聚焦于FAK，打造起多功能产品组合以满足巨大的未满足医疗需求。 事实上， 根据灼识咨询的资料 ， 全球选择性 FAK抑制剂市场预计 将从 2026年起以71.1%的复合 年增长率在 2035年 增至 55.62亿美 元 ，中国 选择性 FAK抑制剂市场规模 则预计将从 2027年 起以 54.6% 的复合年增长率在 2035年 增至 15.71亿 美元 。这意味着，凭借 FDA 和 NMPA的 监管认可，以及在高发病率适应症领域的重要地位，应世生物已具备优势可在全球及中国选择性FAK 抑制剂市场中 占据 大量市场份额。 除核心产品外， 应世生物 具 有协同效应的管线 亦能 开发出 "同类最优"且"疾病领域最佳"的联合 治疗方案 ， 主要管线资产 还包括 IN10028、OMTX705、IN30758 以及 IN30778 ——其中， 第二代选择性 FAK抑制剂 IN10028旨在与不同的抗肿瘤药物联合使用 ，以保持在这一赛道的领先 地位 ，应世生物 预计今年 第四季度提交该候选产品的 IND申请 ， 首次人体临床试验 则 预计将于 2026年第一季度开始 。而另外三款 ADC 管线同样能够 形成机制互补 ： ...

在创新药投资的淘金浪潮中，真正值得长期押注的，永远是那些能够定义赛道、并拥有清晰商业化路径的破局者。 当行业从概念炒作回归价值本质，一家聚焦肿瘤耐药这一核心难题的生物科技公司——应世生物（InxMed Limited），正悄然临近它的价值兑现时刻。 不同于仍停留在故事阶段的Biotech，应世生物已凭借其核心产品ifebemtinib的突破性临床数据，即将迎来商业化阶 段。随着港股18A通道的推进，这家企业不再只是一个研发平台，而是一位手握王牌、战略清晰、即将推开商业化大 门的实力玩家。 当肿瘤耐药治疗成为下一代创新药的主战场，应世生物如何凭借其FAK抑制剂平台构建护城河？它的上市又将为行业 带来怎样的新叙事？ 创新药政策春风，肿瘤耐药治疗迎黄金发展期 从创新药行业表现来看，应世生物正在迎来其赛道的黄金发展期。 首先，政策与资本形成双轮驱动，为本土创新药企创造有利环境。 近年来，鼓励真创新的政策接连出台：药品集采规则持续优化，商业健康险的创新药目录有望推出，医保局探索 的"新药首发价格机制"更赋予创新药自主定价空间。审评审批效率也在不断提升，为具有明确临床价值的创新药铺设 了快速通道。 资本市场同样提供有力支 ...

Core Viewpoint - The Hong Kong stock market for innovative drug companies is experiencing a rebound, with significant gains in stocks such as ABL Bio, WuXi AppTec, Innovent Biologics, BeiGene, and others, alongside a more than 4% increase in the Hong Kong Innovative Drug ETF (513120) [1] Company Overview - Ying Shi Biotechnology submitted its application for a Hong Kong IPO on August 25, seeking to list under Chapter 18A, with CITIC Securities and Jianyin International as joint sponsors [3] - Founded in 2017 and headquartered in Nanjing, Ying Shi Biotechnology focuses on innovative drug development for cancer treatment, specifically addressing drug resistance caused by tumor defenses [3][7] - The company has raised funds through six financing rounds, with a post-money valuation of approximately $306 million (about 2.18 billion RMB) following its C round on August 22 [3] Product Pipeline - Ying Shi Biotechnology's product pipeline includes five candidates, with the core product ifebemtinib being a highly selective FAK inhibitor nearing commercialization [11][12] - Ifebemtinib is currently undergoing multiple clinical development projects in China and has received breakthrough therapy designation from the NMPA for three indications and fast track designation from the FDA for one indication [14] - The company also develops a second-generation selective FAK inhibitor (IN10028) and three antibody-drug conjugates (ADCs) [20][21] Market Context - The global cancer treatment market is projected to reach approximately $262.1 billion, with China's market estimated at $37.2 billion by 2024 [11] - The global selective FAK inhibitor market is expected to grow significantly, with a projected market size of $5.562 billion by 2035 and a compound annual growth rate of 71.7% starting in 2026 [17] Financial Performance - Ying Shi Biotechnology has not generated any revenue from product sales and has incurred losses of 252 million RMB over the past two years [23][24] - The company reported operating losses of 174 million RMB, 143 million RMB, and 27.5 million RMB for the years 2023, 2024, and the first quarter of 2025, respectively [24][25] - As of March 31, 2025, the company had cash and cash equivalents of 134 million RMB, with sufficient operating funds to cover costs for at least the next 12 months [25]

Core Viewpoint - 应世生物 has submitted its listing application to the Hong Kong Stock Exchange, with CITIC Securities and Jianyin International as joint sponsors, focusing on addressing tumor resistance issues in cancer treatment [1] Company Overview - 应世生物 is a biotechnology company specializing in cancer treatment, particularly targeting the FAK and integrin pathways, which are believed to play a crucial role in tumor cell survival and treatment failure [1] Product Pipeline - The product pipeline includes the core product ifebemtinib, a highly selective FAK inhibitor, along with the second-generation FAK inhibitor IN10028 and three innovative antibody-drug conjugates (ADCs) [1] - ifebemtinib has received breakthrough therapy designation from the NMPA and fast track designation from the FDA, indicating its potential as a cornerstone therapy for cancer treatment [1] Future Plans - 应世生物 plans to submit an IND application for IN10028 in 2025 and aims to initiate the first human clinical trial in the first quarter of 2026 [1]

Core Viewpoint - InxMed Limited is a late-stage clinical biotechnology company focused on improving cancer treatment options, particularly addressing drug resistance caused by tumor defenses [1][2]. Group 1: Company Overview - InxMed Limited was established in 2017 and is currently in the late clinical stage of development [1]. - The company aims to tackle core challenges in cancer treatment, specifically targeting key signaling pathways such as FAK and integrin pathways that play critical roles in tumor cell survival [1][2]. Group 2: Product Pipeline - The product pipeline includes: - Ifebemtinib, a highly selective FAK inhibitor nearing commercialization, which has received breakthrough therapy designation from NMPA for three indications and fast track designation from FDA for one indication, indicating its potential as a cornerstone therapy for cancer [2]. - IN10028, a second-generation selective FAK inhibitor aimed at maintaining a leading position in the market [2][3]. - Three innovative antibody-drug conjugates (ADCs): - OMTX705, targeting CAFs in the tumor microenvironment, showing synergy with anti-PD-1 therapies [2]. - IN30758, focusing on upstream FAK signaling pathways, which works synergistically with FAK inhibitors [2]. - IN30778, targeting unique tumor-associated antigens expressed in various solid tumors [2]. Group 3: Financial Performance - Financial results for the fiscal years ending March 31 are as follows: - 2023: Net income of approximately -392,000 RMB - 2024: Net income of approximately 2.472 million RMB - 2025: Net income of approximately 1.603 million RMB - The company reported losses of approximately -209 million RMB, -185 million RMB, and -3.369 million RMB for the same periods [3].

Core Viewpoint - InxMed Limited, a late-stage biotech company focused on improving cancer treatment, has submitted its listing application to the Hong Kong Stock Exchange, with CITIC Securities and CCB International as joint sponsors [1][3]. Company Overview - InxMed Limited was established in 2017 and aims to address the core challenges of cancer treatment, particularly drug resistance caused by tumor defenses [1][3]. - The company focuses on key signaling pathways common across various tumor types, especially the FAK and integrin pathways, which play critical roles in tumor cell survival [3]. Product Pipeline - The product pipeline includes: - **Ifebemtinib**: A highly selective FAK inhibitor nearing commercialization, currently undergoing multiple clinical development projects in China. It has received breakthrough therapy designation from NMPA for three indications and fast track designation from FDA for one indication, indicating its potential as a cornerstone therapy for cancer [3][4]. - **IN10028**: A second-generation selective FAK inhibitor aimed at maintaining a leading position in the field, with an IND application expected to be submitted by 2025 and first human clinical trials anticipated to start in Q1 2026 [4]. - **Three innovative antibody-drug conjugates (ADCs)**: - **OMTX705**: Targets CAFs in the tumor microenvironment and shows synergy with various therapies, including anti-PD-1 [3]. - **IN30758**: Focuses on upstream signaling pathways of FAK, showing synergy with FAK inhibitors [3]. - **IN30778**: Targets unique tumor-associated antigens that are highly expressed in various solid tumors [3]. Financial Overview - Financial performance for the three months ending March 31 for the years 2023 to 2025 shows: - Net other income/loss: -392 thousand RMB in 2023, 2,472 thousand RMB in 2024, and 397 thousand RMB in 2025 [5]. - Administrative expenses: -38,104 thousand RMB in 2023, -45,071 thousand RMB in 2024, and -9,866 thousand RMB in 2025 [5]. - R&D expenses: -135,517 thousand RMB in 2023, -99,999 thousand RMB in 2024, and -17,207 thousand RMB in 2025 [5]. - Operating loss: -174,013 thousand RMB in 2023, -142,598 thousand RMB in 2024, and -26,676 thousand RMB in 2025 [5]. - Net loss for the year: -209,249 thousand RMB in 2023, -184,619 thousand RMB in 2024, and -29,712 thousand RMB in 2025 [5].

智通财经APP获悉，据港交所8月25日披露，应世生物(InxMed Limited)向港交所主板递交上市申请，中信证券和建银国际为其联席保荐人。据招股书，应世 生物是一家于2017年成立的处于临床后期阶段的生物科技公司，致力于改进目前疗效有限的肿瘤治疗方案。公司的使命是解决肿瘤治疗的核心挑战-由肿瘤 防御所引起的耐药。 招股书显示，应世生物聚焦于多种肿瘤类型共有拥有的关键讯号传导枢纽，尤其是 FAK及整合素通路，它们在肿瘤细胞存活中发挥关键作用，并导致不同 治疗案失败。同时，应世生物通过靶向CAFs来拆除肿瘤细胞周围的保护屏障。通过靶向耐药关键通路，应世生物为重塑癌症治疗合理用药方案，开辟治疗 创新的新前沿。 据应世生物在招股书中或存在的风险因素中提到，公司在很大程度上依赖于候选产品的成功。倘若无法成功完成临床开发或实现临床阶段及临床前阶段产品 线的商业化，或者倘若在上述任何环节遇到重大延误或成本超支，则公司的业务及前景可能会受到重大不利影响。 截至最后实际可行日期，应世生物的产品管线包括：(i)核心产品ifebemtinib (一种接近商业化的高选择性FAK抑制剂)，其正在中国进行多项临床开发项目;其 针对 ...