云顶新耀(01952)涨超3%，截至发稿，涨3.46%，报48.44港元，成交额1.31亿港元。 消息面上，据云顶新耀官微消息，12月17日，公司宣布，美国食品药品监督管理局(FDA)已批准LIB Therapeutics旗下心血管疾病领域产品乐瑞泊(LEROCHOLTM,通用名:lerodalcibep-liga)注射液的生物制品 许可申请(BLA)，在饮食控制和运动的基础上，用于降低成人高胆固醇血症(包括杂合子型家族性高胆固 醇血症(HeFH))患者的低密度脂蛋白胆固醇(LDL-C)水平。2025年12月，云顶新耀与海森生物签署授权 许可协议，获得了在大中华区开展乐瑞泊(莱达西贝普，Lerodalcibep)的后续临床开发、注册和商业化的 独家许可。 乐瑞泊是一款新型小分子蛋白结合的第三代PCSK9抑制剂，旨在帮助患者达成并长期维持其LDL-C控制 目标。作为首个PCSK9抑制剂融合蛋白，乐瑞泊免疫原性低，安全性出众。乐瑞泊经开发为更贴近患者 需求、更加便捷，可由患者自行给药、每月一针、单次小体积皮下注射，并具有较长的室温稳定性(最 长可达3个月)，可使患者自行选择时间和地点用药，居家旅行皆可方便储存或携 ...

消息面上，据云顶新耀官微消息，12月17日，公司宣布，美国食品药品监督管理局(FDA)已批准LIB Therapeutics旗下心血管疾病领域产品乐瑞泊(LEROCHOLTM, 通用名: lerodalcibep-liga)注射液的生物制 品许可申请(BLA)，在饮食控制和运动的基础上，用于降低成人高胆固醇血症(包括杂合子型家族性高胆 固醇血症(HeFH))患者的低密度脂蛋白胆固醇(LDL-C)水平。2025年12月，云顶新耀与海森生物签署授 权许可协议，获得了在大中华区开展乐瑞泊(莱达西贝普，Lerodalcibep)的后续临床开发、注册和商业化 的独家许可。 乐瑞泊®是一款新型小分子蛋白结合的第三代PCSK9抑制剂，旨在帮助患者达成并长期维持其LDL-C控 制目标。作为首个PCSK9抑制剂融合蛋白，乐瑞泊免疫原性低，安全性出众。乐瑞泊经开发为更贴近患 者需求、更加便捷，可由患者自行给药、每月一针、单次小体积皮下注射，并具有较长的室温稳定性 (最长可达3个月)，可使患者自行选择时间和地点用药，居家旅行皆可方便储存或携带。以上特点使乐 瑞泊成为已获批的PCSK9抑制剂的独特替代方案。 智通财经APP获悉，云顶 ...

从市场需求看，心血管疾病是全球及中国主要死亡原因，LDL-C水平升高是引发动脉粥样硬化、冠心 病、脑梗死等严重心血管事件的关键因素，降低LDL-C水平可改善患者预后。但现有疗法下，数百万心 血管疾病患者或高风险人群(包括FH)未能达到最新指南推荐的LDL-C控制目标。中国血脂异常人群约4 亿，仅14%接受降脂治疗，存在显著未满足医疗需求，而PCSK9抑制剂在降LDL-C方面疗效与安全性俱 佳，市场潜力大。 当前中国已有多款PCSK9抑制剂获批，2024年市场规模约30亿元，同比增长95%。据弗若斯特沙利文报 告，预计2030年该市场将扩至约100亿元。值得关注的是，乐瑞泊在中国的专利独占期至2039年，叠加 产品优势与临床数据支撑，有望在市场竞争中占据一席之地。 据悉，云顶新耀于2025年12月与海森生物签署授权许可协议，获得乐瑞泊在大中华区后续临床开发、注 册及商业化的独家许可。目前，该产品已向欧洲药品管理局(EMA)递交上市申请，预计2026年上半年于 大中华区递交BLA，最快2027年获批上市，将为公司心血管业务增长注入动力。 乐瑞泊是一款新型小分子蛋白结合的第三代PCSK9抑制剂，作为首个PCSK9抑 ...

12月17日，港股创新药企云顶新耀(1952.HK)宣布，美国食品药品监督管理局(FDA)已批准LIB Therapeutics旗下心血管疾病领域创新产品乐瑞泊®(LEROCHOLTM, 通用名: lerodalcibep-liga)注射液的 生物制品许可申请(BLA)，在饮食控制和运动的基础上，用于降低成人高胆固醇血症(包括杂合子型家族 性高胆固醇血症(HeFH))患者的低密度脂蛋白胆固醇(LDL-C)水平。云顶新耀拥有该产品在大中华区的 后续临床开发、注册和商业化的独家许可，预计明年上半年于大中华区递交BLA，为其心血管业务的长 期增长注入强劲动力。 高效、便捷、安全三位一体 乐瑞泊®是一款新型小分子蛋白结合的第三代PCSK9抑制剂，由美国公司LIB Therapeutics研发，旨在帮 助患者达成并长期维持其 LDL-C 控制目标。作为首个PCSK9抑制剂融合蛋白，乐瑞泊®免疫原性低， 安全性出众，且经开发为更贴近患者需求、更加便捷，可由患者自行给药、每月一针、单次小体积皮下 注射，并具有较长的室温稳定性(最长可达3个月)，可使患者自行选择时间和地点用药，居家旅行皆可 方便储存或携带。以上特点使乐瑞泊® ...

高效、便捷、安全三位一体 乐瑞泊®有望开启降脂治疗新格局 12月17日，港股创新药企云顶新耀(1952.HK)宣布，美国食品药品监督管理局(FDA)已批准LIB Therapeutics旗下心血管疾病领域创新产品乐瑞泊(LEROCHOL, 通用名: lerodalcibep-liga)注射液的生物制 品许可申请(BLA)，在饮食控制和运动的基础上，用于降低成人高胆固醇血症(包括杂合子型家族性高胆 固醇血症(HeFH))患者的低密度脂蛋白胆固醇(LDL-C)水平。云顶新耀拥有该产品在大中华区的后续临 床开发、注册和商业化的独家许可，预计明年上半年于大中华区递交BLA，为其心血管业务的长期增长 注入强劲动力。 PCSK9 抑制剂具有强效降脂作用，在降低 LDL-C 水平方面显示出优良的疗效与安全性，从而显著减少 心血管事件风险。随着乐瑞泊®的获批，这一治疗格局有望迎来重要升级。 成熟商业化体系加持 云顶新耀加速乐瑞泊®大中华区落地 此次乐瑞泊®获得FDA批准，是云顶新耀在心血管代谢领域的重要战略进展。2025年12月，云顶新耀与 海森生物签署授权许可协议，获得了在大中华区开展乐瑞泊®的后续临床开发、注册和商业化的 ...

Core Viewpoint - Amgen's drug Repatha® (evolocumab injection) has shown significant efficacy in reducing the incidence of first major cardiovascular events by 25% and first myocardial infarctions by 36% in high-risk patients without prior events, supporting the broader application of PCSK9 inhibitors [1] Group 1 - Amgen's stock price increased by 0.9% following the announcement of the VESALIUS-CV study results [1] - The VESALIUS-CV study results indicate a substantial reduction in cardiovascular events, which may enhance the market potential for PCSK9 inhibitors [1]

Core Points - The 2025 National Medical Insurance Directory negotiations have officially commenced, highlighting the importance of pharmaceutical innovation and patient access to medications [1] - The atmosphere at the negotiations is characterized by a cautious and low-key approach from pharmaceutical representatives, with an increased emphasis on confidentiality [3][4] - A total of 535 drugs are under review, with 311 outside the directory and 224 within it, alongside 121 high-value drugs reviewed under the commercial insurance innovation drug directory [9][10] Group 1: Negotiation Atmosphere - The entry process for pharmaceutical representatives was notably quieter and more orderly compared to previous years, reflecting a more subdued approach [3][4] - Representatives from both domestic and multinational pharmaceutical companies, including notable names like 恒瑞医药 and 阿斯利康, participated in the negotiations [4][9] Group 2: Key Drug Categories - Antibacterial drugs are expected to be a significant focus in the afternoon session of the negotiations, with specific products like 万古霉素 being highlighted [9][10] - Innovative drugs, including CAR-T products and new lipid-lowering medications, are also under consideration, with 恒瑞医药 presenting multiple products for initial review [10][12] Group 3: Market Insights - The PCSK9 inhibitor 瑞卡西单抗 has gained attention for its long-acting properties, with a market size of 1.32 billion yuan in 2023, representing 7.8% of the national lipid-lowering drug market [10][11] - The long-acting 阿立哌唑微球 from 丽珠集团 is another product of interest, potentially replacing oral formulations and capturing market share if included in the insurance directory [12]

Core Insights - Merck & Co., Inc. (NYSE:MRK) is recognized for its potential as a strong investment, particularly highlighted in the context of Roth IRA stocks [1][4]. Group 1: Clinical Trial Results - Merck reported positive topline results from its Phase 3 CORALreef Lipids trial for enlicitide decanoate, an investigational oral PCSK9 inhibitor for hypercholesterolemia, on September 2, 2025 [2]. - The study met all endpoints, showing significant reductions in LDL-C, non-HDL-C, ApoB, and Lp(a) compared to placebo at Week 24 [3]. - Safety outcomes were favorable, with low discontinuation rates and no significant differences in adverse events between treatment groups, reinforcing the drug's promise as the first oral macrocyclic peptide PCSK9 inhibitor [3]. Group 2: Company Overview - Merck & Co., Inc. is a global biopharmaceutical company focused on developing innovative medicines, vaccines, and health solutions aimed at saving and improving lives worldwide [4].

Financial Data and Key Metrics Changes - Merck is in a transformation phase with a diversified set of growth drivers, aiming for over $50 billion in revenues by the mid-2030s from its pipeline [3][4] - The company is launching 20 products, most of which have blockbuster potential [3][4] Business Line Data and Key Metrics Changes - KEYTRUDA continues to show strong growth with 42 approved indications in the U.S. across 18 tumor types, with expectations for continued growth from new indications [6][7] - The subcutaneous formulation of KEYTRUDA is anticipated to achieve 30% to 40% adoption within 18 to 24 months post-launch [9][11] Market Data and Key Metrics Changes - The company is well-positioned to manage the impact of tariffs and has a diverse supply chain footprint [41][42] - The impact of the Most Favored Nation (MFN) policy is expected to be manageable, as it only accounts for less than 10% of revenues [42][43] Company Strategy and Development Direction - Merck is focused on innovation and expanding its pipeline, with plans to increase R&D investments due to a strong pipeline of 80 Phase III clinical programs [51][52] - Business development remains a priority, with a focus on bringing in innovative science that addresses unmet medical needs [67][68] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in navigating the loss of exclusivity for KEYTRUDA and emphasized the importance of their pipeline in driving future growth [5][6] - The company is optimistic about the readouts from its oncology and HIV pipelines in the coming year [80][81] Other Important Information - The company is preparing for the launch of its oral PCSK9 inhibitor, which is expected to democratize access to this treatment [60][62] - Merck is also excited about its cancer vaccine program, focusing on early-stage cancers with potential curative opportunities [39][40] Q&A Session Summary Question: What are the growth avenues for KEYTRUDA? - Management expects continued growth from new indications, including early-stage lung cancer and women's cancers [7][8] Question: How will the adoption of the subcutaneous formulation of KEYTRUDA be affected? - Factors such as pricing, access, and the J code will influence adoption rates, with expectations of 30% to 40% adoption within 18 to 24 months [10][11] Question: What is the confidence level in the TROP-two ADC program? - Management expressed confidence based on early signals and extensive clinical trials, highlighting its unique properties and potential in maintenance settings [17][18] Question: How does Merck plan to address macroeconomic headwinds like tariffs? - The company has a diverse supply chain and is well-positioned to manage tariff impacts, focusing on innovation and product launches [41][42] Question: What is the outlook for Gardasil in China? - Gardasil is not expected to drive significant growth in China, with future growth anticipated from international markets and new product launches [69][70] Question: What are the expectations for the cancer vaccine program? - The program is focused on early-stage cancers, with positive readouts expected in the next couple of years [39][40]

Core Viewpoint - Merck (MRK.US) announced positive results from the Phase III CORALreef Lipids study for Enlicitide, a treatment for hypercholesterolemia, marking the largest Phase III study completed for this drug [1] Group 1: Study Results - The CORALreef Lipids study is the largest Phase III trial completed for Enlicitide, which has previously successfully completed two other Phase III studies [1] - Enlicitide (MK-0616) is an oral cyclic peptide PCSK9 inhibitor developed by Merck [1] Group 2: Mechanism of Action - PCSK9 (proprotein convertase subtilisin/kexin type 9) is primarily expressed in the liver and is a contributor to elevated levels of "bad cholesterol" LDL-C [1] - PCSK9 binds to receptors on liver cells responsible for clearing LDL-C, resulting in a significant portion of LDL-C being unable to be absorbed [1]