Summary of Baicheng Pharmaceutical Conference Call Company Overview - Baicheng Pharmaceutical has been transitioning to innovative drug development since 2018, responding to changes in centralized procurement policies and the MH system [2][4] - The company has received two IND approvals for innovative drugs and 11 clinical approvals for improved new drugs [2] Core Business and R&D Focus - The company has three main R&D platforms: small molecule innovative drug development, large molecule innovative drug development, and innovative drug discovery and evaluation [6] - Key products include: - Small molecule drug 0,618 targeting neuropathic pain and OSA (Obstructive Sleep Apnea) daytime sleepiness, with significant market potential [2][14] - Antitumor drug XPO1 target 0,629 showing superior efficacy in mouse trials compared to positive controls [2][15] - Other ongoing projects include 0,623 for itching and pain, 0,632 for neuropathic pain, and 0,635 for tumors [6][18] Business Development (BD) Strategy - Baicheng Pharmaceutical is actively expanding its BD market, targeting global markets including Africa, Southeast Asia, Japan, Korea, and Europe, and has obtained EU CEP certification [2][7] - The company aims to make BD a key focus for 2025, seeking to finalize projects through business collaborations [2][9] Financial Performance and Future Outlook - In Q1 2025, the company continued to experience a pessimistic trend with losses exceeding 20 million yuan, but hopes for gradual improvement throughout the year [3] - The company plans to maintain an annual investment of approximately 20% in innovative R&D [5][19] Market Trends and Regulatory Environment - The domestic and international BD markets are thriving, with increasing quality and quantity of Chinese innovative drugs [7][12] - Recent government policies are supportive of innovative drug development, providing unprecedented opportunities [12] Potential Products and Market Prospects - The 0,618 project is expected to enter Phase II clinical trials in July 2025, with significant market potential due to the high prevalence of OSA [14] - The company has a broad layout in oncology, enteritis, allergy, and itching drugs, with promising market prospects [13] Long-term Vision - The actual controller and chairman of Baicheng Pharmaceutical expresses confidence in the company's long-term development and plans to increase shareholding [10][20] - The company aims to embrace the capital market for stable long-term growth and value creation [10] Class Organoid Technology - Baicheng Pharmaceutical is investing in organoid technology, which is seen as a future trend for drug development, potentially replacing animal testing [11] Conclusion - Baicheng Pharmaceutical is in a transitional phase from generic to innovative drug development, with a strong focus on R&D and strategic partnerships to enhance its market position and product pipeline [20]

Core Viewpoint - The OTC2025 forum focuses on the advanced applications of organoids and 3D cell culture, discussing topics such as disease modeling, drug screening, AI-driven organ-on-chip technologies, and quality control in organoid cultivation [1][4]. Group 1: Forum Overview - The forum will take place on July 24-25 in Shanghai, featuring over 50 speakers and more than 800 attendees [1]. - Organized by Shanghai Aoshun Pharmaceutical, Shanghai Bai'ao Tai Pharmaceutical Technology, and Yao Jingtong Bio, with support from various academic and medical institutions [1]. Group 2: Agenda Highlights - The main sessions include discussions on tumor organoid drug sensitivity testing, bone organoids, and AI applications in drug screening [4][5]. - Specific topics include retinal organoid technology, high-throughput analysis of tumor organoids, and the application of organoids in disease modeling and drug screening [5][6][7]. Group 3: Key Participants - Notable speakers include experts from prestigious institutions such as Peking University, Macau University, and various research institutes [5][6][7]. - The forum will also feature discussions on the integration of AI in analyzing large-scale organoid data for personalized drug screening [52]. Group 4: Industry Trends - The forum emphasizes the importance of developing automated cultivation systems to enhance organoid production efficiency and reduce costs [54]. - There is a focus on combining 3D bioprinting and microfluidic technologies to improve the complexity and functionality of organoids [54].

Core Insights - The successful installation of Asia's first CellXpress.ai in vitro model intelligent factory marks a significant milestone in the strategic collaboration between Danaher Group's Molecular Devices and the Shanghai National Engineering Research Center for Biochips [2][3]. Industry Transformation - The FDA Modernization Act 2.0, enacted in 2022, has fundamentally transformed the preclinical research landscape by recognizing non-animal testing alternatives, allowing the use of organoid models, organ-on-a-chip technologies, and AI algorithms for drug safety and efficacy assessments [3]. - A policy update from the FDA in April 2025 mandates the gradual elimination of mandatory animal testing for specific drugs, integrating organoid and organ-on-a-chip technologies with AI into the regulatory framework [3]. Technological Advancements - The CellXpress.ai platform automates the entire 3D biology process through AI-driven monitoring, cultivation, imaging, and scheduling, significantly reducing manual labor and enhancing efficiency [4]. - Key innovations of the CellXpress.ai system include: - Continuous operation 24/7, ensuring strict control over cultivation and passage schedules, thereby minimizing manual intervention [4]. - Standardized output through AI analysis, providing consistent and physiologically relevant results [4]. - Enhanced growth and expansion efficiency for various stem cell lines and organoids, optimizing screening processes [4]. Broader Implications - The deployment of the CellXpress.ai factory addresses long-standing challenges in the commercialization of organoid technology, such as operational complexity and reproducibility issues [5]. - The integration of organoid technology is expected to accelerate drug development, improving the efficiency of drug safety and efficacy evaluations in response to regulatory demands [5]. - Establishing a national standard for organoid technology is anticipated, promoting the standardized development of this field in China [5]. - The collaboration aims to enhance academic exchanges and training, contributing to the cultivation of high-quality professionals in the organoid industry [5].

OTC2025： 产学研医共促类器官技术突破 类器官技术正在快速发展，并逐步进入临床试验阶段。虽然仍面临挑战，但随着生物工程、人工智能和细 胞培养技术的进步，类器官有望成为精准医疗和再生医学的核心工具，为人类健康带来革命性突破。值此 之际， OTC2025 类器官前沿应用与 3D 培养论坛 重磅来袭：围绕 类器官与疾病建模、 3D 细胞培养、 AI+ 器官芯片推进新药研发、类器官培养及质量控制 等角度展开深度探讨。 论坛名称 ： OTC2025 类器官前沿应用与 3D 培养论坛 02 为何举办OTC2025 1 利用 AI 分析类器官大规模数据 ，加速个性化药物筛选疾病建模； 2 开发 自动化培养系统 ，提高类器官生产效率，降低成本； 3 结合 3D 生物打印和微流控技术，增加类器官的细胞类型和结构复杂度，以更好地模拟人体微环境； 4 研究如何引入血管系统和免疫细胞，增强类器官的功能性； 5 研发临床级培养基和支架材料，减少批次间差异； 6 建立类器官生物库，为临床应用提供稳定的细胞来源。 举办地点 ：上海 论坛规模 ： 50 余授课嘉宾， 800 余参会嘉宾 主办单位 ：上海傲顺医药、上海佰傲泰医药科技、药 ...

Core Insights - Chuangxin International has completed nearly 100 million RMB in Series B financing, led by Yueke Fund and Zhongshan Haochuang Fund, to accelerate the development and global commercialization of organoid technology [2] - The company focuses on precision medicine, new drug development, and intelligent manufacturing, aiming to overcome key industry bottlenecks and promote the intelligent, standardized, and industrialized development of the organoid industry [2][3] - The FDA's new regulation set to be released in April 2025 will phase out animal testing models, recommending human cell models, including organoids, marking a shift towards more realistic human models in life sciences research [2] Company Overview - Chuangxin International Biotech (Guangzhou) Co., Ltd. was established in March 2018 and has built a comprehensive ecosystem covering the entire lifecycle of organoid technology [2] - The company is positioned as a global leader in organoid technology, redefining core pathways in life sciences research through technological innovation and ecosystem reconstruction [3] - The CEO, Dr. Huang Min, stated that the company will leverage this financing round to enhance its technology platform, data intelligence, and industrial applications, aiming to create a product matrix in key areas such as organoid intelligent devices and data systems [3]

Core Insights - Chuangxin International Biotechnology (Guangzhou) Co., Ltd. has completed nearly 100 million RMB in Series B financing, led by Yueke Fund and Zhongshan Haochuang Fund, to accelerate the development and global commercialization of organoid technology [2][3] - Organoids, derived from stem cells and cultivated in 3D, closely mimic the genetic characteristics and structure of the source tissue, making them crucial tools in precision medicine and innovative drug development [2] - The global life sciences research paradigm is shifting from animal models to human cell models, with the FDA planning to phase out animal testing by April 2025, recommending the use of organoids [2] Company Overview - Chuangxin International is a full-chain innovative enterprise in the organoid field, focusing on precision medicine, new drug development, and intelligent manufacturing [2] - The company has established a comprehensive ecosystem covering the entire lifecycle of organoids, aiming to drive the industry towards intelligence, standardization, and industrialization [2] Investment Perspective - Yueke Fund recognizes Chuangxin International's leading organoid technology and its significant application value in precision medicine and new drug development, aligning with its investment philosophy [3] - The investment from Tohoku East, which focuses on early to mid-stage tech enterprises, is seen as a strategic move to enhance the development of the biomedical industry cluster in the Guangdong-Hong Kong-Macao Greater Bay Area [3] Future Plans - Chuangxin International plans to leverage this financing round to build a technology ecosystem covering the entire lifecycle of organoids, focusing on core technology research and product innovation [3] - The company aims to create a product matrix in key areas such as organoid intelligent devices, chips, and data intelligence systems, striving to become a global leader in the organoid industry [3]

Core Insights - Organoid technology is a disruptive breakthrough in life sciences, rapidly transitioning from laboratory research to clinical applications, providing new tools for disease mechanism research, drug screening, and personalized treatment [2] - The integration of organoids with automation technology is accelerating the translation of research outcomes into practical applications in precision medicine [2] Event Overview - An online seminar titled "AI Automation Solutions Accelerating Organoid Research and Drug Development" will be held on May 14, 2025, featuring scholars, technical experts, and industry leaders focusing on academic breakthroughs and automation solutions in organoid technology [2] Speaker Highlights - Lin Xinhua, Executive Director of the Guangdong-Hong Kong-Macao Greater Bay Area Precision Medicine Research Institute, will discuss the application of organoids in precision medicine [5] - Lin Delin, Application Technical Support Engineer at Opentrons, will present on Opentrons' organoid automation solutions [5] - Gao Zhengliang, a researcher at Shanghai University School of Medicine, will cover the application of organoids in brain development and diseases [5] Speaker Backgrounds - Lin Xinhua has extensive experience in genetic engineering and precision medicine, with over 80 publications in high-impact journals and a focus on the clinical translation of organoid technology [8] - Lin Delin specializes in automation pipetting technology in biotechnology, with a strong background in biochemistry and molecular biology [11] - Gao Zhengliang has over 20 years of research experience in developmental biology, stem cells, and organoid technology, with numerous publications in prestigious journals [14]

Core Insights - Organoid technology is a disruptive breakthrough in life sciences, rapidly transitioning from laboratory research to clinical applications, providing new tools for disease mechanism research, drug screening, and personalized treatment [2] - The integration of organoids with automation technology is accelerating the translation of research outcomes into practical applications in precision medicine [2] Event Details - An online seminar titled "AI Automation Solutions Accelerating Organoid Research and Drug Development" will be held on May 14, 2025, from 14:00 to 15:30, organized by Opentrons in collaboration with ISCO [2] - The seminar will feature academic scholars, technical experts, and industry pioneers focusing on academic breakthroughs in organoid technology and automation solutions [2] Speaker Information - Lin Xinhua, Executive Director of the Guangdong-Hong Kong-Macao Greater Bay Area Precision Medicine Research Institute, will present on the application of organoids in precision medicine [4] - Lin Delin, Senior Application Technical Support Engineer at Opentrons, will discuss Opentrons' organoid automation solutions [4][8] - Gao Zhengliang, a researcher at Shanghai University School of Medicine, will cover the application of organoids in brain development and diseases [4][11] Additional Engagement - The live event will include interactive segments with exciting prize draws for participants who engage through comments [12][16]

Core Viewpoint - The company, Yinos, is a leading contract research organization (CRO) in the non-clinical safety evaluation sector, providing comprehensive research services that align with both domestic and international standards, and has recently passed a GLP inspection by the FDA, enhancing its international service capabilities [25][26]. Company Overview - Yinos specializes in non-clinical research services for biopharmaceuticals, being one of the earliest companies in China to obtain GLP certifications from NMPA, OECD, and FDA, thus aligning with international standards [3][4]. - The company has a modern facility of nearly 60,000 square meters and a research team of over 1,000, with locations in Shanghai, Nantong, Shenzhen, Huangshan, and San Francisco [4]. - As of December 31, 2024, Yinos has served over 900 pharmaceutical companies and research institutions, contributing to numerous successful drug development cases [4][18]. Financial Performance - In the reporting period, Yinos achieved a revenue of RMB 1,141.67 million, representing a year-on-year growth of 9.94%, while the net profit attributable to shareholders decreased by 24% to RMB 147.78 million [23]. - The proposed profit distribution plan includes a cash dividend of RMB 3.2 per 10 shares, totaling RMB 45.11 million, which accounts for 30.53% of the net profit for the year [1]. Industry Context - The global CRO market is projected to grow at a compound annual growth rate (CAGR) of 9.0% from 2023 to 2026, with the market size expected to exceed USD 147.7 billion by 2030 [11]. - In China, the CRO service market is estimated to reach RMB 848.2 billion in 2023, with a projected CAGR of 9.9% from 2023 to 2026 [12]. - The industry is supported by government policies aimed at enhancing drug research and development capabilities, which is expected to drive long-term growth in the CRO sector [13][14]. Technological Advancements - Yinos is investing in artificial intelligence (AI) applications in non-clinical research, aiming to enhance efficiency and reduce costs in drug development processes [19]. - The company is also exploring organoid technology for drug screening and toxicity testing, which is gaining traction in the pharmaceutical research field [19][20]. Strategic Positioning - Yinos has established strong partnerships with leading pharmaceutical companies, positioning itself as a strategic partner in the innovative drug development process [18][21]. - The company is expanding its international presence, having established a subsidiary in the United States to enhance its global market share [22].

Group 1 - The company plans to use up to RMB 700 million of its idle funds for entrusted wealth management, effective from the board's approval date until the next annual board meeting [1][10][52] - The purpose of the entrusted wealth management is to improve the efficiency of idle funds and increase investment returns for the company and its shareholders [2][9] - The funds for this investment will come from temporarily idle self-owned funds, ensuring that the company's normal operations are not affected [3][4] Group 2 - The investment products will primarily include low-risk, high-security financial products, such as fixed-income products and securities, and will not involve stock investments [4][5] - The board has authorized the management to make investment decisions and sign relevant legal documents, with the finance and funding departments responsible for implementation [5][6] - The company will disclose information regarding the purchase of wealth management products in accordance with the regulations of the Shanghai Stock Exchange [6] Group 3 - The company has also approved changes to certain fundraising projects, including adjustments to investment amounts and project timelines, as well as the addition of new projects [18][19][45] - The project "Mode Animal Mouse R&D Breeding Integrated Base Construction" will have its investment amount reduced from RMB 611.13 million to RMB 430.26 million, and the expected completion date will be extended to April 2030 [21][45] - A new project, "AI-driven Organoid and Animal Disease Model Multi-modal Preclinical Drug Research Platform," with an investment of RMB 200 million, has been introduced to enhance the company's R&D capabilities [24][45]