Adalimumab

近日，K 药与Nectin-4 ADC维恩妥尤单抗联合疗法在华获批上市，用于一线治疗既往未经治疗的局部晚期或转移性尿路上皮癌（la/mUC）成年患者。这是国内获批的首个针对晚期膀胱癌患者的非铂化疗方案。 K药联合Nectin-4 ADC进军中国市场，默沙东或将继续续写K药销售神话？ 作者｜momo   01   K药药王守卫战 此前，维恩妥尤单抗联合K药先后在FDA和EMA获批用于一线治疗尿路上皮癌。1月8日，该药已在国内获批，联合用于既往未经治疗的局部晚期或转移性尿路上皮癌（la/mUC）成年患者的一线治疗（图1）。 图1.维恩妥尤单抗联合K药获批上市 维恩妥尤单抗是由安斯泰来和Seagen联合开发的全球首款靶向Nectin-4的ADC药物，2024年8月19日，维恩妥尤单抗在中国获批上市，用于治疗既往接受过PD-1/PD-L1抑制剂和含铂化疗治疗的局部晚期或转移性尿路上皮癌患者。 帕博利珠单抗（K药）是默沙东研发的一种PD-1肿瘤免疫疗法，通过靶向阻断PD-1/PD-L1通路，利用人体自身的免疫系统对抗肿瘤，具有治疗多种类型肿瘤的潜力。 2023年，默沙东总营收601.15亿美元（图2），同比增长1%，其中，K药全年营收250.11亿美元，同比增长19%，占据公司总营收的41.6%，超越蝉联10年药王桂冠的修美乐成为全球新任“药王”，仅用修美乐一半的时间，K药销售额就突破了两百亿美元大关，造就默沙东K药销售神话。 图2.默沙东2023年财报 K药之所以能够有如此强劲的销售业绩，得益于K药持续进行的适应症拓展，过去几年中，默沙东始终将K药视为企业营收的基石，不断致力于适应症的拓展与药物联用，2024年6月，K药拿下第40个适应症，覆盖黑色素瘤、肺癌、肝癌、头颈癌等近20个癌种，其中包括多个一线治疗，继续创造传奇。 2024年前三季度K药销售额累计高达216.46亿美元，同比增长18%，成功击败来自诺和诺德的司美格鲁肽，蝉联药王宝座。   02   围猎ADC 近年来，默沙东投入重金进行了大量的ADC BD交易，据统计，近年来默沙东在ADC药物领域license-in交易高达7笔，累计交易金额高达400亿美元，围猎ADC，默沙东“势在必得”。 表1 默沙东在ADC license-in交易汇总 2020年9月14日，默沙东与 Seattle Genetics（seagen 前身）达成合作，共同推进 Ladiratuzumab vedotin 的开发，并将平分其后续的商业化权益。根据协议，Seattle Genetics 将获得 6 亿美元的预付款，默沙东同时将对 Seattle Genetics 进行 10 亿美元的股权投资。此外，SeattleGenetics 有资格获得高达 26 亿美元的里程碑付款。 2020年11月5日，默沙东和VelosBio公司宣布已经达成了协议，前者将以27.5亿美元的现金收购后者所有已发行股票，从而囊获潜在“first-in-class”抗体偶联药物VLS-101。 2022年，默沙东更是先后三次与科伦博泰达成合作，先后拿下9款ADC药物的权益，总金额超110亿美元。 2022年5月13日，默沙东与科伦博泰合作，获得了 Trop2 ADC 药物 SKB264 的相关权益，这款药物首付款及里程碑付款累计达13.63亿美元，并按双方约定的净销售额比例提成。 2022年7月26日，双方合作进一步升级，以3500 万美金首付款、9亿美金里程碑款的条款，成功获取科伦博泰靶向 Claudin 18.2 的 ADC 产品 SKB315 的权益。 2022年12月22日，默沙东再度发力，以 1.75 亿美元首付款和 93 亿美元里程碑款的高额投入，将科伦博泰早期的 ADC 产线纳入麾下，获得 7 款 ADC 产品的海外权益，这一笔交易也创新了当时国产创新药企海外授权金额的最高记录。 然而，默沙东出于对自身业务风险把控和长期发展的考虑，并未把全部的 ADC 资源集中押注在科伦博泰身上。 2023年10月19日，默沙东与第一三共达成合作，默沙东以高达220亿美元的金额获得了第一三共三个ADC产品在全球（除日本）的权益。 2024年8月6日，默沙东再度与第一三共扩大合作，将共同开发DLL3靶向T细胞接合器MK-6070。根据协议，默沙东将获得1.7亿美元预付款，以及根据销售额收取一定的特许权使用费，除了保留日本权利外，默沙东将与第一三共在全球其他地区共同开发和商业化推广。 默沙东在 ADC 领域先后与 Seagen、科伦博泰、第一三共合作，无非是想借 ADC 疗法，延续 K 药竞争力，实现自身利益最大化。   03   HPV疫苗开辟新战场 2025年1月8日，默沙东宣布佳达修Gardasil [四价人乳头瘤病毒疫苗（酿酒酵母）]的多项新适应证已获得国家药品监督管理局的上市批准，适用于9-26岁男性接种（图3）。这是中国首个唯一获批、可适用于男性的 HPV疫苗，HPV疫苗瞄准男性市场。 图3.国内首个HPV疫苗获批 在默沙东的产品营收版图中，Keytruda 和 Gardasil 堪称两大 “吸金王”。Keytruda 收入 250.11 亿美元，Gardasil 收入 88.86 亿美元，分别占总营收的 41.6% 和 14.78%。而公司其他收入超 10 亿美元的产品，仅仅只有 3 款。 如果把 Keytruda 比作默沙东业绩增长的 “头号功臣”，那 Gardasil 绝对是 “最佳拍档”，为K药减轻压力。2021-2023年，Gardasil 在全球市场的收入一路飙升，从 56.73 亿美元增长到 68.97 亿美元，再到 88.86 亿美元，年复合增速高达 25.15%。 图4.Gardasil在2024Q3销售额 如今Gardasil在2024Q3销售23.06亿美元，同比下降10%（图4），这是因为中国市场需求减少，而该产品的销售额在中国以外的全球其他地区都实现了两位数的增长。此次Gardasil在华获批，成功填补了中国男性 HPV 疫苗市场的空白，为HPV疫苗开辟男性新市场。同时为其 HPV 疫苗业务在华发展带来新机遇，有望对销售额产生积极而深远的影响。   结语   默沙东凭借深厚底蕴与创新实力，笃定前行，在未来的市场画卷中，继续续写销售神话。 参考资料 [1]默沙东财报、官微、官网 [2]NMPA 官网 [3]各种公开资料 共建Biomedical创新生态圈！ 如何加入BiG会员？

MEDIA RELEASE Strong first year as standalone company; global leader Sandoz uniquely positioned in attractive and growing USD 200 billion market for generics and biosimilarsLeading in home market Europe, which represents half of total sales; strategically positioning company to become #1 in biosimilars in US, with three US launches expected in 2025Ambitious GLP-1 strategy in place, addressing each opportunity with mix of internal capabilities and external partnershipsIndustry-leading pipeline for rapidly-growing biosimilar segment now comprises 28 moleculesStrongly positioned to capitalize on unprecedented global market opportunity, with reference medicines worth more than USD 400 billion in sales due to lose exclusivity from 2029 onwards Basel, January 14, 2025 – Sandoz, the global leader in generic and biosimilar medicines, will confirm its strategic roadmap and highlight pipeline catalysts in a presentation today at the 43rd Annual J.P. Morgan Healthcare Conference, taking place from January 13 to 16 in San Francisco. CEO Richard Saynor will highlight several recent additions to the global biosimilar pipeline, which now comprises 28 molecules. He will also reiterate the company’s ambition to become the leader in US biosimilars, with three US launches expected in 2025. Richard will say: “We are proud of the progress we have made on our spin-off commitments since October 2023. Generics and biosimilars represent 80% of medicines used by patients worldwide, at 30% of the total cost. That means that, when we deliver on our promises, we create value for all. As we enter our second full year as a standalone company, we will continue to execute our purpose-driven strategy.” Sandoz uniquely positioned to benefit from market fundamentals, aims to lead in US biosimilarsThe global generics and biosimilars market is worth more than USD 200 billion in gross sales and expected to grow at an annual compound rate of 7% for the next 10 years. Growth will be driven by aging populations, higher rates of chronic disease, increasing market adoption as healthcare systems and payors seek to reduce the cost of medicines, and a consistent supply of upcoming losses of exclusivity (LoEs) as patents for reference medicines expire. From 2029 through 2034, reference medicines worth more than USD 400 billion in sales are due to lose exclusivity, significantly more than during any comparable timeframe previously. Nearly half of this opportunity is in the biosimilar segment, while GLP-1 medicines represent by far the single largest opportunity in the generic space. As the global leader, Sandoz is uniquely positioned to benefit from these attractive market fundamentals, in terms of both geographic and portfolio balance. Europe represents half of its total sales, with half of the remainder coming from North America. The portfolio combines a strong focus on the rapidly-growing biosimilar segment with a leading position in its core generics business. Sandoz also aspires to achieve sustainable leadership in the US biosimilar segment. As Richard will say: “We have become the #1 biosimilars provider on a worldwide basis and now have an industry-leading biosimilars pipeline of 28 molecules. We are leading in Europe. In the US, we rank #4 in biosimilars today and have the ambition to become #1.” Sandoz plans five biosimilar launches in the mid-term, including three this year in the US. Pipeline progress and new value drivers fueling future growth Sandoz has made significant progress since spin-off, including successful launches of biosimilar Hyrimoz® (adalimumab) in the US and Tyruko® (natalizumab) in Europe, as well as stabilization of the North American business ahead of key launches. It has also steadily expanded its strong and diverse pipeline, with over 450 generic pipeline products to complement the 28 biosimilars. This progress is underpinned by a strong balance sheet, which offers investment flexibility. Sandoz has also added multiple new value drivers since its initial Capital Markets Day. These include the launch of biosimilar Pyzchiva® (ustekinumab) in Europe, a private-label agreement to boost uptake of Hyrimoz® in the US, the addition of five new biosimilars to the pipeline, a clear strategy to address the emerging GLP-1 opportunity, and potential additional organic investments to support long-term growth. In 2024, pembrolizumab and nivolumab, two large oncology assets addressing more than USD 40 billion of LoE value, entered late-stage clinical trials. Biosimilars as single-biggest growth driverSandoz sales were up over 30% in the first nine months of 2024 and Saynor will say that biosimilars are now the company’s single-biggest growth driver. Its pipeline of 28 biosimilars is industry-leading in terms of both number of assets and coverage of addressable market value. Sandoz is on track with its plans for further biosimilar launches, including four in 2025: Pyzchiva® and Tyruko® (natalizumab) in the US, Wyost®/Jubbonti® (denosumab) in the US and Europe, and Afqlir® (aflibercept) in Europe. These medicines cover the therapy areas of chronic inflammatory diseases (ustekinumab), multiple sclerosis (natalizumab), osteoporosis (denosumab) and various retinal diseases (aflibercept) respectively. By providing these biosimilar alternatives, Sandoz is delivering on its Purpose of pioneering access for patients. GLP-1s as key LoE growth driver in generics spaceSaynor will add: “Since the initial Sandoz Capital Markets Day just 18 months ago, GLP-1s have become the largest LoE opportunity in the industry and the key LoE growth driver in the generics space. Sandoz has a clear and ambitious strategy in place and will address each opportunity with a mix of internal capabilities and external partnerships across development and manufacturing. “Last year, we mentioned our partnership agreement with Pharmathen focused on diabetes indications. We are currently exploring further partnerships to commercialize future GLP-1 medicines in the US, Europe and other markets for weight-loss indications.” Committed to delivering superior value for our shareholders and for society in long termSaynor will conclude: “We are the world leader in a growing market. Our home base is Europe, but we are well positioned in the US and other regions. We have a plan to deliver on our mid-term outlook, in terms of both portfolio and pipeline, bolstered by opportunities to simplify our business. “We have the internal resources to execute on our pipeline and the scale to develop and attract strong partners to capture high-value, long-term opportunities. Our strong balance sheet gives us optionality for future technologies. And all of this is underpinned by our objective of delivering superior value for our shareholders and for society, by consistently delivering on our Purpose.” KEY LINKSWebcast – Live at 09:45 Pacific Time / 18:45 CET Presentation DISCLAIMERThis Media Release contains forward-looking statements, which offer no guarantee with regard to future performance. These statements are made on the basis of management’s views and assumptions regarding future events and business performance at the time the statements are made. They are subject to risks and uncertainties including, but not confined to, future global economic conditions, exchange rates, legal provisions, market conditions, activities by competitors and other factors outside of the control of Sandoz. Should one or more of these risks or uncertainties materialize or should underlying assumptions prove incorrect, actual outcomes may vary materially from those forecasted or expected. Each forward-looking statement speaks only as of the date of the particular statement, and Sandoz undertakes no obligation to publicly update or revise any forward-looking statements, except as required by law. ABOUT SANDOZSandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in generic and biosimilar medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 people of 100 nationalities work together to ensure 800 million patient treatments are provided by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,500 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world’s first oral penicillin in 1951, and the world’s first biosimilar in 2006. In 2023, Sandoz recorded net sales of USD 9.6 billion. CONTACTS Global Media Relations contactsInvestor Relations contactsGlobal.MediaRelations@sandoz.comInvestor.Relations@sandoz.comJoerg E. AllgaeuerLaurent de Weck+49 171 838 4838+41 79 795 7364 Chris LewisTamara Hackl+49 174 244 9501+41 79 790 5217 Gregor Rodehueser +49 170 574 3200 Attachment Media release_JPM Healthcare Conference.pdf