近日，中国证监会发布《境外发行上市备案补充材料要求（2025年12月22日—2025年12月26日）》。中国证监会国际司公示19家企业补充材料要求，其 中，要求时迈药业补充说明公司国有股东履行国有股标识等国资管理程序进展情况等事项。 时迈药业共有4点事项需要补充说明： 补充说明公司国有股东履行国有股标识等国资管理程序进展情况。 补充说明公司历次增资及股权转让价格、定价依据及价格差异原因，是否存在对价异常，并就你公司设立及历次股权变动是否合法合规出具结论性意见。 公司结合药物研发技术路线等情况说明公司及下属公司经营范围、实际业务是否涉及"人体干细胞、基因诊断与治疗技术开发和应用"或其他外商投资准入 限制或禁止领域及相关判断依据，本次发行上市及"全流通"前后是否持续符合外商投资准入政策要求。 补充说明本次拟参与"全流通"股东所持股份是否存在被质押、冻结或其他权利瑕疵的情形。 招股书显示，时迈药业成立于2017年，从成立之日起就专注于TCE药物的开发，目前已经有四款自主研发的临床阶段的候选药物，包括(i) DNV3，一款靶 向激活免疫系统的LAG3单抗(ii) SMET12，一款靶向EGFRxCD3 TCE双抗，( ...

近日，中国证监会发布《境外发行上市备案补充材料要求（2025年12月22日—2025年12月26日）》。中 国证监会国际司公示19家企业补充材料要求，其中，要求时迈药业补充说明公司国有股东履行国有股标 识等国资管理程序进展情况等事项。 时迈药业共有4点事项需要补充说明： 业绩持续亏损的根本原因在于公司尚未有产品进入商业化阶段，未能形成产品销售收入。目前收入主要 来源于政府补助和投资收益，这些来源规模有限，远不足以覆盖高企的研发及运营成本。 公司在招股书中直言"可能永远无法实现或维持盈利"，此次递表，更像是这家公司在资本市场上的"背 水一战"。 "即使我们最终能产生一些收入，也无法保证一定盈利。倘若候选药物在临床或注册阶段失败，我们可 能永远无法实现盈利；即使未来实现盈利，也可能无法维持该状态。" 补充说明公司国有股东履行国有股标识等国资管理程序进展情况。 补充说明公司历次增资及股权转让价格、定价依据及价格差异原因，是否存在对价异常，并就你公司设 立及历次股权变动是否合法合规出具结论性意见。 公司结合药物研发技术路线等情况说明公司及下属公司经营范围、实际业务是否涉及"人体干细胞、基 因诊断与治疗技术开发和应用" ...

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].

Core Viewpoint - Zhejiang Shimai Pharmaceutical Co., Ltd. has submitted its prospectus to the Hong Kong Stock Exchange, aiming for an IPO under Rule 18A, with Huatai International as the sole sponsor. The company focuses on T-cell engagers (TCE) therapies and has attracted investments from notable firms like Betta Pharmaceuticals and Tigermed, achieving a post-Series C valuation of 2.23 billion yuan. However, it faces multiple risks, including reduced R&D investment, frequent changes in financial leadership, and safety concerns regarding core products [1][2]. Financial Performance - The company's revenue for 2023, 2024, and the first half of 2025 is projected to be 14.65 million yuan, 6.62 million yuan, and 2.28 million yuan, respectively, indicating minimal income. Concurrently, net losses are expected to be 74.94 million yuan, 59.89 million yuan, and 25.42 million yuan, leading to cumulative losses exceeding 160 million yuan over two and a half years. Historical cumulative losses since inception are nearing 500 million yuan [2][4]. - R&D expenses have significantly decreased, with figures of 76.11 million yuan, 53.38 million yuan, and 22.39 million yuan for the respective years, reflecting a downward trend. The R&D investment for core products DNV3 and SMET12 has also seen a notable decline [2][4]. Product Development - The company has four clinical-stage candidates, including core products DNV3 and SMET12, which are currently in critical Phase II trials. The reduction in R&D spending during this pivotal phase raises concerns about the company's financial health and ability to validate drug efficacy and safety [4][5]. - DNV3's Phase I trial involved 11 patients, with an adverse event rate of 81.8%, while SMET12's trial included 16 patients, with 93.8% experiencing adverse events. These results raise questions about the safety of the products [6]. Market Position and Valuation - The global TCE market is projected to be only $3 billion in 2024, with the domestic market at 700 million yuan, indicating that TCE therapies are still in the early stages of development compared to the larger oncology market [5]. - The post-Series C valuation of 2.23 billion yuan places the company above industry averages, with a market-to-research ratio of approximately 42 times based on 2024 R&D expenditures. This is significantly higher than the median of 23.21 times for similar unprofitable biotech firms listed under Rule 18A [7].

Core Viewpoint - Zhejiang Shimai Pharmaceutical Co., Ltd. has submitted its prospectus for an IPO on the Hong Kong Stock Exchange, with Huatai International as the sole sponsor, amid a backdrop of significant interest in TCE therapies and multiple rounds of financing from investors like Betta Pharmaceuticals [1][2]. Group 1: Company Overview - Founded in 2017, Shimai Pharmaceutical focuses on the development of TCE (T-cell engager) drugs, with no products commercialized yet and four clinical-stage candidates in its pipeline [2]. - The company reported revenues of 14.65 million yuan, 6.62 million yuan, and 2.28 million yuan for 2023, 2024, and the first half of 2025, respectively, with corresponding losses of 74.94 million yuan, 59.89 million yuan, and 25.42 million yuan, totaling over 160 million yuan in cumulative losses [2]. - The company has received three rounds of financing, with a post-Series C valuation of 2.23 billion yuan, and its major shareholders include the controlling shareholder Xiaozuoxiang and Betta Pharmaceuticals [2]. Group 2: Financial Management - The current CFO, Liu Yang, joined the company shortly before the IPO process, bringing over 12 years of experience in the international healthcare industry and capital markets [4]. - The company has seen frequent changes in its financial leadership, with four different CFOs from 2021 to 2025, indicating potential instability in financial management [5]. - Despite a peak net asset value of 236 million yuan, the company has shown a preference for structured deposits, with financial assets of 216 million yuan, 164 million yuan, and 67 million yuan for the years 2023, 2024, and the first half of 2025, respectively [6]. Group 3: Research and Development - The company has reduced R&D expenses significantly, with expenditures of 76.11 million yuan, 53.38 million yuan, and 22.39 million yuan for 2023, 2024, and the first half of 2025, respectively, alongside a decrease in administrative expenses [7]. - The R&D investment for core products DNV3 and SMET12 has also seen substantial cuts, raising concerns about the company's commitment to its pipeline [7]. - The safety profile of the core products remains a concern, with high rates of adverse events reported in clinical trials, including 81.8% for DNV3 and 93.8% for SMET12 [8].

Core Viewpoint - Zhejiang Shimai Pharmaceutical Co., Ltd. has submitted its listing application to the Hong Kong Stock Exchange, focusing on the development of TCE drugs and aiming to raise funds for clinical development and operational needs [1][5]. Company Overview - Established in 2017, Shimai Pharmaceutical specializes in TCE drug development, with four clinical-stage candidates: DNV3, SMET12, CMD011, and CMDE005 [1]. - The company has a current valuation of 2.23 billion RMB following its latest Series C financing, attracting investments from notable pharmaceutical companies [1]. Financial Performance - For the reporting period from 2023 to the first half of 2025, Shimai Pharmaceutical reported other income and gains of 14.65 million RMB, 6.62 million RMB, and 2.28 million RMB, while total losses reached 74.94 million RMB, 59.90 million RMB, and 25.42 million RMB, accumulating over 160 million RMB in total losses [2][3]. - The company has not yet commercialized any products, leading to significant ongoing losses, with revenue primarily from government subsidies and investment income [2][4]. Research and Development - R&D expenses for the reporting period were 76.11 million RMB, 53.38 million RMB, and 22.39 million RMB, with a notable decrease in R&D spending raising concerns about the progress of core product development [4]. - The R&D expenditure for core product SMET12 decreased by 73.7% in the first half of 2025 compared to the same period in 2024, indicating potential challenges in sustaining development efforts [4]. Market Potential - The global TCE market is projected to reach approximately 3 billion USD by 2024, with a compound annual growth rate of 40% expected to grow to 121.1 billion USD by 2035. The Chinese TCE market is anticipated to reach 700 million RMB by 2024, with a growth rate of 63.8% projected to reach 159.6 billion RMB by 2035 [5].

Core Viewpoint - Shimai Pharmaceutical has submitted an application to the Hong Kong Stock Exchange for its main board listing, with Huatai International acting as the sole sponsor [1] Industry Summary - The T-cell engaging (TCE) therapy market is projected to grow significantly, from $3 billion in 2024 to $121.1 billion by 2035, representing a compound annual growth rate (CAGR) of 40.0% [1] Company Summary - As of November 5, 2025, Shimai Pharmaceutical has four self-developed clinical-stage candidate drugs, including DNV3 targeting LAG3, SMET12 for intravenous use targeting EGFR×CD3, CMD011 targeting GPC3×CD3, and the next-generation cloaked TCE CMDE005 [1] - The company is also developing two preclinical next-generation multifunctional/logic-gated TCE candidates, CMDE101 and CMDE102, targeting FOLR1×PD-L1×CD3 and PSMA×PD-L1×CD3, respectively [1] - Shimai Pharmaceutical emphasizes that its TCE therapies feature selective activation, zero immune cell toxicity, precise tumor recognition, and prevention of tumor recurrence, aiming to become a cornerstone therapy in future tumor immunotherapy [1]

Core Viewpoint - Zhejiang Shimai Pharmaceutical Co., Ltd. has submitted an application to list on the Hong Kong Stock Exchange, with Huatai International as the sole sponsor [1]. Company Overview - Established in 2017, the company is a pioneer and global leader in next-generation T-cell engagers (TCE) therapy, designed to direct T-cells to tumor tissues and activate them to induce targeted cytotoxic effects [3][4]. - The company has developed a next-generation TCE therapy that selectively activates in tumors for the treatment of solid tumors, with a significant market potential [3][4]. Product Pipeline - As of November 5, 2025, the company has four clinical-stage candidates: 1. DNV3, targeting LAG3 2. SMET12, an intravenous EGFR×CD3 TCE 3. CMD011, a GPC3×CD3 TCE 4. CMDE005, a next-generation EGFR×CD3 TCE [4]. - Additionally, two preclinical candidates are in development, targeting FOLR1×PD-L1×CD3 and PSMA×PD-L1×CD3 [4]. Financial Performance - The company reported revenues of RMB 14.649 million, RMB 6.618 million, and RMB 2.278 million for the years 2023, 2024, and the first half of 2025, respectively [7][9]. - Losses for the same periods were RMB 74.943 million, RMB 59.899 million, and RMB 25.420 million [7][9]. - Research and development expenses were RMB 76.109 million, RMB 53.382 million, and RMB 22.389 million for the years 2023, 2024, and the first half of 2025, respectively [8][9]. Market Overview - The global TCE market is projected to grow from USD 4 billion in 2020 to USD 30 billion in 2024, with a compound annual growth rate (CAGR) of 67.6% [12]. - By 2035, the global TCE market is expected to reach USD 121.1 billion [12]. - The Chinese TCE market is anticipated to grow from RMB 1 billion in 2021 to RMB 7 billion in 2024, with a CAGR of 104.0% [12]. By 2035, it is expected to reach RMB 159.6 billion [12]. Board of Directors - The board consists of 9 members, including 3 executive directors, 3 non-executive directors, and 3 independent non-executive directors [15].

Core Viewpoint - The company is a pioneer in next-generation T-cell engagers (TCE) therapy, aiming to leverage the immune system to combat cancer, with significant growth potential in the TCE market projected for the coming years [2][4]. Company Overview - Established in 2017, the company focuses on TCE therapies that target tumor-associated antigens (TAA) and T-cell receptors to activate T-cells against tumors [2]. - The company has developed a next-generation TCE therapy that selectively activates in tumors for treating solid tumors, indicating a strong innovation capability [2][5]. Product Pipeline - As of November 5, 2025, the company has four clinical-stage candidates: 1. DNV3, targeting LAG3 2. SMET12, an EGFR×CD3 TCE 3. CMD011, a GPC3×CD3 TCE 4. CMDE005, a next-generation EGFR×CD3 TCE [3]. - Additionally, two preclinical candidates are in development, targeting FOLR1×PD-L1×CD3 and PSMA×PD-L1×CD3 [3]. Financial Performance - The company reported revenues of RMB 14.649 million, RMB 6.618 million, and RMB 2.278 million for the years 2023, 2024, and the first half of 2025, respectively [6][8]. - Losses for the same periods were RMB 74.943 million, RMB 59.899 million, and RMB 25.420 million [6][8]. - Research and development expenses were RMB 76.109 million, RMB 53.382 million, and RMB 22.389 million for 2023, 2024, and the first half of 2025, respectively [7][8]. Market Overview - The global TCE market is expected to grow from USD 4 billion in 2020 to USD 30 billion in 2024, with a compound annual growth rate (CAGR) of 67.6% [10]. - By 2035, the global TCE market is projected to reach USD 121.1 billion [10]. - The Chinese TCE market is anticipated to grow from RMB 1 billion in 2021 to RMB 7 billion in 2024, with a CAGR of 104.0% [11]. By 2035, it is expected to reach RMB 159.6 billion [11]. Industry Trends - The global oncology drug market is projected to grow from USD 150.3 billion in 2020 to USD 253.3 billion in 2024, with a CAGR of 13.9% [9]. - The Chinese oncology drug market is expected to grow from USD 28.6 billion in 2020 to USD 35.9 billion in 2024, with a CAGR of 5.8% [9].

Core Viewpoint - Zhejiang Shimai Pharmaceutical Co., Ltd. has submitted an application to list on the Hong Kong Stock Exchange, positioning itself as a pioneer and global leader in next-generation T-cell engagers (TCE) therapy [1]. Company Overview - Established in 2017, the company focuses on TCE, which are bispecific or multispecific antibodies designed to target tumor-associated antigens (TAA) on cancer cells and receptors on T-cells, thereby directing T-cells to tumor tissues and activating them to induce targeted cytotoxic effects [1]. - The company recognized the differentiated potential of TCE early on, aiming to leverage and guide the human immune system to combat cancer through next-generation immunotherapy [1]. Product Pipeline - As of November 5, 2025, the company has four self-developed clinical-stage drug candidates: 1. DNV3, a potential best-in-class T-cell modulator targeting LAG3 2. SMET12, a potential first-in-class intravenous EGFR×CD3 TCE 3. CMD011, a potential best-in-class GPC3×CD3 TCE 4. CMDE005, a potential first-in-class next-generation shielding TCE targeting EGFR×CD3 [3]. - Additionally, the company has two preclinical-stage next-generation multifunctional/logical gate TCE candidates, CMDE101 and CMDE102, targeting FOLR1×PD-L1×CD3 and PSMA×PD-L1×CD3, respectively [3].