《科创板日报》11月19日讯（记者 王楚凡） 近日，之江生物（股票代码：688317）召开第二次临时股 东会。本次会议现场及网络投票股东共计112人，代表股份约7282.19万股，占公司总股本的37.9%。 根据会议表决结果，《关于开展外汇衍生品交易业务的议案》以99.52%的高票通过。其中现场参会股 东及代理人6名，持股7169.44万股；网络投票股东106名，持股112.75万股。该公司全体5名董事线上出 席会议，副总经理兼董事会秘书倪卫琴现场出席会议。 据悉，该议案主要内容为：公司及合并范围内子公司拟开展额度不超过2000万美元（或等值其他货币） 的外汇衍生品交易，业务类型包括外汇远期、掉期、期权及结构性远期等产品，交易对手限定为具备资 质、经营稳健的境内大型金融机构。该额度自股东大会审议通过之日起12个月内有效，可滚动使用。 之江生物表示，开展此项业务主要因公司进出口业务多采用美元等外币结算，汇率波动可能对经营业绩 产生影响。通过外汇衍生品交易可有效规避汇率风险，此项业务将以套期保值为目的，不进行单纯投机 性交易。 会议上，有投资者针对该公司三季报提出疑问："公司三季报显示，海外营收仅230余万元，为 ...

Core Insights - The article discusses the promising applications of organoid technology in regenerative medicine, particularly focusing on human pluripotent stem cell (hPSC)-derived kidney organoids and their potential for clinical applications in organ transplantation and tissue regeneration [2][3]. Group 1: Research Breakthroughs - Researchers developed a scalable, reproducible, and cost-effective method to generate human kidney organoids from hPSCs, which can differentiate into various kidney cell types [6]. - The study successfully demonstrated the ex vivo transplantation of hPSC-derived kidney organoids into porcine kidneys, marking a significant milestone in regenerative medicine and personalized healthcare [3][10]. Group 2: Methodology and Findings - The research utilized single-cell RNA sequencing, confocal imaging, and CRISPR-Cas9 engineering to analyze the transcriptional diversity and cellular composition of hPSC-kidney organoids [8]. - The hPSC-kidney organoids were perfused into ex vivo pig kidneys using a room-temperature mechanical perfusion technique, confirming the feasibility and effectiveness of this approach for organ transplantation [8][11]. Group 3: Clinical Implications - The study indicates that combining organoids with ex vivo perfusion technology can facilitate controlled conditions for cell therapy, aiming to regenerate or repair organs before transplantation, thereby reducing patient wait times and increasing the availability of healthy organs [10].

Core Viewpoint - The study demonstrates that patient-derived cancer organoids (PDCO) can accurately predict the response of locally advanced rectal cancer (LARC) to chemoradiation, supporting the use of Irinotecan as a candidate for neoadjuvant therapy in LARC patients [2][4][7]. Group 1 - The research established a biobank of rectal cancer organoids (RCO) from LARC patient samples, confirming that PDCO can predict LARC responses to chemoradiation [4][7]. - The accuracy of predicting clinical outcomes using organoids was found to be 92.50% in the discovery cohort and 93.75% in the validation cohort, indicating a high predictive capability [4][7]. - The study highlighted the importance of the timing of organoid survival data collection, which significantly affects the correlation between organoid treatment responses and patient clinical outcomes [4][7]. Group 2 - The organoids exhibited both synergistic (3.91%) and antagonistic (4.69%) effects in response to combined treatment, showcasing the complexity of treatment interactions [4][7]. - Irinotecan, a topoisomerase I inhibitor, was identified as a candidate drug for neoadjuvant therapy in LARC patients, emphasizing its role in inducing apoptosis in tumor cells [4][7]. - The systematic analysis of rectal cancer organoid responses to chemoradiation may significantly influence the broader application of organoid technology in precision cancer treatment [8].

Core Viewpoint - Organoid technology has emerged as a revolutionary tool in disease mechanism research, drug development, and precision medicine, but traditional manual operations face challenges in standardization, throughput, and reproducibility, which hinder research breakthroughs and clinical translation. The integration of automation technology is injecting new momentum into organoid research, facilitating efficient transitions from research outcomes to industrial applications [2]. Group 1: Event Details - An online seminar titled "Automation Innovation in High-Throughput Organoid Disease Modeling" will be held on September 17, 2025, from 15:00 to 16:20 [4]. - The seminar will focus on the application of automated liquid handling technology in organoid construction, drug screening, and disease modeling, bringing together experts and technology pioneers to discuss how automation solutions can enhance experimental efficiency, data reliability, and research scalability [2][4]. Group 2: Speaker Profiles - Professor Zhou, an assistant professor at the University of Hong Kong's Department of Microbiology, specializes in establishing organoid models and viral research based on organoid technology. Her team has successfully developed the world's first human respiratory organoid culture system and bat intestinal organoids, significantly advancing biomedical research and drug development [6]. - Lin Delin, a senior application support engineer at Opentrons, graduated with a master's degree in biochemistry and molecular biology. He focuses on the application of automated liquid handling technology in the biotechnology field and has accumulated extensive practical experience and published multiple research papers [8].

Summary of the Conference Call for Zhaoyan New Drug (2025) Company Overview - **Company**: Zhaoyan New Drug - **Industry**: Pharmaceutical and CRO (Contract Research Organization) Key Financial Performance - **New Orders**: In the first half of 2025, new orders amounted to 1.02 billion yuan, a year-on-year increase of 13.33%. The second quarter saw a single-quarter increase of 18% with new orders of 590 million yuan [2][5] - **Revenue**: Total revenue for the first half was 669 million yuan, with domestic clients contributing 417 million yuan (62.31%) and international clients contributing 252 million yuan (37.69%) [3] - **Net Profit**: The net profit attributable to shareholders was 60.93 million yuan, marking a turnaround from losses in the same period of 2024 [2][3] - **Gross Margin**: The gross margin was reported at 24.03%, down from previous levels due to a decrease in revenue and fewer high-margin long-cycle orders [3][4] Business Developments - **Technological Investments**: The company is investing in drug evaluation technologies, organoids, organ-on-chip technologies, and has seen a significant increase in antibody, small nucleic acid, and ADC project numbers [2][6] - **CMA Certification**: The Suzhou facility has passed CMA certification, allowing it to conduct medical device testing and non-clinical research [2][6] - **Innovation in Domestic Market**: The booming domestic innovative drug business is enhancing international recognition of Chinese innovations, leading to increased R&D investments [2][7] Market Dynamics - **Experimental Monkey Pricing**: Prices for experimental monkeys are stable, with quarterly fair value changes expected to be around 50 million yuan due to natural growth impacts [2][8] - **Offshore Outsourcing**: The company is focusing on expanding its offshore outsourcing business, with a double-digit growth in order numbers, although the total order value remains stable [2][9] Challenges and Risks - **Aging Monkey Population**: The aging population of experimental monkeys in China poses a long-term capacity risk. The company is implementing measures to ensure stable supply and quality [2][10] - **Cost Pressures**: Rising costs due to overseas inflation have led to a decrease in gross margin for international business, which fell to 26% in the first half of 2025 [3][35] Future Outlook - **Capital Expenditure**: The company plans to invest 200 to 300 million yuan in capital expenditures for facility expansions and new laboratory constructions [3][26] - **Order Trends**: The company anticipates a slight decline in overseas orders but aims to maintain overall order levels [3][13] - **Market Positioning**: The company is optimistic about the future of the innovative drug sector in China and plans to continue developing its capabilities in organoid and AI technologies [2][38] Additional Insights - **Client Composition**: In the second quarter, new orders were primarily from biotech companies, which accounted for over 50% of the total, while traditional pharmaceutical companies contributed less than 50% [3][27] - **Impact of FDA Regulations**: The company is monitoring potential impacts from FDA regulations that may reduce animal testing requirements and is prepared to adjust its R&D strategies accordingly [3][17] This summary encapsulates the key points from the conference call, highlighting the financial performance, business developments, market dynamics, challenges, and future outlook for Zhaoyan New Drug.

Core Viewpoint - The report highlights the financial performance and strategic initiatives of Suzhou Novoprotein Scientific Inc. for the first half of 2025, emphasizing its focus on innovation and market adaptation in the biopharmaceutical sector [4][6]. Financial Performance - The company's revenue for the first half of 2025 was approximately 72.09 million RMB, representing a 20.85% increase compared to 59.66 million RMB in the same period last year [5]. - The total profit for the period was a loss of approximately 28.92 million RMB, compared to a loss of 16.48 million RMB in the previous year [5]. - The net profit attributable to shareholders was approximately -24.22 million RMB, compared to -8.91 million RMB in the same period last year [5]. - The net cash flow from operating activities was -14.08 million RMB, a significant decrease from 23.30 million RMB in the previous year, reflecting a 160.45% decline [5]. Business Overview - The company specializes in the research, development, production, and sales of target and factor proteins, recombinant antibodies, enzymes, and reagents, providing comprehensive solutions in biopharmaceuticals, in vitro diagnostics, and life sciences [6][8]. - The company has developed a total of 3,566 types of target and factor proteins, focusing on areas such as oncology, metabolism, and autoimmune diseases [8][9]. - The company has 166 types of recombinant antibodies, which are used in immunodiagnostic reagents, new vaccines, and antibody drugs [9]. Strategic Initiatives - The company is actively engaging in gene and cell therapy, leveraging its GMP production technology to provide tools and solutions for gene editing [6][8]. - The company is enhancing its RNA production processes and expanding its product offerings in RNA applications to meet diverse customer needs [6][8]. - The company aims to address the "bottleneck" issues in basic biopharmaceutical raw materials by integrating its seven comprehensive technology platforms and 23 core technologies [8]. Industry Context - The Chinese government is promoting the integration of biotechnology and information technology, aiming to strengthen the biopharmaceutical industry and support innovation in drug development [7][8]. - Recent government initiatives, including the "High-Quality Development Action Plan for the Pharmaceutical Industry," are expected to boost confidence in the pharmaceutical sector and support the development of innovative drugs [7].

Core Insights - The traditional reliance on animal testing in drug development is being challenged by advancements in organoids, organ-on-a-chip technology, and AI simulations, marking a new era in life sciences and pharmaceutical research [1][3] - The FDA has mandated the gradual elimination of mandatory animal testing for monoclonal antibodies and has incorporated organoids and organ-on-a-chip solutions into its regulatory framework [1] - The first fully automated AI organoid system in Asia was showcased at a forum in Shanghai, highlighting the city's potential to leverage this "black technology" for biomedicine [1][4] Organoid and Organ-on-a-Chip Technology - Organoids mimic the structure and function of real organs, such as brain and intestinal organoids, and have been recognized as a top technology by Science magazine in 2013 [2] - Organ-on-a-chip technology combines organoids with microfluidic chips to simulate physiological environments, with over 60 companies globally involved in this sector, projected to reach a market size of $620 million by 2029 [2] Market Growth and Applications - The organoid industry is expected to maintain a compound annual growth rate (CAGR) of over 20% in the coming years, enhancing drug screening efficiency and reducing costs and risks in drug development [3] - Personalized medicine is a significant development direction for organoids, allowing for the creation of patient-specific organoids to simulate disease states for tailored treatment plans [3] Technological Advancements - The newly introduced AI organoid system can automate the entire biological process, significantly improving the efficiency of stem cell and organoid growth, and addressing challenges in clinical applications [4][5] - This system aims to overcome the "valley of death" in biomedicine by providing high-fidelity models that retain tumor microenvironments and generating predictive models for drug efficacy [4] Strategic Initiatives in Shanghai - Shanghai is positioning itself as a leader in the organoid innovation ecosystem, having supported various projects since 2021 focused on drug screening and personalized medicine [6] - The city has established a framework for integrating cutting-edge technologies like AI and organoids into clinical research, with policies that encourage innovation [6][7] - Shanghai's unique advantages include rich clinical resources, a robust AI infrastructure, and pioneering regulatory frameworks that facilitate clinical validation of organoid technologies [7]

Summary of Key Points from the Conference Call Industry Overview - The conference call discusses the **global and Chinese laboratory animal market**, highlighting a pre-pandemic growth rate of **5%-7%** globally, with China reaching **15%-20%**. Post-pandemic, China's growth has slowed to **5%-7%** primarily due to price increases, not volume changes. The domestic market size is approximately **40 billion RMB**, with ancillary services generating around **20 billion RMB** in revenue [1][2]. Core Insights and Arguments - **Price Increases**: The rise in laboratory animal prices is attributed to multiple factors, including increasing labor, feed, energy costs, and testing fees [4]. - **Market Dynamics**: If internal demand from pharmaceutical companies is included, the overall market space would significantly expand, although specific data is currently unavailable [5]. - **Outsourcing Trends**: Pharmaceutical companies are reducing outsourcing to cut costs but are increasingly adopting one-stop services to enhance R&D efficiency. Many firms are opting for phased outsourcing, keeping early research in-house while outsourcing evaluation stages to ensure objectivity [6]. - **Market Leaders**: In the U.S., key players include **Jackson Laboratory**, **Charles River Laboratories**, and **Taconic Biosciences**, each with distinct market strategies and growth trajectories [7][8]. - **Regulatory Impact**: New U.S. policies from **FDA** and **NIH** limiting animal use may lead to a contraction in the U.S. market, shifting focus towards cell or organoid projects [10]. Additional Important Content - **European Market**: The European laboratory animal industry is fragmented, with strict animal welfare regulations leading to a shift towards cell-based alternatives [9]. - **Gene Editing Technologies**: The conference highlights the dominance of **CRISPR/Cas9** technology in gene editing, with companies like **百奥** and **博** leading in humanized antibody mouse technology [3][14]. - **Market Trends**: Demand for laboratory animals is increasing from pharmaceutical companies, with a **10%** year-on-year sales growth noted, particularly for specific strains like **C57** and **SD rats** [21]. - **CRO Challenges**: The decline in orders from Contract Research Organizations (CROs) is linked to U.S. government restrictions on using Chinese CROs, leading to a shift in orders to South Korea and Japan [22]. - **Future Directions**: The laboratory animal industry is expected to consolidate, with smaller companies potentially being acquired by larger firms, emphasizing the importance of scale in reducing costs [28][29]. - **Emerging Research Areas**: While tumor immunology has been a focus, research into metabolic diseases is gaining traction, indicating a shift in research priorities [30]. Conclusion The laboratory animal market is experiencing significant changes driven by regulatory shifts, cost pressures, and evolving research needs. The consolidation trend suggests that larger firms will dominate, while emerging areas of research may redefine market dynamics in the coming years.

Core Viewpoint - Organoid technology is a revolutionary breakthrough in life sciences, showing great potential in drug development, disease mechanism analysis, and personalized medicine, with the FDA planning to phase out animal testing by 2025 and positioning organoids as a core tool for drug safety evaluation [1] Group 1: Challenges in Organoid Technology - Insufficient technological maturity remains the primary challenge, with over 60% necrosis rate in long-term cultures due to the lack of vascular networks and immune microenvironments [1] - The absence of standardization is a significant issue, leading to substantial batch-to-batch heterogeneity and a lack of international standards for evaluating morphological, functional, and molecular characteristics [1] - Low automation equipment penetration rates contribute to human operational errors and limit high-throughput capabilities, hindering clinical application promotion [1] Group 2: Upcoming Conference - The "Third Organoid Technology Innovation and Application Progress Online Conference" will be held on July 15-16, focusing on "Technical Breakthroughs - Standard Co-construction - Ecological Collaboration" [2] - The conference will feature four thematic sessions: "Progress in Organoid Simulation Technology," "Clinical Applications and Transformation of Organoids," "Organoid Model Construction and Drug Development," and "Standardization and Automation of Organoids" [2] Group 3: Conference Agenda Highlights - On July 15, sessions will cover topics such as bio 3D printing and high-throughput genetic screening technologies in organoids, with notable speakers from Tsinghua University and Shanghai University [3][4] - The second day will focus on organoid model construction and drug development, including discussions on animal alternatives and optimization methods for 3D organoid culture [4]

Group 1: Innovation Drug Development - The company is actively pursuing new business growth points through dual development of innovative and generic drugs, focusing on self-initiated innovative drug projects in key medical fields such as oncology, autoimmune diseases, and respiratory diseases [1] - The small molecule innovative drug R&D center has two approved cases, with several ongoing projects including BIOS-0629, BIOS-0623, BIOS-0632, and BIOS-0635, the latter being a key project targeting tumors [1][2] - The global market for targeted cancer drugs is over 60%, with immunotherapy accounting for 23.4% of the market, indicating a growing demand for innovative treatments [2] Group 2: Organoid Technology - Organoids have been recognized as a significant technology since 2013, with multiple mature organoid models developed by the company for drug efficacy evaluation and personalized medicine [3] - The company has established a service platform for organoids, focusing on drug screening, efficacy evaluation, and safety assessment, enhancing the precision and efficiency of drug development [4] Group 3: Market Potential of Drug 0618 - Drug 0618 targets the H3 receptor and addresses two indications: daytime sleepiness in OSA patients, with approximately 2.1 billion OSA patients in China, and neuropathic pain affecting around 90 million people [6] - The market expectations for the competing drug Pitolisant are significant, with projected sales of $582 million in 2023 and $710 million in 2024 [6] Group 4: New Drug R&D Platform and Team - The company’s new drug development encompasses various stages from compound discovery to clinical trials, focusing on both fast follow-on and first-in-class products [7] - The R&D team consists of over 200 members, with more than 80% holding advanced degrees, emphasizing the importance of talent in the industry [8] - The company collaborates with universities and research institutions to attract top talent, ensuring a strong foundation for innovative drug development [8]