据港交所12月29日披露，悦康药业集团股份有限公司(简称：悦康药业(688658.SH))向港交所主板提交上市申请，中信证券为其独家保荐人。 公司简介 招股书披露，悦康药业是一家生物制药公司，专注于研究、开发、生产和商业化四种模式的疗法：寡核苷酸、信使核糖核酸(mRNA)疫苗、多肽和中药创新 药。公司利用商业化产品组合、跨模态研发技术平台和能力、药品生产质量管理规范(GMP) 认证的生产系统及遍布全国的商业化网络等综合优势，为拥有 大量未满足需求及长期增长潜力的主要治疗领域推进候选产品的差异化创新管线。 | | | | 截至12月31日止年度 | | | | | 截至7月31日止七個月 | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | 2022年 | | 2023年 | | 2024年 | | 2024年 | | 2025年 | | | | (人民幣于元) | 8 | (人民幣于元) | ક | (人民幣于元) | હ | (人民幣于元) | હુર | (人民幣于元) | 多 | | | | | | | ...

智通财经APP获悉，据港交所12月29日披露，悦康药业集团股份有限公司(简称：悦康药业(688658.SH))向港交所主板提交上市申请，中信证券为其独家保荐 人。 公司简介 招股书披露，悦康药业是一家生物制药公司，专注于研究、开发、生产和商业化四种模式的疗法：寡核苷酸、信使核糖核酸(mRNA)疫苗、多肽和中药创新 药。公司利用商业化产品组合、跨模态研发技术平台和能力、药品生产质量管理规范(GMP) 认证的生产系统及遍布全国的商业化网络等综合优势，为拥有 大量未满足需求及长期增长潜力的主要治疗领域推进候选产品的差异化创新管线。 公司多款旗舰产品凭借良好的市场接受度为公司的收入及现金流带来重要贡献，为持续研发投资和产能扩张提供财务基础。悦康通® （银杏叶提取物注射 液）在中国的医院覆盖面广泛，包括三级及二级医院，用于管理脑血管和外周血管障碍。爱力士® （枸橼酸爱地那非片）在中国的泌尿科和男科环境中用 于处方，治疗男性勃起功能障碍。立卫克® （奥美拉唑肠溶胶囊）和悦达宁® （盐酸二甲双胍缓释片）等其他关键产品进一步扩大了公司在主要治疗领域 的覆盖面。公司亦销售具有广泛标示适应症的头孢菌素抗生素。 公司的管线包括创新 ...

Financial Overview - Revenue for H1 2025 reached 3,188 million RMB, an increase from 2,697 million RMB in H1 2024 [80] - Adjusted net profit for H1 2025 was 617 million RMB, up from 499 million RMB in H1 2024 [80] - Gross profit margin improved to 43.5%, up from 42.2% in H1 2024 [64] Performance Highlights - Gross margin increased by 1.3 percentage points to 43.5% [13] - Net profit growth outpaced revenue growth by 5.5 percentage points [14] - The company reported a backlog of orders worth 10.88 billion USD, with a year-on-year increase of over 40% [13] Segment Performance Small Molecule Business - Revenue for small molecule CDMO business was 24.29 billion RMB, a 10.6% increase year-on-year [20] - Gross margin for small molecule business reached 47.8%, up 0.6 percentage points [32] Emerging Business - Emerging business revenue surged by 51.2% to 7.56 billion RMB [19] - Gross margin for emerging business was 29.8%, an increase of 9.5 percentage points [20] Clinical CRO Business - Revenue for clinical CRO business was 1.39 billion RMB, reflecting a growth of 44.8% [42] - The company supported 13 projects to obtain clinical trial approvals in China [42] Market Expansion - The company added over 150 new CDMO business clients during the reporting period [22] - Revenue from the US market was 1.789 billion RMB, a slight increase of 0.5% year-on-year [25] - Revenue from the European market grew by over 200% to 548 million RMB [25] Future Outlook - The company anticipates a revenue growth of 13% to 15% for the full year of 2025 [77] - Plans to enhance operational efficiency and profitability, aiming for profit growth to exceed revenue growth [77] - Continued focus on expanding capabilities in peptide, oligonucleotide, and conjugated drug segments [77]

Summary of Conference Call Records Industry Overview - The conference call discusses the **clinical CRO (Contract Research Organization)** sector, particularly focusing on the impact of recent order improvements on companies like **Madpace** and **Charles River** [1][2][4]. Key Points and Arguments - **Madpace's Stock Performance**: Madpace's stock price increase reflects improved order conditions, with the net book to bill ratio rising from below 0.9 to above 1, indicating a potential acceleration in future revenue growth [1][2]. - **Global CRO Sector Recovery**: The global clinical CRO sector shows signs of recovery, with Charles River reporting better-than-expected order data and a net book to bill value exceeding 1 for the first time, suggesting a demand-side recovery that may continue [1][4]. - **Importance of CRO Services for Biotech**: Biotech companies, which often lack commercialized products, rely heavily on CRO services to accelerate clinical trials and attract investment. This reliance is crucial for their survival and competitiveness [5][6]. - **Domestic CDMO Landscape**: The domestic pharmaceutical industry is primarily led by export-oriented CDMO companies. After significant expansion from 2020 to 2022, the industry faced a downturn, but is expected to recover in 2024, with leading companies achieving full capacity first [1][8]. - **Geopolitical Impact**: Geopolitical relations affect domestic CXO companies' operations in the U.S. Companies like WuXi Biologics have stable orders due to their production capabilities, while WuXi AppTec's reliance on local raw materials makes it more vulnerable [1][9]. - **Innovation-Driven Market Cycles**: The pharmaceutical industry's development cycles depend on innovation in areas like ADCs, small nucleic acids, and peptides. Breakthroughs in these fields could lead to a new upward market cycle [3][10][11]. - **Market Sentiment and New Drug Categories**: Emerging drug categories, such as weight loss medications, are expected to influence market dynamics and sentiment, indicating a shift in consumer demand [3][10]. Additional Important Insights - **CRO Response to Order Fluctuations**: Companies in the clinical sector may face overcapacity during order declines, leading to potential layoffs. Conversely, when orders exceed a certain level, companies may consider expanding capacity [7]. - **CDMO Pricing Strategies**: In a low-capacity environment, CDMO companies may lower prices to secure orders, but as demand increases, they can achieve both volume and price growth [8]. - **Generational Changes in Pharma**: The pharmaceutical industry has undergone several generational changes, with each new major product category influencing market conditions. For instance, breakthroughs in small nucleic acids have significantly impacted market performance [11][12].

Core Insights - Hanyu Pharmaceutical (300199) has recently conducted investor research, discussing the progress of the HY3003 new drug project, its layout in the innovative drug field, and overseas market expansion [1][2] Group 1: HY3003 New Drug Project - The HY3003 project has completed preclinical candidate compound screening and raw material process development, officially entering the raw material pilot scale-up phase, which validates the producibility of the molecular structure for subsequent IND application and clinical transformation [1] - HY3003 is a GLP-1R/GIPR/GCGR receptor agonist developed using AI peptide chip technology, aimed at weight loss indications [1] - The project employs a multi-formulation parallel development strategy, including weekly, ultra-long-acting monthly, and oral formulations, with the ultra-long-acting formulation designed to reduce dosing frequency and improve medication adherence [1] Group 2: siRNA and Other Drug Developments - The company is also developing siRNA drugs such as Inclisiran and Zilebesiran for treating high cholesterol and hypertension, as well as Pegcetacoplan for treating geographic atrophy [1] Group 3: Overseas Market Expansion - Currently, the company's raw materials are sold to over 20 countries and regions, with formulations licensed in over 90 countries and regions [2] - The company has signed cooperation agreements for the semaglutide injection (weekly formulation) and oral tablets in markets including China, Brazil, Egypt, Mexico, Eurasian Union, GCC member countries, and North Africa [2] - The company has completed the enrollment of all participants in the Phase III clinical trial for semaglutide injection as of January this year, with plans to submit for approval in China by 2026, followed by the US and other global markets [2] Group 4: Future Pipeline - Hanyu Pharmaceutical has a rich pipeline of peptide and small nucleic acid formulations, planning to launch no less than 20 formulations over the next 10 years, including innovative drugs, micro-innovative drugs, and ANDA [2]

Investment Rating - The industry investment rating is positive [1] Core Viewpoints - The report indicates that a turning point has been reached in the CXO sector, suggesting a positive outlook for investment [6][66] - The report highlights that the performance of domestic CXO companies has shown significant improvement, with major players like WuXi AppTec and Kintor Pharmaceutical demonstrating strong order growth [6][66] - The report emphasizes the recovery of revenue growth, with a year-over-year increase of 8.2% in Q1 2025 for CXO companies, indicating a positive trend in the sector [6][26] Financial Analysis - Domestic performance: The medical R&D outsourcing index increased by 0.82% from December 31, 2024, to April 30, 2025, outperforming the pharmaceutical and biotech index by 0.64 percentage points [5][13] - International performance: The report notes a divergence in performance among international CXO companies, with Lonza showing optimistic growth projections for its CDMO business, expecting nearly 20% growth in 2025 [5][18] - Profitability: The average gross margin for Q1 2025 was 30.9%, reflecting a year-over-year increase of 1.1 percentage points, with some companies like Medpace and Boteng showing significant improvements [6][31] - Operational efficiency: Inventory turnover rates have stabilized, with an average of 3.36 in 2024, indicating a positive trend in operational efficiency [6][36] Investment Strategy - The report suggests that the CXO sector is at a turning point, with strong growth potential in small and large molecule CDMO orders, as well as in clinical CRO opportunities driven by domestic innovation policies [6][66] - Recommended companies include WuXi AppTec and Kintor Pharmaceutical for clinical CRO, and WuXi Biologics and Kelun Pharmaceutical for CDMO [6][66] - The report highlights an increase in institutional holdings in CXO companies, indicating growing confidence in the sector [6][60]