Policy Developments - The National Medical Products Administration (NMPA) is focusing on the quality supervision of selected drugs in centralized procurement, emphasizing the importance of quality safety and compliance in production [1] - The NMPA will implement comprehensive production inspections and product sampling for selected drugs, optimizing work mechanisms and exploring risk monitoring [1] - The NMPA acknowledges the development of the medical device industry in Chongqing and stresses the need for a robust quality safety responsibility system [2] Drug and Device Approvals - Baiyunshan's subsidiary Zhongyi Pharmaceutical received a registration certificate for the traditional medicine An Gong Niu Huang Wan from Vietnam's Ministry of Health, aiding market expansion [3] - Huyou Pharmaceutical announced that its subsidiary Seacross Pharmaceuticals Ltd. received marketing approvals for multiple products from regulatory authorities in Pakistan, the UK, and North Macedonia [4] - Zhifei Biological's recombinant herpes zoster vaccine (ZFA01) clinical trial application has been accepted by the NMPA, which may enhance vaccine efficacy [5] Capital Market Activities - Puluo Pharmaceutical plans to repurchase shares worth between RMB 180 million and RMB 360 million, with a maximum price of RMB 23 per share [6][7] - Sinovac Biotech received a delisting notice from NASDAQ due to failure to submit its annual report by the deadline, with potential trading suspension imminent [8] Industry Developments - Researchers published a detailed immune response map following pig kidney transplants in brain-dead patient models, identifying key factors for transplant success [9] - Haizheng Pharmaceutical's subsidiary plans to collaborate with the East China Institute for the biomanufacturing of heparin, with a project budget not exceeding RMB 120 million [10] Public Sentiment Alerts - Guangyuyuan announced the resignation of Vice President Wang Junbo due to work adjustments, effective immediately [11] - Medici's shareholder Chen Guoxing plans to reduce his stake by up to 1.64% through trading methods due to personal financial needs [12]

这些研究为异种移植基因改造猪肾提供了详细的人类免疫反应图谱。未来研究可应用这些见解，提升长 期移植的成功率。 异种移植（将一个物种的器官移植到另一个物种身上）被视为解决终末期器官衰竭患者供体短缺的潜在 解决方案。移植经基因改造的猪肾结合免疫抑制治疗方案已经展现出一些前景。然而，器官排异是所有 移植的常见并发症，人们对利用其它物种器官的排异反应所知更少。由于此前对这一过程的研究随访时 间较短，人们尚未充分了解引发排异的免疫反应机制。 团队确定了免疫细胞响应移植的关键动员通路，并在第二篇论文中绘制了相关基因组学图谱。 美国纽约大学朗格尼分校移植研究所团队在移植基因改造猪肾到脑死亡患者体内后，绘制了移植后较长 时期的免疫反应详细图谱。他们发现，尽管移植肾经历了两次排异反应，但仍能维持生命支持功能长达 61天，直至实验结束。这些排异反应通过现有疗法成功治疗，肾功能保持稳定。 科学家通过将猪肾移植到脑死亡患者的模型，构建了移植后人类详细免疫反应图谱，系统阐明了此后两 个月中发生的免疫排斥反应。这两项发表于最新一期《自然》的研究，指出了导致异种移植失败的核心 因素与潜在标志物，为后续提升移植成功率提供了关键依据。 （文章 ...

Core Viewpoint - A groundbreaking achievement in organ transplantation has been made by Chinese scientists, marking the world's first successful transplantation of gene-edited pig lungs into a brain-dead patient, which functioned effectively for over 10 days [1] Group 1: Breakthrough in Organ Transplantation - The successful transplantation represents a significant advancement in xenotransplantation, a concept that has been pursued for over a century [4] - Pigs are considered ideal organ donors due to their organ size and function being similar to humans, but the human immune system poses a major challenge [4][5] - The use of gene editing technology has allowed for modifications in the pig's genome, effectively creating a "pass" for the pig organs to be accepted by the human body [5] Group 2: Role of BGI Genomics - BGI Genomics, based in Shenzhen, played a crucial role in ensuring the safety of the transplantation by utilizing its high-throughput sequencing technology [8] - The DNBSEQ sequencing platform conducted comprehensive genomic screening of the pig lung, identifying any potential pathogens that could pose risks to human health [8] - The sequencing process provided a detailed "health report" confirming the absence of known pathogens, which was essential for the success of the surgery [8] Group 3: Implications for Future Transplantation - The surgery was successful, with the transplanted pig lung performing normal respiratory functions without signs of acute rejection [9] - This historic step indicates the feasibility of xenogeneic lung transplantation, offering hope to countless patients awaiting suitable organ donors [9] - The advancements in gene editing and reliable domestic sequencing platforms highlight the potential for future breakthroughs in organ transplantation [9]

Core Insights - The successful transplantation of gene-edited pig lungs into a human patient marks a significant milestone in the field of xenotransplantation, addressing the critical shortage of human lung donors [1][2][3] - The research demonstrates the feasibility of using genetically modified pig organs, specifically lungs, to potentially alleviate the organ shortage crisis faced by terminally ill patients [1][9] Group 1: Research Breakthrough - The study published in *Nature Medicine* details the process of transplanting a genetically edited left lung from a Chinese Bama pig into a 39-year-old male patient who was brain dead, with the lung surviving for 9 days [3][2] - The total cold ischemia time from organ retrieval to re-infusion was 206 minutes, and the lung maintained vitality and function without signs of hyperacute rejection during the monitoring period [3][4] Group 2: Challenges and Future Directions - Despite the successful initial results, significant challenges remain, including immune rejection, ischemia-reperfusion injury, and the need for optimized immunosuppressive protocols [5][6][7] - The research team aims to enhance gene editing strategies and anti-rejection treatments to prolong the survival and functionality of transplanted organs, with plans to apply their self-developed non-invasive techniques to reduce lung damage during mechanical ventilation [7][9] Group 3: Market and Clinical Implications - The current organ supply-demand ratio in China is approximately 1:8, highlighting the urgent need for alternative organ sources like xenotransplantation [9][14] - The potential for pig lungs to serve as a viable alternative for human lung transplants could significantly impact the organ transplant landscape, especially given the historical challenges associated with lung transplants [4][5] Group 4: Technological Advancements - The use of gene editing to modify pig organs aims to reduce immunogenicity, making them more compatible for human transplantation [5][15] - Companies like Zhongke Aoge and Dashuo Group are at the forefront of developing genetically modified pigs, with ongoing research into various organ types, including kidneys and livers, to facilitate clinical trials [18][17]

Core Insights - The successful transplantation of genetically edited pig lungs into a human patient marks a significant milestone in the field of xenotransplantation, addressing the critical shortage of human lung donors [2][4][10] - The research indicates that the genetically modified pig lung can survive and function for 9 days in a human body, demonstrating the potential for clinical applications in the future [5][8] Group 1: Research Breakthrough - The study published in "Nature Medicine" details the process of transplanting a genetically edited pig lung into a 39-year-old male patient who was brain dead, with a total cold ischemia time of 206 minutes [4][5] - This is the first successful case of pig lung transplantation into a human, which is considered a major advancement in the scientific community [4][7] Group 2: Challenges and Future Directions - Despite the success, significant challenges remain, including immune rejection and the need for optimized immunosuppressive protocols [5][6][15] - The research team aims to enhance gene editing strategies and anti-rejection treatments to prolong the survival and functionality of transplanted organs [8][19] Group 3: Industry Context - The demand for transplantable organs far exceeds supply, with a projected donor-to-recipient ratio of 1:8 in China by 2024, highlighting the urgency for alternative sources like xenotransplantation [10][15] - The use of genetically modified pigs is seen as a promising solution to the organ shortage, as their organs are similar in size to human organs and can be produced without the same limitations as human donors [10][17] Group 4: Technological Advancements - The genetic editing technology used to create the donor pigs is at the forefront of scientific innovation, allowing for the removal of genes that trigger strong immune responses in humans [6][17] - Companies like Zhongke Aoge and Dashuo Group are leading efforts in developing these genetically modified pigs, contributing to China's position in the global xenotransplantation landscape [18][19]

Core Insights - The research team from Guangzhou Medical University has successfully conducted the world's first case of gene-edited pig lung transplantation into a brain-dead human, maintaining ventilation and gas exchange for 9 days without acute rejection [1][3][4] - This breakthrough aims to address the organ shortage issue by providing a stable and controllable source of donor organs through xenotransplantation [1][4] Group 1: Research Details - The pig lung used in the transplantation was genetically edited at six sites to reduce immune risks upon transplantation into humans [4] - The study adhered to national laws and ethical guidelines, with the brain-dead patient’s family consenting to the research [4] - The research is seen as a significant step in the field of xenotransplantation, with plans to optimize gene editing strategies and anti-rejection treatments to extend the survival and functionality of transplanted organs [4][5] Group 2: Challenges and Future Directions - Despite the initial success, challenges remain, including the need to validate the lung's functionality, long-term stability, and the burden of immunosuppressive therapy [5][6][8] - The World Health Organization reports a severe imbalance in organ supply and demand in China, with approximately 300,000 patients waiting for transplants and only about 15,000 available organs annually [7] - The potential of xenotransplantation is highlighted by previous successful cases of pig organ transplants, but issues such as antibody-mediated rejection and viral risks from pig organs still need to be addressed [8][9]

Core Insights - A research paper published in the journal Nature Medicine indicates that a genetically engineered pig lung can survive for 9 days and function after being transplanted into a human patient diagnosed with brain death, marking a potential breakthrough in cross-species lung transplantation [1][2] - The study highlights the challenges of lung transplantation due to its anatomical and physiological complexities compared to other solid organ transplants, but suggests that xenotransplantation could address the shortage of human transplant organs [1] Group 1 - The research team, led by Professor He Jianxing from Guangzhou Medical University, successfully transplanted the left lung of a genetically edited pig into a 39-year-old human patient [1] - The donor pig underwent CRISPR gene editing to remove antigens that could activate the human immune system, resulting in the transplanted lung not experiencing immediate rejection [2] - Despite the initial success, signs of lung injury were observed 24 hours post-transplant, with antibody-mediated rejection noted on days 3 and 6, indicating the need for further research [2] Group 2 - The study concludes that while this represents a significant first step in pig lung transplantation into humans, further improvements are necessary in genetic modifications of donor pigs and the development of immunosuppressive drugs to prevent rejection and maintain long-term lung function [2]

Core Viewpoint - The article discusses significant advancements in xenotransplantation, particularly focusing on the successful transplantation of genetically edited pig organs into human patients, highlighting the potential to alleviate organ shortages in humans [3][4][5]. Summary by Sections Breakthroughs in Xenotransplantation - In October 2021, NYU Langone Medical Center performed the first transplantation of a genetically edited pig kidney into a brain-dead woman [3]. - In January 2022, the University of Maryland conducted the first live transplantation of a genetically edited pig heart, with the patient surviving for approximately two months [3]. Recent Research on Pig Lung Transplantation - In March 2025, a team from Xijing Hospital published a paper in Nature, reporting the first successful transplantation of a genetically edited pig liver into a brain-dead patient, with the organ functioning for 10 days [4]. - In August 2025, a study published in Nature Medicine documented the world's first successful transplantation of a genetically edited pig lung into a brain-dead human, with the lung surviving for 9 days and functioning properly [5][4]. Genetic Modifications and Challenges - The pig lung used in the transplantation was genetically modified by deleting three "dangerous" genes (GTKO, CMAH, B4GALNT2) and adding three protective human genes (hCD46, hCD55, hTBM) to mitigate immune rejection [7][9]. - During a 216-hour monitoring period, the transplanted pig lung maintained vitality and function without signs of hyperacute rejection or infection, although complications such as severe edema and antibody-mediated rejection were observed [9][10]. Future Directions and Considerations - The study indicates that further genetic modifications may be necessary to improve outcomes, particularly in addressing coagulation disorders and enhancing graft survival [11][12]. - The complexity of lung transplantation poses greater challenges compared to other organs, necessitating ongoing preclinical research to overcome these barriers [12]. China's Leadership in Xenotransplantation - Chinese scientists are at the forefront of xenotransplantation research, having completed the world's first human transplant of genetically edited pig liver and lung, as well as a kidney transplant with a patient surviving for nearly six months [12].

Core Insights - Recent breakthroughs in xenotransplantation using genetically modified pigs have garnered global attention, particularly in addressing the shortage of human organ donors [1][2] - The first successful transplantation of a genetically edited pig liver into a human recipient was reported in March 2024, demonstrating the potential for pig organs to serve as a transitional therapy for patients with liver failure [1][2] Group 1: Research Developments - In October 2021, NYU Langone Medical Center performed the first transplantation of a genetically edited pig kidney into a brain-dead woman [1] - In January 2022, the University of Maryland conducted the first live transplantation of a genetically edited pig heart, with the patient surviving for approximately two months [1] - A study published in Nature Medicine in July 2025 analyzed the immune cell landscape in a human recipient of a pig liver xenograft, highlighting the immune response post-transplantation [2][3] Group 2: Immune Response Analysis - The research utilized single-cell and spatial transcriptomics to characterize immune cell changes in the peripheral blood and transplanted liver of the human patient [3][7] - The study found that T cells in the peripheral blood were gradually activated, while γδT cells and exhausted T cells infiltrated the pig liver, indicating impaired adaptive immunity [8] - Two distinct monocyte subpopulations, THBS1+ and C1QC+, were identified, which may influence coagulation and immune responses post-xenotransplantation [9][11] Group 3: Implications for Future Research - The findings emphasize the role of innate immune cells in influencing coagulation and immune pathways following pig liver xenotransplantation, suggesting avenues for further research [11] - Understanding the roles of THBS1+ and C1QC+ monocytes could provide insights into early rejection responses and adaptive immune regulation in xenotransplantation [11]

Core Insights - The Second Lake District Life and Health Scientist Conference was held in Kunshan, Jiangsu, attracting over 200 top scientists, clinical experts, entrepreneurs, and investors to explore future solutions for human health [1][2] Industry Overview - The biopharmaceutical sector is identified as the primary industry in Suzhou, with Kunshan accelerating the construction of an innovative industrial cluster [1] - As of May 2023, Kunshan has over 230 biopharmaceutical-related enterprises [1] Strategic Development - The town of Dushan Lake is leveraging its strategic location within the Yangtze River Delta integration plan, being only 30 minutes from Hongqiao Hub, and its ecological resources with a 14-kilometer golden lakeshore [1] - Dushan Lake is focusing on cutting-edge life sciences technologies to establish a new framework for scientific innovation in the region [1] Conference Highlights - The conference featured presentations from leading experts on topics such as the relationship between inflammatory microenvironments and tissue regeneration, brain-computer interfaces, and the disruptive applications of artificial intelligence in drug screening and antibody drug development [2] - Discussions also included ethical norms and clinical pathways related to xenotransplantation [2] Research and Innovation - Since the establishment of the Extraordinary Life Science Industry Innovation Center in 2022, over 30 projects have been attracted to Dushan Lake, showcasing the "Lake District Effect" in the life and health industry [3] - The Kunshan LingSi Life Health Innovation Research Institute has formed an innovative team of over 50 young scientists, creating a mentorship model of "academicians leading, youth following" [3] Collaborative Efforts - Dushan Lake is collaborating with the Shanghai Modern Service Industry Association's Medical Service Committee and scientific teams to drive the industrialization of medical research achievements [3] - The unveiling of the "Fudan University Experimental Animal Center Kunshan Branch" marks another achievement in the collaborative development between Shanghai and Kunshan [4] Resource Utilization - The Kunshan branch will utilize Fudan University's leading international animal experiment resources and innovation standards to enhance the support for high-precision fields such as pharmacology, cell biology, and molecular biology [4] - The Extraordinary Life Science Industry Innovation Center aims to gather over 1,000 R&D talents within the next decade, with more than 100 biopharmaceutical scientists already in residence [4]