TIL(肿瘤浸润淋巴细胞)疗法，被科学界誉为"最懂肿瘤的免疫细胞"。它从患者自身的肿瘤组织中提 取、扩增再回输，如同一支经过特种训练的"精准卫队"，在晚期实体瘤治疗中展现出治愈性潜力。 然而，常规TIL疗法也面临由于其高度个性化的制备工艺流程所带来的高成本、长周期、显著毒性与高 临床管理门槛。君赛生物的核心突破在于底层平台的技术突围，构建DeepTIL细胞富集扩增平台、 NovaGMP非病毒载体基因修饰平台以及RiverTIL内生TIL平台几大技术支柱。 DeepTIL平台采用无滋养细胞培养工艺，在确保细胞活性的同时，大幅降低生产成本并摆脱了对高剂量 IL-2的依赖。这不仅从源头上提升了产品安全性，更使得治疗场景从重症监护降级至普通病房成为可 能，显著降低医院端的实施门槛。 NovaGMP平台则通过非病毒载体技术开发基因修饰TIL产品，在提升疗效潜力的同时，避免了病毒载体 高昂的成本与复杂工艺，为疗法的长期经济性奠定基础。 在此基础上，其重点产品如GC203(全球首创非病毒载体基因修饰TIL疗法)则聚焦于疗效提升，通过基 因修饰赋予TIL更强的肿瘤归巢、存活与免疫微环境重塑能力，旨在攻克更具挑战性的晚期实体瘤 ...

内容概要：TIL细胞疗法可与多种药物形式兼容，进一步提升疗效，有望成为继PD-(L)1抗体之后，新一 代肿瘤免疫治疗的基石药物。TIL疗法成为全球创新药领域近年冉冉升起的一颗新星。截至2024年12 月，全球共有88条TIL疗法管线处于临床试验阶段，其中，处于I期临床试验阶段占69.3%，处于I/II期临 床试验阶段占15.9%，处于II期临床试验阶段占13.6%，处于Ⅲ期临床试验阶段占1.1%。2024年全球TIL 疗法市场规模达到1.04亿美元，2025年、2026年、2027年预计分别约为2.08亿美元、3.70亿美元、5.98亿 美元。中国首款TIL疗法预计将于2027年前后进入商业市场，预计约0.18亿美元左右。预计2030全球TIL 疗法市场规模将达到16.92亿美元，中国TIL疗法市场规模将达到2亿美元。 相关企业：上海君赛生物科技有限公司、深圳沙砾生物科技有限公司、杭州厚无生物医药科技有限公 司、北京天科雅生物科技有限公司、苏州蓝马医疗技术有限公司、北京循生生物医学研究有限公司、广 州百吉生物制药有限公司、青岛华赛伯曼医学细胞生物有限公司、IovanceBiotherapeutics、 Obs ...

Core Viewpoint - The Hong Kong stock market for the biopharmaceutical sector is experiencing a surge in IPO activity, with several companies successfully passing hearings and submitting applications, indicating a positive market sentiment and growth potential in the industry [1][5]. Market Performance - Since December, companies like Jiahe Biotech, Hansai Aitai, Mingji Hospital, and Huazhang Biotech have progressed in the IPO process, while others like Hemei Pharmaceuticals and Gaoguang Pharmaceuticals have submitted their applications [1]. - On December 10, Baoji Pharmaceuticals debuted on the Hong Kong stock market, opening 129% higher and closing at HKD 69 per share, with a total market capitalization of HKD 22.493 billion [1]. - In the first three quarters of this year, 28 companies in the domestic healthcare sector went public, a 100% increase year-on-year, with over 40% being innovative drug companies [1]. Future Outlook - The primary market for biopharmaceutical IPOs in Hong Kong is expected to remain strong, with predictions that it will continue to be the preferred listing location for Chinese biotech companies through 2026 [1]. - The Hong Kong Securities and Futures Commission and the Hong Kong Stock Exchange have emphasized the importance of maintaining quality standards in IPO applications while encouraging market participation [1]. Innovation and Competition - The evaluation criteria for innovative drug companies are becoming more comprehensive, focusing on core R&D pipeline competitiveness, product commercialization progress, and profitability [3]. - Companies like Junshi Biosciences and Gaoguang Pharmaceuticals are advancing in business development (BD) collaborations, while others like Hemei Pharmaceuticals and Shiyao Innovation are entering commercialization phases [5][7]. Market Dynamics - The global market for Tumor Infiltrating Lymphocyte (TIL) therapy is projected to grow from USD 104 million in 2024 to USD 1.692 billion by 2030, with the first TIL therapy expected to enter the Chinese market around 2027 [5]. - The number of clinical trials for oncology conducted by Chinese companies has reached 39% of the global total, reflecting the competitive landscape in the oncology sector [6]. Financial Performance - Despite advancements, companies like Hemei Pharmaceuticals and Gaoguang Pharmaceuticals are facing profitability challenges, with reported losses of CNY 73 million and CNY 190 million, respectively, for the first half of 2025 [7]. - Shiyao Innovation, focusing on biopharmaceuticals, reported a net loss of CNY 226 million in the first seven months of 2025, highlighting the financial pressures in the sector [9]. A+H Listing Strategy - The trend of A+H dual listing is becoming more common among biopharmaceutical companies, with Shiyao Innovation exemplifying this strategy [9][10]. - Companies are increasingly cautious about market conditions, as seen with Baili Tianheng delaying its H-share IPO due to concerns over market sentiment and pricing [10][11]. Investment Sentiment - Investors are shifting focus from storytelling to data-driven approaches, emphasizing pipeline focus, data differentiation, and cash flow management to enhance company valuations [11].

君赛生物向港交所递交上市申请，中信证券为其独家保荐人。君赛生物是一家致力于实体瘤创新细胞疗 法与创新药开发的生物科技企业，专注开发更安全、更有效、更可及、更可负担的免疫细胞疗法。 TIL疗法是一项个性化疗法，其核心优势在于突破性的疗效，劣势在于制备工艺繁琐，临床方案复杂， 导致综合成本过高，可及性较低，限制其广泛应用。为了使高临床价值的TIL疗法惠及更广大患者，公 司实现从生产端到临床端的创新，在维持TIL疗法治癒性机会的前提下，简化生产工艺与临床方案，显 著提升TIL细胞疗法的安全性、可及性和可负担性。 近年来，全球肿瘤药物市场实现了强劲增长。2024年，该市场规模增至2533亿美元，2020年至2024年的 复合年增长率为13.9%。预计到2030年，市场规模将进一步扩大至4525亿美元，2024年至2030年的复合 年增长率为10.2%，到2035年，市场规模将达到7027亿美元，2030年至2035年的复合年增长率为9.2%。 2024年，中国肿瘤药物市场规模达到人民币2582亿元，2020年至2024年的复合年增长率为6.9%。未来 几年，该市场预计将加速增长，到2030年，市场规模将增至人民币52 ...

Core Viewpoint - The article discusses the limitations of current T cell-based immunotherapy strategies in treating solid tumors, primarily due to insufficient dendritic cell (DC) activity, particularly the conventional type 1 dendritic cells (cDC1) [2][3]. Group 1: Limitations of Current Therapies - CAR-T cell therapy has revolutionized cancer treatment, showing significant efficacy in B cell malignancies, but its effectiveness in solid tumors remains limited due to factors like poor tumor infiltration and immunosuppressive tumor microenvironment (TME) [3]. - T cell receptor (TCR) engineered T cells (TCR-T) and tumor-infiltrating lymphocytes (TIL) therapies show promising prospects in solid tumor treatment, highlighting the importance of DC-T cell interactions [3][4]. Group 2: Importance of Dendritic Cells - cDC1 cells are crucial for antigen cross-presentation and T cell activation, and the process of antigen spreading is vital for durable therapeutic efficacy [4]. - Manipulating dendritic cells to enhance polyclonal T cell responses is essential for improving cancer treatment outcomes [4]. Group 3: Recent Research Findings - A study published in Cell Reports Medicine demonstrated that engineered T cells overexpressing Flt3L and XCL1 can stimulate dendritic cell recruitment and enhance antigen spreading, leading to improved anti-tumor immunity [5][10]. - The research found that Tpex cells expressing XCL1 correlate with better prognosis and that the Flt3L-XCL1 signaling axis plays a key role in recruiting cDC1 cells [7][8]. Group 4: Implications for CAR-T Therapy - The engineered T cells (FX-T cells) significantly enhance dendritic cell migration and maturation, improving T cell interactions and leading to robust antigen spreading and effective polyclonal T cell responses [7][8]. - FX-modified CAR-T cells exhibited superior anti-tumor activity in both mouse and humanized mouse models, suggesting a promising new strategy for enhancing CAR-T therapy in solid tumors [8][10].