Group 1 - The China Securities Regulatory Commission (CSRC) has published supplementary material requirements for overseas listing applications, specifically requesting additional information from Zhejiang Shimai Pharmaceutical Co., Ltd. regarding state-owned shareholder management procedures [1] - The CSRC has outlined specific areas for Shimai Pharmaceutical to clarify, including the progress of state-owned shareholder compliance with state asset management procedures and the legality of past capital increases and share transfers [1] - The company is also required to provide details on its business scope and operations, particularly concerning compliance with foreign investment restrictions related to human stem cells and gene diagnosis and treatment technologies [1] Group 2 - The company, established in 2017, is a pioneer in next-generation T-cell engagers (TCE) therapy and is recognized as a global leader in this field [2] - TCEs are designed to target tumor cells by simultaneously binding to tumor-associated antigens (TAA) and T-cell receptors, thereby activating T-cells to induce targeted cytotoxic effects against cancer [2] - The company has developed innovative TCE therapies, including a next-generation masked TCE that can be selectively activated within tumors for the treatment of solid tumors [2]

Group 1 - The China Securities Regulatory Commission (CSRC) has issued supplementary material requirements for 19 companies, including Shimai Pharmaceutical, which is required to clarify the progress of state-owned shareholder compliance with state asset management procedures [1] - The CSRC requests Shimai Pharmaceutical to provide legal opinions on several matters, including the pricing basis for past capital increases and share transfers, and whether there are any irregularities in the pricing [1] - The company must also clarify whether its business operations involve restricted foreign investment areas, particularly in relation to human stem cells and gene diagnosis and treatment technologies [1] Group 2 - The company, established in 2017, is a pioneer in next-generation T-cell engagers (TCE) therapy and a global leader in this field [2] - TCEs are designed to simultaneously bind to tumor-associated antigens on cancer cells and receptors on T-cells, directing them to tumor tissues to activate T-cells for targeted cytotoxic effects [2] - The company has developed innovative clinical-stage products, including a next-generation TCE that can be selectively activated in tumors for the treatment of solid tumors [2]

Core Viewpoint - Zhejiang Shimai Pharmaceutical Co., Ltd. has submitted an IPO application to the Hong Kong Stock Exchange, aiming to capitalize on the growing T cell engager (TCE) therapy market, which is experiencing rapid development and increasing interest from major international pharmaceutical companies [1][6]. Company Overview - Founded in 2017, Shimai Pharmaceutical is a pioneer in next-generation TCE therapies, focusing on utilizing the human immune system to combat cancer [1]. - The company has developed a next-generation TCE therapy that can be selectively activated in tumors for the treatment of solid tumors [1]. Financial Performance - Shimai Pharmaceutical is currently in the clinical research phase with no commercialized products. The company reported revenues of 14.649 million, 6.618 million, and 2.278 million RMB for 2023, 2024, and the first half of 2025, respectively [2]. - The company has incurred losses of 74.943 million, 59.899 million, and 25.42 million RMB over the same periods, showing a trend of narrowing losses [2]. - Research and development expenses were 76.109 million, 53.382 million, and 22.389 million RMB for the same periods, with employee costs being a significant component [2]. Product Pipeline - Shimai Pharmaceutical has four innovative drug candidates in clinical stages and two additional candidates in preclinical stages targeting solid tumors [2][5]. - The lead candidate, DNV3, targets LAG3 and has shown promising clinical data, including a 44.4% objective response rate in melanoma patients previously treated with PD-(L)1 inhibitors [3][4]. - SMET12, another candidate, is a potential first-in-class intravenous TCE for EGFR-positive advanced solid tumors and is currently in Phase IIa clinical trials [5]. Market Potential - The global TCE market is projected to grow from $400 million in 2020 to $3 billion by 2024, with a compound annual growth rate of 67.6%, and could reach $47.5 billion by 2030 and over $120 billion by 2035 [9][11]. - The TCE therapy offers advantages over CAR-T therapies and antibody-drug conjugates (ADCs), making it a promising direction for next-generation cancer immunotherapy [6][9]. Competitive Landscape - The TCE field is witnessing significant interest, with over $8.5 billion in transactions in 2024 alone, as major pharmaceutical companies enter the market [8]. - Currently, only two TCE drugs for solid tumors have been globally approved, indicating a substantial market opportunity for companies like Shimai Pharmaceutical that focus on this area [11][13]. Strategic Positioning - Shimai Pharmaceutical's focus on solid tumor TCE therapies positions it well in a market with limited competition, as most domestic players are still concentrated on hematological malignancies [13][14]. - The company’s innovative drug candidates are developed through specialized platforms, creating a competitive barrier in the TCE space [5].

Group 1 - Shimai Pharmaceutical plans to list on the Hong Kong Stock Exchange, having submitted its application with Huatai International as the sole sponsor [1] - Established in 2017, Shimai is a pioneer in next-generation T-cell engagers (TCE) aimed at utilizing the human immune system to combat cancer, with four self-developed clinical-stage candidates [1] - The company's core technology, the masking TCE, is designed for selective activation in tumors, focusing on solid tumors, which aligns with the growth trend in the TCE sector [1] Group 2 - Gilead Sciences announced the entry of its new generation of drugs ASC36 and ASC35 into clinical development, targeting obesity with a planned FDA submission in Q2 2026 [2] - ASC36 and ASC35 are proprietary long-acting combination formulations with superior physicochemical stability, designed to avoid aggregation and precipitation [2] - ASC36 is positioned as a cornerstone therapy for treating metabolic diseases, potentially offering better efficacy and tolerability compared to GLP-1 therapies [2] Group 3 - InnoCare Pharma's new drug DB-1418 has been approved for clinical trials in China, targeting advanced/metastatic solid tumors as an EGFR/HER3 bispecific antibody-drug conjugate (ADC) [3] - The approval of DB-1418 aims to address treatment bottlenecks in resistant solid tumors, enhancing the company's pipeline competitiveness [3] Group 4 - InnoCare Pharma reported a nearly 60% increase in total revenue for the first three quarters of 2025, reaching 1.12 billion yuan, driven by the sales growth of its core product, BTK inhibitor Orelabrutinib [4] - Orelabrutinib's revenue increased by 45.8% year-on-year, surpassing last year's total revenue, while the company's losses narrowed by 74.8% to 70 million yuan [4] - The revenue growth and reduced losses indicate a potential profitability turning point, which may accelerate the advancement of the innovation pipeline and strengthen the company's position in the BTK field [4]