Core Insights - In the wave of investment in innovative drugs, companies that can define their niche and have a clear commercialization path are the ones worth long-term investment [1] - InxMed Limited, focusing on the core issue of tumor resistance, is approaching its value realization moment with its core product ifebemtinib showing breakthrough clinical data [1][2] - The company is transitioning from a research platform to a strong player ready for commercialization as the Hong Kong Stock Exchange's Chapter 18A progresses [1] Industry Overview - The innovative drug sector is experiencing a golden development period, driven by supportive policies and capital [2] - Recent policies encouraging true innovation include optimized drug procurement rules and the potential introduction of a new drug pricing mechanism, enhancing the environment for local innovative drug companies [2] - The capital market is also supportive, with the average stock price increase of 185% for Chapter 18A companies reflecting renewed market confidence in the innovative drug sector [2] Clinical Demand - The tumor resistance market presents a vast growth opportunity, becoming a core growth point for the future [3] - Resistance is a common and severe challenge in cancer treatment, necessitating therapies that can overcome or delay resistance to improve patient survival and quality of life [3] - FAK signaling pathways are seen as a key to addressing resistance, with FAK inhibitors expected to enhance the efficacy of other treatments [3] Market Potential - The global selective FAK inhibitor market is projected to reach approximately $5.56 billion by 2035, with a compound annual growth rate (CAGR) of 71.7% starting in 2026 [4] - The Chinese market is also promising, with the first FAK inhibitor expected to be approved by 2026, potentially reaching a market size of about $1.57 billion by 2035 [4] Competitive Landscape - Currently, only one selective FAK inhibitor is expected to receive FDA approval by 2025 for a small indication, with InxMed's ifebemtinib leading in clinical progress and facing relatively low competitive pressure [8] Product Pipeline - InxMed's core product ifebemtinib has received three breakthrough therapy designations, highlighting its significant clinical advantages and regulatory recognition [13] - Clinical data shows ifebemtinib's objective response rate (ORR) of 40.7% in platinum-resistant recurrent ovarian cancer, with a median progression-free survival (mPFS) of 7.5 months [13] - The company is also developing a second-generation FAK inhibitor and innovative ADC drugs, creating a layered product matrix [14] Financial Position - As of March 31, 2025, InxMed had approximately 134 million yuan in cash and equivalents, supported by a recent C-round financing of about 164 million yuan [19] - The company plans to use IPO proceeds to support the commercialization of ifebemtinib and further research and development [19] Future Outlook - With the commercialization process underway, InxMed is expected to gradually achieve self-sustaining capabilities [20] - The ongoing development of its product pipeline and the deepening of the FAK inhibitor combination therapy platform will support its transition from a biotech to a biopharma company [20]

Investment Rating - The report maintains a "Buy" rating for the company, indicating an expected relative performance increase of over 15% compared to the benchmark index within the next 6 to 12 months [23]. Core Insights - The company is transitioning from a biotech to a biopharma entity, with a focus on its first commercialized product, Aorebatinib, and the promising APG-2575, which is expected to partially replace and surpass Venetoclax in the large MDS and MM markets [4][21]. - APG-2575 is positioned as a potential "Best-in-Class" BCL-2 inhibitor, with unique clinical data supporting its convenient dosing regimen and improved safety profile compared to existing treatments [14][18]. - The company has a robust pipeline with multiple promising candidates, including APG-2449 and various apoptosis pathway inhibitors, which are expected to enhance its market position and growth potential [15][18]. Summary by Sections Financial Forecasts and Valuation - The company is projected to achieve revenues of 589 million, 1.509 billion, and 1.449 billion yuan for the years 2025 to 2027, with growth rates of -40%, 156%, and -4% respectively [4][21]. - The net profit attributable to the parent company is expected to be -681 million, 196 million, and 156 million yuan for the same period, indicating a significant turnaround [4][21]. - Earnings per share (EPS) are forecasted to improve from -1.83 yuan in 2025 to 0.42 yuan in 2027 [4][21]. Product and Market Insights - Aorebatinib's sales are expected to continue growing, with a 93% year-on-year increase to 217 million yuan in the first half of 2025, driven by effective hospital access and chronic disease management strategies [7][11]. - APG-2575 is anticipated to receive regulatory approval in mid-2025, further solidifying the company's leadership in the domestic hematological oncology market [11][12]. - The report highlights the potential of APG-2575 to achieve rapid relief and improved safety in treating high-risk myelodysplastic syndromes (HR MDS) compared to existing therapies [14][18]. Pipeline and Future Developments - The company has several promising candidates in its pipeline, including APG-2449, which is undergoing Phase III trials for ALK-positive NSCLC, and various apoptosis inhibitors that are expected to provide competitive advantages in the oncology market [15][18]. - Upcoming milestones include the completion of several Phase III clinical trials for key products, which are expected to enhance the company's market presence and revenue potential [20].

Core Viewpoint - The enthusiasm for innovative drug companies entering the Hong Kong stock market continues, with Ying Shi Biotech being a recent applicant focusing on cancer drug development [1] Company Overview - Ying Shi Biotech was founded in 2017 and specializes in the research and development of new cancer drugs, led by founder Wang Zaiqi, who has extensive experience in multinational pharmaceutical companies [1][2] - The company has completed six rounds of financing totaling $130 million, with a post-C round valuation of $306 million [1] Market Context - In 2023, Ying Shi Biotech began preparations for its IPO, but faced challenges due to policy changes affecting unprofitable biotech companies in China [2] - The market has since recovered, with 60 healthcare companies applying for listing on the Hong Kong Stock Exchange, over 50% of which are innovative drug companies [2] Product Focus - Ying Shi Biotech is developing Ifebemtinib, a FAK (Focal Adhesion Kinase) small molecule inhibitor, targeting the issue of drug resistance in cancer treatment [2][4] - The company aims to address the common problem of drug resistance, which affects 80%-90% of cancer patients, by inhibiting FAK to disrupt cancer cells' defense mechanisms [4][5] Clinical Development - Ifebemtinib has shown promising results in clinical trials, particularly in combination with chemotherapy for platinum-resistant recurrent ovarian cancer, achieving an objective response rate (ORR) of 40.7% [5] - The drug has received breakthrough therapy designation from the FDA and the NMPA, with plans to submit a marketing application by the end of this year or early next year [5][6] Commercialization Strategy - Ying Shi Biotech has not yet achieved profitability, with operating losses of 174 million yuan, 143 million yuan, and 27.5 million yuan in 2023, 2024, and Q1 2025, respectively [6] - The company is building a sales team and collaborating with top hospitals to facilitate commercialization, while also exploring partnerships with established contract sales organizations (CSOs) [6][7] Competitive Landscape - The FAK inhibitor market is relatively new, with limited competition, as the first FAK inhibitor for ovarian cancer was only approved by the FDA in May 2023 [6][7] - The potential for Ifebemtinib in combination therapies may provide a competitive edge, as it can enhance the efficacy of existing treatments without direct competition [7][8]

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 ...