目录 | 关于本报告 | 01 | | --- | --- | | 报告简介 | 01 | | 报告范围 | 01 | | 本报告出现的附属公司名称及简称对照表 | 01 | | 编制依据 | 01 | | 信息来源 | 01 | | 报告原则 | 02 | | 报告批准与获取 | 02 | | 免责声明 | 02 | | 董事长致辞 | 03 | | 关于诺诚健华 | 05 | | 公司概况 | 05 | | 企业使命、愿景与价值观 | 05 | | 诺诚健华 2024 年大事件 | 07 | | 数说 2024 | 08 | | 2024 年度荣誉奖项 | 09 | | ESG 管理 | 11 | | 附录 | 86 | | 意见反馈 | 100 | 1 2 诚信经营，行稳致远 绿色发展，守护未来 | 公司治理 | 17 | | --- | --- | | 风险管控 | 21 | | 廉洁守规 | 25 | | 气候变化 | 29 | | --- | --- | | 环境管理 | 32 | | 节约资源 | 34 | | 绿色运营 | 36 | 3 品质争先，进而有为 4 关爱员工，以人为本 | 人才吸引 ...

此乃要件 請即處理 閣下如對本通函任何方面或應採取的行動有任何疑問，應諮詢股票經紀或其他註冊證券交易商、銀行經理、 律師、專業會計師或其他專業顧問。 閣下如已將名下所有諾誠健華醫藥有限公司的股份出售或轉讓，應立即將本通函交予買主或承讓人或經手 買賣的銀行、股票經紀或其他代理商，以便轉交買主或承讓人。 香港交易及結算所有限公司及香港聯合交易所有限公司對本通函的內容概不負責，對其準確性或完整性亦 不發表任何聲明，並明確表示，概不就本通函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。 InnoCare Pharma Limited 諾誠健華醫藥有限公司 （ 於 開 曼 群 島 註 冊 成 立 的 有 限 公 司 ） （股份代號：9969） (1) 2024年年度報告； (2) 董事會2024年度工作報告； (3) 2024年度公司利潤分配計劃； (4) 建議發行及購回股份的一般授權； (5) 重選退任董事； (6) 重新委任核數師； (7) 建議為董事及高級管理層購買責任保險； (8) 建議更新人民幣股份發行募集資金用途； 及 (9) 股東週年大會通告 諾誠健華醫藥有限公司謹訂於2025年 ...

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責，對其準確 性或完整性亦不發表任何聲明，並明確表示，概不對因本公告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。 InnoCare Pharma Limited 諾誠健華醫藥有限公司 （ 於 開 曼 群 島 註 冊 成 立 的 有 限 公 司 ） （股份代號：9969） 董事會召開日期 諾誠健華醫藥有限公司 主席兼執行董事 崔霽松博士 香港，2025年4月28日 於本公告日期，董事會包括主席兼執行董事崔霽松博士；執行董事趙仁濱博士；非執行董事 施一公博士及謝榕剛先生；以及獨立非執行董事胡蘭女士、董丹丹博士及管坤良教授。 諾誠健華醫藥有限公司（「本公司」）董事會（「董事會」）謹此宣佈，本公司將於 2025年5月13日（星期二）舉行董事會會議，藉以（其中包括）考慮及批准本公司 及其附屬公司截至2025年3月31日止三個月之未經審核第一季度業績及其發佈。 承董事會命 ...

Core Viewpoint - The approval of the new BTK inhibitor, Oubatinib (brand name: Yinuokai), by the National Medical Products Administration (NMPA) in China for first-line treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) represents a significant advancement in the treatment options available for lymphoma patients [1] Group 1: Company Overview - Nocare Biopharma (stock codes: 688428 on SSE; 09969 on HKEX) is a biopharmaceutical high-tech company focused on the development of innovative drugs for malignant tumors and autoimmune diseases [3] - The company has multiple new drug products at various stages of commercialization, clinical trials, and preclinical research, with branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States [3] Group 2: Product Approval and Impact - Oubatinib has previously been approved in China for treating relapsed/refractory CLL/SLL, mantle cell lymphoma (R/R MCL), and marginal zone lymphoma (R/R MZL), all of which are included in the national medical insurance [1] - The first-line approval for CLL/SLL is expected to benefit a larger number of lymphoma patients, with clinical trials showing a complete remission rate of 12.1% [1] - Experts have highlighted Oubatinib's high selectivity and low off-target effects, which enhance its efficacy and safety in treating blood cancers [1] Group 3: Clinical Research and Expert Opinions - Clinical researchers noted that Oubatinib demonstrated significant efficacy and safety even during the challenges posed by the COVID-19 pandemic, confirming its innovative nature [1] - The drug has been included as a Class I recommendation in the CSCO lymphoma treatment guidelines for first-line therapy of CLL/SLL, indicating its recognized importance in clinical practice [1] - Experts anticipate that the accumulation of real-world data will further guide clinical practices and improve treatment options for more lymphoma patients [1]

| A | 股代码：688428 | 股简称：诺诚健华 A | 公告编号：2025-013 | | --- | --- | --- | --- | | 港股代码：09969 | | 港股简称：诺诚健华 | | 诺诚健华医药有限公司 自愿披露关于奥布替尼新适应症 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。 近日，诺诚健华医药有限公司（以下简称"公司"或"诺诚健华"）收到国家药 品监督管理局（NMPA）核准签发的《药品注册证书》，奥布替尼（商品名：宜 诺凯®）用于一线治疗慢性淋巴细胞白血病/小淋巴细胞淋巴瘤（以下简称 "CLL/SLL"）的新适应症上市申请获得批准。现将相关情况公告如下： 一、药品情况 药品名称：奥布替尼片 申请事项：药品注册（境内生产） 受理号：CXHS2400078 证书编号：2025S01123 上市许可持有人：北京诺诚健华医药科技有限公司 审批结论：批准增加适应症，新增适应症为：本品单药适用于成人慢性淋巴 细胞白血病（CLL）/小淋巴细胞淋巴瘤（SLL）患者。 二、药品 ...

Group 1 - The core viewpoint is that Innovent Biologics (09969) has seen a significant stock increase of over 15%, currently trading at HKD 10.16, with a transaction volume of HKD 421 million due to the acceptance of a new drug application for Zurletrectinib by the NMPA [1] - Zurletrectinib is a next-generation pan-TRK inhibitor developed by Innovent, effective against TRKA, TRKB, TRKC, and can overcome resistance mutations such as G595R and G667C, addressing limitations of first-generation TRK inhibitors [1] Group 2 - Pacific Securities highlights a rich pipeline of catalysts for the company in the next 12 months, particularly in the hematological malignancies field with approvals for drugs like Obinutuzumab and Tazemetostat [2] - In the autoimmune field, multiple clinical trials are progressing, including phase 3 trials for Obinutuzumab in ITP and phase 2 trials for ICP-332 in atopic dermatitis, indicating a robust development strategy [2]

Group 1 - The Hong Kong innovative drug sector showed strong performance in the afternoon, with notable increases in stock prices for companies such as Innovent Biologics and I-Mab, both rising over 10% [1] - BeiGene's stock also experienced a significant increase, nearing 10%, alongside substantial gains for CSPC Pharmaceutical Group, Rongchang Biopharmaceutical, and WuXi Biologics [1] - The article highlights that investors can buy Hong Kong stocks through A-share accounts without the need for the Hong Kong Stock Connect, allowing for T+0 trading [1]

Investment Rating - The report maintains a "Buy" rating for the company with a target price of 23.29 RMB, compared to the last closing price of 17.86 RMB [1][6]. Core Insights - The company's revenue for 2024 reached 1.009 billion RMB, representing a year-on-year growth of 36.7%. The core product, Aobutini, achieved sales exceeding 1 billion RMB, with a year-on-year increase of 49.1% due to the expansion of MZL indications and improved commercialization capabilities [4]. - The gross margin increased to 86.3% in 2024, up 3.7 percentage points from 2023, primarily driven by changes in revenue structure and enhanced production efficiency of Aobutini [4]. - The company reported a loss of 453 million RMB for the period, a reduction of 193 million RMB or 29.9% year-on-year, attributed to increased drug sales, improved cost efficiency, and reduced unrealized exchange losses [4]. - As of December 31, 2024, the company had approximately 7.8 billion RMB in cash and cash equivalents [4]. Summary by Sections Financial Performance - Revenue for 2024 is projected at 1.009 billion RMB, with growth rates of 36.68% for 2024, 29.87% for 2025, 41.80% for 2026, and 32.16% for 2027 [9]. - The company expects to continue narrowing losses, with projected net losses of 441 million RMB in 2024 and 461 million RMB in 2025 [9]. Product Pipeline and Clinical Progress - In the hematological malignancies sector, Aobutini's NDA for first-line CLL/SLL has been accepted by NMPA, with approval expected in 2025. Additionally, Aobutini in combination with BCL2 inhibitor ICP-248 is entering Phase 3 clinical trials [5]. - In the autoimmune sector, Aobutini's Phase 3 clinical trial for ITP is accelerating, and the 2b phase for SLE has completed patient enrollment [5]. Future Catalysts - The company has a rich pipeline of catalysts expected within the next 12 months, including potential approvals for Aobutini and other products in various indications [6].

| 序号 | 工作内容 | 持续督导情况 | | --- | --- | --- | | 1 | 建立健全并有效执行持续督导工作制度，并针对 具体的持续督导工作制定相应的工作计划 | 保荐机构已建立健全并有效执 行了持续督导制度，并制定了 | | | | 相应的工作计划 | | 2 | 根据中国证监会相关规定，在持续督导工作开始 议，明确双方在持续督导期间的权利义务，并报 | 保 荐 机 构 已 与 诺 诚健 华 签 订 《保荐协议》及《持续督导协 | | | 前，与上市公司或相关当事人签署持续督导协 | 议》，该协议明确了双方在持 | | | | 续督导期间的权利和义务，并 | | | 上海证券交易所备案 | 报上海证券交易所备案 | | 3 | 持续督导期间，按照有关规定对上市公司违法违 规事项公开发表声明的，应于披露前向上海证券 | 2024年度诺诚健华在持续督导 期间未发生按有关规定需保荐 机构公开发表声明的违法违规 | | | 媒体上公告 | 情况 | | 4 | 违规、违背承诺等事项的，应自发现或应当自发 | 年度诺诚健华在持续督导 2024 期间未发生违法违规或违背承 | | 5 | 通过日常沟 ...