| A 股代码：688428 | A 股简称：诺诚健华 | | --- | --- | | 港股代码：09969 | 港股简称：诺诚健华 | 诺诚健华医药有限公司 2024 年科创板限制性股票激励计划 （草案） 诺诚健华医药有限公司 二零二四年十一月 1 声明 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。 本公司所有激励对象承诺，公司因信息披露文件中有虚假记载、误导性陈述 或者重大遗漏，导致不符合授予权益或权益归属安排的，激励对象应当自相关信 息披露文件被确认存在虚假记载、误导性陈述或者重大遗漏后，将由本激励计划 所获得的全部利益返还公司。 2 特别提示 一、本激励计划系依据《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》《上市公司股权激励管理办法》《科创板上市公司自律监管指南 第 4 号——股权激励信息披露》《香港联合交易所有限公司证券上市规则》等有 关法律、法规、规范性文件，以及《公司章程》制订。 二、本激励计划采取的激励工具为限制性股票（第二类限制性股票）。股票 来源为诺诚健华医药有限公司（以下简称" ...

A 股代码：688428 A 股简称：诺诚健华 港股代码：09969 港股简称：诺诚健华 2024 年 11 月 上海荣正企业咨询服务（集团）股份有限公司 关于 诺诚健华医药有限公司 2024 年科创板限制性股票激励计划 （草案） | 一、释义 | 2 | | --- | --- | | 二、声明 | 4 | | 三、基本假设 | 5 | | 四、本次限制性股票激励计划的主要内容 | 6 | | （一）激励对象的范围及分配情况 | 6 | | （二）授予的限制性股票数量 | 8 | | （三）股票来源 | 8 | | （四）限制性股票的有效期、授予日及授予后相关时间安排 | 8 | | （五）限制性股票授予价格 | 11 | | （六）激励计划的授予及归属条件 | 11 | | （七）激励计划其他内容 | 16 | | 五、独立财务顾问意见 | 16 | | （一）对限制性股票激励计划是否符合政策法规规定的核查意见 | 16 | | （二）对公司实行股权激励计划可行性的核查意见 | 17 | | （三）对激励对象范围和资格的核查意见 | 18 | | （四）对股权激励计划权益授出额度的核查意见 | 18 | ...

FANGDA PARTNERS http://www.fangdalaw.com 邮政编码：200041 传 真 Fax.: +86-21-5298 5599 中国上海市石门一路 288 号 电子邮件 E-mail: email@fangdalaw.com 兴业太古汇香港兴业中心二座 24 楼 电 话 Tel.: +86-21-2208 1166 24/F, HKRI Centre Two HKRI Taikoo Hui 288 Shi Men Yi Road Shanghai, PRC 200041 上海市方达律师事务所 关于诺诚健华医药有限公司（InnoCare Pharma Limited） 2024 年科创板限制性股票激励计划（草案） 的法律意见书 致：诺诚健华医药有限公司（InnoCare Pharma Limited） 上海市方达律师事务所（以下简称"本所"）是具有中华人民共和国境内法律 执业资格的律师事务所。根据诺诚健华医药有限公司（InnoCare Pharma Limited） （以下简称"诺诚健华"、"公司"或"上市公司"）的委托，本所担任诺诚健华 2024 年科创板限制性股票激励计划项目 ...

Core Insights - The company successfully held its 2024 R&D Day, focusing on "Science-Driven Innovation" and showcasing advancements in autoimmune disease research, aiming to establish a second growth curve in this area [1] Group 1: Company Performance and Outlook - The company reported outstanding Q3 performance with accelerated commercialization growth, achieving the highest quarterly revenue for its core product, Oubatinib, since its launch [2] - The CEO highlighted breakthroughs in autoimmune disease research, with six indications poised for development, and projected five to six innovative drugs to be approved in the next three to five years, aligning with the company's 2.0 development goals [2] Group 2: Market Potential and Strategy - The CFO discussed the vast market potential for autoimmune diseases, with a forecasted global market size of $176 billion by 2030, indicating significant growth opportunities compared to the oncology market [2] - The company is strategically focusing on six autoimmune indications to create a solid foundation for future growth [2] Group 3: Research and Development Progress - The company employs a "pipeline-in-a-pill" strategy to maximize drug value, with Oubatinib targeting both peripheral and central nervous systems for various autoimmune indications [2] - Oubatinib is undergoing global Phase III clinical trials for primary progressive multiple sclerosis (PPMS) and secondary progressive multiple sclerosis (SPMS) [2] - The company is advancing Oubatinib for the treatment of immune thrombocytopenia (ITP), with promising results from Phase II trials [2][3] Group 4: New Drug Developments - New oral TYK2 inhibitors, ICP-332 and ICP-488, are showing effectiveness in treating moderate to severe atopic dermatitis and psoriasis, respectively, with positive results from Phase II clinical studies [3] - The company is enhancing its drug discovery platform to develop innovative small and large molecule therapies for autoimmune diseases [3] Group 5: Business Development Strategy - The company is pursuing a flexible business development strategy to foster global collaborations and maximize the value of its pipeline through various partnership opportunities [3]

Investment Rating - The report assigns an "Accumulate" rating for the company [1]. Core Views - The company is entering a rapid growth phase with significant potential in the NHL and autoimmune drug markets, particularly with the BTK inhibitor applications [3][4]. - The management team is experienced and has established an integrated R&D and production platform, with a focus on innovative drug development [4][18]. - The company has a robust pipeline with 13 drugs in development and has achieved rapid revenue growth driven by its lead product, Aobutini [5][60]. Summary by Sections Company Overview - The company is a comprehensive innovative biotech firm focused on oncology and autoimmune diseases, with a fully integrated biopharmaceutical platform [18]. - Founded in 2015, the company has developed a strong R&D capability and has multiple promising drug candidates [18]. Management and Shareholder Structure - The company has a dispersed shareholding structure with no controlling shareholder, ensuring diverse governance [20]. R&D and Clinical Development - The company has established six core technology platforms for drug development and has over 30 clinical trials ongoing globally [53]. - Aobutini, the lead product, has shown significant market potential with multiple approved indications and rapid sales growth [60]. Financial Performance - The company has shown a significant increase in revenue, with projected revenues of 1.051 billion, 1.232 billion, and 1.433 billion yuan for 2024, 2025, and 2026 respectively [6]. - The net loss has narrowed, indicating improving profitability, with a forecasted EPS of -0.20 yuan for 2024 [6][5]. Market Potential - The NHL market is expected to grow significantly, with the number of patients in China projected to reach 730,000 by 2030 [3][69]. - BTK inhibitors are increasingly replacing traditional chemotherapy in NHL treatment, indicating a shift in treatment paradigms [71]. Investment Recommendations - The report suggests that Aobutini has substantial growth potential in the hematological malignancy indications, supporting the "Accumulate" rating [5].

Investment Rating - The report maintains a "Buy" rating for the Hong Kong stock of the company and adjusts the target price to HKD 9.2, indicating a potential upside of 23% from the current price of HKD 7.5 [2][4][12] - The A-share target price is raised to RMB 14.5, but the rating is downgraded to "Hold" due to the stock being in a reasonable valuation range [2][4][6] Core Insights - The company has raised its full-year sales guidance for the drug Orelabrutinib to a growth rate of 45% year-on-year, driven by strong sales performance and new indications being added to insurance coverage [3][4] - In Q3 2024, the company reported a significant narrowing of net losses to RMB 13.57 million, a decrease of 87.5% year-on-year, attributed to better-than-expected R&D expenses and favorable foreign exchange gains [2][3] - The company achieved revenue of RMB 278 million in Q3 2024, representing a 74% year-on-year increase, with Orelabrutinib sales contributing RMB 276 million, up 75.5% year-on-year [2][3] Financial Performance Summary - For the first nine months of 2024, total revenue reached RMB 698 million, a 29.8% increase year-on-year, with Orelabrutinib product revenue at RMB 693 million, up 45% year-on-year [2][3] - The gross margin improved to 86% compared to 81.2% in the same period last year, while the net loss attributable to shareholders for the nine months was RMB 275 million, down 53.7% year-on-year [2][3] - The company forecasts total revenue for 2024 to be RMB 989 million, with a projected growth rate of 34% year-on-year [7][10] Clinical Development and Pipeline - The company is advancing two TYK2 inhibitors for autoimmune indications, with clinical trials for ICP-332 and ICP-488 progressing as planned [4][6] - The management expects Orelabrutinib's overseas potential for progressive multifocal leukoencephalopathy (PML) indications to reach approximately USD 3 billion in sales [3][4] - Clinical trials for the ITP indication are expected to complete by 2025, with ongoing discussions with the FDA for other indications [3][4]

Group 1: Clinical Development Progress - The FDA has reached an agreement with the company to initiate Phase III clinical trials for Obechizumab in patients with Primary Progressive Multiple Sclerosis (PPMS) and has recommended starting a second Phase III trial for Secondary Progressive Multiple Sclerosis (SPMS) [2] - The company is currently conducting an international Phase III clinical trial for PPMS and preparing the SPMS Phase III clinical trial protocol [2] Group 2: Product Development and Results - ICP-488 has completed a Phase II clinical trial for psoriasis in China, showing significant improvement in the Psoriasis Area and Severity Index (PASI) scores, with at least a 75% reduction in PASI scores at week 12 for patients treated with 6mg and 9mg doses compared to placebo [3] - The proportion of patients achieving PASI 90 and PASI 100 was significantly higher in the treatment group compared to the placebo group [3] Group 3: Financial Performance - The company's gross margin for the first nine months of 2024 is 86.0%, an increase of 4.8 percentage points from 81.2% in the same period last year [3] - Obechizumab generated sales revenue of 276 million yuan in Q3 2024, a year-on-year increase of 75.5%, with total sales revenue of 693 million yuan for the first nine months of 2024, reflecting a growth of 45.0% [4] Group 4: Market Expansion and Future Prospects - Obechizumab has received insurance coverage for three indications, including Chronic Lymphocytic Leukemia (CLL), Mantle Cell Lymphoma (MCL), and Marginal Zone Lymphoma (MZL), making it the first and only BTK inhibitor approved for MZL in China [4] - The company aims to achieve at least six commercialized products by 2028, including Tafasitamab and ICP-488 for autoimmune disease indications [5]

证券代码：688428 证券简称：诺诚健华 诺诚健华医药有限公司 2024 年第三季度报告 诺诚健华医药有限公司 2024 年第三季度报告 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： 公司董事会及董事、高级管理人员保证季度报告内容的真实、准确、完整，不存在虚假记载、误 导性陈述或重大遗漏，并承担个别和连带的法律责任。 公司负责人、主管会计工作负责人及会计机构负责人（会计主管人员）保证季度报告中财务信息 的真实、准确、完整。 第三季度财务报表是否经审计 □是 √否 管理层业绩评述 诺诚健华医药有限公司（以下简称"诺诚健华"或"公司"）管理层评论说："公司是一家 以卓越的自主研发能力为核心驱动力的高科技创新生物医药企业，拥有全面的研发、生产和商业 化能力，专注于肿瘤和自身免疫性疾病等存在巨大未满足临床需求的领域，在全球市场内开发具 有突破性潜力的同类首创或同类最佳药物。 公司核心产品奥布替尼（宜诺凯®）2024年第三季度实现销售收入2.76亿元，同比增长75.5%， 2024 年 1-9 月共实现其销售收入 ...

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: 2024年10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: 2024年11月5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 ...

| A | A 股简称：诺诚健华 公告编号：2024-030 | 股代码：688428 | | --- | --- | --- | | 港股代码：09969 | 港股简称：诺诚健华 | | 关于召开 2024 年第三季度业绩说明会的公告 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、准确性和完整性承担法律责任。 重要内容提示： 会议召开时间：2024 年 11 月 12 日(星期二)上午 11:00-12:00 会 议 召 开 地 点 ： 上 海 证 券 交 易 所 上 证 路 演 中 心 （ 网 址 ： http://roadshow.sseinfo.com/） 会议召开方式：上证路演中心网络互动 投资者可于 2024 年 11 月 5 日(星期二)至 11 月 11 日(星期一)16:00 前登 录上证路演中心网站首页点击 " 提问预征集 " 栏目或通过公司邮箱 IR@innocarepharma.com 进行提问。公司将在说明会上对投资者普遍关注的问题 进行回答 诺诚健华医药有限公司（以下简称"公司"）将于 2024 年 11 月 12 日发布公 ...