Bristol Myers Squibb Co.

License out项目近年来，中国创新药企业通过对外授权、合作开发和NewCo等出海模式，与国际MNC达成BD交易，以此拓展全球市场。这种模式不仅加速了中国创新药的国际化进程，也为中国药企带来了可观的经济效益。对外授权(license out)模式由国内企业将产品的海外权益授予合作企业，获得首付款、进入注册临床或批准上市的里程碑付款、以及一定比例的销售分成;合作企业负责授权后的国际临床开发和商业化销售。对外授权可大幅降低创新药出海的投入门槛，同时缓解企业资金营运压力，成为目前创新药出海的主流模式。根据美柏资本、医药魔方及各大公司公告等公开数据显示，2024年中国创新药license out交易数量超过120起，交易总金额超500亿美元，超越2023年的披露交易总金额465亿美元，创新药出海增长势头仍在延续。据百英诺科技不完全统计，2024全年发生的药物授权许可的交易共计70笔，占整体license out的50%以上，以下数据分析只针对药物授权许可交易，不包括技术平台授权、合作开发等其他交易模式。恒瑞医药与Hercules就GLP-1类药物签订的60亿美元合同，成为2024年度国产创新药license out交易的领头羊。2024年国产创新药license out交易总金额TOP10如下：国际上，近年来，更多的国产创新药资产的价值得到阿斯利康、诺华、默沙东等诸多国际MNC认可，收购的权益包括小分子、ADC、单抗、多抗和小核酸等多个方向。此外，近期的license out交易不再仅限于百济神州、信达生物等Biotech企业。越来越多于近年来处于早期阶段的Biotech，如宜联生物、安锐生物、舶望制药等，也开始积极参与这一模式，寻求与国际市场的合作机会。同时，恒瑞医药等传统转型药企在license out交易中的出现频次也有所增加，这进一步证明了该模式在中国创新药出海战略中的重要地位。国内方面，国谈下创新药价格降幅明显，处于药品实际商业回报率普遍低于预期的承压环境。以2023年医保谈判为例，部分企业的明星产品虽然成功续约，但价格降幅明显，如翰森的培唑帕尼和辉凌的奥雷巴替尼等，续约价格分别下降45%和40%。医药产业下游的医疗终端同样面临控费压力，其中医院端受到“药占比”“零加成”DRG/DIP模式等政策影响进一步控制诊疗成本，零售端在药品比价系统、医保个账改革等措施实行后利润空间将被压缩。在此背景下，中国药企纷纷开始寻求新的发展之路，主动地参与到国外的竞合大循环中。与国内市场相比，部分海外市场的药品定价相对较高，且部分国家和地区的医保体系较为完善，能够为创新药提供较好的支付保障，使得国内创新药企看到了在海外市场获得更高回报的可能性。如今，出海成为中国药企消化供给、赢回市场回报的关键策略之一。图：2021年全球前25名畅销药在各国的相对价格水平（假设美国药价水平为100%）资料来源：头豹研究院，中国银河证券研究院高频领域从交易项目所在的疾病领域来看，肿瘤仍是2024年交易最火热的适应症，共产生44笔交易。同时，自免领域（10笔）、代谢性疾病（3笔）和心血管疾病（3笔）等领域的交易事件开始增多。企业的BD交易更加注重满足当前未满足的临床需求。对2024年中国创新药对外授权许可的药物类型进一步分析，抗体、小分子和ADC药物是交易的主要阵地。29笔抗体类药物交易中，包含单抗类药物20个，双抗药物11个，多抗药物2个。从已披露的项目研发阶段来看，license out呈现出显著的更早期的项目偏好性，其中临床前（包括IND）项目数量远超其他阶段管线，已上市的成熟项目也颇受关注。早期和后期临床研究的项目占比较小。结合药物类型和项目交易阶段分析，ADC项目和小分子项目以临床前为主要交易阶段，抗体类药物在临床前、I期、II期和上市阶段均有交易。创新技术不断推陈出新，不同于美国等发达国家在化学药、单抗药等领域布局早且具有显著的优势，新兴的双抗和ADC等为中国创新药出海提供了机会，海外企业也正积极将具有管线创新性与临床价值的产品收入囊中。活跃企业2024年，默沙东、阿斯利康和IDEAYA Biosciences是国际MNC活跃度TOP3，默沙东与4家中国药企分别签订了授权许可协议，位居第一，其中3笔交易在本年度国产创新药license out交易总金额TOP10榜上有名。阿斯利康和IDEAYA Biosciences均三度出手买入国内创新药权益。交易项目信息如下表所示:                                         国内创新药license out趋势分析岁末年初，创新药出海浪潮再起。2025刚开年，国内Biotech便接连达成了数笔BD交易，Roches对信达DLL3-ADC的全球独家许可；和正医药与强生在BTK Protac 赛道的全球研发战略合作；宜联与AZ在抗肿瘤ADC联合用药的临床研究合作；先声再明与艾伯维就T细胞衔接器技术平台在多发性抗骨髓瘤的临床开发进程的合作，都可圈可点。预计2025年国内创新药的出海在交易标的、合作模式和规模上都会有更大的突破和进展。（一）潜在BD交易标的1.1 中枢神经系统疾病阿尔兹海默症（AD）人群广、病程长、市场需求旺盛。国内已有至少983万AD患者，随着人口老龄化的发展，国内AD患者数量也将维持增长态势。AD病程可达12年，早诊断及治疗助于延缓疾病进展。2024年12月6日，Muna Therapeutics宣布与GSK达成一项研究合作，本次合作的核心是Muna的专有MiND-MAP平台，利用单细胞空间多组学和生物信息学技术来识别与特定疾病相关的遗传、细胞和其他分子机制，旨在发现和验证用于治疗阿尔茨海默病的创新药物靶点。Muna将从GSK获得3350万欧元（约2.57亿元人民币）的预付款。此外，Muna发现的每个靶点还可获得高达1.4亿欧元（约10.76亿元人民币）的里程碑付款，Muna将有权获得任何商业化产品的分层版税。1.2 放射性核素偶联药物（RDC）诺华的Pluvicto于2022年3月在美国获批，是首款用于治疗转移性去势抵抗性前列腺癌（mCRPC）患者的靶向放射性药物，2022年全球销售额2.71亿美元，2023年达到9.8亿美元，同比暴涨261%。除了诺华，礼来、阿斯利康，拜耳外，礼来、强生、BMS和罗氏等跨国药企巨头也在布局核药赛道。2024年6月，Radionetics Oncology宣布，已经与礼来达成战略合作，将共同推进靶向GPCR的小分子放射性药物。此次合作的预付款为1.4亿美元，礼来还拥有未来以10亿美元收购该公司的独家选择权。国内方面，辐联科技在今年7月达成1笔临床前的RDC项目的授权许可交易：1.3 小核酸药物2024年，国内小核酸BD不容小觑。舶望制药的近42亿美元出海，高居小核酸历年BD交易额榜首。瑞博生物与勃林格殷格翰的20亿美元合作，也挤进了历年交易额TOP10。其较高的转让金额也验证了其管线创新性与较高的临床价值，这也成为了继ADC、单抗等领域之后，本土创新药孕育又一得到全球市场认可的细分新药研发领域。医药魔方数据显示，国内小核酸在研管线主要集中在肝病、心血管疾病、抗病毒感染、抗肿瘤和代谢类疾病，相对应全球分别是抗肿瘤、神经系统疾病、肝病、心血管疾病和抗感染。中国和全球的管线所涉及的适应症整体较为一致，有利于国产相关创新药向海外有兴趣的公司出售。1.4 GLP-1类药物据GlobalData统计，2019年至2024年，针对GLP-1药物的全球交易金额增长595%，仅2024年就已达成超过62亿美元的交易额。从2019年至今，针对GLP-1的药物的许可交易总金额达到122亿美元。2024年5月，恒瑞医药更是以60.35亿美元的交易总金额向Hercules授权3款在研GLP-1药物。同年，翰森制药和先为达生物也纷纷出让GLP-1药物权益。（二）合作开发合作开发，也称联手出海，即中国药企与海外药企联合开发，分担成本和收益。主要通过股权授权、销售渠道合作等方式与海外当地成熟的企业合作来实现产品出海。在此模式下，中国药企能广泛筛选海外企业，寻找那些在海外商业化能力强且能助其在海外临床积累经验的合作伙伴。但同时，中国药企难以直接掌控海外市场销售策略及结果，商业化收益也可能受到合作伙伴的制约。2022年2月，传奇生物与合作伙伴强生旗下的杨森制药联合宣布:由传奇生物研发的CAR-T产品西达基奥仑赛获FDA批准上市，用于治疗终末线复发或难治性多发性骨瘤患者。2018年，传奇生物与强生达成合作协议，两家共同推进西达基奥仑赛的国际临床和商业化，截至目前，传奇生物已获得强生支付的3.5亿美元预付款和3亿美元里程碑付款，潜在里程碑金额仍有10亿美元。君实生物也同样是合作开发出海中的佼佼者，在特瑞普利单抗的商业化布局方面，公司除了与Coherus共同开发北美市场之外，也已经和Hikma、Dr.Reddys、康联达生技等，在中东、北非、拉丁美洲、印度、南非、东南亚、澳大利亚、新西兰等超过50个国家达成商业化合作。国内采用合作开发模式的相关企业案例如下表所示：（三）NewCoNewCo模式，即由国内生物医药企业与海外投资机构合作成立新公司，将企业的特定管线资产授权给新公司，以获取融资和海外市场拓展机会的交易方式。2024年先后有恒瑞、康诺亚、嘉和生物和岸迈生物成功利用NewCo吸引多元化投资，获得现金回报和管线股权。对于创新药企来说，研发和商业化过程需要大量资金投入。NewCo模式通过与海外投资机构合作成立新公司，能够引入海外资本，为企业发展提供新的资金来源，缓解企业的资金压力，有助于推动药物的研发、临床试验和市场推广等工作。同时，创新药研发存在较大的不确定性，临床试验结果可能不如预期。在NewCo模式下，国内药企将管线授权给NewCo公司后，部分研发风险转移给了NewCo公司及其投资者。如果临床试验失败，国内药企的损失相对减少；而如果研发成功，国内药企可以通过股权等方式分享收益。与传统的license out模式不同，NewCo模式下国内药企通常仍持有NewCo公司的一定股权，保留了对核心资产的部分掌控权。当NewCo公司发展壮大、价值提升时，国内药企可以分享其股权增值带来的收益。国内药企作为股东，有权参与NewCo公司的运营和决策过程，在一定程度上可以影响产品的开发方向、市场策略等，保障自身的利益和话语权，确保产品的研发和商业化符合企业的整体战略。NewCo模式凭借其资金与资源支持、风险分散、保留权益与控制权、提升企业估值以及灵活性与适应性等诸多优势，为创新药企提供了一种全新的发展路径。这种模式不仅能够帮助企业解决资金瓶颈问题，还能有效分散研发和市场风险，同时确保企业对核心资产的掌控权和决策参与权。国内采用NewCo模式的相关企业案例如下表所示：百英诺科技认为，无论是何种出海模式，作为国内的Biotech，想要吸引国际MNC的关注并与其开展合作，需要具备以下几点因素：第一，对于创新药的成功出海，创新疗法、独特的分子结构或给药方式等带来的临床价值是核心要素。开发出具有自主知识产权和核心竞争力的创新药产品，才能为出海奠定坚实的基础。第二，企业与购买方公司的管线和发展需求契合度较高。例如，作为国内CAR-T治疗法的领跑者，南京传奇生物与美国强生签订全球化合作协议，共同开发、生产和销售LCAR-B38M（西达基奥仑赛），一定程度上弥补了强生在多发性骨髓瘤管线中CAR-T疗法的缺口。第三，进度靠前的管线是国际MNC重点关注的对象，中国在双抗、ADC和小核酸等领域的发展使市场中有逐渐增多的全球研发进度靠前、有更高出海机会的管线。在IND或IND前进行出海交易可以尽早的抢占更多市场空间，从而获得更高的销售利润。综上所述，国内Biotech想要实现自身产品的出海，在加大在新药研发方面的投入，提高研发效率和创新能力的同时，要深入了解海外不同国家和地区的医药市场情况，包括市场规模、增长趋势、疾病谱分布、医疗保障体系、药品监管政策、竞争格局等，结合自身产品的特点和优势，确定目标市场和目标客户群体。研发与临床试验阶段，严格按照国际通行的药品研发规范和质量标准进行药物研发，在药物发现、先导化合物合成、药效评价以及毒理学研究等环节参照美国和欧盟对IND申报的要求，尽可能多地获取不同口径的数据。并在后期选择合适的国家和地区开展国际多中心临床试验，通过在不同地区的临床试验，可以更好地验证药物的疗效和安全性，同时也为产品在多个国家和地区的注册上市提供依据。注册审批方面，深入研究目标国家的药品注册法规、审批流程和要求，如美国的FDA审批、欧盟的EMA审批等，组建专业的注册团队或与专业的三方服务机构合作，确保注册申报工作的合法合规及申报材料的完整性、准确性和合规性。声明本微信公众号对所有原创、转载的内容、陈述、观点判断均保持中立，推送内容仅供公益性分享，部分转载作品、图片如有作者来源标记有误或涉及侵权，请联系小编删除。END▲点击图片了解  《聚焦“国之大者”CBIITA 联合体荣获“中国产学研合作十大好平台”》更多优质内容，欢迎关注 媒体合作投稿转载/资料领取/加入社群 请添加药小咖与/智/者/同/行   为/创/新/赋/能

WINREVAIR significantly reduced the risk of major morbidity and mortality events, the primary endpoint, in adults with PAH (Group 1 PH) WHO* functional class (FC) III or IV at high risk of mortality who are on maximum tolerated background PAH therapy ZENITH results presented today at ACC.25 as a late-breaking oral presentation and simultaneously published in the New England Journal of Medicine RAHWAY, NJ, USA I March 31, 2025 I Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the first presentation of results from the Phase 3 ZENITH trial evaluating WINREVAIR™ (sotatercept-csrk) compared to placebo in adults with pulmonary arterial hypertension (PAH, Group 1 PH) WHO* functional class (FC) III or IV at high risk of mortality who were on maximum tolerated background PAH therapy. At a median follow-up of10.6 months (range, 0.3-26.1), WINREVAIR reduced the relative risk of major morbidity and mortality events (the composite of all-cause death, lung transplantation and PAH worsening-related hospitalization of ≥24 hours) by 76% (HR=0.24 [95% CI, 0.13-0.43]; p<0.0001 [1-sided]) compared to placebo.For patients treated with WINREVAIR, 17.4% (n=15/86) experienced one or more major morbidity and mortality events, compared with 54.7% (n=47/86) of patients in the placebo arm. The safety profile of WINREVAIR in ZENITH was generally consistent with that observed in previous studies. These results were presented today as a late-breaking oral presentation at the American College of Cardiology’s Annual Scientific Session and Expo (ACC.25) and simultaneously published in the New England Journal of Medicine . These results follow Merck’s announcement in November 2024 that, based on the recommendation of an independent data monitoring committee, the ZENITH study wasstopping early due to overwhelming efficacy, and study participants were offered the opportunity to receive WINREVAIR through the SOTERIA open-label extension study. “The ZENITH study represents the first PAH clinical trial with a primary endpoint comprised entirely of major outcome measures – all-cause death, lung transplantation and hospitalization for PAH,” said Dr. Marc Humbert, Department of Respiratory and Intensive Care Medicine Hospital Bicêtre (AP-HP), University Paris-Saclay and Inserm Unit 999. “WINREVAIR had a significant and clinically meaningful impact on the composite of these outcomes, and together with the growing body of evidence from the clinical development program, these data support the practice-changing potential of WINREVAIR for a broad range of patients with PAH.” “The impressive results from ZENITH demonstrated that patients on WINREVAIR had a 76 percent risk reduction in the composite of all-cause death, lung transplantation and hospitalization for PAH compared to placebo, with improvement observed early in treatment and increasing benefit throughout the study,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “These results led to the ZENITH study being the first PAH clinical trial stopped early due to overwhelming efficacy, representing an important milestone in clinical research with promise for the PAH community.” In this trial stopped early due to overwhelming efficacy demonstrated in the primary endpoint, the key secondary endpoint of overall survival did not reach the heightened threshold (p<0.0021) that was required to establish statistical significance at the interim analysis (HR=0.42 [95% CI, 0.17-1.07]; p=0.0313]). Subsequent secondary endpoints showed numerical improvements in the WINREVAIR arm, but were not formally tested due to the prespecified hierarchical testing strategy. ZENITH is the second Phase 3 study of WINREVAIR to demonstrate efficacy in adults with PAH. The first was the Phase 3 STELLAR trial previously presented at ACC.23. Results from the ZENITH trial will be shared with regulatory authorities around the world. WINREVAIR is currently approved in more than 40 countries based on the results from the STELLAR trial. Merck announced in January 2025 that the Phase 3 HYPERION study evaluating WINREVAIR when added to background PAH therapy in newly diagnosed patients with PAH FC II or III at intermediate or high risk of disease progression was stopping early and moving directly to final analysis. The decision to stop the HYPERION study prior to its scheduled completion and offer patients the opportunity to receive WINREVAIR through the SOTERIA open-label extension study was based on the positive results from the interim analysis of the ZENITH trial and a review of the totality of data from the WINREVAIR clinical program to date. Findings from the HYPERION study will be available later this year and presented at a future medical congress. Study design and additional data from the ZENITH trial The ZENITH trial ( NCT04896008 ) is a pivotal Phase 3 multicenter, double-blind, placebo-controlled trial evaluating WINREVAIR versus placebo for the treatment of adult patients with WHO FC III or IV PAH at high risk of mortality who were on maximum tolerated background PAH therapy. The primary outcome measure was time to first confirmed morbidity or mortality event, with events defined as all-cause death, lung transplantation or PAH worsening-related hospitalization of ≥24 hours. Secondary outcome measures include overall survival, transplant-free survival and several additional measures. The trial enrolled 172 participants receiving the maximum tolerated background PAH therapy, who were randomized in a 1:1 ratio to receive either WINREVAIR (n=86) once every 3 weeks at a dose of 0.3 mg/kg at visit 1 and a dose of 0.7 mg/kg thereafter or placebo (n=86). The study population characteristics were: mean [±SD] 54.4 ± 14.3 years of age; 87% white; and 77% female. In total, 124 of the randomized patients (72.1%) were receiving triple therapy and 48 patients (27.9%) were receiving double therapy; 102 patients (59.3%) were receiving prostacyclin infusion therapy. Additionally, 25.6% of patients in the WINREVAIR arm and 30.2% in the placebo arm had PAH associated with connective-tissue disease. Demographic and baseline characteristics were similar between the WINREVAIR and placebo groups. When examined as standalone outcomes, each component of the primary composite endpoint was directionally consistent with the overall treatment effect. There were seven deaths in the WINREVAIR arm (8.1%) compared with 13 in the placebo arm (15.1%); lung transplantation occurred in one patient treated with WINREVAIR (1.2%) compared to six patients treated with placebo (7.0%); and hospitalizations for PAH occurred in eight patients in the WINREVAIR arm (9.0%) compared to 43 patients in the placebo group (50.0%). Individual patients could experience one or more component. The safety profile of WINREVAIR was generally consistent with that observed in previous studies. In the ZENITH trial, no patients treated with WINREVAIR discontinued treatment due to an adverse event. Serious adverse events occurred in 53.5% of patients treated with WINREVAIR versus 64.0% in the placebo arm. Treatment-related adverse events (TRAEs) occurred in 65.1% of patients who received WINREVAIR versus 32.6% of patients who received placebo, and serious TRAEs were observed in 3.5% versus 2.3% of patients, respectively. Bleeding events occurred in 62.8% of patients treated with WINREVAIR versus 34.9% treated with placebo (mostly non-serious epistaxis and gingival bleeding). There was a 1.1% difference in the risk of serious bleeding events (5.8% versus 4.7%, respectively), which were similar between treatment groups. Adverse events leading to death occurred in five patients (5.8%) in the WINREVAIR treatment group and 12 patients (14.0%) in the placebo group. Adverse events that occurred more frequently with WINREVAIR versus placebo were cutaneous telangiectasia (25.6% versus 3.5%), increased hemoglobin (12.8% versus 1.2%) and thrombocytopenia (14% versus 8.1%). All participants who have completed the ZENITH trial were offered the opportunity to receive WINREVAIR as part of the open-label, long-term extension trial, SOTERIA ( NCT04796337 ), consistent with that trial’s eligibility criteria. About WINREVAIR ™ (sotatercept-csrk) for injection, for subcutaneous use, 45 mg, 60 mg WINREVAIR is FDA-approved for the treatment of adults with pulmonary arterial hypertension (PAH, WHO Group 1) to increase exercise capacity, improve WHO functional class (FC) and reduce the risk of clinical worsening events. WINREVAIR is the first activin signaling inhibitor therapy approved to treat PAH. WINREVAIR improves the balance between pro-proliferative and anti-proliferative signaling to modulate vascular proliferation. In preclinical models, WINREVAIR induced cellular changes that were associated with thinner vessel walls, partial reversal of right ventricular remodeling, and improved hemodynamics. WINREVAIR is the subject of a licensing agreement with Bristol Myers Squibb. About PAH Pulmonary arterial hypertension (PAH) is a rare, progressive and life-threatening blood vessel disorder characterized by the constriction of small pulmonary arteries and elevated blood pressure in the pulmonary circulation. Approximately 40,000 people in the U.S. are living with PAH. The disease progresses rapidly for many patients. PAH results in significant strain on the heart, leading to limited physical activity, heart failure and reduced life expectancy. The five-year mortality rate for patients with PAH is approximately 43%. 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 . SOURCE: Merck

氨基观察-创新药组原创出品作者 | 黄恺国内肝癌一线治疗格局生变。3月31日，百时美施贵宝宣布，纳武利尤单抗与伊匹木单抗的联合疗法获NMPA批准新增适应症，适用于不可切除或晚期肝细胞癌成人患者的一线治疗，成为中国首个且目前唯一获批的肝细胞癌一线双免疫联合疗法。脑机接口支持政策密集落地。3月31日，湖北省医保局发布全国首个脑机接口医疗服务价格。侵入式脑机接口置入费为6552元/次，侵入式脑机接口取出费为3139元/次，非侵入式脑机接口适配费为966元/次。随着脑机接口相关医疗服务价格项目在湖北的率先落实，湖北省医保局将持续支持医疗创新，推动脑机接口技术发展，让临床研究成果惠及更多患者。在过去的一天里，国内外医药市场还有哪些热点值得关注？让氨基君带你一探究竟。/ 01 /市场速递1）8500万美元！默克向和誉医药支付期权行使费3月28日，德国默克宣布，已行使与上海和誉医药技术有限公司的期权，在全球范围内推广和销售骨肿瘤治疗药物Pimicotinib（匹米替尼），将该药物的商业化权利扩展到亚洲以外，并将向和誉医药支付8500万美元的期权行使费。/ 02 /资本信息1）和铂医药2024年净利润1941万元3月31日，和铂医药发布2024年财报。报告期内，公司收入2.74亿元，净利润1941万元，经营性现金流2.2亿元。2）迈威生物2024年收入1.99亿元3月30日，迈威生物发布2024年财报。报告期内，公司收入1.99亿元，亏损额为10.43亿元。3）恒瑞医药2024年收入279亿元3月30日，恒瑞医药发布2024年财报。报告期内，公司收入279亿元，同比增长22.63%；净利润63.36亿元，同比增长47.28%。/ 03 /医药动态1）金赛药业GenSci128片获临床许可3月31日，据CDE官网，金赛药业GenSci128片获临床许可，拟用于治疗携带TP53 Y220C突变的局部晚期或转移性实体瘤。2）再鼎医药注射用ZL-1310获临床许可3月31日，据CDE官网，再鼎医药注射用ZL-1310获临床许可，拟用于治疗胃肠胰神经内分泌癌（GEP-NEC）以及其他神经内分泌癌（NEC）或表达DLL3的实体瘤患者。3）质肽生物ZT006片获临床许可3月31日，据CDE官网，质肽生物ZT006片获临床许可，拟开展治疗阿尔茨海默病的研究。4）罗氏多发性硬化症药物奥瑞利珠单抗获批上市3月31日，罗氏宣布，奥瑞利珠单抗获NMPA批准上市，每六个月静脉输注一次给药，用于治疗成人复发型多发性硬化症和成人原发进展型多发性硬化症。5）BMS双免联合疗法获批肝癌一线治疗3月31日，百时美施贵宝宣布，纳武利尤单抗与伊匹木单抗的联合疗法获NMPA批准新增适应症，适用于不可切除或晚期肝细胞癌成人患者的一线治疗，成为中国首个且目前唯一获批的肝细胞癌一线双免疫联合疗法。6）优时比FcRn单抗罗泽利昔珠获批上市3月31日，据NMPA官网，优时比的FcRn单抗罗泽利昔珠获批上市，用于治疗重症肌无力患者。/ 04 /器械跟踪1）巴迪脉通医疗经外周植入中心静脉导管及套件获注册许可3月31日，据NMPA官网，巴迪脉通医疗经外周植入中心静脉导管及套件获注册许可。2）春立正达医疗肩关节假体获注册许可3月31日，据NMPA官网，春立正达医疗肩关节假体获注册许可。3）心玮医疗颅内取栓支架获注册许可3月31日，据NMPA官网，心玮医疗颅内取栓支架获注册许可。4）微创医疗冠脉雷帕霉素洗脱钴基合金支架系统获注册许可3月31日，据NMPA官网，微创医疗冠脉雷帕霉素洗脱钴基合金支架系统获注册许可。/ 05 /数字医疗日报1）湖北为脑机接口医疗服务定价3月31日，湖北省医保局发布全国首个脑机接口医疗服务价格。侵入式脑机接口置入费为6552元/次，侵入式脑机接口取出费为3139元/次，非侵入式脑机接口适配费为966元/次。随着脑机接口相关医疗服务价格项目在湖北的率先落实，湖北省医保局将持续支持医疗创新，推动脑机接口技术发展，让临床研究成果惠及更多患者。/ 06 /海外药闻1）礼来长效siRNA疗法II期研究结果出炉3月30日，礼来宣布其小干扰RNA（siRNA）疗法lepodisiran的II期ALPACA研究取得积极结果。数据显示，lepodisiran在最高剂量下，使Lp(a)水平在治疗后60至180天期间平均降低93.9%，达到主要终点，其中一些患者的降低时间持续近1.5年。接受lepodisiran 16mg和96mg剂量治疗的受试者，同期Lp(a)水平分别降低40.8%和75.2%。PS：欢迎扫描下方二维码，添加氨基君微信号交流。