Core Viewpoint - 康龙化成 is experiencing a positive trend in its CMC service gross margin, with expectations for continued growth in the upcoming quarters [1] Financial Performance - The gross margin for CMC services in Q3 2025 is reported at 34.6%, reflecting a 4 percentage point increase quarter-over-quarter [1] - The company anticipates that the gross margin for Q4 will continue to improve sequentially, with the full-year gross margin expected to be slightly above 33%, compared to the same period last year [1] Capital Expenditure - The projected capital expenditure for 2025 is over 2 billion yuan, primarily allocated for laboratory services in China and small molecule CDMO capacity expansion, including new capacity in Beijing and the second phase project in Shaoxing [1] - Future capital expenditures are expected to remain at similar levels, with operating cash flow sufficient to cover these expenditures [1] Innovation and Technology Investment - 康龙化成 is committed to ongoing investments in new technology areas, including organoids and AI [1] - The company aims to maintain sustainable positive free cash flow [1]

Summary of the Conference Call for 康龙化成 (Crown Bioscience) Company Overview - 康龙化成 reported a revenue of 10.086 billion yuan for the first three quarters of 2025, representing a year-on-year growth of 14.4% [2][4] - Adjusted net profit for the same period was 1.227 billion yuan, up 10.8% year-on-year [2][4] - The company has raised its full-year revenue guidance to a growth of 12%-16% [5][10] Key Business Segments Performance Laboratory Services - Revenue for the laboratory services segment in the first three quarters was 6.004 billion yuan, a 15% increase year-on-year [2][6] - Gross margin maintained around 45% with new orders growing over 12% [2][6] - In Q3 alone, revenue was 2.111 billion yuan, a 3.7% increase from the previous quarter and a 14.3% increase year-on-year [6] CMC Services - CMC services generated 2.293 billion yuan in revenue for the first three quarters, a 16% year-on-year increase [2][6] - Gross margin for this segment was 34.6%, with new orders increasing approximately 20% [2][6] - Q3 revenue was 903 million yuan, showing a significant 29.6% quarter-on-quarter increase and a 12.7% year-on-year increase [6][17] Clinical Services - Clinical services revenue for the first three quarters was 1.44 billion yuan, up 10.3% year-on-year [2][6] - Q3 revenue was 501 million yuan, a 1.7% increase from the previous quarter and an 8.2% increase year-on-year [6][22] Macromolecule and CGT Services - Revenue for this segment was 336 million yuan in the first three quarters, an 8% year-on-year increase [2][6] - Q3 revenue was 125 million yuan, a 10.6% quarter-on-quarter increase and a 25.1% year-on-year increase [6] Customer and Geographic Performance - North American clients accounted for 64% of total revenue, with multinational corporations contributing 18% and Chinese clients 15% [7][8] - The company serves 15 out of the top 20 global pharmaceutical companies, which contributed 18% of total revenue, showing a strong year-on-year increase of 37.9% [7] M&A Activities - 康龙化成 plans to acquire Wuxi Baode Biological Science to enhance its structural biology capabilities and improve early antibody discovery and optimization [9] Future Outlook - The company expects continued growth driven by increasing health demands and technological innovations, with a positive outlook for both overseas and domestic client demands [10][11] - The anticipated capital expenditure for 2025 is over 2 billion yuan, focusing on laboratory and CDMO capacity expansion [21] Competitive Landscape and Strategy - The laboratory R&D market remains competitive, but 康龙化成 is increasing its market share, particularly in the biological sciences segment, which has grown over 15% [15] - The company is committed to enhancing automation and AI capabilities to improve R&D efficiency and is focusing on long-term growth in new segments like macromolecules and gene cell therapy [27][28] Recruitment Plans - 康龙化成 is increasing recruitment efforts in 2025 to support the growth in laboratory service orders [24][26] Conclusion - 康龙化成's overall performance in 2025 is optimistic, with significant growth across various segments and a strategic focus on enhancing capabilities through acquisitions and technological investments [25]

Core Viewpoint - The article discusses a groundbreaking research study from Shanghai Jiao Tong University that introduces a new paradigm in regenerative medicine, allowing for direct differentiation of human adult adipose tissue into functional organoids without the need for complex cellular manipulation, thus overcoming significant clinical challenges in the field [3][4]. Group 1: Research Breakthroughs - The study presents a novel "tissue → new tissue" reprogramming paradigm that activates the endogenous differentiation potential of adult adipose tissue, enabling the generation of various functional organoids [4]. - Three major advantages of this research are highlighted: 1. Tissue-level reprogramming that preserves the ecological niche and homeostasis of multiple cell types within adipose tissue, avoiding genomic instability risks associated with cellular manipulation [7]. 2. The breakthrough of germ layer restrictions, successfully directing adipose tissue to differentiate into functional endodermal and ectodermal organoids [7]. 3. Clinical safety assurance through a process that avoids pluripotent states and cell passage, with long-term trials showing no tumorigenicity [7]. Group 2: Methodology and Findings - The research team developed an innovative technique that maintains the natural microenvironment of adipose tissue, leading to the formation of three-dimensional active microtissues with a high proportion of mesenchymal stem cells [8]. - The reaggregated microfat (RMF) particles demonstrated significant differentiation potential, successfully constructing functional human-derived bone marrow organoids that exhibited progressive ossification and superior hematopoietic support capabilities [9]. - The study also achieved the construction of pancreatic organoids with a notable percentage of functional β-like cells, significantly enhancing insulin secretion in response to glucose stimulation [10]. Group 3: Clinical Implications - The findings suggest that adipose tissue can serve as a "natural stem cell reservoir," providing a safe, economical, and scalable treatment strategy for conditions such as diabetes, blood disorders, and nerve injuries [13]. - The research team has initiated clinical translation studies for diabetes treatment, potentially leading to a new chapter in regenerative medicine where liposuction can be utilized for significant health benefits [13].

Core Insights - The "2025 Guangzhou Medical and Health Industry Expo" will be held from August 22 to 24 at the China Import and Export Fair Complex, organized by the Guangzhou Municipal Government and relevant health authorities [1] - The expo will cover an exhibition area of 30,000 square meters, featuring 3 pavilions and 18 exhibition areas, showcasing cutting-edge technologies such as gene editing, cell therapy, organoids, organ-on-a-chip, nuclear medicine, 3D printing, biomanufacturing, and synthetic biology [1] - The event aims to encompass the entire industry chain, including R&D, transformation, production, clinical application, third-party services, and financial support [1] Industry Participation - The expo has attracted participation from health administrative departments from various regions including Anhui, Sichuan, Fujian, Chongqing, and Xinjiang [1] - Top research institutions such as Guangzhou laboratories and technology transfer centers from universities, along with over 50 local tertiary hospitals, have been invited to exhibit [1] Corporate Involvement - Notable exhibitors include large pharmaceutical companies like China Resources, Sinopharm, and Guangzhou Pharmaceutical, as well as innovative firms such as BeiGene, CanSino, and Yipin Hong [1] - Telecommunications companies like China Telecom, China Unicom, and China Mobile are also participating in the expo [1]

Core Viewpoint - Zhaoyan New Drug (06127) has seen a significant stock price increase of over 9%, currently trading at 24.62 HKD, with a transaction volume of 391 million HKD, indicating positive market sentiment towards the company [1] Group 1: Company Performance and Outlook - Huatai Securities reports that Zhaoyan New Drug experienced high growth from 2018 to 2022, but is facing order volume and price pressures from 2023 to 2025. However, starting in 2026, the company is expected to enter a new growth phase driven by domestic recovery and overseas outsourcing [1] - The report highlights that the price of experimental monkeys, a key indicator of supply and demand in the safety evaluation industry, is currently stable at 80,000 to 100,000 RMB per monkey, with a potential upward trend as supply-demand gaps widen [1] Group 2: Market Concerns and Long-term Perspectives - Contrary to market concerns regarding the impact of FDA new policies and overseas business growth potential, Huatai Securities believes that the new policies are primarily focused on monoclonal antibodies and have not yet been adopted domestically. Animal testing will remain the dominant method in global drug safety evaluation for the next 3-5 years [1] - The long-term application of new methodologies such as AI and organoids is still uncertain, requiring careful consideration of transitional results and technological maturity. The company is expected to enhance its overall capabilities through proactive engagement with new methodologies [1]

Core Viewpoint - The FDA has initiated a significant project aimed at validating non-animal methods for predicting drug-induced liver injury, with completion expected in Q1 2026 [1][3]. Group 1: FDA's Initiative - The FDA is collaborating with multiple organizations, including YaoSu Technology, to implement a cross-platform drug validation project using organ-on-a-chip technology [3][4]. - The project aims to enhance the accuracy and efficiency of toxicity assessments, reducing reliance on animal testing [4][6]. - The FDA's recent policy updates encourage the use of organ chips and AI modeling in early drug development stages, signaling a shift in research funding priorities [3][10]. Group 2: Cost and Time Efficiency - Utilizing organ-on-a-chip technology can significantly reduce the time required for toxicity testing, with some tests potentially completed in two weeks compared to several months for traditional animal testing [5][6]. - The cost of animal testing is substantial, with a mouse costing around 100 yuan and a monkey potentially costing up to 100,000 yuan, making non-animal methods financially attractive [4][6]. Group 3: Accuracy of Testing Methods - Current animal models have a liver injury prediction accuracy of only 50% to 65%, which is marginally better than random chance [6][9]. - Organ-on-a-chip technology could improve prediction accuracy to between 80% and 90%, leading to significant cost savings in drug development [6][9]. Group 4: Challenges and Future Directions - There are still significant technical and regulatory hurdles to fully replace animal testing, with a complete transition unlikely within the next decade [8][10]. - The FDA's goal is not to eliminate animal testing entirely but to shift the focus towards in vitro models, using animals only when necessary [9][11]. - The development of multi-organ chips that can simulate human physiology remains a long-term objective, requiring further research and standardization [9][10].

Summary of Preclinical CRO Industry Conference Call Industry Overview - The preclinical CRO industry is experiencing a decline in demand and increased competition since the second half of 2023, leading to a price war. The overall industry is expected to remain sluggish in 2024, with only slight growth anticipated in 2025, recovering slowly [1][2] - Large pharmaceutical companies now account for 70% of orders, while biotechnology companies have seen their share drop to 30% [5] Key Trends and Insights - There has been a slight increase in domestic project demand, but foreign orders remain scarce. Expanding into international markets, particularly in monkey resources, could enhance profit margins [1][6] - The fastest-growing drug types are concentrated in ADC, bispecific antibodies, and small nucleic acids, while orders for cell and gene therapies have decreased significantly [7][8] - The average cost of monkeys in China is currently around 80,000 yuan, expected to rise to approximately 100,000 yuan in the second half of the year due to reduced supply. However, this price increase is seen as temporary, with potential declines anticipated by 2026 as import channels open [11][12] Pricing and Competition - The preclinical CRO industry entered a price war in the second half of 2023, with prices dropping by 20% in the first half of 2023 and reaching a 50% decline by the end of the year. Prices stabilized at around 40-50% of original levels in 2024 [3][28] - Some leading companies, such as WuXi AppTec, have begun raising prices for animal testing to maintain profit margins, indicating a potential recovery trend [9][10] Market Dynamics - The competitive landscape remains intense, with approximately 70 companies holding GLP certification, but only about 20 capable of handling projects. Market orders are primarily concentrated among a few top-tier companies [16] - Companies are optimizing non-core segments and downsizing to improve efficiency, a trend expected to continue into 2026 [17] Regulatory and Cost Factors - Rising tariffs have increased the cost of testing reagents by less than 10%, primarily affecting project scheduling rather than pricing. Companies are seeking domestic alternatives to mitigate cost pressures [18][19] - The improvement in the domestic investment environment is expected to reflect in order volumes by the second or third quarter of the following year [22] Future Outlook - The industry is actively exploring alternatives to animal testing, such as organoids and organ-on-chip technologies, although complete replacement of animal testing is not yet feasible [23][24] - The opening of import channels for monkeys could lead to a decrease in domestic prices, contingent on government policy [13][14] Conclusion - The preclinical CRO industry is navigating a challenging landscape characterized by declining demand, price competition, and evolving regulatory requirements. Companies are adapting by optimizing operations and exploring new technologies to remain competitive in the long term [2][23]

Core Viewpoint - The article discusses a groundbreaking study that successfully developed highly vascularized lung and gut organoids using human induced pluripotent stem cells (iPSCs), addressing the limitations of traditional organoid models that lack functional vascular networks and organ-specific characteristics [2][11]. Group 1: Research Background - The study was published in the journal Cell on June 30, 2025, by teams from Cincinnati Children's Hospital and UCLA, marking a significant advancement in organoid research [1]. - Prior to this research, organoids generally lacked organ-specific vascular networks, particularly in endoderm-derived organs like the lung and gut, which limited their application in disease modeling and therapeutic contexts [1][2]. Group 2: Methodology and Findings - The research established an in vitro vascularized organoid platform that accurately replicates the co-development of mesoderm and endoderm lineages, enabling efficient differentiation of endoderm-derived cells into organotypic endothelial and mesenchymal cell populations [11]. - The new method requires fewer factors for organoid development: only one inhibitor (Noggin) for lung organoids and three activators (CHIR99021, FGF4, and VEGFA) for gut organoids, allowing for spontaneous formation of vascular networks [13]. - The resulting vascularized organoids exhibited enhanced cellular diversity, improved three-dimensional structure, and physiological functions, such as tight barriers in lung organoids for gas exchange and high permeability in gut organoids for nutrient absorption [13]. Group 3: Implications for Disease Modeling - The vascularized organoids can be utilized to study abnormal intercellular interactions in various disease contexts, such as ACDMPV, a congenital lung disease caused by FOXF1 gene mutations [14]. - By differentiating patient-derived iPSCs with FOXF1 mutations into vascularized lung organoids, the study successfully replicated primary endothelial defects and secondary epithelial abnormalities associated with the disease [14]. - This platform allows for the simultaneous modeling of multi-organ interactions in diseases, providing insights into complex conditions that traditional models could not address [14][15].

撰文丨王聪 编辑丨王多鱼 排版丨水成文 近年来，研究人员创造了各种类器官以模拟人体器官的功能，然而，一直难以构建出能够增殖且功能完备的 肝脏类器官 。这是因为，在实验室条件下， 肝脏中 的主要细胞肝细胞会发生 胆管化生，转变为胆管细胞样细胞，以平衡细胞功能和增殖之间的能量消耗，这导致肝细胞的功能最多只能维持 1-2 周。 2025 年 4 月 16 日， 庆应义塾大学医学院 佐藤俊朗 教授团队在国际顶尖学术期刊 Nature 上发表了题为 ： Generation of human adult hepatocyte organoids with metabolic functions 的研究论文。 该研究从直接取自人类患者的冷冻保存的成人肝细胞中培养出了 具有代谢功能的成人肝细胞类器官 。研究团队使用 参与炎症反应的信号蛋白 抑瘤素M （ Oncostatin-M，OSM ） 进行处理，使得肝细胞类器官的增殖量达到了百万倍，这与之前研究中的肝细胞几乎不生长的情况形成了鲜明对比。这些肝细胞类器官 持续生长了三个月，并且在半年内仍保持分化能力。这些肝细胞类器官为肝脏疾病的建模和治疗提供了新平台。 在这项最新研究中 ...