证券研究报告|医药生物|2025年4月5日 www.hczq.com 华创医药投资观点&研究专题周周谈·第120期 苑东生物研发管线更新 联系人:朱珂琛 | 华创医药团队： | | | --- | --- | | 首席分析师 郑辰 | 执业编号: S0360520110002 邮箱: zhengchen@hcyjs.com | | 联席首席分析师 刘浩 | 执业编号：S0360520120002 邮箱：liuhao@hcyjs.com | | 医疗器械组组长 李焯娟 | 执业编号：S0360520110004 邮箱：lichanjuan@hcyjs.com | | 中药和流通组组长 高初蕾 | 执业编号：S0360524070002 邮箱：gaochulei@hcyjs.com | | 分析师 万梦蝶 | 执业编号: S0360523080008 邮箱: wanmengdie@hcyjs.com | | 分析师 王宏雨 | 执业编号: S0360523080006 邮箱: wanghongyu@hcyjs.com | | 分析师 朱珂琛 | 执业编号: S0360524070007 邮箱: zhukechen ...

-凯铃 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 东方生物 多瑞医药 能特科技 欧康医药 48.62% 双成药业 伟思医疗 31.80% 百普塞斯 哈三联 31.15% 1% 迪瑞圆疗 润都股份 27.01% 0% 昭衍新药 圣诺生物 21.54% -1% 海创药业-U 20.74% 未名医药 -29 药明康德 赛开药业 19.00% 海泰新光 金河生物 18.80% 留非经非 海昇药业 18.39% 30% 10% 20% 40% 609 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 w · 本周，中信医药指数上涨1.15%，跑赢沪深300指数2.52个百分点，在中信30个一级行业中排名第3位。 · 本周涨幅前十名股票为多瑞医药、欧康医药、伟思医疗、哈三联、润都股份、圣诺生物、海创药业-U、赛开药业、金河生物、海昇药业, 本周跌幅前十名股票为东方生物、能特科技、双成药业、百普赛斯、迪瑞医疗、昭衍新药、未名医药、药明康德 ...

Financial Data and Key Metrics Changes - In 2024, the company achieved drug sales growth of 49.7%, primarily driven by core product Aureloproteinib, which reached RMB1 billion in sales, reflecting a 49.1% increase compared to 2023 [11][12] - The net loss for the year decreased by 29.9%, from RMB646 million in 2023 to RMB453 million in 2024, indicating improved operational efficiency [11][12] - Gross margin ratio increased from 82.6% in 2023 to 86.3% in 2024, demonstrating enhanced manufacturing efficiency and revenue growth [12] Business Line Data and Key Metrics Changes - The commercialization of Aureloproteinib was a significant driver, achieving over RMB1 billion in sales, marking a milestone for the company [10][14] - The launch of the AMZAL indication for Aureloproteinib contributed to its rapid growth, establishing the company as the first mover in this market [13][14] Market Data and Key Metrics Changes - The company is focusing on expanding its market reach in China, particularly in low-tier cities, to enhance hospital coverage and sales for its hematology products [77] - The company anticipates that the MZL contribution to sales will grow to around 50% by the end of 2025, indicating strong market potential [76] Company Strategy and Development Direction - The company aims to accelerate its pipeline development, with expectations of three to four large asset approvals in the next three years [16] - Strategic collaborations, such as the partnership with Voluum for the development of CD2063 antibody, are key to expanding the company's global reach [15] - The company is prioritizing business development and aims to secure first-line approvals for its products in both China and globally [64] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving a growth rate of at least 30% in 2025, driven by the continued success of MZL and expansion into new markets [76][78] - The company is optimistic about the approval timelines for its key products, including tafacitumab, which is expected to receive approval in the second quarter of 2025 [80] Other Important Information - The company has made significant advancements in its innovative pipeline, with 50 drugs in various stages of development, including pre-IND, Phase I, II, and III trials [16] - The ADC platform is a new focus area for the company, with the first candidate B7 ADC expected to enter clinical trials soon, showcasing the company's commitment to expanding its therapeutic offerings [45][50] Q&A Session Summary Question: Can you elaborate on the ADC platform and its differentiation? - Management highlighted the strengths of the ADC platform, emphasizing the innovative linker and payload design that enhances efficacy and safety compared to existing therapies [45][50] Question: What is the strategy for ICP-248 and its positioning in the market? - Management acknowledged the competitive landscape but expressed confidence in securing first-line approval for their BCL2 inhibitor in China, while also pursuing global opportunities [64][66] Question: What is the timeline for the Phase III trial of orilabrutinib in SLE? - Management indicated that the Phase IIb data would be available in the fourth quarter, with a high possibility of initiating the Phase III trial within the same year [72] Question: What are the expectations for tafacitumab's approval timeline? - Management anticipates approval for tafacitumab around the second quarter of 2025, with preparations for commercial launch already underway [80] Question: How does the company view competition in the hematology space? - Management acknowledged the competitive data presented by peers but remains focused on improving their own efficacy and securing market share through strategic positioning [60][84]

Market Overview - After the Spring Festival and during the Two Sessions, the TMT sector led by Deepseek has initiated a "revaluation of Chinese assets" trend, supported by a relatively stable RMB exchange rate and positive policy expectations[1] - The A-share and Hong Kong technology sectors currently exhibit a high risk appetite, although adjustments have been observed since mid-March due to uncertainties surrounding the new round of "reciprocal tariffs" from the US and concerns over AI "computing power bubbles"[1] - In March, the Shanghai Composite Index, CSI 300 Index, and ChiNext Index recorded gains of +0.45%, -0.07%, and -3.07%, respectively[1] Policy and Economic Outlook - The 2025 Two Sessions emphasized expanding domestic demand and promoting consumption as primary objectives, with a focus on addressing low domestic inflation and external uncertainties[2] - The "Consumption Promotion Action Plan" issued on March 16 aims to enhance consumer capacity and stabilize the stock market, with expectations for new capital market policies to accelerate implementation[2] - The central bank reiterated the need for a moderately loose monetary policy, with potential for reserve requirement ratio (RRR) and interest rate cuts based on economic conditions[2] Investment Recommendations - Focus on large consumption and cyclical industries in Q2, particularly those showing signs of recovery or strong performance[3] - Continue to monitor defensive sectors such as banking and dividend stocks due to external uncertainties[4] - The long-term trend for AI remains positive, with significant investment from major domestic companies, presenting potential short-term investment opportunities during market corrections[5] Selected Stock Portfolio - The recommended portfolio includes stocks from various sectors: China Mobile, Hongri Da, Lu Wei Optoelectronics, Sinovac Biotech, and others, covering telecommunications, pharmaceuticals, machinery, and non-bank financials[5]

Investment Rating - The investment rating for the company is "Buy" and the rating has been maintained [2][3]. Core Insights - The company achieved a revenue of 1.009 billion yuan in 2024, representing a year-on-year growth of 36.68%, with drug sales revenue reaching 1.006 billion yuan, up 49.74% [3]. - The net profit attributable to shareholders was a loss of 444 million yuan, narrowing by 30% [3]. - The company’s first commercialized product, the BTK inhibitor Acalabrutinib, saw sales exceed 1 billion yuan in 2024, with a growth rate of 49.14% [4]. - The company is advancing its ADC platform and plans to submit its first IND application within the year [4][8]. Financial Performance - The company forecasts revenues of 1.411 billion yuan, 1.702 billion yuan, and 2.058 billion yuan for 2025, 2026, and 2027 respectively, with net profits expected to be losses of 427 million yuan, 355 million yuan, and 235 million yuan [9][11]. - The company’s R&D expenses for 2024 were 815 million yuan, reflecting a year-on-year increase of 7.57% [3]. Product Pipeline and Clinical Trials - The company is progressing with multiple clinical trials, including a Phase III trial for ICP-248 in combination with Acalabrutinib for 1L CLL/SLL, which has shown promising clinical data [5]. - Tafasitamab is expected to be approved in the first half of 2025, contributing to the company's growth trajectory [4]. - The company is also exploring Acalabrutinib's potential in autoimmune diseases, with several clinical trials underway [6]. Market Position and Future Outlook - The company is well-positioned with its core product Acalabrutinib and the anticipated approval of Tafasitamab, which is expected to enhance its revenue streams [9]. - The ADC platform is expected to target hard-to-treat solid tumors, indicating a strategic expansion into new therapeutic areas [8].

自免管线陆续兑现，挖掘未满足临床需求。奥布替尼治疗PPMS和SPMS的全球IⅡI期临床正在启动，有 望在2025年内实现FPI。同时已实现治疗ITF的POC，计划2025年底前完成Ⅲ期注册临床，并于2026年上 半年递交NDA；SLE适应症IIb期试验已完成患者招募，预计2025年四季度数据读出。另外两款差异化 TYK2抑制剂，ICP-332特应性皮炎Ⅲ期临床已入组超过110例惠者，自激风其/Ⅲ期临床已启动，结节性 择疹全球其期临床计划开展；ICP488正加速推进银屑病Ⅲ期临床，首例患者完成入组。公司持续布局 自身免疫性疾病口服疗法，进一步挖掘未满足临床需求。 持续拓展实体瘤领域，首主开发ADC平台值得期待。第二代泛TRK抑制剂ICP-723针对NTRK融合阳性 晚期实体瘤已完成I期注册临床，计划2025年4月初递交NDA，儿童适应症计划2025年下半年递交 NDA。公司自主研发的ADC平台采用不可逆生物偶联技术、亲水链接子及创新型载荷，具备强大的肿 瘤杀伤效应和充足的安全窗口，首款ADC产品ICP-B794（B7-H3ADC)计划于2025年上半年递交IND申 请。 事件：2025年3月28日，诺诚健华发布 ...

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]

瑞康曲妥珠单抗上市申请申报的首个适应症为二线治疗局部晚期或转移性HER2突变成人非小细胞肺 癌。恒瑞医药提交的该适应症申请于2024年9月14日获国家药监局受理，并被纳入优先审评。该药是国 内非小细胞肺癌领域首个申报上市的国产HER2 ADC。据恒瑞医药2024年年报，瑞康曲妥珠单抗具备同 类最佳潜力。截至2024年末，瑞康曲妥珠单抗已有七个适应症被国家药监局认定为突破性疗法。 泽尼达妥单抗为靶向HER2的双抗药物，其针对胆道癌二线治疗的新药上市许可申请已于2024年6月7日 获国家药监局受理。2024年11月，该药获美国食品药品监督管理局加速批准上市，用于治疗经治、不可 切除、局部晚期或转移性HER2阳性胆道癌患者。Insight数据库显示，这是全球首个且唯一一个获批用 于HER2+胆道癌的HER2双抗。 博度曲妥珠单抗的上市申请获受理时间更早。2023年5月11日，博度曲妥珠单抗上市申请获受理，用于 既往经二线及以上抗HER2治疗失败的HER2阳性不可切除的局部晚期、复发或转移性乳腺癌（三线治 疗），预计今年第二季度能获批上市。此外，今年1月，博度曲妥珠单抗二线治疗HER2阳性乳腺癌的适 应症上市申请也已 ...

Group 1 - The core viewpoint of the articles highlights the financial performance and market position of BeiGene, a global biotechnology company focused on innovative drug development and commercialization [1][2] - As of April 1, BeiGene's stock closed at 249.51 yuan, reflecting a 4.47% increase, with a market capitalization of 349.402 billion yuan and a price-to-book ratio of 14.45 [1] - The latest quarterly report for Q3 2024 shows BeiGene achieved a revenue of 19.136 billion yuan, representing a year-on-year increase of 48.63%, while the net profit was -3.686694 million yuan, a year-on-year decrease of 4.94%, with a gross margin of 83.94% [1] Group 2 - The shareholder structure indicates that as of September 30, 2024, BeiGene had 33,458 shareholders, a decrease of 4,146 from the previous count, with an average holding value of 352,800 yuan and an average shareholding of 27,600 shares per shareholder [1] - In comparison to industry peers, BeiGene's price-to-earnings ratio (TTM) is -70.19, while the industry average is 42.46, indicating a significant divergence in valuation metrics [2] - The industry median price-to-earnings ratio is 37.51, further illustrating the relative valuation challenges faced by BeiGene compared to its competitors [2]