事件：2024 年公司实现营业收入10.1 亿元，同比增长36.7%；归母净亏损4.4 亿元，同比缩窄30.2%。 奥布替尼收入持续高增，新适应症快速推进：2024 年奥布替尼收入10.0 亿元，同比增长49.1%，主要是 归功于r/r MZL 适应症纳入医保后在2024 年实现快速放量，以及商业化团队能力的不断加强。截至2025 年3 月，在血液瘤领域，奥布替尼有三项适应症贡献收入，一项适应症（1L CLL/SLL）处于NDA 阶 段。在自免领域，ITP、MS、SLE 等适应症已推进至临床2/3 期。新适应症的快速推进将持续为奥布替 尼收入增长注入新活力，支撑公司整体业绩稳步增长。 靶向B7H3 ADC 发布，丰富肿瘤管线布局：根据2024 年报，公司推出高度差异化的ADC 平台，采用自 主研发的连接子-载荷（LP）技术，在提高疗效的同时进一步优化安全性。基于该平台，一款靶向B7H3 的新型ADC（ICP-B794）计划于2025 年上半年递交IND申请。在临床前研究中，ICP-B794在SCLC、 NSCLC 及其他实体瘤的CDX 小鼠模型中展现了强效的抗肿瘤活性。 2025 年重要催化剂：1）奥布替尼1 ...

Investment Rating - The report maintains a "Recommended" rating for the company, indicating an expectation that the stock will outperform the market by 10% to 20% over the next six months [10]. Core Insights - The company achieved a total revenue of 1.009 billion yuan in 2024, with its core product, Aobutini, reaching sales of over 1 billion yuan, representing a year-on-year growth of 49% [4]. - The gross margin for 2024 is reported at 86.3%, an increase of 3.7 percentage points compared to the previous year [4]. - The company has a strong cash position with a cash balance of 7.76 billion yuan, which supports the acceleration of clinical trial developments [4]. - The revenue forecasts for 2025, 2026, and 2027 have been adjusted to 1.403 billion yuan, 1.702 billion yuan, and 1.994 billion yuan respectively, with growth rates of 39%, 21.3%, and 17.2% [8]. Financial Summary - The company reported a significant reduction in losses, with an overall loss of 450 million yuan in 2024, down from 650 million yuan in the same period of 2023 [4]. - The operating expenses for 2024 are detailed as follows: sales expenses of 420 million yuan, R&D expenses of 815 million yuan, and management expenses of 169 million yuan, with respective year-on-year growth rates of 14.5%, 7.6%, and a decrease of 8.5% [4]. - The projected net profit for 2025 is expected to be -413 million yuan, with a gradual improvement in subsequent years [6]. Pipeline Development - The company is advancing its pipeline in hematological malignancies, with Aobutini's NDA for 1L CLL/SLL accepted in August 2024, and expected approval in 2025 [7]. - In the autoimmune segment, Aobutini is in Phase 3 trials for PPMS and has reached an agreement with the FDA for the SPMS clinical trial protocol [7]. - The company is also developing an ADC platform, with the ICP-B794 (B7H3 ADC) expected to submit an IND application in the first half of 2025 [7].

Investment Rating - The report maintains a "Recommended" rating for the company [8][10] Core Views - The company achieved a revenue of 1.009 billion yuan in 2024, with its core product, Aobutini, reaching sales of over 1 billion yuan, representing a year-on-year growth of 49% [4] - The gross margin for 2024 is reported at 86.3%, an increase of 3.7 percentage points year-on-year [4] - The company has a strong cash position with a cash balance of 7.76 billion yuan, which supports the acceleration of clinical trial development [4] - The revenue forecasts for 2025, 2026, and 2027 have been adjusted to 1.403 billion yuan, 1.702 billion yuan, and 1.994 billion yuan respectively, with growth rates of 39%, 21.3%, and 17.2% [8] Financial Summary - The company reported a significant reduction in losses, with an overall loss of 450 million yuan in 2024 compared to 650 million yuan in the same period of 2023 [4] - The operating expenses for 2024 are detailed as follows: sales expenses of 420 million yuan, R&D expenses of 815 million yuan, and management expenses of 169 million yuan, with respective year-on-year growth rates of 14.5%, 7.6%, and a decrease of 8.5% [4] - The projected net profit for 2025 is estimated at -413 million yuan, improving to -346 million yuan in 2026 and -237 million yuan in 2027 [6] Pipeline Progress - The company has made significant advancements in its pipeline, with Aobutini's NDA for 1L CLL/SLL accepted in August 2024, expected to be approved in 2025 [7] - The company is also advancing its ADC platform, with the ICP-B794 (B7H3 ADC) expected to submit an IND application in the first half of 2025 [7]

诺诚健华 20250328 摘要 Q&A 诺诚健华在 2024 年的业绩表现如何？ 2024 年，诺诚健华取得了显著的成绩。公司的药品销售收入实现了高速增长， 达到 49.7%，其中核心产品奥布替尼的销售收入突破 10 亿元人民币，同比增长 49.1%。这一成绩远远超过了公司年初给市场的 30%的指引。由于收入增加，公 司亏损也大幅收窄，从 2023 年的 6.46 亿元人民币降至 2024 年的 4.53 亿元人 民币，缩小了 29.9%。毛利率从 82.6%提升到 86.3%，销售费用率从 55%降低到 42%。此外，公司拥有 78 亿元人民币的现金储备，为长期发展提供了灵活性和 • 诺诚健华 2024 年总收入达 10 亿元人民币，远超年初 30%的指引，亏损收 窄 29.9%至 4.53 亿元人民币，毛利率提升至 86.3%，销售费用率降至 42%， 现金储备达 78 亿元人民币，为长期发展提供保障。 • 奥布替尼一线 CLL/SLL 上市申请已提交，并在海外递交多个上市申请。实 体瘤药物 Zurantrapinib 完成注册临床研究，计划提交 NDA 上市申请。 BCL-2 抑制剂联合奥布替尼一线 ...

研发费用高昂也是导致诺诚健华持续亏损的原因之一。2018年-2024年合计亏损额超51亿元，在2024年 年报中，对于亏损的原因，诺诚健华表示，主要由于公司大部分产品管线仍处于新药研发阶段，尚未形 成销售，研发支出金额较大，且报告期内产品的销售收入尚不能覆盖所有成本及费用。 2021年、2022年、2023年，诺诚健华研发费用分别为7.33亿元、6.49亿元、7.57亿元。2024年，诺诚健 华的研发费用为8.15亿元，与上年同期相比增长7.57%。 诺诚健华主要专注于肿瘤和自身免疫性疾病等领域的一类新药研制，以奥布替尼为核心，诺诚健华在开 发覆盖所有重要的血液肿瘤靶点的创新药，奥布替尼还在开发包括多发性硬化症在内的4个自免疾病适 应症。此外，自身免疫性疾病领域，已布局多个全球前沿靶点，覆盖免疫性血小板减少症、系统性红斑 狼疮、特应性皮肤炎等。在实体瘤方面，布局了单抗、双特异性抗体及小分子。截至2024年年底，诺诚 健华正在进行30多项处于不同临床阶段的全球试验。 3月27日晚间，诺诚健华发布2024年年度报告，报告期内，公司实现营业收入10.09亿元，较上年同期增 加36.68%；归属上市公司股东净利润约- ...

证监会审核华创证券投资咨询业务资格批文号：证监许可（2009）1210 号 未经许可，禁止转载 资料来源: Wind, 华创证券 ω · 本周，中信医药指数上涨1.04%，跑赢沪深300指数1.03个百分点，在中信30个一级行业中排名第1位。 · 本周涨幅前十名股票为怡和嘉业、润都股份、德源药业、智翔金泰-U、河化股份、荣昌生物、康弘药业、博腾股份、迈威生物-U、三元基因, • 本周跌幅前十名股票为ST香雪、创新医疗、爱朋医疗、*ST龙津、东方生物、恩威医药、*ST吉药、康惠制药、普瑞服科、翔宇医疗。 管 == $( +) 行情回顾 01 02 板块观点和投资组合 03 行业和个股事件 本周行情回顾 =半创研究 本周中信一级行业指数涨跌幅 本周涨幅排名前/后十名的股票 -40.829 ST香雪 怡和露业 40 200 22.7496 创新医疗 润都股份 | 21.83% 爱朋医疗 德源药业 19.07% 0% *ST龙津 智翔金泰-U 18.34% -1% 河化股份 东方生物 16.23% -29 圆威医药 美昌生物 15.38% -36 *ST吉药 康弘药业 15.3596 -11.54% -49 康惠制药 ...

记者注意到，过去三年，奥布替尼的销售额增速分别为163.63%、18.52%、49.14%。目前，奥布替尼的3项适应症均已纳入国家医保目录，且是国内首个且 唯一获批针对复发或难治性MZL适应症的BTK抑制剂。但由于这些适应症均为二线疗法，市场规模相对有限。 一线疗法何时获批，是投资者最关注的事项之一。去年8月，奥布替尼一线治疗慢性淋巴细胞白血病(CLL)/小淋巴细胞淋巴瘤(SLL)的新药上市申请获受理， 在2024年年报中，诺诚健华预计该适应症将于2025年获批。 另外，公司还预计第二款商业化产品Tafasitamab（坦昔妥单抗）将于2025年上半年在内地获批。这款靶向CD19的人源化单克隆抗体药物，主要用于治疗复 发或难治性弥漫大B细胞淋巴瘤（DLBCL），目前已获批在大湾区及博鳌超级医院作为临床急需进口药品使用。 每经记者 林姿辰 每经编辑 董兴生 近日，诺诚健华（SH688428）发布2024年年报，其核心产品奥布替尼在上市4年后，终于迈过了年销10亿元的大关。而且，公司预计奥布替尼一线治疗慢性 淋巴细胞白血病（CLL）/小淋巴细胞淋巴瘤（SLL）的适应症将于2025年获批，第二款商业化产品Tafas ...

2025年3月28日，诺诚健华(688428.SH)发布2024年年度报告。截至2025年3月27日，共有32个机构投资 者披露持有诺诚健华A股股份，合计持股量达1.04亿股，占诺诚健华总股本的5.90%。其中，前十大机 构投资者包括中国农业银行股份有限公司-鹏华医药科技股票型证券投资基金、中国建设银行股份有限 公司-富国精准医疗灵活配置混合型证券投资基金、中国银行股份有限公司-易方达医疗保健行业混合型 证券投资基金、招商银行股份有限公司-汇添富医疗服务灵活配置混合型证券投资基金、广州高新区科 技控股集团有限公司、万家经济新动能混合A、农银医疗保健股票、平安医疗健康混合A、东方红医疗 升级股票发起A、宝盈医疗健康沪港深股票A，前十大机构投资者合计持股比例达4.61%。相较于上一 季度，前十大机构持股比例合计下跌了0.37个百分点。 公募基金方面，本期较上一期持股增加的公募基金共计2个，包括平安医疗健康混合A、汇添富医疗服 务灵活配置混合A，持股增加占比达0.14%。本期较上一季度持股减少的公募基金共计2个，包括易方达 医疗保健行业混合A、鹏华医药科技股票A，持股减少占比达0.15%。本期较上一季度新披露的公募 ...

Core Insights - In 2024, the company reported significant revenue growth of 36.68% year-on-year, reaching a total revenue of 1.009 billion yuan, but still recorded a net loss of 441 million yuan, which narrowed by 30.20% compared to the previous year [1] - The core product, Oubatinib, achieved sales of 1 billion yuan, marking a 49.14% increase, and accounted for 99.1% of total revenue, highlighting the risk of product line dependency [1][2] - The company faces challenges in commercialization and high R&D costs, with R&D expenses reaching 815 million yuan, representing 80.7% of revenue, which raises concerns about balancing innovation investment and profitability [3] Revenue and Profitability - The company’s total revenue for 2024 was 1.009 billion yuan, with a year-on-year growth of 36.68% [1] - The net loss for the year was 441 million yuan, a reduction of 30.20% compared to the previous year [1] - The fourth quarter saw a significant drop in net profit, with a decrease of 1117.57% quarter-on-quarter, indicating volatility in earnings due to revenue structure imbalance [2] Product Performance - Oubatinib's sales reached 1 billion yuan in 2024, with a year-on-year increase of 49.14% [1] - The product's strong market penetration is evidenced by a fourth-quarter revenue of 312 million yuan, reflecting a quarter-on-quarter growth of 12.12% [1] - The company currently relies heavily on Oubatinib, with only one other commercialized product and 30+ projects in development, of which only three are in Phase III clinical trials [2] R&D Investment - R&D expenses for 2024 totaled 815 million yuan, a 7.57% increase year-on-year, constituting 80.7% of total revenue [3] - The company has 13 products at various clinical stages, with two in Phase III trials, indicating a structured R&D pipeline [3] - Despite a reduction in losses, the actual operating loss is increasing when excluding non-recurring government subsidies, with a net cash flow from operating activities of -366 million yuan [3] Internationalization Strategy - The company accelerated its internationalization efforts in 2024, forming overseas partnerships to expand its global market presence [4] - Oubatinib has completed Phase II clinical trials for autoimmune disease indications in the U.S., with plans for key registration studies in 2025 [4] - However, overseas revenue remains below 1%, and the company faces significant competition in the BTK inhibitor market, dominated by established players [4] Operational Challenges - The company’s production capacity is currently limited to meet domestic demand, necessitating the establishment of overseas production bases for global supply [4] - Inventory turnover days increased by 15 days to 98 days, indicating a need for improved supply chain management efficiency [4] - The company must enhance its commercialization capabilities to compete effectively against multinational pharmaceutical companies [2][4]

| A 股代码：688428 | A 股简称：诺诚健华 | 公告编号：2025-008 | | --- | --- | --- | | 港股代码：09969 | 港股简称：诺诚健华 | | 诺诚健华医药有限公司 董事会决议公告 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。 一、 董事会会议召开情况 公司 2024 年年度报告包括 A 股年报和港股年报。其中，A 股年报包括 2024 年年度报告全文和 2024 年年度报告摘要，系根据《上海证券交易所科创板股票 上市规则》等要求编制；港股年报包括 2024 年度报告，系根据《香港联合交易 所有限公司证券上市规则》等要求编制。 本议案尚需提交股东周年大会审议。 本议案事项已经审核委员会审议通过。 表决结果：7 票赞成，0 票弃权，0 票反对。 具体内容详见公司于 2025 年 3 月 28 日在上海证券交易所（以下简称"上交 所"）网站（www.sse.com.cn）披露的《诺诚健华医药有限公司 2024 年年度报告》 及《诺诚健华医药有限公司 2024 年年度报告摘要》，以 ...