证券研究报告：医药生物 | 公司点评报告 发布时间：2025-10-09 股票投资评级 买入|首次覆盖 个股表现 公司基本情况 | 最新收盘价（港元） | 74.50 | | --- | --- | | 总股本/流通股本（亿股）12.28/12.28 | | | 总市值/流通市值（亿港 | 914.86/914.86 | | 元） | | | 52 周内最高/最低价 | 78.55/ 18.52 | | 资产负债率(%) | 29.94 | | 市盈率 62.9 | | | 第一大股东 | 药明生物技术有限公司 | 研究所 分析师:盛丽华 SAC 登记编号:S1340525060001 Email:shenglihua@cnpsec.com 分析师:陈灿 SAC 登记编号:S1340525070001 Email:chencan@cnpsec.com 药明合联(2268.HK) 业绩维持快速增长，产能扩张节奏顺利 ⚫ 事件 公司公布 2025 年上半年业绩，25H1 实现收入 27.0 亿元（+62.2%， 同比增速，下同）、净利润 7.5 亿元（+52.7%）、不含利息收支经调整 净利润 7.3 亿元（+6 ...

首款创新药预计明年商业化落地 本报讯 （记者蒙婷婷）9月29日晚间，ADC（抗体偶联药物）龙头四川百利天恒药业股份有限公司（以 下简称"百利天恒"）发布公告称，公司于当日重新向香港联合交易所有限公司（以下简称"港交所"）递 交了H股发行上市的申请。此前，百利天恒已获得港股上市备案批复。此次百利天恒再度冲刺港交所， 致力于加速国际化战略布局，为港股生物科技板块注入新活力。 前不久，百利天恒刚刚对外宣布，公司已经成功完成向特定对象发行A股股票计划，成功募集资金总额 37.64亿元。该定增吸引了国内外18家知名机构踊跃参与，所募集资金将用于加速推进国内创新药管线 研发，拓展其在研产品布局的深度和广度，为实现更多产品的商业化奠定坚实基础。 其中，百利天恒核心产品BL-B01D1/iza-bren是其自主研发的全球首创（First-in-class）、新概念（New concept）且唯一进入Ⅲ期临床阶段的EGFR×HER3双抗ADC，目前用于治疗末线鼻咽癌Ⅲ期临床试验 （BL-B01D1-303）的期中分析达到主要研究终点。 百利天恒相关负责人表示，目前，公司已与CDE（国家药品监督管理局药品审评中心）完成了上述药物 ...

Core Insights - The healthcare indices in Hong Kong have shown positive performance, with the Hang Seng Healthcare Index rising by 0.67% and the Hang Seng Innovation Drug Selection Index increasing by 0.74% as of September 25, 2025 [3][5] - Notable stock performances include a 6.57% increase in Crystal Technology Holdings and a 6.41% rise in Junshi Biosciences [3][5] - The liquidity of the ETFs tracking these indices is robust, with significant trading volumes and turnover rates [3][5][7] ETF Performance - The Hang Seng Healthcare ETF (513060) has seen a 27.42% increase over the past three months, ranking in the top third among comparable funds [3] - The Hong Kong Innovation Drug Selection ETF (520690) has recorded a 2.63% increase since its inception [5] - The Medical 50 ETF (159838) has increased by 2.19% over the past month, ranking in the top half among comparable funds [7] Company Developments - Heng Rui Medicine has entered an overseas licensing agreement with Glenmark for the drug Rukang Qumai (HER2 ADC), which includes an upfront payment of $18 million and potential milestone payments and sales royalties totaling nearly $1.1 billion, indicating international recognition of its ADC products [7][8] - The National Healthcare Security Administration is actively seeking information on innovative medical consumables such as brain-computer interfaces and surgical robots, aiming to accelerate the coding process for medical insurance and support the commercialization of innovative medical devices [7][8] Market Sentiment - The dual boost from the international licensing agreement and proactive government engagement in innovative technologies is expected to enhance sentiment in the healthcare sector, particularly for companies with technological barriers in ADCs, surgical robots, and brain-computer interfaces [8]

Summary of Key Points from Conference Call Records Industry Overview - The conference call discusses the **Chinese innovative drug industry** and its current trends, particularly focusing on the **CRO (Contract Research Organization)** and **CDMO (Contract Development and Manufacturing Organization)** sectors [1][3][13]. Core Insights and Arguments - **Valuation Trends**: The valuation of Chinese innovative drugs is currently lower than historical peaks, with a static PS (Price to Sales) ratio around 7 times, compared to a high of 9.3 times. However, due to global competitiveness, the theoretical static PS is expected to exceed previous levels, driven by significant product cycles [2][4]. - **BD Activity**: There has been a surge in business development (BD) transactions among domestic innovative drug companies, with upfront payments in the first nine months of the year reaching **6.58 billion yuan**, surpassing the total of **6 billion yuan** for the entire previous year. The total transaction amount also exceeded **56.4 billion yuan** compared to **48.9 billion yuan** last year [4]. - **Immunotherapy and ADC Developments**: Chinese companies are showing strong global competitiveness in the dual-antibody sector, with significant clinical advancements. For instance, **AK12** from Kangfang Biotech has multiple ongoing Phase III trials, and **IBI363** from Innovent has received FDA approval for a global Phase III study in lung cancer [5][6]. - **Weight Loss Sector**: The weight loss sector is highlighted as a competitive area, with promising data from Eli Lilly's oral GLP-1 molecule, **ofgliprant**, providing opportunities for Chinese companies to improve their offerings [8][10]. Additional Important Insights - **CRO and CDMO Recovery**: The CRO industry has moved past its most challenging period, with increased investment activity and a recovery in overseas demand for Chinese CDMO companies. Key players such as WuXi AppTec and Tigermed are recommended for attention [3][13]. - **Upstream Pharmaceutical Chain Recovery**: There are signs of recovery in the upstream pharmaceutical supply chain, particularly in R&D, with companies like **BaiPuSiSi** experiencing a resurgence in market demand [14]. - **Global Competitiveness Strategies**: Chinese innovative drug companies are encouraged to enhance their global competitiveness through overseas sales, R&D, and potential licensing opportunities. Companies like BeiGene and Legend Biotech are highlighted for their performance in this regard [12]. Conclusion The conference call provides a comprehensive overview of the current state and future prospects of the Chinese innovative drug industry, emphasizing the importance of global competitiveness, active BD transactions, and the recovery of the CRO and CDMO sectors. The insights presented indicate a positive outlook for the industry, driven by innovation and strategic partnerships.

申万宏源主要观点如下： 再鼎医药为一家处于商业化阶段的创新型全球生物制药公司。凭借授权引进(license-in)与自主研发，目 前公司共有七款产品于国内获批上市，包括四款肿瘤产品(则乐、爱普盾、擎乐、奥凯乐)、一款免疫产 品(艾加莫德)，以及两款感染性疾病产品(纽再乐、鼎优乐)。此外，公司拥有涵盖肿瘤、免疫、神经科 学和感染性疾病的广泛产品管线。 核心产品持续销售放量，新产品有望进一步丰富产品组合 2019年以来，随着首款商业化产品尼拉帕利于国内获批上市，目前公司已有七款商业化产品。2024年公 司总收入达到3.99亿美元，同比增长50%，主要由于卫伟迦/卫力迦、纽再乐等产品销售放量。新产品方 面，公司已于今年上半年向NMPA递交了KarXT和维替索妥尤单抗(TF ADC)的上市申请。此外，公司预 计将于今年下半年向NMPA递交贝玛妥珠单抗针对1L胃癌的上市申请。随着现有商业化产品的销售放 量，以及Kar-XT、贝玛妥珠单抗、ZL-1310(DLL3ADC)、povetacicept等新产品未来获批上市，公司预计 2028年营收有望达到20亿美元。 申万宏源发布研报称，随着商业化产品的销售放量，以及本地化生 ...

Core Viewpoint - The CXO sector is experiencing stable revenue growth and significant profit increases, driven by industry recovery, improved operational efficiency, and cost reduction efforts [1][2]. Revenue and Profit Performance - In the first half of 2025, the CXO sector achieved revenue of 47.096 billion yuan, a year-on-year increase of 13.25%, and a net profit attributable to shareholders of 11.743 billion yuan, up 61.19% year-on-year [1][2]. - In Q2 2025, the CXO sector reported revenue of 24.750 billion yuan, a 13.95% increase year-on-year, and a net profit of 6.674 billion yuan, reflecting a 52.26% year-on-year growth [2]. Productivity and Efficiency - In H1 2025, per capita revenue increased to 411,100 yuan, a 12.62% year-on-year rise, while per capita profit reached 114,000 yuan, up 52.41% year-on-year, indicating improved operational efficiency [3]. - The fixed asset turnover rate was 1.00 times, a 7.03% increase year-on-year, attributed to industry recovery and enhanced operational efficiency [3]. Demand and Supply Dynamics - As of H1 2025, contract liabilities and advance receipts amounted to 7.549 billion yuan, a 3.71% year-on-year increase, indicating stabilization in industry demand and a slight recovery in orders [4]. - Fixed assets totaled 47.274 billion yuan, a 5.81% year-on-year increase, with ongoing projects valued at 15.810 billion yuan, up 7.69% year-on-year [4]. Investment Recommendations - The easing of liquidity due to anticipated interest rate cuts by the Federal Reserve is expected to positively impact market conditions [5]. - The domestic A+H share innovative drug companies are seeing significant market capitalization increases, which may enhance local investment and financing conditions [5]. - Key areas to focus on include the impact of U.S. monetary policy, changes in investment and financing dynamics, and the gradual recovery of overseas demand [5]. Company-Specific Focus - Companies benefiting from domestic innovative drug support policies include clinical CROs like Sunshine Nuohuo and Nuo Si Ge [6]. - Life sciences upstream companies with strong overseas business performance include Haoyuan Pharmaceutical and Bid Pharma [6]. - Companies involved in weight loss drugs, Alzheimer's treatments, ADC, and AI concepts, such as Hongbo Pharmaceutical, are also of interest [6]. - Companies with unexpectedly high new order signings, like Pruis, should be monitored [6].

Core Insights - BioNTech has evolved from being a leading mRNA vaccine company to a diversified player in the biopharmaceutical industry, engaging in multiple therapeutic areas including dual antibodies (ADC) and mRNA vaccines [1][14] - The company has made significant strategic moves, including a $12.5 billion acquisition of CureVac and a $111 billion licensing deal with BMS for the PD-L1/VEGF dual antibody BNT327, which has reshaped the competitive landscape of the mRNA market [2][5] Group 1: Strategic Developments - BioNTech's acquisition of CureVac has strengthened its position in the mRNA sector, allowing for enhanced capabilities in cancer immunotherapy and a more robust pipeline [10][11] - The company has established a diverse pipeline in ADCs, with significant investments in multiple ADC candidates, including DB-1303/BNT323 and DB-1311/BNT324, totaling over $16 billion [4][12] - BioNTech's collaboration with Chinese biotech firms has expanded its ADC and dual antibody pipeline, enhancing its future growth prospects [4][10] Group 2: Financial Performance - BioNTech's market capitalization reached $27.04 billion, significantly higher than Moderna's $9.78 billion, reflecting investor confidence in its diversified strategy [2] - The company generated substantial revenue from its COVID-19 vaccine, with sales reaching $15 billion in 2021 and $17.3 billion in 2022, which has been reinvested into new therapeutic areas [2][14] Group 3: Clinical Advancements - BioNTech's PM8002/BNT327 is currently in advanced clinical trials, showing promising results in treating extensive-stage small cell lung cancer (ES-SCLC) with a confirmed overall response rate (cORR) of 76.3% [6][7] - The company is actively conducting multiple clinical trials combining PM8002/BNT327 with various ADCs, indicating a strong commitment to innovative treatment strategies [8][9] Group 4: Future Outlook - BioNTech aims to leverage its extensive pipeline and strategic partnerships to maintain its leadership in mRNA technology and expand its presence in oncology and infectious diseases [14] - The company is focusing on the commercialization of its diverse product offerings, particularly in the oncology space, where it has established a strong foothold [10][14]

Core Insights - The Chinese biopharmaceutical market has become the second largest globally, with innovative drugs accounting for approximately 30% of global research and development [1] - During the "14th Five-Year Plan" period, China approved 210 innovative drugs and 269 innovative medical devices, showing a trend of accelerated growth [1] - The total amount of innovative drug licensing from China reached nearly $66 billion in the first half of 2025, indicating increasing global recognition of Chinese innovative drugs [1] R&D Investment - In the chemical preparation sector, the top ten pharmaceutical companies spent a total of 17.636 billion yuan on R&D in the first half of 2025, a year-on-year increase of 12.66% [2] - BeiGene led the sector with R&D expenses of 7.278 billion yuan, accounting for 41.54% of its total revenue, marking a 9.8% increase year-on-year [2] - Other companies like Hengrui Medicine and Fosun Pharma also invested over 1 billion yuan in R&D, reflecting a strong emphasis on innovation [1][2] Oncology Drug Development - Oncology remains a core focus for Chinese innovative pharmaceutical companies, with significant investments in R&D from firms like BeiGene and Hengrui Medicine [3] - BeiGene is developing several promising products in the hematological oncology space, including the BTK inhibitor Bruton and two late-stage products with global potential [3] - The global oncology drug market is expected to reach $328.6 billion by 2026, with China's market projected to grow to 376 billion yuan by 2026 and further to 755.1 billion yuan by 2031, reflecting a compound annual growth rate of 16.0% from 2024 to 2031 [4] Market Dynamics - The demand for oncology products is driving revenue for many pharmaceutical companies, with Hansoh Pharmaceutical reporting that its innovative oncology product Ameluz generated approximately 4.531 billion yuan in revenue, accounting for 60.9% of total revenue [5] - The industry is entering a phase of diverse development, with significant opportunities in ADC (antibody-drug conjugates) and other innovative therapies [5] - The five-year survival rate for cancer patients in China has improved from 40.5% in 2018 to 43.7% in 2022, indicating progress in cancer prevention and treatment [5] Technological Advancements - AI and digital technologies are reshaping the pharmaceutical R&D landscape, with new guidelines from the FDA aimed at integrating AI into preclinical research [7] - The competition in the oncology sector is intensifying, with a significant number of similar products in development, particularly in the dual-antibody and single-antibody markets [8] - The industry is focusing on creating a closed-loop research ecosystem that connects clinical needs with laboratory innovations to accelerate the translation of research into clinical applications [9]

Core Viewpoint - WuXi AppTec has emerged as a leader in the global XDC outsourcing service industry, providing comprehensive R&D and production services from its Wuxi base and expanding to Singapore [1][2]. Industry Summary - The global XDC market is experiencing rapid growth, with the ADC market also expanding significantly. The growth rate in the Chinese market surpasses the global average, driven by advancements in technology that address efficacy and safety issues of ADC drugs [1][2]. - In 2024, 60% of new XDC trials globally will be initiated by Chinese companies, highlighting China's active role in the licensing of XDC-related drugs [2]. Company Summary - WuXi AppTec's total revenue is projected to grow from 311 million yuan in 2021 to 4.052 billion yuan in 2024, reflecting a compound annual growth rate (CAGR) of 135% [2]. - As of the first half of 2025, the company has 19 projects in Phase III clinical trials and 11 in the PPQ stage, with a backlog of orders amounting to 1.329 billion USD, a 58% year-on-year increase [2][3]. - The company is investing heavily in capital expenditures, with over 1.5 billion yuan planned for 2024 and an expected total of over 7 billion yuan from 2026 to 2029 to support R&D and commercial production [3]. - WuXi AppTec is at the forefront of XDC innovation, developing competitive technology platforms such as WuXiDARx conjugation platform and X-LinC linker platform [3]. - The company is rated as a "buy" with a target price of 74.0 HKD, with projected revenue growth of 45.7%, 35.7%, and 30.9% for 2025E, 2026E, and 2027E respectively [3].

Group 1 - The core theme of the conference is "Source Without Boundaries," focusing on the innovative ecosystem and industrial strength in advanced therapies in Zhangjiang [1] - Since 2019, Pudong has approved 29 Class 1 new drugs, accounting for 78% of Shanghai's total, and 31 innovative medical devices, accounting for 57% of Shanghai's total [1] - In 2023, Pudong has seen the approval of 6 Class 1 innovative drugs and 4 innovative medical devices, covering multiple major disease areas with several "first" and "first-of-its-kind" breakthroughs [1] Group 2 - Pudong has gathered over 170 upstream and downstream enterprises in the cell and gene therapy field, achieving significant breakthroughs in first and first-of-its-kind cell gene drugs [1] - The Shanghai Zhangjiang Group aims to enhance the brand influence of Zhangjiang Medicine Valley by unifying the name to "Zhangjiang Medicine Valley+" and standardizing services [2] - Zhangjiang Medicine Valley has developed a complete ecosystem from basic research to industrial transformation, becoming a source and benchmark for China's cell therapy industry [2] Group 3 - Pudong will continue to integrate technological and industrial innovation, enhancing innovation capabilities and product carrying capacity while focusing on emerging fields such as cell gene therapy and brain-computer interfaces [3] - The goal is to establish Pudong as a global hub for biopharmaceutical innovation [3]