Financial Performance - The company reported a net loss of 453 million yuan for the fiscal year 2024, with a cash-adjusted loss of 431 million yuan after excluding non-cash items[3]. - The company will not distribute profits for the fiscal year 2024, pending approval at the annual shareholders' meeting[8]. - The company reported a total revenue of RMB 1.2 billion for the fiscal year 2024, representing a year-over-year increase of 15%[20]. - The net loss attributable to shareholders decreased by 30.20% year-on-year, amounting to approximately RMB 440.63 million in 2024, compared to RMB 631.26 million in 2023, due to increased sales of the drug Orelabrutinib and reduced foreign exchange losses[32]. - The net cash outflow from operating activities improved significantly, decreasing from RMB 665.49 million in 2023 to RMB 365.55 million in 2024, attributed to increased sales and cash receipts from goods sold[32]. - The company reported a gross margin of 60% for the fiscal year 2024, an improvement from 55% in the previous year[20]. - Operating expenses were reduced by 10% year-over-year, contributing to improved profitability[20]. - The adjusted net loss for the year, excluding certain non-cash items, was RMB 430.80 million, compared to RMB 490.67 million in the prior year, reflecting a decrease of about 12%[41]. Research and Development - Research and development expenses increased by 7.57% year-on-year to 815 million yuan, reflecting the company's ongoing investment in new technology platforms and clinical trials[3]. - The company is investing RMB 200 million in R&D for new technologies, focusing on enhancing product efficiency and user experience[20]. - Research and development expenses accounted for 80.70% of total revenue in 2024, a decrease of 21.83 percentage points from 102.53% in 2023, reflecting the substantial growth in revenue[31]. - The company has established a comprehensive research and development platform to accelerate drug discovery and improve clinical trial efficiency[49]. - The company is engaged in developing innovative small molecules, monoclonal antibodies, and bispecific antibodies targeting promising indications in hematological malignancies and solid tumors[88]. Product Pipeline and Approvals - The company has a robust product pipeline in hematological malignancies, autoimmune diseases, and solid tumors, with its core product, Orelabrutinib, already commercialized[4]. - The BLA for the Tafasitamab and Lenalidomide combination therapy has been accepted by the CDE and is under priority review, expected to receive approval in the first half of 2025[4]. - The company has multiple products in various stages of clinical trials, with several expected to advance to market approval by mid-2025, including Tafasitamab combined with Lenalidomide for treating relapsed or refractory DLBCL[46]. - The company aims to establish a leadership position in the hematological oncology field, focusing on treatments for Non-Hodgkin Lymphoma (NHL), leukemia, and multiple myeloma (MM)[47]. - The company aims to establish a competitive drug portfolio for the treatment of various solid tumors, utilizing targeted therapies, immuno-oncology methods, and advanced ADC technology[78]. Market Expansion and Strategy - The company expects revenue guidance for 2025 to be between RMB 1.5 billion and RMB 1.7 billion, indicating a growth rate of 25% to 42%[20]. - Market expansion plans include entering two new international markets by Q3 2025, aiming for a 10% market share in each[20]. - The company is exploring potential acquisitions to enhance its product portfolio, with a budget of up to RMB 500 million allocated for this purpose[20]. - A strategic partnership with a leading tech firm is expected to enhance distribution channels and increase market penetration by 30%[20]. - The company plans to continue expanding its market presence and product offerings, focusing on the ongoing development of innovative therapies[32]. Clinical Trials and Efficacy - The ORR for Tafasitamab combined with Lenalidomide in clinical trials was reported at 73.1%, with 32.7% of patients achieving CR[55]. - ICP-248, a new oral BCL-2 inhibitor, has shown promising results in early trials, with an ORR of 87.5% in r/r CLL/SLL patients[59]. - The company aims to complete the Phase III clinical trial for Obinutuzumab in ITP by the end of 2025 and submit the NDA in the first half of 2026[68]. - The Phase II clinical trial data for Obinutuzumab in ITP will be published in The American Journal of Hematology in April 2024, with a Phase III trial expected to complete in 2025[141]. - The ongoing clinical trials for ICP-490 and ICP-B05 are expected to further evaluate their safety and efficacy in various cancer indications[123][124]. Innovation and Technology - The company is leveraging its proprietary ADC platform to develop differentiated ADC products aimed at improving efficacy and safety in cancer treatment[49]. - The proprietary ADC platform features irreversible bioconjugation technology and a drug-antibody ratio (DAR) of 8, aiming to enhance stability and therapeutic efficacy[82]. - The ADC platform utilizes proprietary linker-payload technology, achieving a drug-antibody ratio (DAR) of 8, aimed at providing effective and targeted cancer therapies[175]. - The company has completed the IV formulation dose escalation for ICP-B02, which shows good efficacy in FL and DLBCL patients[117]. Management and Governance - The company’s management team has extensive experience from major pharmaceutical companies, enhancing its capabilities in drug development and commercialization[45]. - The company operates as a red-chip enterprise, listed on both the Hong Kong Stock Exchange and the Shanghai Stock Exchange's Sci-Tech Innovation Board[10]. Market Trends and Projections - The global pharmaceutical market size was $1.50 trillion in 2022 and is expected to reach approximately $2.09 trillion by 2030[189]. - The global oncology drug market size grew from $143.5 billion in 2019 to $228.9 billion in 2023, with a CAGR of 12.4%, and is projected to reach $419.8 billion by 2030, with a CAGR of 9.1% from 2023 to 2030[197]. - The global autoimmune disease treatment market is projected to reach $185 billion by 2029, with a compound annual growth rate (CAGR) of 3.7%[66].

一、主要会计数据和财务指标 | 名称 | 持有数量(万股) | 占总股本比例 | 增减情况(万 | | --- | --- | --- | --- | | | | (%) | 股) | | HKSCC NOMINEES LIMITED | 85769.22 | 48.66 | 0.10 | | HHLR Fund, L.P.及其一致行动人 | 20867.12 | 11.84 | 不变 | | King Bridge Investments Limited及其一致行动人 | 15858.86 | 9.00 | 不变 | | Sunny View Holdings Limited与Renbin Zhao(赵仁 滨)家族 | 14471.79 | 8.21 | 不变 | | Sunland BioMed Ltd与Jisong Cui(崔霁松)家族 | 12660.03 | 7.18 | 不变 | | 鹏华医药科技股票A | 1880.49 | 1.07 | -34.57 | | 富国精准医疗灵活配置混合A | 1282.34 | 0.73 | 不变 | | 易方达医疗保健行业混合A | 916.34 | 0.52 ...

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） 諾誠健華醫藥有限公司 （「本公司」） 提名委員會職權範圍 InnoCare Pharma Limited 諾誠健華醫藥有限公司 1. 就本職權範圍（「職權範圍」）而言： 董事會指本公司的董事會。 財務總監指董事會不時委任負責財務管理的本公司高級行政人員。 公司秘書指本公司的公司秘書。 董事指董事會成員。 本集團指於有關期間，本公司及其附屬公司和聯營公司；或若文義另有 所指，於本公司成為其現時附屬公司和聯營公司的控股公司前期間，本公 司現時附屬公司和聯營公司；或其現時附屬公司和聯營公司或其前身（視 乎具體情況）所營運的業務。 上市規則指《香港聯合交易所有限公司證券上市規則》（經不時修訂）。 提名委員會指董事會根據本職權範圍第2條通過的決議案而設立的提名委 員會。 （ 於 開 曼 群 島 註 冊 成 立 的 有 限 公 司 ） （股份代號：9969） 提名委員會職權範圍 定義 – 1 – 高級管理層指主席、行政總裁、首席醫學官、首席財務官、首席技術官及 本公 ...

Financial Performance - Total revenue increased by 36.7% from RMB 738.5 million in 2023 to RMB 1,009.4 million in 2024, primarily driven by strong sales growth of Oubatinib[4] - Gross profit rose by 42.8% from RMB 610.1 million in 2023 to RMB 871.0 million in 2024, with a gross margin of 86.3%, up 3.7 percentage points from 82.6% in 2023[4] - The net loss decreased by 29.9% from RMB 645.6 million in 2023 to RMB 452.9 million in 2024, indicating improved financial performance[6] - Total revenue for the year ending December 31, 2024, was RMB 1,009.4 million, with revenue from Orelabrutinib exceeding RMB 1 billion for the first time, marking a 49.1% increase from the previous year[46] - Net sales of drugs rose by 49.7% from RMB 671.6 million in 2023 to RMB 1,005.6 million in 2024, driven by rapid growth in sales of the drug Oubatinib[146] Expenses and Costs - Operating expenses increased by 8.1% from RMB 1,311.6 million in 2023 to RMB 1,417.8 million in 2024, with sales and distribution expenses rising by 14.5%[5] - Research and development expenses rose to RMB 814.0 million in 2024, up from RMB 751.2 million in 2023, reflecting increased investment in technology platform innovation and clinical trials[5] - The ratio of sales and distribution expenses to drug sales decreased from 54.6% in 2023 to 41.8% in 2024, indicating improved operational efficiency[5] - Administrative expenses decreased from RMB 193.5 million in 2023 to RMB 183.9 million in 2024, mainly due to a one-time payment related to the termination of an intellectual property transfer agreement[156] Cash and Assets - Cash and cash equivalents as of December 31, 2024, were approximately RMB 7.76 billion, providing flexibility for clinical development and investment in competitive product lines[6] - The net current assets amounted to RMB 6,759.2 million as of December 31, 2024, supported by cash and bank balances of RMB 6,222.6 million[162] - The company recorded a loss of RMB 5.3 million from joint ventures in 2024, compared to a loss of RMB 4.9 million in 2023[160] - Trade receivables and bills increased from RMB 307.6 million as of December 31, 2023, to RMB 351.0 million as of December 31, 2024, with a significant rise in receivables within three months from RMB 248.9 million to RMB 345.9 million[163] Product Development and Clinical Trials - The company is advancing over 30 ongoing global trials across various clinical stages, focusing on a strong and diverse pipeline of products[9] - The company aims to establish leadership in the hematology field, with Oubatinib as a core therapy and plans for regulatory approval of Tanshitumomab in the first half of 2025[10] - The NDA for Obinutuzumab's use in first-line CLL/SLL treatment was accepted by the CDE in August 2024, with approval expected within the year[11] - The BLA for the combination therapy of Tazemetostat and Lenalidomide for treating relapsed/refractory DLBCL has been accepted for priority review by the NMPA, with approval anticipated in the first half of 2025[13] - The company has initiated a Phase III clinical trial for ICP-248 in CLL/SLL patients, with the first patient expected to be enrolled in March 2025[15] Market and Competitive Position - The global autoimmune disease treatment market is projected to reach $185 billion by 2029, growing at a CAGR of 3.7%, driven by rising prevalence and new product launches[19] - The company aims to become a leader in the hematological malignancies field, supported by a robust product portfolio including Obinutuzumab and Tanshinone Monoclonal Antibody[37] - The company is positioned to address unmet clinical needs in autoimmune diseases through innovative therapies targeting B and T cell signaling pathways[19] Innovations and Collaborations - The company has enhanced its commercialization capabilities by optimizing its management team and strategies, leading to improved operational efficiency and market penetration[11] - A licensing agreement for the development and commercialization of ICP-B02 has been established, with potential milestone payments totaling up to $502.5 million based on clinical and regulatory achievements[16] - The company is actively seeking licensing and clinical collaboration opportunities to complement its existing product pipeline and enhance operational efficiency[41] Regulatory and Approval Updates - Obinutuzumab has been approved as the first and only BTK inhibitor for treating relapsed/refractory Marginal Zone Lymphoma (MZL) in China, and is listed as a first-line recommendation in the CSCO guidelines for MZL treatment[11] - The company has reached an agreement with the FDA to initiate Phase III trials for Obinutuzumab in treating primary progressive multiple sclerosis (PPMS) and secondary progressive multiple sclerosis (SPMS) patients[20] - The combination therapy of Tazemetostat and Lenalidomide has received accelerated approval in the US and conditional approval in Europe for treating relapsed refractory DLBCL[67] Future Plans and Projections - The company plans to submit the IND application for ICP-B794 in the first half of 2025 and initiate clinical trials in the second half of 2025, aiming to enhance its oncology portfolio[40] - The company plans to submit the New Drug Application (NDA) for ICP-723 by the end of March 2025[29] - The company aims to accelerate the progress of its clinical trials to meet the urgent treatment needs of patients[84]

诺诚健华医药有限公司 关于召开 2024 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： | A 股代码：688428 | A 股简称：诺诚健华 | 公告编号：2025-007 | | --- | --- | --- | | 港股代码：09969 | 港股简称：诺诚健华 | | 会议召开时间：2025 年 3 月 28 日(星期五)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 2025 年 3 月 21 日(星期五)至 3 月 27 日(星期四)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 ...

Investment Rating - The report assigns a "Buy" rating for the company, marking it as the first coverage [4]. Core Viewpoints - The company is positioned as a leader in the domestic blood cancer drug market, with continuous innovation driving steady growth. It has a strong pipeline of products in development and is expected to expand its commercial offerings significantly in the near future [8][15]. - The company has successfully raised a total of $1.34 billion through multiple funding rounds from 2020 to 2022, which has been directed towards enhancing research and development efforts [8][15]. - The company is expected to achieve revenues of 1.01 billion yuan in 2024, representing a year-on-year growth of 36.8%, with a projected net loss of 444 million yuan, a reduction of approximately 30% compared to the previous year [8][15]. Financial Summary - **Revenue Forecasts**: - 2022: 625 million yuan - 2023: 739 million yuan - 2024E: 1,010 million yuan - 2025E: 1,442 million yuan - 2026E: 1,797 million yuan - **Growth Rates**: - 2023: 18.1% - 2024E: 36.8% - 2025E: 42.7% - 2026E: 24.7% [8][15]. - **Net Profit Forecasts**: - 2022: -887 million yuan - 2023: -631 million yuan - 2024E: -444 million yuan - 2025E: -300 million yuan - 2026E: -214 million yuan [8][15]. - **Return on Equity (ROE)**: - 2022: -11.7% - 2023: -9.0% - 2024E: -6.7% - 2025E: -4.8% - 2026E: -3.5% [8][15]. Product Pipeline - The company has 13 products in development, with two already commercialized. The pipeline includes several products that are expected to enter the market soon, such as ICP-723 and various indications for Obinutuzumab [8][23]. - The company is focusing on blood cancers, autoimmune diseases, and solid tumors, with a significant number of products in late-stage clinical trials [8][23]. Market Position - The company is recognized as the fifth A+H listed pharmaceutical company in China, with a management team that possesses extensive experience in drug development and commercialization [15][19]. - The company has established a strong market presence through its lead product, Obinutuzumab, which has been pivotal in its revenue growth since its launch [8][15].

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） 承董事會命 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3月14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。 董事會召開日期 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3月27日（星期四）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2024年12月31日止之全年業績及其發佈。 ...

诺诚健华医药有限公司 自愿披露关于 ICP-488 治疗银屑病数据在 2025 年美国皮肤病学会（AAD）年会 以重磅口头报告发布的公告 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"）在 2025 年 美国皮肤病学会（AAD）年会上以重磅口头报告的形式，发布了标题为《高选择 性口服 TYK2 抑制剂 ICP-488 治疗中重度斑块状银屑病的疗效和安全性：一项随 机双盲安慰剂对照 II 期临床试验》的报告。现将主要情况公告如下： 一、ICP-488 临床数据 研究结果表明，ICP-488 在每天一次（QD）6 毫克和每天一次 9 毫克的剂量 下对银屑病患者均具有显著疗效，且展现出良好的安全性和耐受性，为中重度银 屑病患者提供了有价值的治疗选择。 129 例银屑病患者按 1:1:1 比例随机分为三组，接受 12 周治疗：6 毫克 QD 组、9 毫克 QD 组和安慰剂组。主要终点为第 12 周时银屑病皮损面积与严重程 度指数较基线改善至少 75%（PASI 75）的患 ...

Market Overview - The overall sentiment in the pharmaceutical sector remains optimistic, with low valuations and public fund allocations to the sector at a low point. The industry is expected to see growth driven by macroeconomic factors and significant product demand by 2025 [7][8]. - The CITIC pharmaceutical index increased by 1.08%, underperforming the CSI 300 index by 0.03 percentage points, ranking 18th among 30 primary sectors [4]. Key Stocks Performance - Top-performing stocks this week include: - Rejuve Bio: 34.39% - Berry Genomics: 25.72% - Anbiping: 19.90% - Aidi Pharmaceutical: 18.17% [3][4]. - Underperforming stocks include: - Jiangsu Wuzhong: -14.47% - Baili Tianheng: -12% - S*ST Longjin: -10% [4]. Investment Themes - **Innovative Drugs**: The domestic innovative drug sector is transitioning from quantity to quality, focusing on differentiated and internationalized pipelines. Companies to watch include Hengrui, BeiGene, and others [7]. - **Medical Devices**: The sector is expected to benefit from new equipment update policies, with key players like Mindray Medical and others positioned for growth [7]. - **Chinese Medicine**: The market for essential medicines is anticipated to grow, with companies like Kunming Pharmaceutical and Kangyuan Pharmaceutical highlighted for their potential [12]. - **Pharmacy Sector**: The pharmacy sector is expected to see significant growth due to prescription outflow and market optimization, with companies like YaoBai and YiFeng Pharmacy recommended for investment [12]. - **Medical Services**: The private medical sector is expected to gain competitiveness due to anti-corruption measures and the expansion of commercial insurance [12]. AED Industry Insights - The AED market is projected to grow significantly, with the global market expected to reach 161.2 billion yuan by 2028, driven by increasing cardiovascular disease rates [22]. - In China, the AED procurement amount is expected to rise from 3.95 billion yuan in 2021 to 6 billion yuan in 2024, indicating a strong growth trajectory [25]. - The domestic AED market is seeing a shift from reliance on imports to a higher domestic production rate, with the domestic market share expected to reach 79% by 2024 [27][29]. Policy Support for AED - National policies are increasingly supporting AED proliferation, with guidelines established for public spaces and healthcare facilities to ensure adequate AED availability [16][19]. - Local governments are also implementing specific policies to enhance AED distribution, such as requiring a certain number of AEDs per population in public areas [20]. Competitive Landscape - The AED market has shifted from heavy reliance on imports to a more competitive domestic landscape, with Mindray Medical leading the market with a 47.74% share [36]. - Companies like Yiyue Medical are expanding their AED offerings through acquisitions and product development, enhancing their market presence [37].