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2025CMC-China第七届中国制药工业博览很高兴宣布：风云药谈 创始人-张廷杰将出席分论坛【仿制药和改良新药立项“稳准狠”大会】；并分享主题报告：新集采（11批）、大接续、价格治理下的产品布局8月1-2日 扫码免费注册嘉宾介绍张廷杰，风云药谈创始人，人大中睿EMBA特约讲师，交大药械MBA特聘讲师，多家大型企业战略顾问，医药行业投资人。研究领域包括国家及地方医药政策研究，市场数据调研及分析，产品立项及战略规划分析，是医药行业中产品立项、政策分析与市场实战兼顾型专家，培训结合政策趋势、具前瞻性，逻辑严密、紧贴市场、实战性强。立即扫码🔎限时免费通道开放中01.论坛日程精准把握立项政策走向8月1日 9:30-10:2009:30-10:00探讨新集采（11批）、大接续、价格治理下的产品布局张廷杰 风云药谈 创始人10:00-10:20探讨低价集采形势下，仿制药还能立项吗?张彦忠 北京阳光诺和药物研究股份有限公司 立项总监基于企业战略定位立项8月1日 10:30-11:5010:20-10:50改良型新药市场化立项策略郭新峰 南京循证生物科技有限公司 创始人10:50-11:10原料药制剂一体化建设对于仿制药立项的意义安晓霞 上海迪赛诺医药集团股份有限公司 总经理11:10-11:30改良型新药的合作研发：立项精准化与模式多样化刘超 山东百诺医药 市场部总监11:30-11:50改良制剂立项与临床开发策略夏燕 百花村医药集团副总经理，江苏礼华生物技术有限公司 董事长基于临床需求立项8月1日 14:00-14:4014:00-14:20基于临床问题的儿童改良型新药立项与研发赵维 山东大学药品监管科学研究院副院长、临床药理研究所所长14:20-14:40基于临床需求立项与AI的结合管峥 北京科临迈创科技有限公司 总经理立项成功&失败案例分享8月1日 14:40-16:1014:40-15:10市场引导立项的成功案例分享陈洪 千金研究院院长15:10-15:40仿制药及改良新药立项成败关键因素与经典案例深度解析孙立杰  石家庄四药有限公司 药物研究院院长15:40-16:10基于企业实践：改良型新药立项中的风险预判与应对策略吴四清 湖南九维生物医药有限公司 创始人&董事长仿制药&改良新药立项8月2日 9:30-10:3009:30-9:50医保导向下从仿制向改良型新药转型的立项策略王立峰 慧药咨询 创始人09:50-10:10药械结合！看仿制药立项如何绝处逢生陈宇哲 北京升斗小药梦想科技有限公司 董事长，华诺通（北京）医药科技有限公司 副总裁10:10-10:30OTC老药如何“逆龄生长”？欧美日经验与中国市场的创新答案王文龙 北京中创安堂医药科技有限公司，众创安堂（天津）制药有限公司， 总经理聚焦高技术壁垒立项8月2日 10:30-11:3010:30-10:50缓控释制剂立项的技术选择杨继荣 卡乐康中国  释药配方技术经理10:50-11:10中药改良型新药：顶层设计与实施策略李范珠 浙江中医药大学教授11:10-11:30改良新儿药立项策略赵刚 健民集团研究院院长*议程更新中，以现场为准...02.嘉宾介绍张廷杰风云药谈 创始人张廷杰，风云药谈创始人，人大中睿EMBA特约讲师，交大药械MBA特聘讲师，多家大型企业战略顾问，医药行业投资人。研究领域包括国家及地方医药政策研究，市场数据调研及分析，产品立项及战略规划分析，是医药行业中产品立项、政策分析与市场实战兼顾型专家，培训结合政策趋势、具前瞻性，逻辑严密、紧贴市场、实战性强。张彦忠北京阳光诺和药物研究股份有限公司 立项总监头部CRO上市公司立项总监。拥有大型CRO公司、咨询公司及制药企业的复合背景，精通数据分析及产品立项，时刻跟踪医药市场的前沿动态。从事产品立项七年以上，涉猎广泛，个人原创自媒体公众号“篱笆外边”欢迎关注。孙立杰石家庄四药有限公司药物研究院院长香港科技大学博士后，高级工程师，石家庄四药集团执行总裁、河北省化学药品无菌制剂产业技术研究院院长，“百人计划”专家，在原料药的合成路线选择、工艺设计及其质量研究方面实践经验丰富，颇有造诣。王立峰慧药咨询创始人沈阳药科大学制药60期，南开大学法律硕士，高级工程师，长三角药学高等研究院硕士生导师，曾在中国药学会科技开发中心、济民可信、北大方正医药、北京康远制药等公司就职，创办《中国新药述评》，参与《跨国药企成功启示录》编写，30年从事新药立项评估和企业产品线规划工作经验，共完成170余项各类创新药物及器械产品的评价与估值，参与完成500余项各类药物立项决策参考意见，完成40余家企业战略规划或产品线规划，完成7家公司上市募投计划书撰写，完成6个医药化工类园区规划，完成3个医药企业研究院建设方案，并为多家企业进行研究院管理体系及考核体系设计，促成10余个药物及医疗器械项目购并转让。扑满山沙龙、益研堂等多个行业论坛沙龙发起人。陈  洪千金药业研究院院长四川省“千人计划”医药专家，河北省“百人计划”医药专家和外专局特聘专家，他于1996年获得美国Cleveland State University分析化学博士学位，之后又在全美心脏科排名第一的Cleveland Clinic Foundation 做了两年生物医药博士后研究。曾担任过全球最大仿制药公司Teva的分析和技术服务总监以及美国Nexgen Pharma的研发总监和高级总监，拥有25年在美国Adolor、J&J、Teva和Nexgen Pharma和国内药业公司丰富的工作和管理经历，亲自领导和参与70多个新药和仿制药的研发，其中一个一类新药（Entereg）、20个ANDA固体和液体制剂产品获得美国FDA批准和50个中国仿制药批准上市。曾带领国内一上市公司化药团队在4年半内实现了3个零的突破：第一个国际化批文，第一个一致性批件，第一个BD转让。曾经出版、演讲和展示了120多篇在药物研发，生物医学方面的科学论文。现任某上市生物制药股份有限公司副总经理，研究院院长，负责小分子创新药、大分子生物药、改良型新药、高端仿制药研发和国际制剂注册申报，有着丰富的团队建设、项目管理、国际认证、研发质量体系建立、制剂注册申报的经验。吴四清湖南九维生物医药有限公司创始人&董事长吴四清，湖南九维生物医药有限公司创始人&董事长。1993年武汉大学化学系研究生毕业后赴美国留学，就读于Philadelphia College of Pharmacy and Science （美国第一所药学院：美国费城药学院）并获得全额奖学金。1998年至2005年在美国Merck制药（MSD默沙东）研发实验室 Merck Research Laboratories (MRL)和Merck Manufacturing Division（MMD）药物分析和药政法规部门（Regulatory and Analytical Science) 工作，获得年度最高成就奖。2006年加入美国药典委员会USP工作（Senior Scientist）。 2007年决定回国发展，先后在天津天士力集团，上海药明康德新药研发公司（合全药业）等担任企业高管和研发负责人，带领研发团队成功完成多个原料药 API 和制剂项目的药学研究，国际/国内注册申报和产业化，获选江苏省南京市2017年高端人才团队项目负责人。2020年初回到家乡湖南长沙，创立从关键医药中间体，原料药 API，高端制剂和新药研发一站式CDMO服务平台，致力成为具有国际先进水平的生物医药研发和生产企业。李范珠浙江中医药大学教授李范珠 理学博士，二级教授，博士生导师，博士后合作导师，浙江省教学名师，享受国务院特殊津贴专家。浙江中医药大学（富阳）中药制剂研究中心主任，浙江中医药大学中药制剂研究所所长。曾任浙江中医药大学药学院院长、浙江中医药大学中医药科学院副院长、浙江中医药大学浙八味（道地药材）研究所所长，主要从事中药学和药剂学领域研究。赵  刚健民集团研究院院长赵刚，博士，教授级高工，主要从事中药创新与儿科制剂的研发工作，现任健民集团研究院院长，专注于中药新药研发及儿科新制剂的立项开发。赵  维山东大学药品监管科学研究院副院长临床药理研究所所长山东大学药品监管科学研究院副院长山东大学临床药理研究所所长、药学院临床药学系主任山东大学齐鲁医院药械临床试验中心执行主任山东大学第二医院机构副主任山东省千佛山医院药物临床研究中心主任国家药品监督管理局创新药物临床研究与评价重点实验室常务副主任国家药品监督管理局新药审评专家；欧盟药监局新药审评专家、建模与仿真委员会常务委员、创新方法委员会专家；法国药监局儿科药物评审委员会副主任；British Journal of Clinical Pharmacology、Journal of Clinical Pharmacology等6本SCI杂志副主编/编委在Lancet Child Adolesc Health, EBioMedicine, Adv Drug Deliv Rev, Clin Microbiol Infect, Clin Pharmacol Ther, J Control Release, Eur J Med Chem等杂志发表SCI论文170余篇。获得国家发改委“两重”项目、科技部重大新药创制专项、国家重点研发计划、国家自然科学基金、欧盟第七框架、地平线2020等20余项课题资助；做为PI主持创新药早期临床试验100余项；荣获省部级科技进步二等奖3项、教学成果二等奖1项。陈宇哲北京升斗小药梦想科技有限公司董事长华诺通（北京）医药科技有限公司 副总裁陈宇哲，北京升斗小药梦想科技有限公司董事长，华诺通（北京）医药科技有限公司副总裁、中国医药报专栏作者，资深医药投资人，目前进行药械结合药物开发、药械结合资源整合工作。王文龙北京中创安堂医药科技有限公司众创安堂（天津）制药有限公司， 总经理毕业于中国药科大学药物制剂专业，执业药师。中国非处方药协会国际化专业委员会副秘书长。具有近三十年年的药品生产、研发经验。曾任职天津中央药业，北京舒泰神药业，北京中创安堂医药科技有限公司等，历任生产部长，质量部长和研发总监等职位。参与鼠神经生长因子（1类新药），黄芪多糖注射剂（1类新药）的注册和落产。主持过50余个仿制药的开发和注册。熟悉中美欧日等药品注册的法规，对国内外非处方药的监管和注册有深入的研究。刘超山东百诺医药市场部总监刘超 硕士研究生/工程师/执业药师山东百诺医药股份有限公司   市场部总监hcxf Pharmaceutical Co.,Ltd.博士工作站特聘专家中国食品学会酶制剂技术委员会委员中国中医药研究促进会肛肠分会理事临沂市医药生物技术学会委员《生物传感器转化项目》荣获山东省科技创新二等奖；《胃肠道健康菌群的产业化与应用》荣获山东省知识产权服务协会科学技术进步奖；2012-2022年在L司陆续担任学术经理、产品经理、市场部产品线总监等职务，担任产品线总监期间其负责的肿瘤、泌尿、呼吸、妇科、眼科领域主打10余个品种销售额超越40亿/年。荣获全国工商联泰山医药论坛《 2023-2024年度医药企业优秀管理人才》。郭新峰南京循证生物科技有限公司创始人CPU92级化学制药专业，在外企上海强生、葛兰素史克从事医药销售10年，在广东一心药业、南京海辰药业、永信药品等上市公司从事学术推广和市场规划8年市场总监，2013年创办南京循证生物科技有限公司。特长：发表营销、招标、推广等文章上百篇，长期担任知名药企营销顾问。洞察医药宏观政策，深刻理解产品优势，把握营销风向，长期为药企和医药自然人量身定做产品代理咨询、营销方案设计、国家集采报价及接续中选等实战项目。安晓霞上海迪赛诺医药集团股份有限公司 总经理教授级工程师，1989年毕业于中国科学院长春应用化学研究所，现任上海迪赛诺医药集团股份有限公司总经理，国家抗艾滋病病毒药物工程技术研究中心副主任，上海抗肿瘤化学药物工程技术研究中心主任，沈阳药科大学兼职教授，辽宁大学特聘创业导师，上海生物医药行业协会理事。近年来先后主持完成国家及省部级科技项目8项，授权中国发明专利34项。“十三五”期间，作为项目负责人主持参与国家重大新药创制科技重大专项2项，分别是“抗艾滋病一线用药依非韦伦片国内首仿获批生产”和“抗肿瘤一类新药希明哌瑞临床试验研究”。目前主要负责公司全球制剂业务，带领公司致力于科技创新和产业化推进，特别在艾滋病药物、抗肿瘤药物的创新和产业化方面作出重要贡献。夏燕百花村医药集团副总经理，礼华生物夏燕董事长临床药理专业背景，近20年临床CRO公司运营经验，曾领导和负责过百项新药II/III临床研究,涉及多个医学领域。曾承担国家重大新药专项全新靶点创新药早期临床研究负责人,以及973国家课题、卫生部行业基金课题口服砷剂临床研究负责人。曾领导和负责的过百项创新药I期临床研究及仿制药BE临床研究, 对临床试验医学服务及临床开发策略、临床运营管理、注册风险控制及临床研究质量体系建设,以及仿制药生物等效临床试验具有丰富的经验。管峥北京科临迈创科技有限公司 总经理北京大学药学院本科/硕士，荷兰莱顿大学临床药理学博士培训。曾任职于荷兰莱顿人类药物研究中心(CHDR)与强生中国研发临床药理部。先后为深度智耀，水木未来，深原质药等初创公司核心团队成员，现任北京科临迈创科技有限公司总经理。发表20余篇论文，申请国内外专利合计申请20余项。杨继荣卡乐康中国  释药配方技术经理从事药物制剂及辅料相关的技术工作二十多年。有多年的药物开发、生产及质量管理经验。 在亲水凝胶缓释骨架系统、缓释多颗粒系统以及渗透泵制剂方面有着丰富的配方开发及实践经验。*更多嘉宾更新中限时免费立即扫码报名参会咨询胡女士 13065724378

July 8, 2025 6:45 am ET RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that new data from its research pipeline for HIV prevention and treatment will be presented at the 13th International AIDS Society Conference on HIV Science (IAS 2025) taking place July 13-17, 2025, in Kigali, Rwanda. Merck will share new scientific findings from its HIV clinical development programs, including Phase 2 data on the safety and pharmacokinetics of MK-8527, an investigational, novel nucleoside reverse transcriptase translocation inhibitor (NRTTI), dosed orally once monthly, in development for the prevention of HIV as pre-exposure prophylaxis (PrEP). HIV clinical data presented at IAS 2025 from three Phase 3 trials (P051: NCT05631093; P052: NCT05630755; P054: NCT05766501) will examine the impact of preexisting resistance-associated mutations (RAMs) in proviral DNA on the virologic response to doravirine/islatravir (DOR/ISL), with a primary focus on M184I/V in proviral DNA. Data will also be presented on the clinical development program for a once-weekly oral combination of islatravir and ulonivirine (ISL/ULO) for the treatment of adults with HIV-1 infection. Data from two Phase 1 trials evaluating the safety and tolerability of weekly ulonivirine and drug interactions between islatravir and ulonivirine dosed weekly in adults without HIV and a Phase 2b dose-ranging study utilizing a higher (20mg) dose of islatravir and 3 doses of ulonivirine in treatment naive adults living with HIV-1 will be presented. Based on results from these trials and pharmacokinetic modeling that will also be presented, a once-weekly oral combination of islatravir (2mg) and ulonivirine (200mg) (MK-8591B) is moving forward in clinical development. “As we continue to advance our HIV research, we are excited to present data from across our HIV pipeline at IAS 2025, including new data from our nucleoside reverse transcriptase translocation inhibitors development programs,” said Dr. Elizabeth Rhee, vice president, global clinical development, Merck Research Laboratories. “With daily, weekly and monthly oral regimens in development, we aim to offer choices that can help address the evolving needs of individuals living with or impacted by HIV.” Select abstracts in the IAS 2025 program include: Abstract Title and Author Date HIV PREVENTION Safety and Pharmacokinetics of Once-Monthly MK-8527: a Phase 2 Study in Adults at Low Risk of HIV-1 Exposure, Mayer, K, et al. Late-Breaker Oral Presentation Wednesday, July 16, 2025 (15:00 – 16:00 CAT) HIV TREATMENT Switching to Doravirine/Islatravir (100mg/0.25mg) Once Daily Maintained Viral Suppression in the Presence of Archived M184I/V Resistance-Associated Mutations in Proviral DNA, Diamond, T, et al. Poster Session Wednesday, July 16, 2025 (12:15 – 13:15 CAT) A Double-Blind, Active-Controlled, Phase 2b Study to Evaluate the Efficacy and Safety of Ulonivirine in Combination with Islatravir in Virologically Suppressed Adults Living With HIV-1, Molina, J.M., et al. (*) Oral Presentation ART Strategies Tuesday, July 15, 2025 (10:45 – 11:45 CAT) A Double-Blind Placebo-Controlled, Phase 1 Study to Evaluate Extended Multiple Dosing of Ulonivirine (MK-8507) in Adults Without HIV, Nussbaum, J, et al. Virtual Poster An Open-Label Phase 1 Study to Evaluate Drug Interactions Between Multiple Weekly Doses of Ulonivirine (MK-8507) and Single Doses of Islatravir in Adults Without HIV, Nussbaum, J, et al. Virtual Poster Phase 2 Once-Weekly Dose Optimization for Ulonivirine (MK-8507) in Combination with Islatravir (2mg), Pham, M, et al. Virtual Poster (*) Previous ulonivirine development program utilizing a higher (20mg) dose of islatravir. This year at IAS, Merck will host a policy symposium “Harnessing the Private Sector to Deliver HIV Prevention” on Tuesday, July 15, from 18:00 – 19:30 CAT. Merck will also host a medical symposium “Let’s Talk About It – Practical Case Discussions” on Wednesday, July 16, from 12:15 – 13:15 CAT, which will cover critical considerations when treating HIV today, as well as a deep dive into the DOR/ISL resistance profile based on Phase 3 data. Both events will be open to all registered attendees, virtually and in-person. Separately, Merck will be hosting a virtual investor event where scientific and commercial leaders will give an overview of the company’s advancing research pipeline in HIV treatment and prevention on Thursday, July 17, at 9:00AM ET. Investors, analysts, members of the media, and the general public are invited to listen to a webcast of the presentation at this weblink. For more details about Merck’s clinical development program in HIV treatment and prevention, click here. Merck’s Commitment to HIV For more than 35 years, Merck has been committed to scientific research and discovery in HIV leading to scientific breakthroughs that have helped change HIV treatment. Our work has helped pioneer the development of new options across multiple drug classes to help those impacted by HIV. Today, we are developing a series of antiviral options designed to help people manage their HIV and to help prevent HIV, with the goal of reducing the growing burden of infection worldwide. We want to ensure people are not defined by HIV, and our work focuses on transformational innovations, collaborations with others in the global HIV community, and access initiatives aimed at helping to end the HIV epidemic for everyone. Indications and usage for PIFELTRO® (doravirine) and DELSTRIGO® (doravirine, lamivudine, and tenofovir disoproxil fumarate) in the U.S. PIFELTRO is indicated in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in adult patients with no prior ARV treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable ARV regimen with no history of treatment failure and no known substitutions associated with resistance to doravirine. DELSTRIGO is indicated as a complete regimen for the treatment of HIV-1 infection in adult patients with no prior ARV treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable ARV regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of DELSTRIGO. Selected Safety Information Warning: Posttreatment Acute Exacerbation of Hepatitis B Virus (HBV) for DELSTRIGO All patients with HIV-1 should be tested for the presence of HBV before initiating ARV therapy. Severe acute exacerbations of HBV have been reported in people with concomitant HIV-1 and HBV who have discontinued products containing lamivudine or tenofovir disoproxil fumarate (TDF), which are components of DELSTRIGO. Patients coinfected with HIV-1 and HBV who discontinue DELSTRIGO should be monitored with both clinical and laboratory follow-up for at least several months after stopping DELSTRIGO. If appropriate, initiation of anti-HBV therapy may be warranted. Contraindications PIFELTRO and DELSTRIGO are contraindicated when coadministered with drugs that are strong cytochrome P450 (CYP)3A enzyme inducers (including the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, and phenytoin; the androgen receptor inhibitor enzalutamide; the antimycobacterials rifampin and rifapentine; the cytotoxic agent mitotane; and the herbal product St. John’s wort (Hypericum perforatum)), as significant decreases in doravirine plasma concentrations may occur, which may decrease the effectiveness of DELSTRIGO and PIFELTRO. DELSTRIGO is contraindicated in patients with a previous hypersensitivity reaction to lamivudine. Warnings and Precautions Severe Skin Reactions Severe skin reactions, including Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN), have been reported during the postmarketing experience with doravirine-containing regimens. Discontinue PIFELTRO or DELSTRIGO, and other medications known to be associated with severe skin reactions, immediately if a painful rash with mucosal involvement or a progressive severe rash develops. Clinical status should be closely monitored, and appropriate therapy should be initiated. New or Worsening Renal Impairment Renal impairment, including cases of acute renal failure and Fanconi syndrome, have been reported with the use of TDF. DELSTRIGO should be avoided with concurrent or recent use of a nephrotoxic agent (eg, high-dose or multiple NSAIDs). Cases of acute renal failure after initiation of high-dose or multiple NSAIDs have been reported in people living with HIV with risk factors for renal dysfunction who appeared stable on TDF. Prior to or when initiating DELSTRIGO, and during treatment, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus. Discontinue DELSTRIGO in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome. Discontinue DELSTRIGO if estimated creatinine clearance declines below 50 mL/min. Bone Loss and Mineralization Defects In clinical trials in adults living with HIV, TDF was associated with slightly greater decreases in bone mineral density (BMD) and increases in biochemical markers of bone metabolism. Serum parathyroid hormone levels and 1,25 Vitamin D levels were also higher. Cases of osteomalacia associated with proximal renal tubulopathy have been reported with the use of TDF. The effects of TDF-associated changes in BMD and biochemical markers on long-term bone health and future fracture risk in adults are unknown. Immune Reconstitution Syndrome Immune reconstitution syndrome can occur, including the occurrence of autoimmune disorders with variable time to onset, which may necessitate further evaluation and treatment. Drug Interactions Because DELSTRIGO is a complete regimen, coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended. Coadministration of PIFELTRO with efavirenz, etravirine, or nevirapine is not recommended. If DELSTRIGO is coadministered with rifabutin, take one tablet of DELSTRIGO once daily, followed by one tablet of doravirine (PIFELTRO) approximately 12 hours after the dose of DELSTRIGO. If PIFELTRO is coadministered with rifabutin, increase PIFELTRO dosage to one tablet twice daily (approximately 12 hours apart). Consult the full Prescribing Information prior to and during treatment for more information on potential drug-drug interactions. Dosage and Administration/Specific Populations Renal Impairment Because DELSTRIGO is a fixed-dose combination tablet and the dosage of lamivudine and TDF cannot be adjusted, DELSTRIGO is not recommended in patients with estimated creatinine clearance less than 50 mL/min. Adverse Reactions The most common adverse reactions with DELSTRIGO (incidence ≥5%, all intensities) were dizziness (7%), nausea (5%), and abnormal dreams (5%). The most common adverse reactions with PIFELTRO (incidence ≥5%, all intensities) were nausea (7%), dizziness (7%), headache (6%), fatigue (6%), diarrhea (6%), abdominal pain (5%), and abnormal dreams (5%). By week 96 in DRIVE-FORWARD, 2% of adult participants in the PIFELTRO group and 3% in the darunavir+ritonavir (DRV+r) group had adverse events leading to discontinuation of study medication. By week 96 in DRIVE-AHEAD, 3% of adult participants in the DELSTRIGO group and 7% in the efavirenz (EFV)/emtricitabine (FTC)/TDF group had adverse events leading to discontinuation of study medication. In DRIVE-FORWARD, mean changes from baseline at week 48 in LDL-cholesterol (LDL-C) and non-HDL-cholesterol (non-HDL-C) were pre-specified. LDL-C: -4.6 mg/dL in the PIFELTRO group vs 9.5 mg/dL in the DRV+r group. Non-HDL-C: -5.4 mg/dL in the PIFELTRO group vs 13.7 mg/dL in the DRV+r group. The clinical benefits of these findings have not been demonstrated. In DRIVE-AHEAD, mean changes from baseline at week 48 in LDL-C and non-HDL-C were pre-specified. LDL-C: -2.1 mg/dL in the DELSTRIGO group vs 8.3 mg/dL in the EFV/FTC/TDF group. Non-HDL-C: -4.1 mg/dL in the DELSTRIGO group vs 12.7 mg/dL in the EFV/FTC/TDF group. The clinical benefits of these findings have not been demonstrated. In DRIVE-SHIFT, mean changes from baseline at week 24 in LDL-C and non-HDL-C were pre-specified. LDL-C: -16.3 mg/dL in the DELSTRIGO group vs -2.6 mg/dL in the PI + ritonavir group. Non-HDL-C: -24.8 mg/dL in the DELSTRIGO group vs -2.1 mg/dL in the PI + ritonavir group. The clinical benefits of these findings have not been demonstrated. In DRIVE-AHEAD, neuropsychiatric adverse events were reported in the three pre-specified categories of sleep disorders and disturbances, dizziness, and altered sensorium. Twelve percent of adult participants in the DELSTRIGO group and 26% in the EFV/FTC/TDF group reported neuropsychiatric adverse events of sleep disorders and disturbances; 9% in the DELSTRIGO group and 37% in the EFV/FTC/TDF group reported dizziness; and 4% in the DELSTRIGO group and 8% in the EFV/FTC/TDF group reported altered sensorium. The safety of DELSTRIGO in virologically-suppressed adults was based on week 48 data from participants in the DRIVE-SHIFT trial. Overall, the safety profile in virologically-suppressed adult participants was similar to that in participants with no ARV treatment history. Serum ALT and AST Elevations: In the DRIVE-SHIFT trial, 22% and 16% of participants in the immediate switch group experienced ALT and AST elevations greater than 1.25 X ULN, respectively, through 48 weeks on DELSTRIGO. For these ALT and AST elevations, no apparent patterns with regard to time to onset relative to switch were observed. One percent of participants had ALT or AST elevations greater than 5 X ULN through 48 weeks on DELSTRIGO. The ALT and AST elevations were generally asymptomatic, and not associated with bilirubin elevations. In comparison, 4% and 4% of participants in the delayed switch group experienced ALT and AST elevations of greater than 1.25 X ULN through 24 weeks on their baseline regimen. Pregnancy/Breastfeeding There is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to PIFELTRO or DELSTRIGO during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Inform individuals with HIV-1 infection of the potential risks of breastfeeding, including: (1) HIV-1 transmission (in HIV-1–negative infants), (2) developing viral resistance (in HIV-1–positive infants), and (3) serious adverse reactions in a breastfed infant similar to those seen in adults. About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2024 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov). Please see Prescribing Information for PIFELTRO (doravirine) at: https://www-merck-com.libproxy1.nus.edu.sg/product/usa/pi_circulars/p/pifeltro/pifeltro_pi.pdf and Patient Information for PIFELTRO at: https://www-merck-com.libproxy1.nus.edu.sg/product/usa/pi_circulars/p/pifeltro/pifeltro_ppi.pdf Please see Prescribing Information for DELSTRIGO (doravirine, lamivudine, and tenofovir disoproxil fumarate) at: https://www-merck-com.libproxy1.nus.edu.sg/product/usa/pi_circulars/d/delstrigo/delstrigo_pi.pdf and Patient Information for DELSTRIGO at: https://www-merck-com.libproxy1.nus.edu.sg/product/usa/pi_circulars/d/delstrigo/delstrigo_ppi.pdf Media Contacts: Julie Cunningham, (617) 519-6264 Deb Wambold, (215) 779-2234 Investor Contacts: Peter Dannenbaum, (732) 594-1579 Steven Graziano, (732) 594-1583