Core Viewpoint - The company Nocare Biopharma showcases its commitment to innovation and high-quality development at the 2025 Zhongguancun Forum, emphasizing its contributions to global patient accessibility and technological advancements in the biopharmaceutical sector [1][2]. Group 1: Recognition and Awards - Nocare Biopharma received two significant recognitions at the Zhongguancun Forum, including being the only biopharmaceutical company selected for the Beijing Municipal Government Quality Management Award and having its novel oral BCL2 inhibitor Mesutoclax (ICP-248) included in the "Top 100 New Technologies and Products List" [1][2]. - The company was nominated for the Beijing Municipal Government Quality Management Award, standing out among over 300 applicants, with only 10 companies receiving awards [1]. Group 2: Innovative Products and Pipeline - Nocare Biopharma's new oral high-selectivity BCL2 inhibitor ICP-248 was highlighted at the forum, marking the third innovative product from the company to be recognized in the "Top 100 New Technologies and Products List" [2]. - The company showcased its innovative pipeline in hematological malignancies and autoimmune diseases, including new BTK inhibitors and TYK2 inhibitors [2]. Group 3: Market Potential and Research Focus - The global market for autoimmune diseases is projected to reach $185 billion by 2029, prompting Nocare Biopharma to enhance its drug discovery platform and accelerate clinical research for its high-potential TYK2 inhibitors targeting unmet clinical needs [3]. - The company is focused on addressing various autoimmune diseases such as atopic dermatitis and psoriasis through its innovative drug development efforts [3]. Group 4: Integration of AI in Drug Development - Nocare Biopharma is actively exploring the integration of artificial intelligence (AI) in its drug development processes, aiming to enhance molecular screening and clinical trial efficiency [4][5]. - The company has established a dedicated R&D team to develop and upgrade its computational chemistry platform, which includes modules for predicting physicochemical properties and drug design [4].

Core Insights - The company achieved a revenue of 1.01 billion yuan in 2024, representing a year-on-year growth of 36.7%, while narrowing its net loss to 440 million yuan, a decrease of 30.2% compared to the previous year [1] - The revenue from Oubatin increased significantly to 1 billion yuan in 2024, marking a 49.1% year-on-year growth, driven by the inclusion of r/r MZL indication in medical insurance and the strengthening of the commercialization team [1] - The gross profit improved significantly to 870 million yuan, with a gross margin of 86.3%, an increase of 3.7 percentage points year-on-year, primarily due to a decrease in unit sales costs [1] Revenue and Financial Performance - In 2024, the company reported a total revenue of 1.01 billion yuan, with a gross profit of 870 million yuan, reflecting a gross margin of 86.3% [1] - The company's expenses included sales, management, and R&D costs of 420 million, 170 million, and 820 million yuan respectively, with sales expenses increasing by 14.5% due to enhanced commercialization efforts [1] Product Development and Pipeline - Oubatin has three indications contributing to revenue in the hematological malignancies field, with one indication (1L CLL/SLL) currently in the NDA stage [1] - The company is advancing new indications in the autoimmune field, including ITP, MS, and SLE, which are in clinical phases 2/3 [1] - The company signed an exclusive licensing agreement for ICP-B02, granting Prolium rights for development and commercialization in non-oncology and global oncology markets outside Asia, with potential milestone payments totaling up to 502.5 million USD [2] Future Catalysts - Key upcoming catalysts for 2025 include the approval of Oubatin for 1L CLL/SLL, initiation of global phase 2 clinical trials for nodular prurigo, and submission of IND for ICP-B794 [3] - The company anticipates revenue growth projections of 1.383 billion, 1.797 billion, and 2.222 billion yuan for 2025, 2026, and 2027 respectively, with year-on-year growth rates of 37.0%, 29.9%, and 23.7% [3]

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]

中信证券 创新药和集采政策趋势 20250330 摘要 Q&A 当前医药板块在政策方面有哪些重要变化？ 近期，医药板块在政策方面出现了显著变化，尤其是集采政策的优化和商保的 快速落地。首先，关于集采政策，上周业内流传的相关内容显示，第十批集采 相关舆情之后，医保监管部门进行了相应调整。在两会期间，总理报告中提到 要"优化集采"和"完善药品价格形成机制"，这表明未来将更多体现市场化 竞争机制。这一变化缓解了过去对行业估值压制的担忧。 具体而言，此次调整 可能使得更多差异化和品牌类型产品能够进入市场，从而重新评估市场模型。 • 集采政策优化及医保支付标准调整：两会期间强调"优化集采"和"完善 药品价格形成机制"，预示着市场化竞争机制的回归，缓解了行业估值压 制，利好差异化和品牌类型产品，降低非医保支付品类的价格干预风险。 • 多元化支付体系加速构建：商业健康险目录的推出，特别是城市定制型商 业医疗保险如上海"全药保"，覆盖更多创新药和进口原料药，为临床刚 需创新药提供新的支付契机，预计商业保险市场规模将超万亿。 • 创新药企迎来发展机遇：恒瑞医药、百济神州、信达生物等企业预计实现 首次或持续盈利，并可能推出重磅产 ...

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- ...

Market Review - The CITIC Pharmaceutical Index increased by 1.04%, outperforming the CSI 300 Index by 1.03 percentage points, ranking first among CITIC's 30 primary industries [5] - The top ten stocks by increase this week include Yihe Jiaye, Rundu Co., De Yuan Pharmaceutical, and others, while the top ten stocks by decrease include ST Xiangxue, Innovation Medical, and others [4][5] Overall Viewpoint and Investment Themes - The current valuation of the pharmaceutical sector is low, with public funds (excluding pharmaceutical funds) having low allocation to this sector. The macro environment, including the recovery of US Treasury yields, supports optimism for the pharmaceutical industry's growth by 2025 [9] - In the innovative drug sector, there is a shift from quantity to quality, emphasizing products that can generate profits. Companies to watch include Heng Rui, Bai Ji, Bei Da, and others [9] - In the medical device sector, there is a notable recovery in bidding volumes for imaging equipment, and home medical devices are benefiting from subsidy policies. Key companies include Mindray, United Imaging, and Yiyuan [9] - The CXO and life sciences services sector is expected to see a recovery in overseas investment and financing, with a positive outlook for 2025 [9] - The pharmaceutical industry is anticipated to enter a new growth cycle, particularly in the specialty API sector, with companies like Tonghe Pharmaceutical and Tianyu Co. being highlighted [9] Industry and Company Events - The medical device market is expected to improve significantly from Q4 2024, with a projected 47.82% year-on-year growth in January 2025 [18] - The blood products sector is poised for growth due to relaxed approval for plasma stations and an increase in demand post-pandemic. Companies like Tiantan Biological and Boya Biological are recommended [12] - The retail pharmacy sector is expected to benefit from the acceleration of prescription outflow and an improved competitive landscape, with companies like Lao Bai Xing and Yifeng Pharmacy being highlighted [30] - The traditional Chinese medicine sector is recommended for its potential growth driven by basic drug reforms and state-owned enterprise reforms, with companies like Kunming Pharmaceutical and Kangyuan Pharmaceutical being noted [31] - The life sciences services sector is seeing a recovery in demand, with a focus on domestic and overseas market expansion. Companies are encouraged to pursue mergers and acquisitions to strengthen their market positions [29][30]

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 ...