer and 30% in advanced melanoma patients, positioning it as a potential first TIL therapy approved in China [1][3] - GC203, the world's first non-viral vector gene-modified TIL therapy, has demonstrated a 33.3% ORR in heavily pre-treated ovarian cancer patients [4] 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, outpacing global growth [4] Financial Challenges - The company has not yet generated product sales revenue and is experiencing increasing R&D expenditures, which reached 57.62 million yuan in 2023 and are projected to rise further [5] - Junshi Biosciences faces significant cash flow pressure due to ongoing losses and rising operational costs [5] Competitive Landscape - The TIL therapy market is highly competitive, with over ten similar therapies in development globally, including Iovance's approved product, Amtagvi [6] - Junshi Biosciences must continue to build advantages in clinical progress, efficacy data, and cost control to stand out in the competitive environment [6] Regulatory Environment - Positive signals from industry policies, such as breakthrough therapy designations and conditional approval processes, are accelerating the approval of innovative cell therapies in China [6]