Core Insights - TIL cell therapy is emerging as a cornerstone drug for tumor immunotherapy, compatible with various drug forms, and is expected to follow PD-(L)1 antibodies as a new generation treatment [1][7] - The global TIL therapy market is projected to reach $1.04 billion in 2024, with estimates of $2.08 billion in 2025, $3.70 billion in 2026, and $5.98 billion in 2027 [1][7] - By 2030, the global TIL therapy market is expected to grow to $16.92 billion, with China's market reaching approximately $2 billion [1][7] TIL Therapy Industry Definition and Characteristics - TIL refers to immune cells present in the tumor microenvironment, including T cells, B cells, NK cells, and macrophages, which are crucial for anti-tumor immunity [2] - TIL therapy involves extracting TIL cells from a patient's tumor, expanding and activating them in a lab, and reinfusing them to enhance anti-cancer effects [3][5] TIL Therapy Clinical Trial Pipeline - As of December 2024, there are 88 TIL therapy pipelines in clinical trials globally, with 69.3% in Phase I, 15.9% in Phase I/II, 13.6% in Phase II, and 1.1% in Phase III [1][7][8] TIL Therapy Market Size and Growth - The TIL therapy market is rapidly expanding, with significant growth expected in the coming years, driven by increasing clinical trial activity and market demand [1][7][15] - The first TIL therapy in China is anticipated to enter the commercial market around 2027, with an estimated market size of $0.18 billion [1][7] TIL Therapy Industry Chain - The TIL therapy industry chain includes upstream components like cell culture media and equipment, midstream personalized drug production, and downstream applications in hospitals and treatment centers [8] Competitive Landscape - Several companies are actively developing TIL therapies, including Iovance Biotherapeutics, Obsidian Therapeutics, and Junshi Biosciences, with Junshi's GC101 being a leading candidate in China [9][11] Development Trends in TIL Therapy - TIL therapy is still in clinical trial stages, with ongoing research focused on improving efficacy, safety, and accessibility [15] - The industry is expected to see increased capital investment and innovation, with a focus on overcoming immune suppression in the tumor microenvironment [15]

Core Business and Business Model - Junshi Biosciences focuses on innovative cell therapies for solid tumors, with its core product being the world's first TIL therapy GC101, which does not require high-intensity lymphodepleting chemotherapy or IL-2 injections [1] - The company utilizes the DeepTIL™ cell enrichment and expansion platform and the NovaGMP™ non-viral vector gene modification technology to develop a pipeline of cell therapies targeting melanoma, non-small cell lung cancer, and cervical cancer [1] - As of June 2025, the company has five products in development, with GC101 in a critical Phase II clinical trial and GC203 in Phase I, but no products have been commercialized yet [1] - The business model is primarily based on self-research, aiming to convert personalized therapies into near-inventory products through a "time-segmented production process" to reduce costs, though this model remains theoretical and unverified [1] Financial Core Indicators - The company has experienced a continuous increase in net losses, with a pre-tax loss of 94.39 million yuan in 2023, expanding to 164 million yuan in 2024, a year-on-year increase of 73.4% [2] - R&D costs surged to 91 million yuan in 2024 (+58.0%), and administrative expenses rose to 24.75 million yuan (+88.3%) [2] - The liquidity ratio dropped significantly from 4.0 at the end of 2024 to 1.6 by June 2025, indicating a substantial weakening of short-term debt repayment capability [2] - Net debt increased from 138 million yuan in 2023 to 427 million yuan by June 2025, a rise of 209.9% [2] R&D Investment Concentration - In 2024, 66.5% (60.5 million yuan) of the 91 million yuan R&D investment was allocated to the core product GC101, which accounted for 58.7% of total R&D expenses by June 2025 [3] - The over-concentration of R&D resources on a single product poses a risk of significant sunk costs if GC101 fails in clinical trials or does not meet commercialization expectations [3] Clinical and Commercialization Risks - GC101's clinical data shows an overall response rate (ORR) of only 30% in Phase II trials for melanoma and 41.7% in Phase I trials for non-small cell lung cancer, which does not significantly outperform similar products in development [4][5] - The competitive landscape is intense, with 11 TIL therapies already in clinical stages globally, and the company faces challenges in demonstrating superior efficacy [4][5] Commercialization Outlook - The company aims to control the treatment cost of GC101 to within 500,000 yuan, but the personalized production nature of TIL therapies leads to high costs, with international counterparts priced above 400,000 USD (approximately 2.9 million yuan) [5] - Even if cost targets are met, the company faces pricing pressure from health insurance negotiations and patient payment capabilities, with a net cash outflow of 98.26 million yuan in 2024 [5] Supply Chain and Governance Risks - The top five suppliers accounted for 46.5% of total procurement in 2024, indicating a vulnerability in the supply chain, with the largest supplier contributing 27.3% [6] - The founder controls 34.5% of the shares, which raises governance risks related to decision-making and potential conflicts of interest, as well as concerns about the fairness of related party transactions [6] Industry Comparison - Compared to domestic TIL therapy companies, Junshi Biosciences has a lower absolute R&D investment, with 91 million yuan in 2024, compared to 123 million yuan by a competitor [7] - The company's cash reserves of 64 million yuan are only 34.6% of a competitor's 185 million yuan, which may hinder its ability to seize market opportunities [7] Conclusion - Junshi Biosciences presents both innovative potential and significant risks, with expanding net losses, deteriorating financial conditions, and concentrated supply chain and governance issues [8] - Investors are advised to closely monitor the critical Phase II clinical data for GC101 in 2026, the use of IPO fundraising, and progress in cost control before making investment decisions [8]