三、请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。 四、请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。 据招股书，该公司成立于2017年，是下一代T细胞衔接器(TCE)疗法的先驱及全球领军企业。TCE为双 特异性或多特异性抗体，其设计原理是通过同时结合肿瘤细胞上的肿瘤相关抗原(TAA)及T细胞上的受 体，从而定向至肿瘤组织并激活T细胞，以诱导靶向细胞毒性作用。该公司早年就洞察到TCE的差异化 潜力，这是一类旨在利用并引导人体免疫系统对抗癌症的下一代免疫疗法。 12月26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。据港交所11月12日披露，浙江时迈药业股份有限公司-B(简称： 时迈药业)递表港交所主板，华 ...

Group 1 - Shimai Pharmaceutical has submitted a listing application to the Hong Kong Stock Exchange, with Huatai International as the sole sponsor. The company, founded in 2017, is a pioneer in next-generation T cell engagers (TCE) aimed at utilizing the human immune system to combat cancer. It has developed a next-generation TCE therapy that can be selectively activated in tumors for the treatment of solid tumors, with four self-developed clinical-stage candidates currently in its pipeline [1] - The listing will accelerate research and development, allowing the company to seize market opportunities in the growing TCE sector [1] Group 2 - Gilead Sciences announced that its new generation of once-monthly GLP-1 receptor agonist ASC36 and dual-target agonist ASC35 has entered clinical development. The company expects to submit clinical trial applications to the FDA for ASC36 and ASC35 for obesity treatment by the second quarter of 2026 [2] - ASC36 and ASC35 are proprietary long-acting formulations with superior physicochemical stability, designed to treat metabolic diseases including obesity. ASC36 is positioned as a cornerstone therapy with potential efficacy and tolerability advantages over existing GLP-1 therapies [2] Group 3 - InnoCare Pharma reported a nearly 60% increase in total revenue for the first three quarters of 2025, reaching 1.12 billion yuan, driven by sustained sales growth of its core product, the BTK inhibitor Orelabrutinib, and upfront payments from licensing agreements [4] - The revenue from Orelabrutinib increased by 45.8% year-on-year, surpassing last year's total revenue. The company's losses narrowed by 74.8% to 70 million yuan, indicating a potential turning point in profitability [4] Group 4 - InnoCare's revenue growth and reduced losses are attributed to the expansion of Orelabrutinib's indications and additional licensing income, which will accelerate the advancement of its innovative pipeline and strengthen its position in the BTK field [4] Group 5 - Ying'en Biopharma's new drug DB-1418 has been approved for clinical trials in China, targeting advanced/metastatic solid tumors. This drug is an EGFR/HER3 bispecific antibody-drug conjugate (ADC) [3] - The approval of this ADC aims to address treatment bottlenecks in resistant solid tumors and enhance the company's pipeline competitiveness, providing new options for solid tumor treatment [3]

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]

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, with Huatai International as the sole sponsor, highlighting its position as a pioneer and global leader in next-generation T cell engagers (TCE) therapy [1][4]. Group 1: Company Overview - The company was established in 2017 and focuses on TCE therapy, which utilizes 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 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]. Group 2: Product Pipeline - As of November 5, 2025, the company has four self-developed clinical-stage candidate drugs: (i) DNV3, a potential best-in-class T cell modulator targeting LAG3, (ii) SMET12, a potential first-in-class intravenous EGFR×CD3 TCE, (iii) CMD011, a potential best-in-class GPC3×CD3 TCE, and (iv) CMDE005, a potential first-in-class next-generation shielding TCE targeting EGFR×CD3 [4]. - Additionally, the company has two preclinical-stage next-generation multifunctional/logic-gated TCE candidates, CMDE101 and CMDE102, targeting FOLR1×PD-L1×CD3 and PSMA×PD-L1×CD3, respectively [4].