Core Viewpoint - The China Securities Regulatory Commission (CSRC) has issued supplementary material requirements for 19 companies, including Shimai Pharmaceutical, which must clarify the progress of state-owned shareholder management procedures and other matters related to its overseas listing application [1]. Group 1: Company Requirements - Shimai Pharmaceutical needs to provide details on the progress of state-owned shareholders fulfilling state-owned stock identification and management procedures [2]. - The company must explain the pricing basis and reasons for price differences in past capital increases and share transfers, and confirm the legality and compliance of its establishment and share changes [3]. - It is required to clarify whether the shares held by shareholders participating in the "full circulation" are subject to pledges, freezes, or other rights defects [4]. Group 2: Financial Performance - Shimai Pharmaceutical has not generated any drug sales revenue or milestone payments, with total other income of approximately 14.65 million yuan, 6.62 million yuan, and 2.28 million yuan for 2023, 2024, and the first half of 2025, respectively [4]. - The company reported losses of 74.94 million yuan, 59.90 million yuan, and 25.42 million yuan for the years 2023, 2024, and the first half of 2025, with cumulative losses exceeding 160 million yuan [5]. - The primary reason for ongoing losses is the lack of commercialized products, with income mainly from government subsidies and investment returns, which are insufficient to cover high R&D and operational costs [5]. Group 3: R&D Expenditure - R&D expenses for the company were 76.11 million yuan, 53.38 million yuan, and 22.39 million yuan for 2023, 2024, and the first half of 2025, respectively, indicating a significant decline in R&D investment [6]. - The R&D expenditure for the core product SMET12 decreased by 73.7% in the first half of 2025 compared to the same period in 2024, raising concerns about the development of core products [6]. Group 4: Cash Flow and Financing - As of June 30, 2025, the company's cash and cash equivalents were only 85.74 million yuan, while the average annual R&D expenditure was around 60 million yuan [7]. - By September 30, 2025, cash and cash equivalents sharply declined to 5.71 million yuan, indicating a rapid depletion of funds [8]. - The company has completed three rounds of financing, with a post-Series C valuation of 2.23 billion yuan, supported by investors such as Betta Pharmaceuticals and Tigermed [9]. Group 5: Market Potential - The global TCE market is projected to reach approximately $3 billion by 2024, with a compound annual growth rate (CAGR) of 40% expected to grow to $121.1 billion by 2035 [10]. - The Chinese TCE market is anticipated to reach 700 million yuan by 2024, with a CAGR of 63.8% expected to grow to 159.6 billion yuan by 2035 [10]. Group 6: Shareholder Structure and Future Plans - The company's actual controller, Xiao Zuoxiang, holds 53.2% of the shares, making him the controlling shareholder, while Betta Pharmaceuticals holds 4.75% through its subsidiary [11]. - The company plans to use the funds raised from its Hong Kong listing primarily for clinical development of core products, optimization of technology platforms, new product development, and operational funding [11].

Core Viewpoint - The China Securities Regulatory Commission has issued supplementary material requirements for 19 companies, including Shimai Pharmaceutical, which must clarify the progress of state-owned shareholders in fulfilling state asset management procedures [1][2]. Group 1: Company Overview - Shimai Pharmaceutical was established in 2017 and focuses on the development of T-cell engagers (TCEs), with four clinical-stage candidates: DNV3, SMET12, CMD011, and CMDE005 [2]. - The company has received three rounds of financing, with a post-Series C valuation of 2.23 billion RMB, driven by investor optimism regarding the TCE therapy market [8]. Group 2: Financial Performance - The company reported no drug sales or milestone payments during the reporting period, with other income of approximately 14.65 million RMB in 2023, 6.62 million RMB in 2024, and 2.28 million RMB in the first half of 2025, primarily from government subsidies and investment income [3]. - Shimai Pharmaceutical's losses were 74.94 million RMB in 2023, 59.90 million RMB in 2024, and 25.42 million RMB in the first half of 2025, totaling over 160 million RMB in cumulative losses [3][4]. - The company has indicated that it may never achieve or maintain profitability, as it has not yet commercialized any products [3]. Group 3: Research and Development - Research and development expenses were 76.11 million RMB in 2023, 53.38 million RMB in 2024, and 22.39 million RMB in the first half of 2025, showing a significant decline that raises concerns about the development of core products [4][5]. - The R&D spending for the core product SMET12 decreased by 73.7% to 2.14 million RMB in the first half of 2025 compared to the same period in 2024 [5]. Group 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 [8]. - The Chinese TCE market is expected to reach 700 million RMB by 2024, with a compound annual growth rate of 63.8% projected to grow to 159.6 billion RMB by 2035 [8]. Group 5: Funding and Cash Flow - The company has utilized 62.32 million RMB and 45.23 million RMB for financial investments in 2024 and the first half of 2025, respectively, despite ongoing losses [6]. - As of June 30, 2025, the company's cash and cash equivalents were only 5.71 million RMB, a significant decrease from 85.74 million RMB just three months prior [7].

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 - 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].

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].

香港聯合交易所有限公司與證券及期貨事務監察委員會對本申請版本的內容概不負責，對其準確性或完整 性亦不發表任何意見，並明確表示概不就因本申請版本全部或任何部分內容而產生或因倚賴該等內容而引 致的任何損失承擔任何責任。 Zhejiang Shimai Pharmaceutical Co., Ltd.* 浙江時邁藥業股份有限公司 （「本公司」） （於中華人民共和國註冊成立的股份有限公司） 倘於適當時候向香港公眾人士提出要約或邀請，有意投資者務請僅依據於香港公司註冊處處長登記的本公 司招股章程作出投資決定，招股章程的文本將於發售期內向公眾人士派發。 (a) 本文件僅為向香港公眾人士提供有關本公司的資料，概無任何其他目的。投資者不應根據本文件中 的資料作出任何投資決定； (b) 在聯交所網站登載本文件或其補充、修訂或更換附頁，並不引起本公司、本公司的獨家保薦人、整 體協調人、顧問或包銷團成員在香港或任何其他司法權區必須進行發售活動的責任。本公司最終會 否進行發售仍屬未知之數； (c) 本文件或其補充、修訂或更換附頁的內容可能會亦可能不會在最後正式的上市文件內全部或部分轉 載； (d) 本申請版本並非最終的上市文件，本公 ...