FF301 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年5月31日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 諾誠健華醫藥有限公司（於開曼群島註冊成立的有限公司） 呈交日期: 2025年6月4日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 09969 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 25,000,000,000 | USD | 0.000002 | USD | | 50,000 | | 增加 / 減少 (-) | | | | | | USD | | | | 本月底結存 | | | 25,000,000,000 | USD | 0.000002 | USD | | 50,000 | 本月底法 ...

诺诚健华宣布，公司在2025年美国临床肿瘤学会(ASCO)年会上公布一系列创新管线最新数据，涉及抗 CCR8抗体ICP-B05(CM369)、BCL2抑制剂mesutoclax(ICP-248)和泛TRK抑制剂zurletrectinib(ICP-723)。 (诺诚健华INNOCARE) ...

Core Viewpoint - The company plans to utilize part of its temporarily idle raised funds for cash management, allowing for investment in low-risk financial products while ensuring that the funds are not diverted from their intended projects [1][3][5]. Fund Management and Usage - The company has established a special account for managing raised funds, with all funds deposited into this account upon receipt [2]. - The total amount of raised funds for investment projects is approximately 277.88 million RMB [2]. Cash Management Details - The company will manage up to 1 billion RMB of temporarily idle raised funds, investing in low-risk products such as structured deposits and time deposits, with a maximum investment period of 12 months [1][3][4]. - The cash management decision is valid for 12 months from the board's approval date, and the 1 billion RMB can be used in a rolling manner [4]. Investment Purpose and Products - The objective of cash management is to enhance the efficiency of fund usage and increase company returns without affecting the ongoing investment projects [3][5]. - The company will strictly control risks and will not use the funds for pledging or securities investment [3][4]. Operational Impact - The cash management strategy will not impact the company's main business operations or the progress of investment projects, aiming to improve fund efficiency and shareholder returns [5][7]. - The company will adhere to relevant accounting standards for financial instruments in managing these funds [5]. Approval and Compliance - The board of directors approved the cash management plan on May 29, 2025, ensuring compliance with regulatory requirements [7][8]. - The sponsor institution has confirmed that the plan aligns with regulatory guidelines and does not conflict with the company's investment project implementation [8].

中国国际金融股份有限公司 关于诺诚健华医药有限公司 使用部分暂时闲置募集资金进行现金管理及以通知存款、协定存 款等方式存放募集资金的核查意见 中国国际金融股份有限公司（以下简称"中金公司"或"保荐机构"）作为诺诚健 华医药有限公司（以下简称"诺诚健华"或"公司"）的保荐机构，根据《中华人民共 和国公司法》《中华人民共和国证券法》《上海证券交易所科创板股票上市规则》《上 市公司监管指引第 2 号——上市公司募集资金管理和使用的监管要求》《上海证券交易 所科创板上市公司自律监管指引第 1 号——规范运作》等有关法律、行政法规、部门规 章及业务规则的要求，对诺诚健华使用部分暂时闲置募集资金进行现金管理及以通知存 款、协定存款等方式存放募集资金的事项进行了认真、审慎核查，具体情况如下： 一、募集资金基本情况 公司首次公开发行股票并在科创板上市的注册申请于 2022 年 7 月 15 日经中国证 券监督管理委员会同意（证监许可[2022]1524 号《关于同意诺诚健华医药有限公司首次 公开发行股票注册的批复》），公司据此公开发行了人民币普通股 264,648,217 股股票， 每股发行价格为人民币 11.03 元，募集 ...

| A | 股代码：688428 | 股简称：诺诚健华 A | 公告编号：2025-019 | | --- | --- | --- | --- | | 港股代码：09969 | | 港股简称：诺诚健华 | | 诺诚健华医药有限公司 关于使用部分暂时闲置募集资金进行现金管理及 以通知存款、协定存款等方式存放募集资金的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 2025 年 5 月 29 日，诺诚健华医药有限公司（以下简称"公司"或"诺诚健 华"）召开董事会，审议通过了《使用部分暂时闲置募集资金进行现金管理及以 通知存款、协定存款等方式存放募集资金》的议案，同意公司在确保不影响募集 资金投资项目建设及募集资金使用安排，并有效控制风险的前提下，将最高不超 过 10 亿元人民币的暂时闲置募集资金进行现金管理，购买安全性高、流动性好 的低风险投资产品（包括但不限于结构性存款、定期存款、大额存单等），在董 事会审议通过之日起 12 个月内可进行该现金管理，且该 10 亿元人民币额度可循 环滚动使用；并同意公司以通知存款、协定 ...

Core Insights - Nuo Cheng Jian Hua reported a revenue of 381 million yuan for Q1 2025, representing a year-on-year growth of 129.92%, with a net profit of 14 million yuan, up 109.94% year-on-year [2] - The company's gross margin improved by 5.1 percentage points to 90.5% compared to the same period last year [2] - The main driver of revenue growth is the commercialization of the drug Acalabrutinib, which generated 310 million yuan in revenue during the reporting period, an increase of 89.2% [2] Product Development - Acalabrutinib was approved for first-line treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) in China on April 25, 2023, expanding its market potential [2][6] - The drug has already been included in the national medical insurance for multiple indications, which is expected to further boost sales [2] - The company is also advancing its pipeline with Tafasitamab, a CD19 monoclonal antibody, which has been approved for the treatment of Diffuse Large B-Cell Lymphoma (DLBCL) [3][9] Market Potential - CLL accounts for approximately 3% of adult leukemia cases in China, with about 7,500 new patients diagnosed annually [5] - The approval of Acalabrutinib for first-line treatment is anticipated to significantly enhance treatment options for patients and drive company growth [6] - The market for Tafasitamab is projected to exceed 1.5 billion yuan in peak sales under optimistic scenarios [10] Competitive Landscape - Acalabrutinib is positioned as a potential best-in-class BTK inhibitor, with superior selectivity and safety profile compared to existing competitors [7][8] - The company faces competition from other approved therapies targeting similar indications, particularly in the relapsed or refractory settings [6] Financial Health - Nuo Cheng Jian Hua reported a strong cash position of approximately 7.78 billion yuan as of the end of Q1 2025, which will support ongoing clinical trials and research investments [8]

| | | 诺诚健华医药有限公司 关于坦昔妥单抗（tafasitamab）联合来那度胺 治疗复发/难治性弥漫性大 B 细胞淋巴瘤 在中国上市申请获得批准的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 重要内容提示： 一、药品基本情况 药品名称：注射用坦昔妥单抗 申请事项：药品注册（境外生产） 受理号：JXSS2400050 证书编号：2025S01368 上市许可持有人：Incyte Biosciences Distribution B.V. 审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，本品 1 诺诚健华医药有限公司（以下简称"公司"）收到国家药品监督管理局（NMPA） 的通知，公司靶向 CD19 的产品坦昔妥单抗（tafasitamab）（商品名：明诺 凯®）联合来那度胺治疗不适合自体干细胞移植条件的复发/难治性弥漫性大 B 细胞淋巴瘤（以下简称"r/r DLBCL"）成人患者的上市申请获得批准， 这是中国首个获批治疗 r/r DLBCL 的 CD19 单抗。 由于新药研发具有高科技、高风险、高 ...

Core Viewpoint - The approval of Tafasitamab (brand name: Mingnuokai) in combination with Lenalidomide for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (r/rDLBCL) marks a significant milestone as it is the first CD19 monoclonal antibody approved for this indication in China [1] Company Summary - The company, Innovent Biologics, has received approval from the National Medical Products Administration (NMPA) for its CD19-targeting product Tafasitamab [1] - This approval highlights the company's commitment to addressing unmet medical needs in oncology [1] Industry Summary - The approval of Tafasitamab represents a breakthrough in the treatment landscape for r/rDLBCL in China, potentially improving outcomes for patients who are not suitable for autologous stem cell transplantation [1] - The introduction of this therapy may enhance competition in the oncology market, particularly in the segment of targeted therapies for hematological malignancies [1]

Investment Rating - The report maintains a "Buy" rating for the company with a target price of 27.24 RMB [1][5] Core Insights - The company achieved profitability in Q1 2025, with a revenue of 381 million RMB, representing a year-on-year growth of 129.92%. The core product, Acalabrutinib, generated sales of 311 million RMB, up 89.22% year-on-year [3][4] - The gross margin for Q1 2025 increased to 90.5%, up 5.1 percentage points from the same period last year [3] - The company has a strong cash position with approximately 7.8 billion RMB in cash and cash equivalents as of March 31, 2025 [3] Summary by Sections Financial Performance - Q1 2025 revenue: 381 million RMB, up 129.92% YoY - Q1 2025 net profit: 18 million RMB, with a non-recurring net profit of 1.59 million RMB [3] - R&D expenses in Q1 2025: 208 million RMB, up 16.81% YoY; sales expenses: 114 million RMB, up 27.34% YoY; management expenses: 43 million RMB, up 0.83% YoY [3] Product Pipeline and Clinical Trials - The company is advancing multiple clinical registrations in oncology and autoimmune diseases, with plans to initiate two overseas Phase 3 clinical studies in 2025 [4] - Acalabrutinib received NMPA approval for first-line CLL/SLL treatment, and several other products are in various stages of clinical trials [4][5] Future Catalysts - The report highlights several upcoming catalysts within the next 12 months, particularly focusing on data from SLE and AML studies [5] - The company is expected to release long-term efficacy data for various clinical trials, which could significantly impact its stock performance [5] Valuation - The target market capitalization is estimated at 48 billion RMB, corresponding to a stock price of 27.24 RMB, based on DCF and NPV methods [5]

InnoCare Pharma (9969.HK) Earnings Review Summary Company Overview - **Company**: InnoCare Pharma (9969.HK) - **Industry**: Biotechnology Key Financial Highlights - **1Q Sales Performance**: - Orelabrutinib sales reached Rmb312 million, representing an increase of 89% year-over-year and a slight increase of 1.5% quarter-over-quarter, outperforming expectations [1] - Sales growth driven by volume expansion in Marginal Zone Lymphoma (MZL) due to National Reimbursement Drug List (NRDL) coverage and market share gains in relapsed/refractory Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) and Mantle Cell Lymphoma (MCL) [1] - **Profitability**: - The company turned profitable in 1Q with earnings of Rmb18 million compared to a net loss of Rmb165 million in 4Q24 [1] - **Gross Margin**: - Improved to 88.4% from 85.3% in 1Q24 and 86.8% in 4Q24, attributed to product scale-up [1] - **Expenses**: - Selling expenses increased by 27% year-over-year, but selling expenses as a percentage of total sales decreased to 37% from 47% in 4Q24 [1] - R&D expenses rose by 17% year-over-year as more assets progressed to pivotal stages [1] - **Cash Position**: - As of 1Q25, the company holds a cash balance of Rmb7.8 billion, providing flexibility for global development and in-licensing opportunities [1] Sales Guidance and Forecasts - **Revised Sales Guidance**: - Management raised sales guidance for Orelabrutinib to over 35% year-over-year growth in 2025, up from the previous estimate of 30% [1] - **Future Sales Growth**: - Sales growth in 2026 may depend on the magnitude of price cuts for Orelabrutinib in the 2025 NRDL revision [1] Clinical Development Updates - **Global Trial Acceleration**: - The company is accelerating global clinical trials for selected assets, including: - ICP-332 (TYK2-JH1) for prurigo nodularis, with phase 2 studies starting in 1H25 [2] - Orelabrutinib's phase 3 global trials for Primary Progressive Multiple Sclerosis (PPMS) and Secondary Progressive Multiple Sclerosis (SPMS) set to begin in mid-2025 [2] - NDA filing for MCL in regions outside the US, such as Singapore [2] - Focus on Acute Myeloid Leukemia (AML) for mesuloclax (BCL2) global development [2] Potential Catalysts - **Upcoming Data Releases**: - Expected phase 2b data for Orelabrutinib in Systemic Lupus Erythematosus (SLE) by the end of 2025 [3] - Phase 2 data for ICP-332 in vitiligo anticipated by mid-2026 [3] - Preliminary clinical data for the company's first Antibody-Drug Conjugate (ADC), ICP-B794 (B7-H3), expected by the end of 2025 or early 2026 [6] Price Target and Risks - **Price Target**: - 12-month target price set at HK$12.72 for H shares and Rmb23.10 for A shares, reflecting a potential upside of 33.9% and 13.5% respectively [7][9] - **Key Risks**: - R&D risks for key clinical assets, lack of proven commercialization track record, pricing uncertainties, and potential entry of generic ibrutinib in 2027 in China [8] Conclusion InnoCare Pharma shows strong sales growth and improved profitability in 1Q, with a solid cash position to support ongoing clinical development. The revised sales guidance and upcoming clinical data releases present potential catalysts for future growth, although risks remain in R&D and market competition.