Core Viewpoint - The China Securities Regulatory Commission (CSRC) has published supplementary material requirements for five companies, including Yingshi Biotechnology, which is preparing for an IPO in Hong Kong. The CSRC has requested clarifications on various compliance and operational matters related to the company's offshore structure and shareholder changes [1][2]. Group 1: Compliance and Regulatory Requirements - The CSRC requires Yingshi Biotechnology to clarify the compliance of its offshore structure and return investment, including details on foreign exchange management, overseas investment, and tax management [1]. - The company must provide a legal opinion on the pricing basis and payment methods for acquiring domestic operating entities, ensuring compliance with regulations regarding foreign investment mergers [1][2]. - The CSRC has requested a review of the stock options granted to external consultants and the legality of shareholder structures, particularly regarding any prohibited entities [2]. Group 2: Shareholder and Equity Changes - Yingshi Biotechnology is required to explain the rationale behind the recent equity changes, including the pricing of new shareholders and any discrepancies in investment amounts [2]. - The company must clarify the reasons for capital reduction in its Nanjing entity and ensure compliance with relevant laws regarding capital contributions and tax payments [2][3]. - A review of historical equity changes in the domestic operating entities is necessary to confirm their legality and compliance with regulations [3]. Group 3: Business Operations - The company must detail its business scope and operations, particularly regarding its involvement in human stem cells and gene therapy, ensuring compliance with foreign investment policies [3]. - Financial data, including net asset figures, must be supplemented in the filing report to meet regulatory requirements [3]. - The company is required to explain any inconsistencies between the issuance plan and the materials submitted for the IPO [3]. Group 4: Product Pipeline and Innovation - Yingshi Biotechnology's product pipeline includes ifebemtinib, a highly selective FAK inhibitor nearing commercialization, with multiple clinical projects in China and breakthrough therapy designations from NMPA and FDA [4]. - The pipeline also features IN10028, a second-generation selective FAK inhibitor, and three innovative antibody-drug conjugates (ADCs) targeting tumor microenvironments and enhancing treatment efficacy [4].

Core Viewpoint - The China Securities Regulatory Commission (CSRC) has published supplementary material requirements for five companies, including Yingshi Biotechnology, which is preparing for an overseas listing. The CSRC has requested clarifications on various compliance and operational matters related to the company's offshore structure and shareholder changes [1][2]. Group 1: Compliance and Regulatory Requirements - The CSRC requires Yingshi Biotechnology to clarify the compliance of its offshore structure and return investment, including details on foreign exchange management, overseas investment, and tax management [1]. - The company must provide a legal opinion on the pricing basis, payment methods, and tax obligations related to the acquisition of domestic operating entities [1][2]. - The CSRC has requested a review of the stock option grants to external consultants and the legality of shareholder changes, particularly regarding any prohibited entities [2]. Group 2: Business Operations and Financials - Yingshi Biotechnology's business operations must be assessed to ensure they do not involve restricted areas such as human stem cells and gene therapy, and the company must confirm compliance with foreign investment policies [3]. - The company is required to supplement its filing with net asset data and clarify any inconsistencies in the issuance plan and prospectus [3][4]. - The product pipeline includes ifebemtinib, a selective FAK inhibitor nearing commercialization, and other innovative antibody-drug conjugates, indicating significant potential in cancer treatment [4].

Core Viewpoint - InxMed Limited, a late-stage biotech company, focuses on improving cancer treatment paradigms by targeting key signaling pathways, particularly FAK and integrin pathways, to address unmet medical needs in oncology [2][4]. Product Pipeline - The company has a robust pipeline including its core product ifebemtinib, a highly selective FAK inhibitor, which is nearing commercialization and is expected to be the first approved selective FAK inhibitor in China and the second globally [4][5]. - Ifebemtinib has received regulatory recognition, including FDA Fast Track designation and NMPA Breakthrough Therapy designation for various cancer treatments, indicating its potential as a cornerstone therapy in multiple cancer treatment regimens [5][6]. - Other pipeline assets include IN10028 (a second-generation selective FAK inhibitor), OMTX705, IN30758, and IN30778, which are designed to complement existing therapies and maintain a competitive edge in the oncology market [6][7]. Market Potential - The global market for selective FAK inhibitors is projected to grow at a compound annual growth rate (CAGR) of 71.1%, reaching $5.562 billion by 2035, while the Chinese market is expected to grow at a CAGR of 54.6%, reaching $1.571 billion by 2035 [5][6]. Commercialization Strategy - Since 2022, the company has established strong partnerships with top clinical institutions and key opinion leaders in China, laying a solid foundation for the successful commercialization of its products [7][8]. - The company has raised over 929 million RMB from notable investors, enhancing its financial position ahead of its IPO [8][9]. Financial Overview - Following the last round of financing before the IPO, the company's valuation stands at $306 million, with net proceeds from the IPO primarily allocated to the development and regulatory approval of ifebemtinib and other pipeline assets [9][10].

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]

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].

Core Viewpoint - InxMed Limited, a late-stage biotech company focused on improving cancer treatment, has submitted a listing application to the Hong Kong Stock Exchange, with CITIC Securities and Jianyin 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]. - The company focuses on key signaling pathways, especially FAK and integrin pathways, which play critical roles in tumor cell survival and treatment failures [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 by 2025 and first human clinical trials anticipated in Q1 2026 [4]. - **Three innovative antibody-drug conjugates (ADCs)**: - **OMTX705**: Targets CAFs in the tumor microenvironment and has synergistic effects 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 [6]. - Operating loss: -174,013 thousand RMB in 2023, -142,598 thousand RMB in 2024, and -26,676 thousand RMB in 2025 [6]. - Yearly losses: -209,249 thousand RMB in 2023, -184,619 thousand RMB in 2024, and -29,712 thousand RMB in 2025 [6].