Ritonavir

近期，浙江艾森药业自主研发的奥格特韦钠胶囊（商品名：奥维宁®）凭借其全球首创的双靶点机制，成功入选《Nature Reviews Drug Discovery》2025 年度“十大新靶点药物”榜单！这也是中国创新药首次荣登该权威榜单！ 美迪西助力 上海美迪西生物医药股份有限公司作为艾森药业的合作伙伴， 为奥格特韦钠胶囊提供化合物合成、早期工艺放大、早期毒理批制备等临床前研发服务 ，有力保障了这款全球首创机制抗新冠口服新药的临床前研发与成功上市。 Nature认证 · 创新引领奥格特韦钠胶囊跻身2025年度全新机制靶点创新药行列 作为全球医药领域极具影响力的权威期刊，《Nature Reviews Drug Discovery》的年度靶点药物榜单，是衡量全球新药原创性、先进性与技术含金量的核心标杆，入选药物均为全球首创、具备突破性临床价值的源头创新成果。 2025年获批的具有新型作用机制靶点的药物 据榜单年度数据统计，2025年美国FDA、欧盟EMA、日本PMDA及中国NMPA四大全球核心药品监管机构，全年共批准94款具备明确作用机制靶点的新药。在一众获批新药中，仅有11个靶点为既往无上市药物调控的全新原创靶点，对应仅10款源头创新药物，技术含金量极高。 奥格特韦钠胶囊凭借独一无二的双靶点创新机制成功入围，不仅充分印证了该药物靶点机制的原创性、科学性与领先性，彰显了艾森药业在创新药研发领域的硬核实力，也标志着我国抗新冠创新药研发水平正式跻身全球第一梯队。 艾森药业创始人、CEO徐晓博士（左三）带领团队科研攻关 疫情防控 · 呼唤新解新冠常态化防控亟需国产原研新方案 中疾控数据显示，全国新冠阳性率已升至20.3%。随着病毒持续变异，新冠已从突发公共卫生事件转入常态化呼吸道传染病轨道。老年及基础病人群始终面临较高重症与长新冠风险。而传统抗病毒药物受限于药物相互作用、联用禁忌及耐药屏障等问题，难以满足复杂临床需求，兼具广谱抗病毒活性、高安全性与良好用药便利性的创新药物的创新药物仍是后疫情时代长周期防控体系中亟待补充的关键拼图。 双靶创新 · 优势显著奥格特韦钠胶囊让新冠治疗更安全、更有效 奥格特韦钠胶囊作为全球首个双靶点抑制新冠病毒入侵和复制的新药，在靶点创新、临床方案与循证数据上构筑起多重优势： 1 靶点创新机制，构建“阻入侵+抑复制”双重抗病毒屏障 区别于传统抗新冠药物单一作用路径，奥格特韦钠胶囊的作用靶点是组织蛋白酶L（CTSL）和 3CL 蛋白酶（3CL pro）。其中CTSL这一靶点的独特之处在于—它并非直接攻击病毒本身，而是作用于人体细胞表面的组织蛋白酶L，通过抑制病毒入侵宿主细胞从而发挥抗病毒的作用。同时，奥格特韦钠还能抑制新冠病毒的病毒复制关键酶 -3CL 蛋白酶，起到抑制病毒复制的作用。 奥格特韦钠胶囊作用机制图 2 单药创新方案，破解高危人群联合用药难题 在临床应用层面，奥格特韦钠胶囊实现了无需联用利托那韦的单药治疗方案，突破了传统抗新冠药物多数需联合利托那韦作为药代动力学增强剂的局限，规避了高风险的药物-药物相互作用（DDI），大幅提升了临床用药的安全性与适用性，尤其适合老年和伴有基础疾病的新冠病毒感染患者使用。 3 国际顶刊发表，显著缩短患者恢复时间，安全性高 奥格特韦钠胶囊的III期临床试验结果发表于《NEJM Evidence》，临床研究共纳入1,218例受试者。结果显示，奥格特韦钠胶囊可显著缩短新冠患者11种目标症状（发热、咳嗽、乏力等）的持续恢复时间，较安慰剂组提前恢复2.44天。 奥格特韦钠胶囊III期临床数据 在高风险人群中，奥格特韦钠胶囊的治疗优势尤为突出：60岁以上年龄亚组目标症状的持续临床恢复时间缩短33%，心血管疾病高风险亚组目标症状的持续临床恢复时间缩短 46%，疗效更优。 安全性方面，临床试验数据显示，奥格特韦钠胶囊药物相关AE的严重程度大多为1级或者 2级，未出现发生率大于5%的AE；奥格特韦钠组治疗期间3级以上TEAE发生率低于安慰剂组，未发现4级药物相关TEAE。 作为2025年度十大全新靶点创新药的代表之一，奥格特韦钠胶囊凭借其“安全性高、症状恢复快、无惧药物相互作用风险”的特点，为当前新冠病毒感染患者特别是老年及合并基础疾病患者提供了更佳的治疗选择，也为全球公共卫生安全贡献中国药物治疗的最新方案！ 技术助力 · 平台赋能美迪西助力9件抗疫新药获批临床 美迪西深耕临床前研发二十余年，打造了覆盖药物发现、药学研究、临床前研究的一站式平台，通过NMPA、FDA、OECD GLP及AAALAC国际认证。 在抗病毒药物领域，美迪西拥有ABSL-2和BSL-2实验室，可开展特定的第三类病原微生物的实验以及常规细胞培养、毒株感染/毒力测定、多种类病原微生物体外实验等，同时提供化合物活性筛选、肿瘤细胞株培养、成瘤性实验、疫苗效力评估、抗菌药物PK/PD等多种实验，为各种新药（如AAV基因治疗药物）提供临床前研发服务。目前 美迪西已助力9件抗新冠病毒药物/疫苗获批临床 。 追风赶月莫停留，平芜尽处是春山。生物医药是国家战略性新兴产业，源头创新是产业高质量发展的核心驱动力。未来，美迪西将继续依托一站式生物医药临床前研发服务平台，加速推动更多全新机制、全球首创的国产创新药研发落地，为中国生物医药产业升级和全球重大疾病防治持续注入中国研发力量。

近期，浙江艾森药业自主研发的奥格特韦钠胶囊（商品名：奥维宁®）凭借其全球首创的双靶点机制，成功入选《Nature Reviews Drug Discovery》2025 年度“十大新靶点药物”榜单！这也是中国创新药首次荣登该权威榜单！ 美迪西助力 上海美迪西生物医药股份有限公司作为艾森药业的合作伙伴，为奥格特韦钠胶囊提供化合物合成、早期工艺放大、早期毒理批制备等临床前研发服务，有力保障了这款全球首创机制抗新冠口服新药的临床前研发与成功上市。  Nature认证 · 创新引领  奥格特韦钠胶囊跻身2025年度全新机制靶点创新药行列 作为全球医药领域极具影响力的权威期刊，《Nature Reviews Drug Discovery》的年度靶点药物榜单，是衡量全球新药原创性、先进性与技术含金量的核心标杆，入选药物均为全球首创、具备突破性临床价值的源头创新成果。 2025年获批的具有新型作用机制靶点的药物 据榜单年度数据统计，2025年美国FDA、欧盟EMA、日本PMDA及中国NMPA四大全球核心药品监管机构，全年共批准94款具备明确作用机制靶点的新药。在一众获批新药中，仅有11个靶点为既往无上市药物调控的全新原创靶点，对应仅10款源头创新药物，技术含金量极高。 奥格特韦钠胶囊凭借独一无二的双靶点创新机制成功入围，不仅充分印证了该药物靶点机制的原创性、科学性与领先性，彰显了艾森药业在创新药研发领域的硬核实力，也标志着我国抗新冠创新药研发水平正式跻身全球第一梯队。 艾森药业创始人、CEO徐晓博士（左三）带领团队科研攻关  疫情防控 · 呼唤新解  新冠常态化防控亟需国产原研新方案 中疾控数据显示，全国新冠阳性率已升至20.3%。随着病毒持续变异，新冠已从突发公共卫生事件转入常态化呼吸道传染病轨道。老年及基础病人群始终面临较高重症与长新冠风险。而传统抗病毒药物受限于药物相互作用、联用禁忌及耐药屏障等问题，难以满足复杂临床需求，兼具广谱抗病毒活性、高安全性与良好用药便利性的创新药物的创新药物仍是后疫情时代长周期防控体系中亟待补充的关键拼图。  双靶创新 · 优势显著  奥格特韦钠胶囊让新冠治疗更安全、更有效 奥格特韦钠胶囊作为全球首个双靶点抑制新冠病毒入侵和复制的新药，在靶点创新、临床方案与循证数据上构筑起多重优势： 1 靶点创新机制，构建“阻入侵+抑复制”双重抗病毒屏障 区别于传统抗新冠药物单一作用路径，奥格特韦钠胶囊的作用靶点是组织蛋白酶L（CTSL）和 3CL 蛋白酶（3CL pro）。其中CTSL这一靶点的独特之处在于—它并非直接攻击病毒本身，而是作用于人体细胞表面的组织蛋白酶L，通过抑制病毒入侵宿主细胞从而发挥抗病毒的作用。同时，奥格特韦钠还能抑制新冠病毒的病毒复制关键酶 -3CL 蛋白酶，起到抑制病毒复制的作用。 奥格特韦钠胶囊作用机制图 2 单药创新方案，破解高危人群联合用药难题 在临床应用层面，奥格特韦钠胶囊实现了无需联用利托那韦的单药治疗方案，突破了传统抗新冠药物多数需联合利托那韦作为药代动力学增强剂的局限，规避了高风险的药物-药物相互作用（DDI），大幅提升了临床用药的安全性与适用性，尤其适合老年和伴有基础疾病的新冠病毒感染患者使用。 3 国际顶刊发表，显著缩短患者恢复时间，安全性高 奥格特韦钠胶囊的III期临床试验结果发表于《NEJM Evidence》，临床研究共纳入1,218例受试者。结果显示，奥格特韦钠胶囊可显著缩短新冠患者11种目标症状（发热、咳嗽、乏力等）的持续恢复时间，较安慰剂组提前恢复2.44天。 奥格特韦钠胶囊III期临床数据 在高风险人群中，奥格特韦钠胶囊的治疗优势尤为突出：60岁以上年龄亚组目标症状的持续临床恢复时间缩短33%，心血管疾病高风险亚组目标症状的持续临床恢复时间缩短 46%，疗效更优。 安全性方面，临床试验数据显示，奥格特韦钠胶囊药物相关AE的严重程度大多为1级或者 2级，未出现发生率大于5%的AE；奥格特韦钠组治疗期间3级以上TEAE发生率低于安慰剂组，未发现4级药物相关TEAE。 作为2025年度十大全新靶点创新药的代表之一，奥格特韦钠胶囊凭借其“安全性高、症状恢复快、无惧药物相互作用风险”的特点，为当前新冠病毒感染患者特别是老年及合并基础疾病患者提供了更佳的治疗选择，也为全球公共卫生安全贡献中国药物治疗的最新方案！  技术助力 · 平台赋能  美迪西助力9件抗疫新药获批临床 美迪西深耕临床前研发二十余年，打造了覆盖药物发现、药学研究、临床前研究的一站式平台，通过NMPA、FDA、OECD GLP及AAALAC国际认证。 在抗病毒药物领域，美迪西拥有ABSL-2和BSL-2实验室，可开展特定的第三类病原微生物的实验以及常规细胞培养、毒株感染/毒力测定、多种类病原微生物体外实验等，同时提供化合物活性筛选、肿瘤细胞株培养、成瘤性实验、疫苗效力评估、抗菌药物PK/PD等多种实验，为各种新药（如AAV基因治疗药物）提供临床前研发服务。目前美迪西已助力9件抗新冠病毒药物/疫苗获批临床。 追风赶月莫停留，平芜尽处是春山。生物医药是国家战略性新兴产业，源头创新是产业高质量发展的核心驱动力。未来，美迪西将继续依托一站式生物医药临床前研发服务平台，加速推动更多全新机制、全球首创的国产创新药研发落地，为中国生物医药产业升级和全球重大疾病防治持续注入中国研发力量。 关于艾森药业 “致力于为饱受重大疾病危害的患者开发创新的治疗手段，改善他们的生活质量”，是艾森药业一直以来的使命和目标。艾森药业成立于2015年，专注于在尚未被满足治疗需求的疾病领域开发原创新药，目前在感染、肿瘤、自身免疫、代谢等重大疾病领域正在推动一系列原创新药的研发。公司在美国加州圣地亚哥和中国杭州分别设有研发中心，充分利用中美生物医药创新资源和团队优势，高效组织生物医药前沿技术和产品研发。艾森在浙江衢州建有符合国内外cGMP标准的生产和中试基地，为创新药物的全球临床研究和商业化提供高质量药物。 艾森自主研发的全球首个双靶点抗新冠病毒治疗新药奥格特韦钠于2025年10月在中国获批上市，这是首个针对主蛋白酶Mpro和组织蛋白酶L双靶点抑制，既能阻止病毒进入宿主细胞，又能抑制病毒复制，且不需要利托那韦的联合使用，更加高效和用药安全，特别适合中老年人和有基础疾病的患者的治疗。相关研究发表在国际顶级刊物《MED》和《NEJM Evidence》。后续奥格特韦钠还将在炎症和代谢等方面进一步扩展适应症，满足更多患者的临床治疗需求。此外，艾森还有4个新药分子在白血病、淋巴瘤、肺癌、自免等疾病领域进入临床研究。 随着奥格特韦钠的商业化和更多研发管线进入关键临床研究，艾森将不断践行自己的使命，用创新解决临床需求，用行动履行社会责任，为患者提供价值和福祉的同时也为股东和员工创造价值。 关于美迪西 美迪西（股票代码：688202.SH）成立于2004年，专注于为全球制药企业、研究机构及科研工作者提供全方位的临床前新药研发服务。公司构建了覆盖药物发现、药学研究至临床前研究的一站式综合研发平台，并在ADC、核酸、多肽、CGT、PROTAC、抗体等前沿领域搭建了服务平台。公司建立了符合国际规范的质量体系，已获得中国NMPA、美国FDA、欧盟OECD等GLP认证以及AAALAC国际认证。目前，公司在国内外拥有约9.2万平方米研发实验室。至2026年6月末，公司已为全球超2000家客户提供药物研发服务，参与研发完成的新药项目已有691件IND获批临床，携手国内外合作伙伴共同推动药物创新突破。美迪西将继续立足全球，聚力创新，为人类健康贡献力量！欢迎访问公司官网 www.medicilon.com.cn 了解更多详情。 ACEA Pharma’s Ogrelvir Sodium Capsule Named in Nature’s 2025 Top Novel Target Drugs List with R&D Support from Medicilon Recently, ACEA Pharma has announced that Ogrelvir Sodium Capsule (brand name: Oveinin®), its independently developed oral antiviral agent, has been selected to the Nature Reviews Drug Discovery 2025 Top Novel Target Drugs List. This achievement marks the first time a Chinese innovative drug has earned a spot on this globally recognized authoritative ranking. Medicilon, a long-term strategic partner of ACEA Pharma, provided preclinical R&D support for Ogrelvir Sodium Capsule, covering compound synthesis, early-stage process scale-up and toxicology batch preparation. Medicilon’s rigorous technical services underpinned the successful preclinical development and commercial launch of this world-first dual-target oral anti-COVID-19 drug. Nature-Accredited Innovation: Ogrelvir Sodium Establishes a New Benchmark for Target Discovery Nature Reviews Drug Discovery, a leading authoritative journal in global pharmaceutical research. All listed therapies represent first-in-class breakthroughs with transformative implications for clinical practice. According to the journal’s 2025 industry analysis, four major global regulatory bodies — the U.S. FDA, EU EMA, Japan PMDA and China NMPA — collectively approved 94 new drugs with well-defined mechanism-of-action targets in 2025. Of these approvals, only 11 targets are completely novel with no prior marketed therapies, corresponding to merely 10 first-in-class innovative drugs of exceptional technical rarity and research value. Distinguished by its proprietary dual-target mechanism, Ogrelvir Sodium Capsule verifies the originality, scientific validity and global competitiveness of its therapeutic pathway. This accolade not only underscores ACEA Pharma’s core prowess in innovative drug R&D but also places China’s anti-coronavirus drug development firmly within the global innovation elite. ACEA Pharma team Shifting COVID-19 Landscape Drives Demand for Domestic Innovative Therapeutic Solutions Shifting COVID-19 Landscape Drives Demand for Domestic Innovative Therapeutic Solutions With ongoing viral mutation, COVID-19 has transitioned from an acute public health emergency to an endemic respiratory infectious disease. Elderly populations and patients with underlying comorbidities continue to face elevated risks of severe disease and long COVID complications. Traditional antiviral therapies are frequently limited by drug-drug interactions, combination restrictions and emerging drug resistance, rendering them inadequate for complex clinical scenarios. Innovative antiviral agents with broad-spectrum activity, superior safety profiles and flexible administration have therefore become an essential component of long-term post-pandemic public health preparedness. Dual-Target Mechanism Delivers Safer, More Efficient COVID-19 Treatment As the world’s first oral antiviral drug designed to concurrently block SARS-CoV-2 entry and replication, Ogrelvir Sodium Capsule integrates unparalleled advantages in target innovation, clinical applicability and evidence-based efficacy. 1 Proprietary Dual-Target Mechanism: Dual Protection Against Viral Invasion and Proliferation Unlike conventional single-pathway anti-COVID-19 therapies, Ogrelvir Sodium Capsule acts on two validated targets: Cathepsin L (CTSL) and 3CL protease (3CLpro). The CTSL mechanism works by modulating host cellular protease activity to prevent viral entry into human cells, rather than targeting the virus directly. Complementarily, the drug inhibits 3CLpro, a critical enzyme for viral replication, effectively halting in-vivo viral propagation. Ogrelvir Sodium Capsule: Mechanism of Action 2 Standalone Monotherapy Resolves Medication Challenges for High-Risk Patients Ogrelvir Sodium Capsule enables ritonavir-free monotherapy, overcoming a key limitation of mainstream anti-COVID-19 drugs that rely on ritonavir boosting. This design eliminates the risk of adverse drug-drug interactions (DDIs), substantially improving clinical safety and broadening patient eligibility, particularly for elderly users and patients with chronic underlying conditions. 3 Peer-Reviewed Clinical Data Proves Rapid Symptom Resolution and Favorable Safety The Phase III clinical trial results of Ogrelvir Sodium Capsule, published in NEJM Evidence, were derived from 1,218 enrolled participants. Trial outcomes demonstrated that the drug significantly shortened the duration of 11 core COVID-19 symptoms (including fever, cough and fatigue), delivering a 2.44-day faster clinical recovery compared with the placebo group. Phase III Clinical Data of Ogrelvir Sodium Capsule Superior therapeutic benefits were observed in high-risk patient subgroups. Patients aged 60 and above experienced a 33% reduction in core symptom duration, while individuals with cardiovascular disease risks achieved a 46% shorter recovery timeframe, highlighting enhanced efficacy for vulnerable populations. Safety assessments confirmed a favorable tolerability profile. The majority of treatment-emergent adverse events (TEAEs) associated with Ogrelvir Sodium were Grade 1 or 2 in severity, with no single adverse event (AE) occurring at an incidence above 5%. The trial also recorded a lower rate of Grade 3+ TEAEs in the treatment group versus placebo, with no Grade 4 drug-related adverse events reported. As a flagship novel-target innovative drug of 2025, Ogrelvir Sodium Capsule offers a safe, efficient and DDI-free therapeutic option for COVID-19 patients, especially high-risk groups with advanced age or comorbidities. The agent delivers a state-of-the-art Chinese pharmaceutical solution to strengthen global public health defense systems. Medicilon’s Preclinical Platform Empowers Anti-Pandemic Drug Innovation Boasting over two decades of specialized preclinical R&D experience, Medicilon operates a end-to-end integrated service platform spanning drug discovery, pharmaceutical development and preclinical studies. Medicilon’s facilities and quality systems are certified by NMPA, FDA, OECD GLP and AAALAC international standards. Medicilon’s antiviral research capabilities are supported by dedicated ABSL-2 and BSL-2 laboratories, enabling controlled experimentation on Class III pathogenic microorganisms, viral culture, virulence quantification and a full spectrum of in-vitro pathogen assays. Its comprehensive service portfolio covers compound activity screening, tumor cell biology studies, tumorigenicity evaluation, vaccine potency testing and PK/PD analysis for antimicrobial agents, supporting preclinical development for novel therapies including AAV gene therapeutics. To date, Medicilon has facilitated the clinical advancement of 9 anti-COVID-19 drugs and vaccines. Moving forward, Medicilon will leverage its one-stop preclinical R&D platform to accelerate the development and commercialization of more first-in-class drugs with novel mechanisms. Medicilon will continue to advance the upgrading of global biomedical industry and contribute localized R&D expertise to global major disease prevention and treatment. About Medicilon From its inception in 2004, Shanghai Medicilon Inc. (SHA: 688202)has been committed to providing comprehensive R&D services to pharmaceutical companies, research institutions, and any organizations working in the preclinical space. Medicilon has built an integrated one-stop R&D platform covering drug discovery, CMC and preclinical studies, and has established service platforms in cutting-edge fields such as ADC, nucleic acids, peptides, CGT, PROTAC, and antibodies. Medicilon has established a quality system in compliance with international standards and has obtained GLP certifications from China's NMPA, the US FDA, the EU OECD,as well as AAALAC accreditation. Currently, Medicilon has nearly 92,000 square meters of R&D laboratories. By the end of 2025, Medicilon has provided drug development services to over 2,000 clients worldwide, and has been involved in the research and development of 651 new drugs projects that have been approved for clinical trials with IND applications. For more information, please visit the company's official website at www.medicilon.com.