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，概不就因本公告 全部或任何部分內容而產生或因依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 ） | | 截至6月30日止六個月 | | | --- | --- | --- | | | 2024年 | 2023年 | | | 人民幣千元 | 人民幣千元 | | 收益 | 419,738 | 377,549 | | 銷售成本 | (60,140) | (76,072) | | 毛利 | 359,598 | 301,477 | | 其他收入及收益 | 111,356 | 131,265 | | 銷售及分銷開支 | (157,153) | (191,208) | | 研發開支 | (420,822) | (358,130) | | 行政開支 | (91,511) | (87,299) | | 其他開支 | (33,059) | (179,150) | | 期內虧損 | (2 ...

Financial Performance - In the first half of 2024, the company achieved a net profit of 268 million yuan, a significant improvement compared to a net loss of 429 million yuan in the same period last year, indicating a narrowing of losses [4]. - The company reported a revenue of RMB 1.5 billion for the first half of 2024, representing a year-over-year increase of 25% [13]. - The company's revenue for the first half of 2024 reached RMB 419,737,910.92, an increase of 11.17% compared to RMB 377,549,019.52 in the same period last year [24]. - The net loss attributable to shareholders was RMB -261,840,060.10, an improvement from RMB -422,209,548.49 in the previous year [24]. - The basic and diluted earnings per share were both -0.16, compared to -0.25 in the same period last year [25]. - The company expects a revenue guidance of RMB 3 billion for the second half of 2024, indicating a projected growth of 20% compared to the first half [16]. - The gross margin for the first half of 2024 improved to 60%, up from 55% in the previous year [13]. Research and Development - Research and development expenses amounted to 421 million yuan, an increase of 60 million yuan compared to the same period last year, reflecting the company's ongoing investment in new technology platforms and clinical trials [4]. - Research and development expenses accounted for 100.40% of revenue, an increase of 4.73 percentage points from 95.67% year-on-year [25]. - The company has 13 products in the research pipeline, with 2 products entering the commercialization stage [30]. - The company is conducting over 30 global trials at various clinical stages, indicating a strong commitment to R&D [30]. - The company reported a total R&D investment of ¥421,404,233.69, representing a 16.67% increase compared to ¥361,193,556.11 in the same period last year [144]. - The company has established a biomarker-based translational medicine research platform to enhance drug development efficiency and clinical trial data evaluation [156]. Product Development and Pipeline - The company continues to focus on developing innovative drugs for oncology and autoimmune diseases, addressing significant unmet clinical needs in the global market [4]. - Ongoing research and development efforts have led to the advancement of two new drug candidates, expected to enter clinical trials in Q3 2024 [16]. - The company has completed a strategic acquisition of a smaller biotech firm for RMB 200 million, enhancing its product pipeline [15]. - The core product, Acalabrutinib (Ibrutinib), achieved strong sales of 417 million CNY in the first half of 2024, representing a year-on-year growth of 30.02%, with Q2 2024 showing a remarkable increase of 48.81% [32]. - The company has 485 R&D personnel, accounting for 43.73% of the total workforce, with an average salary of ¥24.39 million [148]. - The company is developing multiple products for autoimmune diseases caused by B or T cell dysfunction, including ICP-332 and ICP-488 [155]. Market Expansion and Strategy - The company is expanding its market presence in Southeast Asia, targeting a 10% market share by 2025 [14]. - New product launches are anticipated to contribute an additional RMB 500 million in revenue by the end of 2024 [15]. - The company aims to establish a leadership position in hematological malignancies, leveraging ibrutinib and a robust pipeline of investigational drugs [52]. - The company is exploring diverse R&D models, including internal development and partnerships, to improve resource utilization in drug development [136]. Regulatory and Compliance - The company must comply with ongoing regulatory scrutiny for its approved drugs, which could impose additional costs and limit commercial potential [175]. - The company has submitted a BLA to the NMPA for urgently needed imported drugs and is included in priority review, while other products are still in the development stage [177]. - The company is subject to ongoing inspections by regulatory authorities to ensure compliance with GMP requirements, and failure to comply could lead to significant delays in product supply [183]. Challenges and Risks - The company faces risks related to adverse events from its products, which could lead to clinical trial suspensions or stricter regulatory requirements [168]. - The company is exposed to risks from rapid technological changes in drug development, which could undermine its competitive advantage [166]. - The company has limited operating history since its establishment in November 2015, making it challenging to predict future performance reliably [190]. - The company faces uncertainty in revenue growth due to reliance on market expansion of products like Obinutuzumab and ongoing R&D projects [191]. - The company may encounter risks from price adjustments in drug policies, which could negatively affect future drug revenues [187].

| A | 股代码：688428 | A 股简称：诺诚健华 | 公告编号：2024-024 | | --- | --- | --- | --- | | | 港股代码：09969 | 港股简称：诺诚健华 | | 诺诚健华医药有限公司 2024 年半年度募集资金存放与实际使用情况 的专项报告 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。 一、 募集资金基本情况 （一）实际募集资金金额、资金到位时间 诺诚健华医药有限公司（以下简称"诺诚健华"或"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 意注册（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》），公司据此采用向战略投资者定向配售、网下向符合条件的 投资者询价配售和网上向持有上海市场非限售 A 股股份和非限售存托凭证市值 的社会公众投资者定价发行相结合的方式公开发行了 264,648,217 股股票，每股 发行价格为人民币 11.03 元，募集资金总额为人民币 291 ...

Financial Performance - Revenue for the six months ended June 30, 2024, was RMB 419.7 million, an increase of 11.2% compared to RMB 377.5 million for the same period in 2023[2]. - Gross profit for the same period was RMB 359.6 million, with a gross margin of 85.7%, up from 79.9% in the previous year[2][3]. - The net loss for the six months ended June 30, 2024, was RMB 268.0 million, a reduction of 37.6% from RMB 429.2 million in the prior year[3][5]. - Adjusted net loss for the period was RMB 242.99 million, compared to RMB 206.26 million in the same period of 2023[5]. - The company reported a basic and diluted loss per share of RMB 0.16 for the six months ended June 30, 2024, compared to RMB 0.25 for the same period in 2023[153]. - The company incurred a loss before tax of RMB 267,923 thousand for the six months ended June 30, 2024, an improvement from a loss of RMB 429,184 thousand in the same period of 2023[153]. - The company reported a loss attributable to equity holders of RMB (261,840) thousand for the six months ended June 30, 2024, an improvement from a loss of RMB (422,211) thousand in 2023[184]. Research and Development - Total operating expenses increased by 5.2% to RMB 669.5 million, driven by a rise in R&D expenses to RMB 420.8 million, reflecting increased investment in technology platform innovation and clinical trials[3]. - R&D expenses for the six months ended June 30, 2024, were RMB 420,822 thousand, compared to RMB 358,130 thousand in the prior year, showing an increase in investment in innovation[153]. - The company is developing drugs targeting B cell signaling and T cell pathway abnormalities for autoimmune diseases[10]. - The company is actively pursuing the development of new candidates targeting T-cell mediated autoimmune diseases, with promising early results for ICP-332 and ICP-488[21]. - The company is developing multiple drugs targeting key hematological malignancy targets, including BCL-2, CD20×CD3, and E3 ligase[28]. Product Development and Clinical Trials - The company plans to accelerate clinical development and invest in competitive product lines, supported by a strong cash position[3]. - The company has completed patient recruitment for a Phase II registration trial for relapsed/refractory mantle cell lymphoma (MCL) in the U.S., with NDA submission plans under discussion[8]. - The company is conducting a Phase III registration trial in China for MCD subtype diffuse large B-cell lymphoma (DLBCL), comparing Acalabrutinib combined with R-CHOP against R-CHOP alone[8]. - The company has initiated a Phase II registration trial for ICP-723 in adult and adolescent patients with NTRK gene fusion-positive advanced solid tumors in mainland China, achieving an observed overall response rate (ORR) of 80-90%[16]. - The company is conducting a Phase III study evaluating the efficacy and safety of obinutuzumab combined with R-CHOP for treating newly diagnosed DLBCL patients with the MCD subtype, currently recruiting patients at 44 clinical trial centers in China[36]. Market and Sales Performance - Revenue from the drug Orelabrutinib increased by 48.8% in Q2 2024, contributing significantly to overall revenue growth[2]. - In the first half of 2024, the company's core product, Acalabrutinib (Obinutuzumab), generated revenue of RMB 417.0 million, a 30.0% increase from RMB 320.7 million in the same period of 2023[6]. - The company aims to leverage single and combination therapies to treat various hematological malignancies, positioning itself as a leader in the global hematological oncology field[6]. - The company is focused on expanding its market coverage and optimizing sales operations to enhance market penetration and increase revenue from Acalabrutinib[6]. - The company anticipates continued strong sales growth in the second half of 2024, supported by its enhanced commercialization capabilities and expanding product portfolio[18]. Financial Position and Assets - Cash and cash equivalents as of June 30, 2024, were approximately RMB 7.99 billion, providing flexibility for clinical development and investment in competitive product lines[3]. - Net current assets amounted to RMB 5,959.0 million as of June 30, 2024, primarily due to cash and bank balances of RMB 6,903.7 million and trade receivables of RMB 280.7 million[112]. - The company's total equity as of June 30, 2024, was RMB 6,938,479 thousand, down from RMB 7,180,705 thousand, reflecting a decrease of approximately 3.4%[158]. - The total amount raised from the issuance of RMB shares was approximately RMB 2,778.82 million, with a significant portion allocated for new drug research and development[151]. - The company has a bank credit line of RMB 400.0 million, of which RMB 43.9 million has been drawn as of June 30, 2024[130]. Corporate Governance and Compliance - The company has established an audit committee consisting of one non-executive director and two independent non-executive directors to oversee financial reporting and internal controls[145]. - The company will continue to review and monitor corporate governance practices to ensure compliance with the corporate governance code[140]. - The company has not made any significant investments or acquisitions as of June 30, 2024, and holds no major investments[128]. - There were no significant litigations or arbitrations involving the company during the reporting period[146]. Future Outlook - The company plans to submit a Biologics License Application (BLA) for the combination of Tanxiaotai monoclonal antibody and Lenalidomide for adult patients with relapsed refractory DLBCL by mid-2025[20]. - The company plans to initiate Phase III trials for ICP-332 in atopic dermatitis in Q4 2024 and has received IND approval from the FDA for further studies[12]. - The company is exploring the use of Aobutinin for various autoimmune diseases, with ongoing trials for systemic lupus erythematosus (SLE) and other indications[21]. - The company plans to explore the combination of ICP-B05 with other immunotherapies across various cancer indications after collecting safety data[53]. - The company is actively seeking licensing and clinical collaboration opportunities to enhance its pipeline and operational efficiency[23].

诺诚健华医药有限公司 关于召开 2024 年半年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 8 月 21 日(星期三)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/） | A | 股代码：688428 | A 股简称：诺诚健华 | 公告编号：2024-023 | | --- | --- | --- | --- | | 港股代码：09969 | | 港股简称：诺诚健华 | | （三） 会议召开方式：上证路演中心网络互动 三、参加人员 董事会主席兼行政总裁：Jisong Cui（崔霁松）博士 会议召开方式：上证路演中心网络互动 投资者可于 2024 年 8 月 14 日(星期三)至 8 月 20 日(星期二)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.c ...

呈交日期: 2024年8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 | 本月底法定/註冊股本總額： USD 50,000 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7月31日 狀態: 新提交 致：香港交易及結算 ...

| 股代码：688428 A | 股简称：诺诚健华 A | 公告编号：2024-022 | | --- | --- | --- | | 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 ICP-332 在美国完成 首例受试者给药的公告 本次临床研究为 ICP-332 首次在美国开展的临床试验，当前已完成首例受试 者给药。 三、风险提示 诺诚健华医药有限公司（以下简称"公司"或"诺诚健华"）于近日获悉，公司 创新药 ICP-332 在美国完成首例受试者给药。现将主要情况公告如下： 一、ICP-332 基本情况介绍 ICP-332 是公司自主研发的具有全球知识产权的 1 类创新药，是高效、高选 择性的新型口服 TYK2 抑制剂。TYK2 是一种非受体酪氨酸激酶，属于 Janus 激 酶（JAK）家族，是 JAK-STAT 信号通道上一个重要激酶，在 T 细胞炎症发病机 制上起到重要作用。 ICP-332 在中国开展的治疗中重度特应性皮炎（AD）的 II 期临床研究达到 多个有效性终点，展示了卓越的疗效和安全性。ICP-332 在与治疗 AD 患者不同 类别/作用机制（MoA ...

| A 股代码：688428 | A 股简称：诺诚健华 | 公告编号：2024-021 | | --- | --- | --- | | 港股代码：09969 | 港股简称：诺诚健华 | | 诺诚健华医药有限公司 关于持股 5%以上股东权益变动的提示性公告 相关股东提供的信息内容不存在任何虚假记载、误导性陈述或者重大遗漏， 并对其真实性、准确性和完整性依法承担法律责任。公司董事会及全体董事保证 本公告内容与信息披露义务人提供的信息一致。 重要内容提示： 诺诚健华医药有限公司（以下简称"诺诚健华"或"公司"）于近日收到公 司股东 Fund VIII、Surplus Fund VIII、Opp Fund、Fund IX、Asia Opp Fund、Co- Invest Fund 发来的《诺诚健华医药有限公司简式权益变动报告书》，现将其有关 2 Opportunity, LLC，Asia Opp Fund 的实际控制方为其普通合伙人 Vivo Asia Opportunity, LLC。Vivo Capital VIII, LLC、Vivo Capital IX, LLC、Vivo Opportunity Fund, ...

诺诚健华医药有限公司 简式权益变动报告书 | 信息披露义务人1： | Vivo | Capital | Fund | | VIII, L.P. | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 注册地址： | 1209 | Orange | | | Street, Wilmington, County | | | of New | Castle, | | | Delaware | | 19801 | | | | | | | | 通讯地址： | 192 | Lytton | Ave., | Palo | | Alto, CA | 94301, the | U.S. | | | 信息披露义务人2： | Vivo | Capital | | Surplus | Fund | | VIII, L.P. | | | | 注册地址： | 1209 | Orange | | | Street, Wilmington, County | | | of New | Castle, | | | Delaware | | 19801 ...

FF305 翌日披露報表 (股份發行人 ── 已發行股份或庫存股份變動、股份購回及/或在場内出售庫存股份) 表格類別： 股票 狀態： 新提交 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7月18日 如上市發行人的已發行股份或庫存股份出現變動而須根據《香港聯合交易所有限公司（「香港聯交所」）證券上市規則》(「《主板上市規則》」)第13.25A條 / 《香港聯合交易所有限公司GEM證券 上市規則》(「《GEM上市規則》」)第17.27A條作出披露，必須填妥第一章節 。 | 第一章節 | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 | 是 | | | 證券代號 (如上市) | 09969 | 說明 | | | | | | | A. 已發行股份或庫存股份變動 | | | | | | | | | | | 已發行股份（不包括庫存股份）變動 | | | 庫存股份變動 | | | | | 事件 | 已發行股份（不包括 ...