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Core Viewpoint - The article discusses the advancements and challenges in the cell and gene therapy (CGT) industry, highlighting the innovative approach of Huakan Bio in developing 3D cell culture technology to reduce costs and improve scalability in cell therapy production [3][4][6]. Industry Overview - CGT is seen as a promising direction for curing major diseases like cancer and rare diseases, but the high cost of treatments, often exceeding $1.5 million (approximately 10.8 million RMB) per course, poses a significant barrier for patients [3]. - The industry faces a fundamental challenge in scaling up the production of precious cells from laboratory settings to meet patient needs efficiently and cost-effectively [3]. Company Profile - Huakan Bio, founded in August 2018 by Tsinghua University professor Du Yanan and his two doctoral students, focuses on 3D microcarrier technology to enhance cell growth and automate production processes, significantly improving efficiency and reducing costs [4][6]. - The company has successfully launched China's first stem cell drug, "Aimi Maitosai Injection," priced at 19,800 RMB per course, which is about 1/70th the price of similar products in the U.S. [6]. Technology and Innovation - Huakan Bio's core technology, the 3D microcarrier, provides a three-dimensional growth environment for cells, enhancing their natural function and scalability compared to traditional 2D culture methods [13]. - The 3D microcarrier technology allows for a cell yield increase of one to two orders of magnitude, with a recovery rate exceeding 98%, supporting the cultivation of billions of cells in a single batch [13][14]. Market Position and Growth - The company has completed multiple funding rounds, with significant investments from various institutions, and has established itself as a leading player in the domestic 3D cell manufacturing sector [15][17]. - Huakan Bio's international business has expanded rapidly, covering over 20 countries, with a growth rate exceeding 200% in 2025 [21]. Future Outlook - The global CGT market is expected to grow rapidly, with China identified as a core market. Huakan Bio aims to leverage its unique technology to meet the increasing demand for scalable and automated cell culture solutions [21].

Focus Review - The hard technology sector is gaining attention, particularly in industrial intelligence and sensors. Recently, the domestic industrial safety sensor company Wan Ce completed over 100 million RMB in A+ round financing, led by Fengyuan Capital, Sanhua Co., and others. Additionally, Huaxuan Sensor announced a new round of strategic financing [4][15][17]. - In the health sector, cell and gene therapy (CGT) is a key focus. Oricell Therapeutics announced a completion of 70 million USD in C1 round financing, led by Beijing Pharmaceutical Health Industry Investment Fund and others. Furthermore, Shize Biopharma completed 400 million RMB in B/B+ and C1 rounds of financing [4][24][28]. - The internet sector is seeing a surge in AI-native applications and development platforms. Manifold AI announced over 100 million RMB in angel+ round financing, with investments from prominent firms like Meihua Venture Capital and Huawei Hubble [5][34]. Hard Technology - The company Zhiwen Robotics recently completed 1 billion RMB in A++ round financing, with participation from ByteDance and Sequoia China [11]. - Xinghuan Juneng successfully completed 1 billion RMB in A round financing, with investments from Shanghai Guotou and others [12]. - Xiangkong Technology announced the completion of over 10 million RMB in angel round financing, led by Liuhe Venture Capital [13]. Health Sector - Yuwei Medical completed nearly 100 million RMB in B round financing, led by Yifeng Capital [25]. - Zeling Biopharma announced nearly 600 million RMB in C round financing, led by Temasek and Qiming Venture Partners [26]. - Qinhao Pharmaceutical completed over 300 million RMB in crossover round financing, led by Songhe Capital [29]. Internet/Enterprise Services - Zhongke Kuyuan completed nearly 100 million RMB in strategic financing, exclusively invested by China Mobile Chain Long Fund [33]. - The company Wuzit Technology announced the completion of several million RMB in Pre-A round financing, with investments from Lion City Capital and Baidu [36]. - Xiaoyi Smart Link completed several million RMB in A round financing, led by Zhixin Empowerment Industry Fund [37].

Core Viewpoint - In the context of profound changes in the pharmaceutical industry, HaiTe Biopharma is adopting a dual-track strategy of "innovation and imitation" to navigate through policy and market fluctuations, aiming to capture opportunities amid challenges [2]. Group 1: Company Strategy - HaiTe Biopharma has successfully launched two national class I new drugs and recognizes the significant impact of policies and funding on the pharmaceutical industry [3]. - The company is expanding its product line to include generic drugs in response to market changes and aims to participate in national procurement to quickly enter the chemical drug market [3][4]. - The company employs an open collaboration strategy for innovative drug development, working with top scientists, research institutions, and investing in biotech companies with potential [4][5]. Group 2: Investment Standards - HaiTe Biopharma has established three key standards for external investments: alignment with industry technology trends, strategic synergy with existing drug areas, and feasibility and commercialization potential of the technology [5][6]. - The company focuses on investing in cell and gene therapy (CGT) technologies, which are seen as the next significant direction in drug development [5][6]. - The investment strategy emphasizes the importance of addressing unmet clinical needs, particularly in oncology and neurological diseases, where there is substantial patient demand and limited existing therapies [7]. Group 3: Market Positioning - The company aims to solidify its current position in the generic drug market while pursuing innovative drugs and frontier investments for future growth [7]. - HaiTe Biopharma's approach reflects a strategic positioning to transition from high-speed growth to high-quality development, focusing on true innovation rather than mere imitation [7].

Core Viewpoint - Weike Bio has recently completed nearly 100 million yuan in Series A financing, primarily to accelerate the establishment of a CGT safety evaluation center in the U.S. and expand overseas business in CGT safety evaluation, clinical services, and biobreeding services [3]. Group 1: Company Overview - Weike Bio focuses on providing CRO services based on safety evaluation for cell and gene therapy (CGT) drugs, with a core team from Heidelberg University and the German Cancer Research Center, possessing extensive experience in CGT safety evaluation [3]. - The company has served over 70 pharmaceutical and research clients, covering more than 100 domestic and international pipelines, and supports multiple companies in achieving dual submissions in China and the U.S. [5]. Group 2: Services Offered - Currently, Weike Bio offers a full range of CRO services for CGT drugs, including early clinical research, CMC development, IIT clinical trials, long-term follow-up, and market application submissions [4]. - The company provides project management, drug safety evaluation, research and quality control services, and clinical communication, data collection, and follow-up testing services during the registration clinical phase [4]. Group 3: Market Position and Strategy - The CGT safety evaluation market in China is still in its early stages due to the late start of the domestic CGT industry, presenting challenges for Weike Bio as a startup to enter the supply chain of major downstream companies [4]. - Weike Bio emphasizes the importance of technical barriers for market competition and aims to customize testing solutions based on past cases and risks to assist clients in regulatory inquiries [4]. Group 4: Future Prospects - Recently, an increasing number of clients are approaching Weike Bio during the early research phase to assess project suitability for further advancement, indicating a gradual opening of the market [4]. - In addition to CGT, Weike Bio is also expanding into biobreeding, synthetic biology, and early diagnosis and screening, having established a subsidiary in Qingdao to serve hundreds of enterprises and research clients in the biobreeding sector [5].

Core Viewpoint - The article highlights the journey of Sun Xiulian, a former doctor turned pharmaceutical entrepreneur, who founded Yiming Bio to focus on the production and early-stage development of cell and gene therapy (CGT) drugs, addressing the challenges in the CGT industry and aiming to improve drug accessibility for patients [3][4][6]. Group 1: Company Overview - Yiming Bio provides one-stop CGT CDMO (Contract Development and Manufacturing Organization) services, assisting innovative drug companies in developing CGT drugs from the lab to clinical trials [4][27]. - The company has collaborated with over a hundred pharmaceutical firms, completing more than 300 batches of various innovative drug productions that meet international GMP standards [27]. Group 2: Industry Challenges - The success rate for new drug projects entering IND (Investigational New Drug) approval is approximately 1 in 10, with CGT projects facing even lower success rates due to complex manufacturing processes and high costs [3][8]. - The average price of CAR-T therapy exceeds 1 million, with production costs around 200,000, making affordability a significant issue for patients [15]. Group 3: Technological Innovations - Yiming Bio has developed methods to significantly reduce the manufacturing costs of CGT drugs, achieving an 80% reduction in the cost of plasmid production through process optimization [16]. - The company can produce LV (Lentivirus) raw materials for CAR-T therapy at a cost of around 100 USD per dose, which is 100 times lower than traditional methods [18]. Group 4: Market Positioning - The CGT industry has a high outsourcing penetration rate of over 65%, compared to 35% for traditional biopharmaceuticals, indicating a strong demand for CDMO services in this sector [9]. - Yiming Bio is strategically focusing on cell therapy, particularly in oncology, due to its broader market potential compared to gene therapy, which faces challenges in commercialization [28]. Group 5: Future Plans - The company aims to expand its global footprint, establishing bases in both China and the United States to cater to the growing demand for CGT products [29][31]. - Yiming Bio's vision is to enhance the accessibility of advanced therapy medicinal products (ATMP) by improving manufacturing efficiency, thereby making innovative drugs more affordable for patients [32].

Core Insights - The cell and gene therapy (CGT) sector is experiencing a dichotomy, with major pharmaceutical companies entering the CAR-T therapy space while others are exiting, indicating a complex market landscape [1][2][10]. Group 1: Market Dynamics - The CGT market has seen rapid growth, with 46 CGT products approved by the FDA and approximately 3,600 active INDs [2]. - Despite the approval of over 10 CAR-T therapies globally, only a few have achieved blockbuster status, with Gilead's Yescarta showing a sales growth of only 4.81% in 2024 [3][4]. - The commercial performance of most CAR-T therapies has been disappointing, with high costs and market access issues limiting their success [6][9]. Group 2: Economic Challenges - The CGT sector faces significant economic challenges, including high R&D costs (estimated at $1.7 to $2.3 billion for CGT drugs compared to $1.25 to $1.48 billion for traditional drugs) and high production costs due to the personalized nature of treatments [11][12]. - The pricing of CAR-T therapies is exorbitant, with Carvykti priced over $500,000 in the U.S. and similar high costs in China, which restricts market accessibility [8][13]. Group 3: Industry Exits - Major multinational corporations (MNCs) like Takeda and Novo Nordisk have announced exits from the CGT space, indicating a shift in focus from technology-driven enthusiasm to financial viability [10][11]. - The industry's narrative has shifted from a focus on unique treatment mechanisms to a more pragmatic assessment of economic returns, highlighting the unsustainable nature of current CGT investments [11]. Group 4: Path to Recovery - The CGT industry is exploring various strategies to overcome its challenges, including the development of off-the-shelf CAR-T therapies to reduce costs and improve accessibility [14]. - Expanding the indications for CGT drugs to target larger patient populations is seen as a potential avenue for growth, similar to how Novartis expanded the application of siRNA therapies [17]. - The shift towards in vivo CAR-T therapies aims to simplify processes and reduce costs significantly, with predictions suggesting treatment costs could drop by an order of magnitude [18]. Group 5: Future Directions - The future of the CGT sector hinges on technological advancements that enhance accessibility, with a focus on universal CAR-T, in vivo therapies, and next-generation delivery technologies [19]. - The strategic movements of MNCs signal a paradigm shift in the industry, emphasizing the need to convert cutting-edge technology into sustainable business models for long-term success [19].

Group 1 - The "2025 International Genomics Conference on Ophthalmology (ICG EYE) and CGT Innovation and Industrial Transformation Summit" was held in Shenyang, focusing on the integration of cell and gene therapy (CGT) with eye health [1][2] - CGT is recognized as a cutting-edge biomedical approach for treating or preventing diseases, showing significant potential in cancer, genetic disorders, and anti-aging [1] - The conference aims to create a multidisciplinary platform for collaboration and innovation, promoting the deep integration of "industry, academia, research, application, and capital" in the field of precision medicine for ophthalmology [1] Group 2 - The conference featured four main thematic forums discussing advancements in CGT applications in ophthalmology, clinical translation, anti-aging mechanisms, and capital empowerment for the CGT industry [2] - Experts shared insights on various topics, including gene therapy for neurodegenerative diseases and the application of gene testing in preventing high myopia [2] - The organizing entities, including He Eye Hospital and Liaoning He Medical College, are focused on establishing a domestic eye gene bank and clinical research center for stem cell applications [3] Group 3 - The conference supports the development of CGT from laboratory research to clinical application, enhancing the entire research and development chain [1][2] - Liaoning He Medical College has joined the China-Japan-Korea Health and Wellness University Alliance, leveraging its advantages in the health and aging industry [3] - The integration of advanced technologies such as big data, artificial intelligence, and gene technology is aimed at promoting intelligent, precise, and inclusive healthcare solutions [3]

Core Points - The newly announced "Regulations on the Management of Clinical Research and Clinical Translation of Biomedical New Technologies" aims to standardize clinical research and application of biomedical technologies, promoting medical innovation and ensuring quality and safety in healthcare [1][7] - The regulations mark a significant shift from a previously ambiguous regulatory environment to a clearer and more structured framework for advanced biomedical technologies such as gene editing and stem cell therapy [1][8] Policy Historical Development - The regulations have been in preparation for six years, with initial drafts and public consultations starting in 2019, leading to the final approval in September 2025 [2] Policy Content Comparison - The regulations provide a clear definition of biomedical new technologies, distinguishing them from traditional medical technologies, which helps clarify the regulatory landscape for companies [3][8] - The regulations establish a structured pathway from preclinical research to clinical application, ensuring that only technologies proven safe and effective can proceed to clinical trials [10][12] Clinical Research Requirements - The regulations require that clinical research can only commence after non-clinical studies have demonstrated the safety and efficacy of the technology [4][12] - Institutions conducting clinical research must be qualified, including being a tertiary hospital with appropriate ethical and academic oversight [12][13] Commercialization Pathway - The regulations outline a clear commercialization pathway for biomedical technologies, allowing for the collection of fees once the technology is approved for clinical application [11][12] - The regulations also emphasize the importance of ethical considerations and the protection of participants in clinical research [5][11] Industry Impact - The regulations are expected to enhance the development of the biomedical industry by providing a clear framework that encourages innovation while ensuring compliance with safety and ethical standards [8][16] - Companies like MOTE Therapeutics are positioned to benefit from this regulatory clarity, as their technologies align with the new definitions and pathways established by the regulations [16][17]

Core Viewpoint - The transformation of the former Xisanqi Building Materials City into the Jingu Life Sciences Innovation Center reflects the rapid growth and restructuring of the cell and gene therapy (CGT) industry, which is expected to reach a global market size of $30.54 billion by 2025 and $36 billion by 2030 [1][2]. Group 1: Industry Growth and Trends - The CGT industry is reshaping the healthcare sector at an astonishing pace, with significant investment opportunities identified in the upcoming years [1]. - Beijing's "14th Five-Year Plan" aims to develop the biomedicine sector into a trillion-yuan industry cluster, with Haidian District prioritizing it as a strategic emerging industry [1]. Group 2: Challenges in the Industry - The industry faces a bottleneck due to the lack of specialized spaces for CGT companies, which need various facilities such as laboratories, pilot workshops, and cold chain storage [2]. - The dispersed resource layout in Beijing's core areas increases collaboration costs among companies, hindering the release of new productive forces [2]. Group 3: Innovative Solutions - The Zhongguancun Xisanqi (Jingu) Science Park is addressing these challenges through a "urban renewal + industrial collaboration" approach, transforming old manufacturing spaces into standardized facilities for biopharmaceutical research [2]. - The Jingu Life Sciences Innovation Center, part of the Zhongguancun Xisanqi Science Park, has a building area of 53,000 square meters and is equipped to create ISO5 cleanrooms, facilitating a collaborative ecosystem for the biomedicine industry [3]. - The park has established a "collaborative matrix" by integrating various resources, including trial production facilities and medical resources from nearby hospitals, to accelerate the transformation of research outcomes [3].