Laboratory Corporation of America Holdings

Brings decades of leadership in laboratory testing, clinical diagnostics, payor strategy, and sales growth Extensive track record in commercializing advanced laboratory testing and insurer strategies IRVINE, Calif., Oct. 08, 2025 (GLOBE NEWSWIRE) -- Biomerica Inc. (NASDAQ: BMRA), a global provider of advanced diagnostic solutions, today announced the appointment of Gary Huff to its Board of Directors as an independent board member. Mr. Huff brings decades of leadership experience in the diagnostics and healthcare services industry, including serving as Chief Executive Officer of LabCorp Diagnostics, one of the world’s largest clinical laboratories. Mr. Huff is a hands-on, inspirational, and growth-oriented executive who possesses a proven track record of successfully managing commercial laboratories of varying sizes, including large, medium, and small enterprises across both public and private equity sectors. Throughout his career, he has consistently achieved sustainable and profitable growth, outstanding financial performance, operational efficiencies, and transformational changes for some of the most influential organizations within the diagnostics field. The remarkable results he has delivered can be attributed to his unique strategic vision and extensive experience in the laboratory industry. In addition to his executive leadership positions, Mr. Huff currently operates his own advisory firm. He is also a member of the boards of Lighthouse Labs and Tribal Diagnostics. Moreover, he has provided advisory services to numerous health systems and a variety of global consulting and investment firms, including McKinsey & Company and Cerberus Capital Management. “Gary’s exceptional track record of building successful diagnostics businesses, forging strategic partnerships, and delivering shareholder value will be invaluable as Biomerica continues to advance its innovative diagnostic portfolio,” said Zack Irani-Cohen, Chief Executive Officer of Biomerica. “We are excited to welcome him to our Board and look forward to his insights as we expand our market presence and pursue our mission of improving patient care and access to our innovative products.” “I am honored to join Biomerica’s Board of Directors at such an exciting time in the company’s growth,” said Mr. Huff. “Biomerica’s innovative pipeline, particularly the inFoods® IBS product, has the potential to transform how patients and physicians manage the widespread condition of irritable bowel syndrome. I look forward to contributing to the Company’s strategic initiatives and working with the leadership team to drive sustainable growth and improved patient outcomes.” About inFoods® IBS inFoods® IBS is a diagnostic-guided therapy that identifies patient-specific food triggers responsible for symptoms such as abdominal pain, bloating, diarrhea, and constipation. Using a simple finger-stick blood sample, the test enables physicians to recommend targeted dietary changes tailored to the patient’s immune response—offering a non-pharmaceutical, precision-based approach to symptom relief. A multicenter, double-blinded sham-controlled trial on the inFoods® IBS test was published in the June 2025 issue of Gastroenterology, a peer-reviewed GI journal. As the study demonstrated statistically significant outcomes: 59.6% of patients in the treatment group (who eliminated identified trigger foods) achieved the FDA’s endpoint for abdominal pain reduction, compared to 42.1% in the control group. Among IBS-C patients, 67.1% of patients in the treatment group vs. 35.8% in the control group. Among IBS-M patients, 66% of patients in the treatment group vs. 29.5% in the control group. These results highlight the potential effectiveness of a personal elimination diet based on using inFoods® IBS in IBS-M patients, a subgroup historically underserved by existing treatments. The study was conducted at leading U.S. institutions including Cleveland Clinic, Mayo Clinic, University of Michigan, and Beth Israel Deaconess Medical Center. For more information about inFoods® IBS, visit www.inFoodsibs.com. inFoods IBS is Laboratory Developed Test (LDT) used within a single laboratory that is certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform high-complexity testing. About Biomerica (NASDAQ: BMRA) Biomerica, Inc. (www.biomerica.com) is a global biomedical technology company that develops, patents, manufactures and markets advanced diagnostic and therapeutic products used at the point of care (in home and in physicians’ offices) and in hospital/clinical laboratories for detection and/or treatment of medical conditions and diseases. The Company’s products are designed to enhance the health and well-being of people, while reducing total healthcare costs. Biomerica’s primarily focus is on gastrointestinal and inflammatory diseases where the Company has multiple diagnostic and therapeutic products in development. The Private Securities Litigation Reform Act of 1995 provides a “safe harbor” for forward-looking statements. Certain information included in this press release contains statements that are forward-looking, such as statements relating to the Company’s current and future cash position, balance sheet, cost savings, sales, revenues, overhead, expenses, cost of goods, operations, and earnings; the Company’s need for raising additional capital; the Company’s expected sales growth for the Company’s inFoods IBS® product, Hp Detect product and other existing products; and diversification of the Company’s revenue streams. Such forward-looking information is based upon the current beliefs and expectations of management and involves important risks and uncertainties that could significantly affect anticipated results. In addition, these forward-looking statements are subject to assumptions with respect to future business strategies and decisions that are subject to change. Accordingly, such results may differ materially from those expressed in any forward-looking statements made by or on behalf of Biomerica. Factors that could cause actual results to differ from those expressed in the forward-looking statements are discussed in the “Risk Factors” section of the Company’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other reports filed with the SEC, and available on the SEC’s website (www.sec.gov). The Company is under no obligation to update any forward-looking statements after the date of this release. Corporate Contact: Zack Irani-Cohen949-645-2111investors@biomerica.comSource: Biomerica, Inc.

Groundbreaking remotely operable robotic system to transform intervention for stroke and cardiovascular disease, while radically expanding access to care for patients around the world. SAN FRANCISCO, Oct. 6, 2025 /PRNewswire/ -- Remedy Robotics, Inc., a leading medical technology company, today debuted the world's first remotely operable endovascular robotic system. By combining proprietary hardware with AI-enabled software, the Remedy N1 System empowers clinicians to deliver faster, safer, and more effective intervention to patients with cardiovascular conditions such as stroke, heart attack, or vascular trauma – whether they are across the room or across the globe. This groundbreaking technology will both elevate the standard of cardiovascular care and dramatically expand access to treatment for time-critical conditions. The Remedy N1 System recently completed a series of first-ever, in-human procedures led by Vitor Mendes Pereira, MD, a world-renowned neurosurgeon at St. Michael's Hospital, Toronto. These procedures included fully remote operations conducted between two separate hospitals within the Unity Health Toronto network: St. Michael's Hospital and St. Joseph's Health Centre. Marking the world's first entirely remotely operated endovascular interventions, these procedures demonstrate the potential of the Remedy N1 System to deliver life-saving treatments for cardiovascular emergencies such as stroke, regardless of distance. "By successfully completing these first remote procedures in humans, we're not just introducing a breakthrough technology - we're taking real steps towards ensuring that every person around the world has access to the best possible endovascular care," said Dr. David Bell, CEO and Co-Founder of Remedy Robotics. "This milestone is a testament to our team's dedication and hard work with our clinical partners, like Dr. Pereira and Unity Health Toronto. We're building a solution that will transform cardiovascular care globally and we're grateful to be able to work with the world's best clinicians to get it out there." Cardiovascular diseases, such as stroke and heart attack, are the leading cause of death and disability worldwide, responsible for more than 19 million deaths each year, according to the National Institutes of Health. Stroke alone carries an immense economic burden, with the World Stroke Organization estimating annual global costs of nearly $900 billion. While endovascular intervention is considered the gold standard of care, it is only currently available at select specialist hospitals. As a result, only 2.8% of eligible stroke patients worldwide have access, underscoring a critical gap in life-saving treatment. Jake Sganga, PhD , CTO and Co-Founder of Remedy Robotics, commented, "The Remedy N1 System represents the next generation of surgical robotics, using advanced AI and machine learning to enable clinicians to operate robotically with a degree of visibility, precision, and control that has never before been possible. The system is engineered for scalability, allowing for straightforward deployment at virtually any hospital and, for the first time, allowing clinicians to complete entire endovascular procedures remotely from start to finish. The N1 System will allow every hospital to provide safe and precise endovascular intervention for cardiovascular procedures, and will empower physicians to provide expert care wherever it's needed." The Remedy N1 System includes an endovascular robot that integrates seamlessly into any catheterization laboratory. With proprietary AI-supported software, the N1 System can precisely control up to 4 tools at a time, including off the shelf wires, microcatheters, stents and coils as well as multiple sizes of proprietary 360-degree steerable catheters. Clinicians use a simple, portable console, designed for ease of deployment from both within and outside hospital environments, to perform the entire procedure robotically, including control of all tools, fluidics and audiovisual communication. The N1 System also provides integrated connectivity management as well as automated preprocessing of CT and MRI scans to allow for seamless integration, in real time, with fluoroscopic x-ray imaging. Dr. Pereira added, "Performing minimally invasive remote robotic interventions is transformative and will open a new avenue to expand care in our field. The Remedy N1 System delivers precise maneuverability that allows for enhanced control and an overall safe procedural experience. The success of these world-first in-human remote procedures is a strong validation of the platform's precision, safety, and potential to transform patient care globally." On speaking about its investment in Remedy Robotics, Blackbird Ventures General Partner Michael Tolo said, "Remedy Robotics is pushing the boundaries of what's possible in modern medicine. The team's ability to combine cutting-edge robotics, advanced machine learning, and real-time imaging to enable remote cardiovascular intervention is nothing short of transformative. We're proud to support a company that's not only pioneering a new era of care, but doing so with global scale and impact in mind." "By integrating advanced AI, machine learning, and computer vision with cutting-edge hardware, Remedy Robotics is distinguishing itself from the MedTech field and leading a new generation of surgical robotics," said DCVC General Partner James Hardiman, commenting on the firm's investment in Remedy Robotics. "With this milestone, the Remedy team is poised to make a profound impact on both patient outcomes and health system operations, and we are proud to support them in their mission." The successful completion of these first-in-human procedures marks a significant milestone for Remedy Robotics, with the company now focused on expanded clinical trials and the development of additional applications across a range of cardiovascular surgical specialties. The Remedy N1 System remains under development and is not yet available for sale. About Remedy Robotics Remedy Robotics is a medical technology company revolutionizing cardiovascular care through its proprietary software and robotic system. The company has developed the world's first remotely-operated endovascular surgical robotic system, empowering physicians to perform life-saving cardiovascular intervention with unparalleled ease and precision across vast distances. By integrating state-of-the-art robotics with advanced machine learning, Remedy is helping overcome geographic barriers and delivering faster, safer and more effective care to patients across the globe. Academic journal articles on remote robotic neurointervention, co-authored by Remedy Robotics CEO David Bell and collaborators, have been published in Interventional Neuroradiology and the American Journal of Neuroradiology, and the company holds 45 patents on its N1 System and software. Headquartered in San Francisco and backed by DCVC, Blackbird, KDTvc, and Tony Fadell's Build Collective, the company is proud to partner with clinicians from leading medical institutions across the US and around the world, including as the exclusive robotic partner of Mission Thrombectomy, a leading global stroke initiative dedicated to expanding access to this life-saving treatment. Learn more at . About Unity Health Toronto Unity Health Toronto is Canada's largest Catholic health care provider with a wingspan across Toronto's core. The breadth of services we provide, strengthened by community partnerships and academic affiliations, positions us as a national model for collaborative, integrated, high-quality care as we work to build a stronger, resilient, and equitable health system for all. Guided by our mission and values, we aim to provide the best care experiences at every stage of our patients' health journey, from pediatric to primary care, urgent and acute care, specialty programs, seniors care, rehabilitation, long-term care, palliative care, and advanced care for the most complex patients. Our strength lies in the combined expertise of our sites: a community, academic, and acute care hospital at St. Joseph's Health Centre, a research-intensive academic health sciences centre at St. Michael's Hospital, a campus of care for seniors, rehabilitation, and long-term care at Providence Healthcare, and a constellation of satellite clinics offering community-based and primary care. As a leading Canadian health research institution and learning destination of choice for health professionals, we are advancing healthcare for all united by one vision: The best care experiences, created together. SOURCE Remedy Robotics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Citeline首席分析师周淑华发言 圆桌现场 研发客主编毛冬蕾与张江全互动 张金晶 威斯津生物合伙人商务发展总监 李安康  腾盛博药CFO 尹思远 传信生物首席运营官 王松立  星核迪赛研发总监 陈进 维亚臻生物临床药理&转化医学副总裁 高璐  圆因生物CEO 张震 徕博科亚太商务开发高级总监 Simon Yu  徕博科中国中心实验室运营总监 研讨会现场图片分享 舶望制药近日与诺华制药就4款小核酸药物达成1.6亿美元预付款的消息，再次证明小核酸药物成为备受关注的热门赛道。全球众多企业布局，中国一批“黑马”公司正凭借独特的技术平台和差异化的管线布局悄然崭露头角。在由研发客与徕博科联合举办的“中国分子，世界引擎”研讨会上，该领域的发展前景成为焦点。 拓展阅读 舶望再度授权诺华siRNA药物，总交易价值达52亿美元！ 李勇：在心血管疾病领域前景广阔 复旦大学华山医院心脏科李勇教授认为，小核酸药物在心血管疾病防治领域正展现出较大潜力。英克司兰（Inclisiran）的成功获批，验证了这一领域的重要性。 小核酸药物在递送系统方面取得了进展。除了目前已经广泛应用的肝细胞递送系统外，通过优化递送载体，科学家已实现了对卵巢细胞、肾脏细胞及脑细胞的有效靶向递送。李勇教授认为，针对脑细胞的靶向递送技术有望在短期取得突破，这为小核酸药物在心血管神经系统疾病的应用提供了可能。 复旦大学华山医院心脏科  李勇教授 心血管疾病如高血压、血脂异常和糖尿病等，多为慢性病，不仅在中国，在全球也有数以亿计的大量患者，而且需要长期维持治疗。李勇教授指出：“糖尿病患者中45%的死亡与心血管疾病相关，而非高血糖本身。慢性肾脏病患者进入透析后，无论在是否已经接受透析治疗，心血管事件也是其首要死因，占比超40%。近10年来越来越受关注的脂肪肝，已经超越消化系统，与糖尿病及慢性炎症密切关联，也会导致心血管疾病风险增高。因此，维护心血管健康是内科疾病防控预防和管理的关键策略。” “心血管事件链”概念于1991年由美国医学科学院院长魏德照Victor Dzao提出，强调从危险因素发展为冠心病、心衰的连续过程中的全程疾病管理及危险因素控制。李勇教授解释，高血压、糖尿病和血脂异常是三大主要危险因素，它们通过激活体内RAAS、炎症、能量/线粒体代谢等某些系统，促使动脉粥样硬化斑块形成和发展、以及心肌、肾脏、血管的纤维化加速进展。 关于高血压，他表示：“高血压不仅造成物理损伤，还会激活某些系统，引起左心室肥厚和舒张功能障碍。中国高血压患者众多，每年约260万人因高血压而此死亡，我国的高血压人口数和死亡人数均居全球之首。目前美国诊断标准为130/80 mmHg，而中国仍采用140/90 mmHg，这在一定程度上影响了防控效果。” 在血脂方面，他说：“LDL-C是动脉粥样硬化的主要致病性危险因素，根据我国著名心血管流行病学家北京安贞医院赵冬教授团队15年的队列研究数据，其升高对心肌梗死风险的贡献达77%。大量随机对照临床试验证实，显著降低LDL-C水平不仅能是防治心血管病的关键，还能降低全因死亡，延长寿命。”对于糖尿病与脂肪肝，他强调这两类患者的心血管风险增加，脂肪肝患者尤其易合并心血管疾病，导致临床结局恶化，建议心血管医生应更多关注这类人群的心血管健康。 在血脂管理方面，他特别提到英克司兰（Inclisiran）：“作为一种靶向PCSK9的小干扰RNA药物，英克司兰通过阻断PCSK9与LDL受体的结合，增加肝细胞表面LDL受体的数量，提升肝细胞清除LDL-C的能力，从而降低血中的LDL-C水平。其独特之处在于，一次注射可维持长达6个月的疗效，大大提高了患者的治疗依从性。临床试验表明，英克司兰单药治疗或与他汀联用，均可降低LDL-C幅度高达水平60%，且安全性良好。” 他还介绍了其他小核酸药物的研究进展：“除了英克司兰外，针对甘油三酯（TG）和脂蛋白(a) [Lp(a)]的小核酸药物也展现出广阔的应用前景。例如，针对ApoC-III的小核酸药物Plozasiran、针对ANGPLT-3的Zodasiran可降低TG水平，并减少急性胰腺炎的发作风险；除了Plecarsen外、多个针对Lp(a)的小核酸药物如Olpasiran、Lepodisiran则可降低其水平达90%以上，有望减少心血管事件的发生。” 在强化降压与降脂治疗的临床意义方面，李勇教授表示：“近年来，多项大规模临床试验表明，将血压控制在更低水平（如收缩压<120 mmHg）可降低心血管事件和死亡率。然而，中国的高血压管理目标值仍为140/90 mmHg，这在一定程度上限制了降压治疗的获益。因此，推动高血压管理目标的下调，对于改善中国心血管疾病防治现状具有重要意义。”小核酸药物在降压领域也有明显的进展，Zilebesiran的II期临床试验显示，每6月一次皮下注射，可获得令人相当满意的降压效果，针对高血压患者的心血管结局随机对照临床试验（CVOT）ZENITH研究已经启动。 他还强调了早期降脂治疗的重要性：“LDL-C的累积暴露时间与动脉粥样硬化的发展密切相关。因此，越早启动降脂治疗并维持较低水平，对心血管的保护作用越大。小核酸药物的出现，为实现长期、稳定的降脂治疗提供了新的手段。” 最近，Lancet发表了小核酸药物用于治疗脂肪肝的II期临床试验结果，ION224-CS2试验表明，采用肝活检来评估，寡核苷酸制剂抑制DGAT-2，能够有效逆转脂肪肝，安全性良好。 展望未来，李勇教授认为小核酸药物在一级预防和多靶点治疗方面具有广阔前景。然而，李勇教授也指出了小核酸药物面临的挑战：例如，如何进一步提高递送效率、降低脱靶效应、优化给药方案等。此外，加强医生和患者对小核酸药物的认知也是推动其应用的关键。 最后，他总结道：“小核酸药物为心血管疾病防治带来了新希望。通过不断优化技术、拓展适应症和加强临床应用研究，相信小核酸药物将在未来心血管疾病防治中发挥越来越重要的作用。” 周淑华：全球核酸药物研发持续活跃 Citeline首席分析师周淑华博士介绍了2025年全球核酸药物研发持续活跃的态势。 Citeline首席分析师 周淑华博士 截至2025年，全球处于活跃开发阶段的药物总数达23,875种，较上一年度增长4.6%，新增药物1,050种，其中4,546种为新加入研发管线的药物。新增药物中，抗癌药占比38.8%，神经系统疾病药物占13.8%。各临床阶段药物数量均增长，Ⅰ期增长6.8%，Ⅱ期增长6.3%，Ⅲ期增长8.8%，临床前研究阶段增长1.8%（低于2024年的5.5%），显示全球研发活跃但临床前研究增速放缓。 核酸药物研发管线中，肿瘤学仍是最大治疗领域，2025年有9,746种药物在研，增长3.7%，占所有在研药物的39.7%（略低于2024年的40.1%）。神经系统疾病药物研发增长率低于平均水平（2024-2025年仅增长4.2%）。顶尖企业中，辉瑞重新夺回研发管线规模榜首，罗氏和诺华紧随其后。前十家企业贡献5.4%的在研药物，前25家贡献10.0%，剩余19.4%来自仅有一两种药物在研的公司。 疾病聚焦方面，乳腺癌仍是研发重点，管线规模增长9.5%，领先于非小细胞肺癌（NSCLC，增长10.0%）。非癌症领域中，新冠病毒退出前十，阿尔茨海默病仍是唯一进入前十的非肿瘤疾病。肥胖治疗药物研发增长43.3%（受Wegovy和Mounjaro等药物影响）。热门药物蛋白靶点中，免疫疗法（I-O）相关靶点主导，CD3e连续第二年位居榜首，EGFR取代Her-2成为第二位热门靶点（应用于多种癌症治疗）。 全球及中国研发合作趋势显示，全球范围内16%的在研药物处于合作研发状态（抗癌药物领域16%，神经系统疾病药物16%，抗感染药物14%，消化/代谢系统疾病药物17%）。2017-2025年,中国合作交易数量和总金额2025年分别达16.4%和33.7%，但首付款比例普遍低于全球水平。 “未来，全球核酸药物研发将持续活跃，中国企业增长势头强劲。中国企业需提升创新效率、加强全球市场洞察、完善内部管理并构建健全的资本体系，以实现可持续发展。”周淑华说。 张江全：小核酸药物非临床安全评价要点 徕博科中国区早期研发负责人张江全剖析了小核酸药物非临床安全评价要点。 在结构与修饰上，siRNA药物可进行多种修饰，这会影响其药代动力学，免疫原性特性和毒性表现，介绍了非临床监管、药代动力学以及免疫原性三个方面的内容。 徕博科中国区早期研发负责人 张江全 小核酸药物的非临床监管主要遵循 ICH M3（R2）原则，标准遗传毒组合试验，一般毒性、DART、致癌性研究使用两种种属，同时需考虑ICH S6 指南部分终点。考虑到siRNA的临床给药周期，重复给药毒性研究周期较长，啮齿类动物 6 个月、非人灵长类 9 个月，对此，多国监管机构有相关原则。 在药代动力学方面，siRNA血浆半衰期短，快速被肝脏摄取，导致PK/PD分离现象。siRNA主要分布于肝脏且在肝组织中半衰期较长，肝脏药代动力学和RNA诱导沉默复合体（RISC）药代动力学是决定药效动力学及其持续时间的关键因素。免疫原性的潜在来源包括有序列依赖性免疫激活、递送系统影响等。 对于动物研究的毒性特征，包括免疫原性相关毒性，通过非 Toll 样受体途径触发促炎细胞因子释放；杂交依赖性毒性有靶点效应、脱靶效应、RNAi 机制饱和等；递送载体毒性方面，各种载体存在各自不同的毒性特征。 此外，张江全还分享了两个案例。一是已报道的SLN360案例，GalNAc结合的siRNA，靶向脂蛋白a mRNA，用于心血管疾病。研究通过GalNAc- 去唾液酸糖蛋白受体（ASGPR）结合实现肝脏特异性递送，旨在降低PLA，进行体外特异性和效力研究、体内生物分布研究（大鼠/食蟹猴）以及29天GLP毒性研究。结果显示，大鼠在不同剂量下，高剂量雌性大鼠体重略有下降，其他方面如食物摄入等无显著变化，观察到的非不良反应在停药8周后可恢复；食蟹猴在不同剂量下，体重等一般观察无SLN360相关影响，无补体激活或细胞因子释放，预期效果良好，非不良反应停药后也可恢复。 案例二是AAA（GalNAc结合的siRNA，用于非酒精性脂肪性肝炎（NASH）），研究每月1次皮下注射给大鼠和食蟹猴，持续12周，评估毒性并确定毒代动力学，观察停药12周后的恢复或持续情况。结果表明，系统暴露量与剂量成正比或高于剂量比，无药物蓄积和性别差异，临床观察未观察到AAA相关影响。临床病理主要为肝脏相关指标改变，镜检观察可见肝脏、淋巴结、胸腺、脾脏、肾脏、注射部位等出现色素沉着、空泡化、淋巴细胞减少等改变。所有病理发现均为轻度，认为是non-adverse，因此两个种属的NOAEL均为高剂量。 与会者表示这些全面的要点和案例分享，为小核酸药物非临床安全评价领域的研究提供了极具价值的参考。 徐中南：正大天晴进军小核酸药物领域 正大天晴药业集团的高级临床总监徐中南分享了正大天晴在小核酸药物开发中的技术演进路径，尤其聚焦TQA3038这一创新药的临床开发策略。 正大天晴药业集团的高级临床总监 徐中南 徐中南分析了慢乙肝治疗领域的严峻现状：中国慢乙肝患者诊断率仅22%，治疗率17%，市场需求迫切。尽管已有NUC和IFN等抗病毒药物，但抗病毒时间长、临床治愈率低的问题依旧突出，因此，针对HBV复制环节开发新药成为研究热点。 在介绍TQA3038时，徐中南阐述了其作为GalNAc偶联修饰siRNA药物的独特机制：“通过皮下注射特异性靶向HBV ORF-X区，有效抑制HBV复制。GalNAc配体与肝脏细胞的高亲和力和迅速内化能力，确保了siRNA的高效作用。” 临床试验方面，TQA3038一期健康受试者SAD研究共设置了6个剂量组，采用递增剂量设计确保安全。TQA3038给药后快速吸收，血浆浓度约4小时达峰，半衰期8.7至9.34小时，24小时内药物基本消除。6个剂量组安全性良好，未发生严重不良事件。需要重点关注ECG的改变情况。 TQA3038与同靶点药物相比的优势：同剂量下，TQA3038体内抗HBV活性优于Vir-2218，包括HBsAg、HBeAg、HBV RNA的下降比例；与ETV单药组相比，TQA3038和ETV联合给药组对小鼠血浆中HBV DNA的降低更明显。 在介绍同靶点药物联合干扰素治疗方案时，他分享了VIR-2218与PEG-IFNα联合治疗的研究成果，显示联合用药的受试者HBsAg下降幅度更大，部分受试者实现HBsAg转阴和血清学转换。同时，他也提及了AB-729与IFN联合治疗的研究进展。 针对TQA3038 Ⅱ期研究，评价TQA3038注射液联合NUC治疗经治慢乙肝患者的初步疗效及安全性。研究显示无严重不良事件发生，TQA3038可快速降低HBsAg水平，高剂量组效果更明显。 最后，他总结了TQA3038的技术演进路径和临床应用前景。TQA3038用药后在外周血浓度快速下降，48小时后检测不到，且GalNAc-siRNA可在肝脏中蓄积并缓慢释放，单次给药即可维持长期疗效，使其成为慢乙肝治疗领域的潜力创新药物。 毕吕存：生物分析策略从方法开发到全球一致性验证 徕博科执行总监及中国生物分析与亚太LCMS实验室负责人毕吕存博士探讨了小核酸药物的生物分析策略包括：药代动力学（PK）生物分析策略和生物标志物（BM）生物分析策略。 徕博科执行总监及中国生物分析与亚太LCMS实验室负责人 毕吕存博士 小核酸药物的基本结构是由20至30个核苷酸基团组成的短线性链，通过磷酸二酯键连接，具有强亲水性和高度负电荷性。在生物分析方法上，毕博士展示了定量分析小核酸药物的各技术手段，特别是液相色谱-质谱联用技术（LC-MS/MS）和高分辨率质谱（LC-HRMS）的应用。通过案例研究，可以利用这些技术对小核酸药物及其代谢物进行精确的定量分析。 针对小核酸药物的生物标志物分析，毕博士强调了评估药效动力学（PD）标志物或其他测量指标的重要性。小核酸药物在脏器组织中具有很长半衰期，能够保持很长疗效，因此评估其药效响应时需考虑组织分布和药效动力学特点。 此外，他还介绍了小核酸药物递送技术的创新，特别是GalNAc（N-乙酰半乳糖胺）递送技术能将小核酸递送至肝细胞，并通过化学修饰改善小核酸药物，很多生物科技公司更专注于肝外递送技术。优秀的生物分析技术能够提供答案，这些修饰后的小核酸药物能否有选择性地递送到达目标器脏，以及这些小核酸药物的体内分布和药效。 在方法开发方面，他介绍了小核酸药物生物分析中的各种困难， 以及解决这些困难的方法，特别是针对组织样品的处理和分析中的经验。通过案例研究，毕博士介绍了如何优化提取条件、色谱分离和质谱检测参数，以提高分析的灵敏度和准确性。 最后，毕博士总结了徕博科在小核酸药物生物分析的经验和成果，强调了多种生物分析工具（如LC-MS、qPCR、Simoa、ELISA、MSD和免疫捕获LC-MS）在支持小核酸药物PK/PD评估中的作用。“这些分析工具为药物设计和决策提供了关键数据，推动了小核酸药物的持续发展。”他说。 李海涛：炫景生物的创新实践 炫景生物联合创始人及CTO李海涛博士介绍了小核酸药物领域的全球研发环境、关键决策点和炫景生物的创新实践。 炫景生物联合创始人及CTO 李海涛博士 他认为，小核酸药物正迎来前所未有的机遇。全球范围内已有超过20款药物成功上市，且市场规模保持高速增长。在中国，小核酸药物开始显示出巨大潜力。 然而，小核酸Biotech公司也面临严峻的生存环境，一级市场融资金额大幅下滑，国内小核酸药热门靶点扎堆，siRNA领域内卷严重，进一步压缩了Biotech的生存空间。李海涛博士强调，Biotech公司是License-out交易项目的主要来源，其创新性在全球合作中发挥着关键作用。 在研发路径与关键决策维度上，李海涛认为，产品差异化和技术创新是小核酸Biotech企业在严苛生存环境中脱颖而出的关键。靶点选择需综合临床需求、竞争格局和审评需求，梯度开发扩展适应症以分散风险。平台适配方面，需权衡自主研发与授权引进的利弊，选择合适的平台（如ASO或siRNA）和技术路线。临床试验则需考虑不同临床方案的优劣、全球多中心的必要性和紧迫性等。此外，商业化准备也是关键一环。 对于小核酸药物的发展趋势，李海涛认为，在经历过第一轮“踩踏式”的肝靶点同质化开发后，越来越多的小核酸企业会转向新靶点新机制的研究，一方面实现真正的产品管线差异化、多元化，另一方面也能满足人们对小核酸药物解决不可成药靶点和真正面向未满足临床需求的期待和愿景。此外，多靶向新结构和组合疗法的应用将迅速兴起、强效保障并长效维持治疗效果。递送技术将突破人体主要组织器官的靶向递送，实现更加精准、高效和安全的药物递送。同时，生产成本降低和规模扩大将提高药物可及性，而AI/ML技术将从辅助工具转变为决策支持。 在介绍炫景生物时，李海涛提到，作为国家高新技术企业和国家级科技型中小企业，炫景生物致力于成为小核酸制药领域的深耕者和变革者。公司自2022年成立以来，已获得近3亿元融资，得到多家知名投资机构的支持。 炫景生物拥有自主研发的药物设计筛选平台RIHOST®、化学修饰平台RICMO®和体内递送平台LICOD®等核心技术平台，形成了独特的技术壁垒。药物设计筛选平台实现了智能化序列设计和高通量筛选，大大缩短了研发周期。 化学修饰平台通过新单体、新模式、新结构的三层次突破，建立了“通式”修饰模式，提高了药物的稳定性、有效性、长效性和安全性。递送技术平台则涵盖了肝内和肝外递送技术，肝靶向载体具有高效的组织靶向性和成本优势等。此外，炫景生物还建立了7个肝外组织的递送技术，其中肾脏靶向递送载体率先完成食蟹猴体内验证，研发进度全球领先。在管线开发方面，首发管线RG002已启动临床Ⅱ期研究，安全性有效性优于同靶点竞品。 谈及创业感悟时，李海涛表示，自己出身于科学家背景，在技术上的挑战并非最为棘手，真正困难在于如何实现从科学家到企业家的角色转变。 会议最后，来自国内小核酸药物领域的企业代表，包括炫景生物、瑞博生物、腾盛博药、思合基因、浩博医药、圣诺医药、海昶生物、传信生物、伽进生物、圆因生物、高田生物、星核迪赛以及维亚臻生物等公司，分享了各自公司的平台技术、研发管线布局、融资进展情况及BD计划等。他们认为，当前是中国小核酸药物行业发展的黄金时机，但同时也指出，递送技术、靶向范围拓展、稳定性提升及免疫原性降低等技术瓶颈仍亟待突破。 编辑 | 姚嘉 yao.jia@PharmaDJ.com 总第2565期 访问研发客网站，深度报道和每日新闻抢鲜看 www.PharmaDJ.com