证券研究报告 远大医药 (512 HK) 港股通 传统业务远航稳舵,核药布局大业新程 | 华泰研究 | | | 首次覆盖 | | --- | --- | --- | --- | | 2025 年 | 5 月 | 19 日│中国香港 | 生物医药 | 首次覆盖远大医药，给予"买入"评级，目标价 10.15 港币(25 年 17x PE)。 公司是业务横跨制药科技、生物科技、核药及心血管精准介入的国际化布局 药企。我们看好其发展为中国核药产业最重要的参与者之一。此外,传统业 务(制药科技+生物科技板块)维持稳健增长,为公司未来发展提供坚实基础。 核药：Y90 微球焕发商业化新机，差异化管线聚焦肿瘤诊疗一体化 公司有国内稀缺的兼具商业化产品及差异化管线的核药布局。该板块收入或 于 25-27 年快速爬坡：1)Y90 微球(销售峰值或超 30 亿港币):目前该疗法渗 透率非常低，后续医院准入+新适应症拓展+潜在商保普及或驱动该产品放 量。2)全球进展领先的核药管线:通过 BD 收获 12 款产品(介入治疗+RDC)， 专注肿瘤诊疗一体化。3)成都生产基地投入运营或驱动板块效率提升。 制药科技：专注独家品种潜力挖掘，多 ...

港股医药股多数高开，三生制药(01530.HK)开涨14.9%，石药集团(01093.HK)开涨3.87%，翰森制药 (03692.HK)、远大医药(00512.HK)等跟涨。 ...

Core Viewpoint - The recent diagnosis of prostate cancer in former U.S. President Biden has highlighted the importance of early cancer screening, which aligns with the comprehensive strategies of Yuan Da Pharmaceutical in the prostate cancer sector [1][3]. Company Overview - Yuan Da Pharmaceutical has established a robust presence in the prostate cancer market with innovative medical devices and a comprehensive product portfolio that integrates diagnosis and treatment [1][2]. - The company has seen a significant stock price increase, reaching a nearly ten-year high of 9 HKD per share, with a cumulative rise of approximately 50% over the past two weeks [1]. Market Dynamics - The global prostate cancer treatment market is projected to grow from 13.5 billion USD in 2025 to 29.9 billion USD by 2034, with a CAGR of 9.2% [7]. - In China, the prostate cancer medication market was valued at approximately 30.3 billion CNY in 2023, reflecting a year-on-year growth of 15.07% [7]. Early Screening Importance - The early detection rate of prostate cancer in China is only 32%, significantly lower than the 92% in the U.S., leading to a higher incidence of late-stage diagnoses [9]. - Early-stage prostate cancer patients have a survival rate of up to 100%, while those with metastatic disease have only a 31% five-year survival rate [3]. Product Development and Clinical Trials - Yuan Da Pharmaceutical's innovative products include TLX591-CDx, which has completed patient enrollment for its Phase III clinical trial in China and is expected to submit for market approval within the year [2][10]. - The company has a pipeline of 15 innovative products in the nuclear medicine sector, covering multiple cancer types, and has achieved significant clinical milestones [16][17]. Strategic Positioning - The establishment of a global nuclear medicine R&D and production base in Chengdu, set to commence operations in June 2025, will enhance Yuan Da's capabilities in the nuclear medicine field [19]. - The company aims to create a comprehensive ecosystem for urogenital system diseases, integrating early screening and treatment solutions [15][20]. Future Outlook - Yuan Da Pharmaceutical is positioned to become a key player in the global pharmaceutical market, with a focus on innovation and expanding its market share in cancer diagnostics and treatment [20].

金十数据5月19日讯，据香港联交所披露易数据显示，CDH Fund V, L.P.于5月16日减持远大医药 (00512.HK)约5054.8万股，平均价格为7.71港元，涉资约3.89亿港元，持股比例由10.05%降至8.62%。 远大医药：被CDH Fund减持约3.89亿港元 ...

智通财经APP获悉，远大医药(00512)高开逾3%，截至发稿，涨3.08%，报8.69港元，成交额796.87万港 元。 消息面上，继多款全球创新核药研发取得进展后，5月18日晚间，核药龙头远大医药再度传来重磅利 好，公司发布公告称，其位于成都温江的核药全球研发及生产基地已获得国家生态环境部颁发的甲级 《辐射安全许可证》，并将于2025年6月正式投入运营。该基地于2022年底签约，2023年4月全面启动环 评，同年11月获得施工许可正式破土动工，仅5个月实现主体封顶，以两年周期刷新了行业建设纪录， 且是目前全球核素种类最全、自动化程度最高的智能工厂之一。 根据公告，远大医药成都温江的核药全球研发及生产基地定位全球创新核药产业化高地，是全球首 个"零辐射"智能核药工厂，全流程辐射监测系统达到核电级安全标准。 该基地占地面积50亩，一期用地25亩，建设总面积超2.6万平方米，总规划投资拟超30亿元，聚焦同位 素工艺开发与制备、核药偶联技术、自动化标记技术等核心领域，覆盖核药早研、工艺开发、质量研 究、非临床研究、智能生产与精准配送一站式全生命周期管理，是目前国际范围内核素种类最全、自动 化程度最高的智能工厂之一 ...

Core Viewpoint - The company, YuanDa Pharmaceutical, has achieved significant milestones in the development of its global nuclear medicine R&D and production base in Chengdu, which is set to become the world's first "zero-radiation" intelligent nuclear medicine factory, marking a strategic leap in the nuclear medicine industry [1][4][11]. Group 1: Company Developments - YuanDa Pharmaceutical's Chengdu base has received a Class A Radiation Safety License from the Ministry of Ecology and Environment, with operations expected to commence in June 2025 [1][11]. - The construction of the base has set a record in the industry, completing the main structure in just five months, and is recognized for its high level of automation and comprehensive range of isotopes [1][4]. - The company has seen its stock price rise significantly, reaching a historical high of HKD 8.95, a nearly 126% increase from its low point this year, with a market capitalization exceeding HKD 30 billion [3]. Group 2: Technological Innovations - The Chengdu base features a state-of-the-art cyclotron from Belgium's IBA, enabling the independent production of critical isotopes, addressing the domestic shortage of imported isotopes [5]. - The facility employs fully automated production processes, enhancing production stability and efficiency, and significantly reducing the production cycle by approximately 80% [7]. - A comprehensive radiation monitoring system has been integrated, ensuring compliance with international safety standards and establishing a new benchmark for safety in the nuclear medicine industry [9][12]. Group 3: Market Position and Growth - The global nuclear medicine market is projected to grow at a compound annual growth rate (CAGR) of 18% from 2022 to 2028, reaching approximately USD 18.7 billion, while China's market is expected to grow at a CAGR of 27% from 2023 to 2030, reaching around RMB 26 billion [12]. - YuanDa Pharmaceutical has established a complete industrial chain in the nuclear medicine sector, with a product pipeline that includes 15 innovative products targeting various cancers [12][15]. - The company is positioned as a leader in the nuclear medicine field, with the most extensive product pipeline and integrated treatment solutions, enhancing its competitive edge in the market [16][17].

Investment Rating - The report maintains an investment rating of "Outperform the Market - A" [7] Core Insights - The treatment of sepsis has significant unmet clinical needs, with recent success in the Phase II clinical trial of STC3141 by Yuan Da Pharmaceutical, marking a breakthrough in sepsis treatment [2][19] - Sepsis is a high-mortality clinical syndrome caused by infection, with an estimated 48.9 million cases and 11 million deaths globally in 2017 according to WHO [2][21] - Current treatments for sepsis primarily focus on symptomatic care, with no effective therapeutic options available [23] - The market for sepsis treatment is vast due to the severe unmet clinical needs, highlighting the potential for new drug developments [2][26] Summary by Sections 1. Weekly New Drug Market Review - From May 12 to May 16, 2025, the top five companies in the new drug sector by stock price increase were Junshengtai (19.78%), Deqi Pharmaceutical (18.34%), Jiahe Biotech (14.48%), Keji Pharmaceutical (14.46%), and Fuhong Hanlin (12.34%) [1][15] - The top five companies by stock price decrease included Gilead Sciences (-17.10%), CanSino Biologics (-8.72%), Yunding New Medicine (-7.77%), Zai Lab (-7.18%), and Chuangsheng Group (-6.96%) [1][15] 2. Key Analysis of the New Drug Industry - Sepsis treatment faces serious unmet clinical needs, with Yuan Da Pharmaceutical's STC3141 achieving clinical endpoints in its Phase II trial in China [2][19] - Sepsis is characterized by a dysregulated host response to infection, leading to life-threatening organ dysfunction [20] - In China, approximately 2.93 million cases of sepsis occur annually, with around 709,315 related deaths [21] - Current therapies are mainly symptomatic, including antibiotics, vasopressors, and supportive care, with no effective treatment options available [23] - The development of new drugs for sepsis is challenging, with many innovative therapies failing in clinical trials [26] 3. New Drug Application Approvals and Acceptances - No new drug or new indication applications were approved this week, but eight new drug applications were accepted [4] 4. New Drug Clinical Application Approvals and Acceptances - This week, 40 new drug clinical applications were approved, and 30 new drug clinical applications were accepted [5] 5. Key Domestic Market Events - Notable events included the initiation of a Phase III trial by BeiGene for its BTK-targeting drug BGB-16673 and the priority review application for a new indication by Kelun-Biotech for SKB264 [11] 6. Key Overseas Market Events - AbbVie announced FDA approval for its c-Met-targeting ADC drug Telisotuzumab Vedotin, marking a significant milestone in the treatment of non-small cell lung cancer [12]

Group 1 - The Hang Seng Medical Index ETF has shown significant liquidity with a turnover of 1% and a transaction volume of 2.6148 million yuan, with an average daily transaction volume of 27.4616 million yuan over the past month [2] - The ETF's scale has increased by 28.6087 million yuan in the past month, ranking first among comparable funds, with a share increase of 12 million units in the last two weeks, also the highest among peers [2] - In terms of capital inflow, the ETF has seen net inflows on 5 out of the last 8 trading days, totaling 14.5271 million yuan [2] - The current price-to-earnings ratio (PE-TTM) of the Hang Seng Medical Healthcare Index is 23.4, which is in the 4.36% percentile over the past year, indicating a valuation lower than 95.64% of the time in the past year, suggesting historical low valuations [2] - The top ten weighted stocks in the Hang Seng Medical Healthcare Index account for 57.09% of the index, including companies like WuXi Biologics and BeiGene [2] Group 2 - Since the reform of new drug research and development policies in 2015, China's innovative drug industry has developed a strong ecosystem, integrating excellent resources in preclinical and clinical stages, which has gained recognition from multinational corporations (MNCs) [3] - The pharmaceutical and biotechnology sector's Q1 2025 financial reports show stable revenue and profit performance, with notable improvements in certain sub-industries, indicating a return of market enthusiasm for the sector [3] - There is a recommendation to focus on international biotech companies, revaluation of innovative pipelines in generic companies, and companies in the CXO industry with significant order and operational improvements [3] - Investors without stock accounts can access investment opportunities in the Hong Kong medical sector through the Hang Seng Medical Index ETF linked fund (018433) [3]

Group 1: Company Developments - Yuan Da Pharmaceutical (00512.HK) announced that its partner, Taisun Pharmaceutical, successfully completed Phase II and III clinical trials for APP13007, a hormone nano-suspension eye drop, which showed significant efficacy in treating postoperative inflammation and pain [1] - Junshi Biosciences (688180.SH) reported that its PARP inhibitor, senaparib, achieved the primary endpoint in a Phase III clinical trial for advanced ovarian cancer, and plans to submit a new drug application soon [4] - Zhongyuan Jianye (09982.HK) successfully held a signing ceremony for 21 projects in Henan, with a total contracted construction area of approximately 1.9515 million square meters [5] Group 2: Sales and Financial Performance - Qiu Tai Technology (01478.HK) disclosed that it sold 37.928 million camera modules in March 2023, a month-on-month increase of 41.8%, but a year-on-year decrease of 2% [2] - China Resources Land (01109.HK) reported a total contract sales amount of approximately RMB 38.8 billion in March 2023, representing a year-on-year increase of 85.7% [3] - Far East Horizon (02163.HK) achieved a revenue of HKD 36.97 million in the first quarter, reflecting a year-on-year growth of 9.41% [7] Group 3: Market and Operational Data - China Metallurgical Group (01618.HK) signed new contracts worth RMB 325.81 billion from January to March 2023, marking a year-on-year increase of 2.1% [8] - Longyuan Power (00916.HK) completed a total power generation of 19.6033 million MWh in the first quarter, a year-on-year increase of 7.61% [8] - MONGOL MINING (00975.HK) sold 1.6 million tons of washed coking coal products in the first quarter, a year-on-year increase of 343% [8]

截至2025年5月15日 10:15，恒生医疗保健指数(HSHCI)上涨0.11%，成分股远大医药(00512)上涨6.15%，诺诚健华(09969)上涨4.36%，巨子生物(02367)上涨 3.75%，药师帮(09885)上涨2.38%，健康之路(02587)上涨1.83%。恒生医疗ETF(513060)上涨0.21%， 冲击3连涨。最新价报0.48元。流动性方面，恒生医疗 ETF盘中换手2.77%，成交2.74亿元。拉长时间看，截至5月14日，恒生医疗ETF近1月日均成交12.54亿元，排名可比基金第一。 2025年5月12日，商务部公布了中美日内瓦经贸会谈联合声明。声明指出：中美双方近期会将4月2日相关的34%关税分为24%（暂缓90天）和10%，中国还将 暂停或取消自2025年4月2日起针对美国的非关税反制措施。中美双方未来还会建立机制，继续就经贸关系进行协商。 湘财证券指出，中美关税的缓和有利于国内医疗器械降低生产成本，扩大海外市场份额。而对于CXO，政策边际缓和有望迎来估值修复。我们看好医疗服 务行业，建议关注出口产业链。 恒生医疗ETF紧密跟踪恒生医疗保健指数，恒生医疗保健指数提供一项市场参考 ...