Asthma

Sionna Therapeutics and Odyssey Therapeutics have joined Metsera and Maze in an attempt to go public via the still rocky IPO route. The biotechs, focused on cystic fibrosis and immunology respectively, filed for their initial public offerings on Friday evening. Sionna and Odyssey departed last week’s annual JP Morgan Healthcare Conference with plans for public life as $SION and $ODTX . They join the Nasdaq queue alongside obesity drug developer Metsera and kidney disease startup Maze , which has spun out other companies and formed joint ventures over the years. None of the IPO hopefuls have yet outlined the size of their planned debuts. If all four biotechs follow through with their plans, they’d create a buzzy start to 2025 compared to the relatively dry IPO market of the past few years. The new entrants Sionna and Odyssey are both well-funded, clinical-stage biotechs with experienced management teams, ticking most of the boxes that public market investors seek for drug development startups in the current IPO environment. Last year, Boston-based Sionna in-licensed three cystic fibrosis drug candidates from AbbVie, just months after disclosing a $182 million Series C that would take it through 2026, CEO Mike Cloonan told Endpoints News last July. Cloonan was a long-time Biogen executive and Sage Therapeutics operating chief before joining Sionna in spring 2021. New details on the AbbVie deal were revealed in Sionna’s S-1 paperwork, which was filed on 17 January. AbbVie got $5 million upfront and $8.6 million worth of common stock. The pharma giant could also get up to $360 million in development and commercial biobucks, plus up to $130 million in commercial and sales-based milestones, according to the S-1 filing . Sionna had $180 million in cash, equivalents and marketable securities at the end of September, according to the filing. The mid-stage biotech spent about $43 million on R&D in the first nine months of 2024, a $12 million jump over the same period the prior year, per the S-1. Sionna has raised about $330 million since its 2019 founding. RA Capital owns the largest chunk of the biotech at 29.2%. TPG Growth holds 17.4%, Atlas Venture owns 11.4% and OrbiMed maintains a 9.9% stake. OrbiMed is also one of the largest stakeholders in Odyssey. SR One is the biggest shareholder at 16.2% followed by OrbiMed (14.3%), Fidelity (6.7%) and Foresite Capital (6%), according to Odyssey’s S-1 filing . Odyssey is developing small molecule therapies for ulcerative colitis, Crohn’s disease, atopic dermatitis, systemic sclerosis and other indications. It’s also creating protein therapeutics for vitiligo, type 1 diabetes, systemic lupus erythematosus and asthma. The preclinical asthma program is part of the burgeoning TSLP arena. Gary Glick, a chemistry professor-turned-serial entrepreneur, leads Odyssey. The biotech startup formed in 2021 and quickly disclosed three successive megaround financings, most recently a $101 million Series C in December 2023. Glick is also a co-founder of Scorpion Therapeutics. During last week’s JPM, Eli Lilly said it would buy Scorpion for up to $2.5 billion . Odyssey spent $81 million on R&D in the first nine months of 2024, a $5 million decrease compared with the same period of 2023. The company had about $155 million in cash, equivalents and marketable securities at the end of September.

The U.S. Department of Health and Human Services unveiled 15 additional drugs chosen for the Medicare Drug Price Negotiation Program on Friday. Many healthcare leaders are applauding the list of selected drugs, while drug manufacturers are coming out against it. Under the program, which was created through the Inflation Reduction Act, the federal government is able to negotiate the price of selected drugs with participating drug companies. The first 10 drugs were announced in August 2023 and the negotiated prices will go into effect in 2026. Negotiations for the next 15 drugs will take place this year and the negotiated prices will go into effect in 2027. The additional drugs selected for the program are: Healthcare Using Data to Help Healthcare Practices Succeed A new report from Relatient, A Data-Driven Guide to Patient Access Succes, highlights how focusing on data accuracy and relevance can enhance the performance of healthcare practices. By Relatient Ozempic; Rybelsus; Wegovy Trelegy Ellipta Xtandi Pomalyst Ibrance Ofev Linzess Calquence Austedo; Austedo XR Breo Ellipta Tradjenta Xifaxan Vraylar Janumet; Janumet XR Otezla These drugs accounted for about $41 billion in total gross covered prescription drug costs under Medicare Part D between November 2023 and October 2024, according to HHS. In addition, during the same time period, about 5.3 million people with Medicare Part D coverage used these drugs for conditions like cancer, type 2 diabetes and asthma. While HHS is touting the program and additional list of drugs as a way to reduce drug prices, some of the drug manufacturers selected for the program say the program is causing more harm than good. For example, Pfizer, the manufacturer of Ibrance, argued in a statement that the Inflation Reduction Act “establishes a dangerous price-setting system that allows the government to dictate the value and price of certain medicines, discouraging continued development.” Novo Nordisk — the manufacturer of Wegovy, Ozempic and Rybelsus — also came out against the list of additional drugs for the program. Sponsored Post The Funding Model for Cancer Innovation is Broken — We Can Fix It Closing cancer health equity gaps require medical breakthroughs made possible by new funding approaches. By Eve McDavid - CEO of Mission-Driven Tech “Novo Nordisk remains opposed to government price setting through the IRA and has significant concerns about how the law is being implemented by this administration, including aggregating multiple products that individually would not meet the requirements of the statute,” a spokesperson said in an email. It’s worth noting that multiple drug companies (including Novo Nordisk) have filed lawsuits against the drug price negotiation program. Teva Pharmaceuticals is the latest to do so. While manufacturers oppose HHS’ announcement, AARP, a nonprofit for Americans aged 50 and older, applauded the list of additional drugs chosen for the negotiation program. “For too long, big drug companies have padded their profits by setting outrageous prices at the expense of American lives, forcing seniors to skip prescriptions they can’t afford. … With Medicare negotiating to lower prices on more drugs and the new out-of-pocket cap, seniors are finally starting to see relief from high drug prices,” said Nancy LeaMond, AARP executive vice president and chief advocacy and engagement officer, in a statement. Patients for Affordable Drugs, a patient advocacy organization, also celebrated the announcement, stating that it will lower costs for millions of patients. However, more work is needed to protect the negotiation program, according to Merith Basey, executive director of Patients for Affordable Drugs. “Let’s be clear: we must keep pushing to expand the wildly popular Medicare negotiation program,” Basey said in a statement. “Patients fought extremely hard for the passage of these reforms and they continue to vigorously defend them against pharma’s attacks – because nobody should have to choose between life-saving drugs and their basic needs.” One healthcare executive — Brooke Boyarsky Pratt, founder and CEO of knownwell — is particularly excited about the selection of Ozempic and Wegovy for the negotiation program. The company offers metabolic health services, primary care, nutrition counseling and health coaching. “Price negotiations for Ozempic and Wegovy have the potential to completely change patient access to comprehensive obesity care,” Boyarsky Pratt told MedCity News. “As has been discussed at length, the question about GLP-1s is about their affordability, not their efficacy. HHS has the opportunity to make these medications affordable for those living with obesity across America and pave the way for commercial plans to cover these medicines at scale.”

一年一度的摩根大通医疗保健会议（JPM大会）又如期落幕，这或许是最被国内Biotech寄予厚望的一届JPM大会。 一直以来，JPM被是为全年全球医药行业发展的风向标。继阿斯利康18亿美元收购Cincor、Ipsen制药9.5亿美元收购Albireo重启2023年的跨国并购热，密集的BD交易点燃2024年资产交易激情后，人们迫切想要近距离观察JPM大会期间的重磅交易，来找到2025年全球医药市场的主流节奏。 每年JPM大会上的重头戏，除了各大药企掌门人公布的最新动态和年度战略，预热环节的社交往往更容易擦出火花。在今年JPM大会正式开始前的行业论坛上，挤满了远渡重洋而来的国内Biotech。“去年我们预计来参会的有600人，最终报名的有800人，超预期比较多。所以今年直接按1000人的规模筹办，结果有1200人报名，会场爆满，外面的走廊上都挤满了人。”一位华人论坛的主办者告诉动脉网。 不同于以往的旁观和成果展示为主，今年的国内Biotech大多带着任务而来，他们想要在这场大会上，发现交易的契机。 01 美元基金抛来橄榄枝 “今年一个很明显的变化，就是大家都在讨论NewCo的可能性。”一位从业者表示，“而且不同于国内，在JPM大会上，能明显看到Biotech与美元基金的双向奔赴，他们也非常积极地拥抱中国资产。” 在国内医药圈，NewCo交易的热度几乎贯穿全年。人们纷纷认为，2025年将会是NewCo交易的井喷之年。2025年开年，医药圈的热情果然又再被NewCo交易点燃。就在JPM大会开幕前的1月10日，康诺亚生物和和铂医药、科伦博泰生物相继公布NewCo交易，打响了新年的第一炮。 2025年1月10日，康诺亚生物宣布，就潜在同类最优的靶向CD38人源化单克隆抗体CM313与Timberlyne Therapeutics达成NewCo交易。根据双方协议，康诺亚授予 Timberlyne 在全球（不包括中国内地、香港、澳门及台湾地区）开发、生产及商业化 CM313 的独家权益，并因此获得3000万美元首付款和近期付款、最多3.375亿美元的额外付款，及特许权使用费。 Timberlyne成立于2024年6月，NewCo交易完成后，Timberlyne获得1.8亿美金的A轮融资，康诺亚生物 Timberlyne 25.79%的股权，并成为该公司的最大股东，康诺亚生物董事长兼首席执行官陈博将加入Timberlyne董事会，首席财务官张延荣则担任Timberlyne董事会观察员。 值得注意的是，这已经是康诺亚的第三次NewCo交易。2024年7月，康诺亚生物将旗下2款双抗新药CM512、CM536除大中华区以外的全球权益授权给Belenos Biosciences，并因此获得1500万美元预付款、1.7亿美元里程碑金额，以及特定比例的销售分成，康诺亚生物全资附属公司一桥香港获得Belenos约30.01%的股权。 4个月后，康诺亚生物将BCMA/CD3双抗CM336除大中华区以外的全球权益授权给Platina Medicines，并收取 1600万美元的首付款和近期付款，此后期间最多6.1 亿美元的额外付款，及Platina Medicines母公司的少部分股权。 同样实在1月10日，和铂医药及科伦博泰生物宣布，与Windward Bio就靶向TSLP单克隆抗体HBM9378/SKB378达成NewCo交易。和铂医药及科伦博泰有权获得高达9.7亿美金的首付款和里程碑付款，其中首付款和近期里程碑为4500万美金，包括现金付款及Windward Bio母公司股权。 这也是和铂医药的第二次NewCo交易。早在2019年，和铂医药就与波士顿儿童医院合资创立了HBM Alpha Therapeutics，并在2023年完成种子轮融资。对于手握优质资产的Biotech而言，通过NewCo来吸金，正在成为一种成熟的策略。“今年来参加JPM的国内Biotech明显比以往更多了，他们都很积极地寻找交易的机会。”一位从业者表示，“如果说活得稍好的国内Biotech都过来了可能有点夸张，但大致也是这样。” 更重要的是，在今年的JPM预热活动中，美元基金对中国资产的态度转变也很明显。一方面，据前述论坛组织者介绍，美元基金参与国内Biotech论坛的积极性很高，嘉宾要求的过程比以往更顺利。另一方面，在这些论坛上，多为来自美元基金的嘉宾表示，希望国内Biotech能够充分信任美元基金，和他们组建的管理团队。 美元基金如此密集地向国内Biotech抛出橄榄枝，是此前的全球制药生态中，见所未见的情形。 02 来自终端的机会 美元基金积极拥抱中国创新药资产的背后，除了这些资产的稀缺性和品质更多得到认可，更重要的原因在于，近年来，作为NewCo最重要终端买家的跨国药企，纷纷面临核心资产的新旧交替，更大的不确定性下，他们越发需要通过并购来快速获得新的增长点。 一方面，旧的核心产品所能提供的业绩增长动力陆续耗尽。比如，在2025年，百时美施贵宝（BMS）将面临专利悬崖的集中到来，Revlimid（来那度胺）、Pomalyst（泊马度胺）和Sprycel（达沙替尼）带来的专利危机。其中，对BMS业绩将造成最大冲击的，是Revlimid的专利到期。据BMS预计，2025年，Revlimid的销售额将缩减至20-25亿美元之间，几乎腰斩。 在JPM上，BMS也提到，2025年，将主要寄希望于obenfy、Opdivo、Reblozyl、Breyanzi、Camzyos等5大新的明星产品撑起公司的半壁江山。其中，2024年获批上市的精神分裂症药物Cobenfy，已经取得了不错的开端，预计销售峰值可以达数十亿美元，成为BMS的关键增长产品之一。BMS首席执行官Chris Boerner表示，BMS预计在未来五年内有望推出10款新药，并获得30项药品新适应症扩展。 再如，辉瑞首席执行官Albert Bourla在JPM大会上表示，公司正在为未来几年将席卷而来的“LOE 浪潮”做准备。所谓的LOE浪潮，即畅销药品独占权的丧失。Bourla指出，专利损失浪潮可能会导致每年约170亿~180亿美元的销售额损失。 另一方面，新的核心产品还难以扛起业绩持续增长的预期。JPM大会期间，美国市值最大的制药公司礼来宣布，盈利不及预期。据STAT News报道，2024年第四季度，礼来创造了约135亿美元的收入，低于此前行业分析师给出的139亿美元的预期。这个消息直接导致礼来股价当日下跌8%。而盈利不及预期的原因在于，礼来的2款GLP-1重磅炸弹药物Mounjaro和Zepbound，销售额均低于预期。 2022年5月，替尔泊肽“降糖注射版”Mounjaro，获得FDA批准上市。此后，Mounjaro先后在中国、比利时上市，获批的适应症包括降糖和减重。2023年11月，替尔泊肽 “减重注射版” Zepbound在美国获批上市。当然，对于这两款重磅药物，礼来的未来预期颇为乐观，预测2025年的销售额将达到580亿美元~610亿美元。 在JPM大会上，强生、吉利德、诺华等多家跨国药企纷纷提到，过去几年间，并购的策略极大改善了经营表现，将适当发挥并购交易的价值。比如，吉利德首席执行官Dan O'Day表示，在经历了2021年至2023年连续两年收入小幅下滑之后，吉利德在2024年扭转这一趋势，并在未来延续积极势头，原因是过去的投资正在转化为商业利益。 到了2033年，吉利德的强效药物Biktarvy将失去市场独占权，后续计划通过推出HIV产品来抵消市场独占权消失时所带来的冲击。其中，吉利德在HIV领域最核心的产品，是每年两次注射的lenacapavir。这是一种首创的、新型的长效HIV-1衣壳抑制剂。2016年，吉利德从Arrowhead Pharmaceuticals引进了lenacapavir的全球开发和商业化权利。2022年，lenacapavir在欧美获批用于治疗HIV-1感染，并被《科学》杂志评选为 2024年度重大突破药物之一。预计到2025年夏季，lenacapavir还将获批用于HIV-1感染的暴露前预防（PrEP）。 此外，2024年，吉利德于以43亿美元收购CymaBay时获得的肝病药物seladelpar，已经获批上市，预计将成为新的增长引擎。 与此同时，辉瑞也在JPM大会中表示，近年来，公司通过一系列收购，在一定程度上抵消了专利权丧失浪潮带来的威胁。首席执行官Bourla指出，此前辉瑞以430亿美元收购的Seagen，预计到2030年，将为公司创造200亿美元的销售额。从目前的营收状况来看，辉瑞的业绩已经开始恢复增长。在2024年前三季度，辉瑞的总营收达到458.64亿美元，同比增加2%。在本次JPM2025大会上，辉瑞公布了2025年业绩指引，总营收预期为610-640亿美元。 现阶段，来自国内Biotech的创新药资产还鲜少成为跨国药企增长的新动力。而跨国药企核心管线的新旧交替，无疑为国内Biotech提供了融入全球医药商业的极好机会。 03 资产交易仍将是年度主题 如果从更长的周期回头看，2025年或许会是资产交易最活跃的一年。 首先是跨国药企出手正变得频繁。除了前文提到了2笔NewCo交易外，甫一开年，就有3家跨国药企宣布了重磅的管线交易。就在JPM大会开幕的第一天，强生宣布重金投入神经科领域，以146亿美元收购专注中枢神经系统疾病创新药研发Intra-Cellular Therapie。刷新了2024年以来，全球生物制药领域资产并购交易的金额记录。 随后，礼来在JPM大会期间宣布，以10亿美元预付款抢下Scorpion Therapeutics的PI3Kα抑制剂项目STX-478，用于治疗包括乳腺癌、子宫内膜癌和尿路上皮癌等在内的晚期实体瘤；吉利德也达成了一笔交易，以17亿美元的总交易额引进Leo Pharma的STAT6抑制剂，用于治疗特应性皮炎、哮喘和慢性阻塞性肺疾病等炎性疾病。 值得注意的是，强生收购Intra-Cellular 的这笔交易，也将超越百时美施贵宝收购Karuna、艾伯维收购Cerevel，成为2023以来，神经系统疾病领域最重磅的一笔并购交易。通过这笔交易，强生获得了Intra-Cellular最核心的资产Caplyta。 这款重磅新药于2019年12月，被FDA批准用于治疗精神分裂症成人患者，并于2021年12月新增适应症，获批用于辅助治疗与I型或II型双相情感障碍（双相抑郁症）相关的抑郁发作。当前，Intra-Cellular还向FDA提交了Caplyta的第3项新适应症上市申请，即用于辅助治疗重度抑郁症。根据强生预测，Caplyta年销售额峰值将超过50亿美元，位列神经学药物销售额TOP3。 其次，国内Biotech的并购表现也更加活跃。在JPM大会前，就有3家国内Biotech密集与海外药企达成并购交易，受权方包括强生这样的跨国药企。 1月9日，天广实生物宣布，单克隆抗体MIL116与Climb Bio达成独家许可协议。根据双方协议，Climb Bio将向天广实生物支付900万美元的预付现金，及相应的里程碑付款、特许权使用费等。据了解，MIL116是天广实生物自主研发的创新型APRIL抗体，主要用于 IgA 肾病的治疗。临床前数据显示，MIL116 优于诺华的同类抗体Zigakibart，展现出了较好的药物代谢动力学特性，具有潜在同类最佳的产品潜力。 次日，和正医药与中国科学院上海药物研究所共同宣布，已经与强生签订全球许可协议，开发潜在最佳的BTK降解剂HZ-Q1070，用于治疗血液瘤和多种自身免疫性疾病。就在同一天，先为达生物宣布就GLP-1产品组合，与Verdiva达成在除大中华区及韩国以外的全球开发和商业化许可与合作协议，交易额超24亿美元。 最后，细分领域方面，除了JPM大会期间重磅交易中涉及的神经系统疾病药物、HIV药物、心血管疾病药物、代谢疾病药物等，双抗/ADC也是2025年值得关注的热门方向。其中，双抗/ADC赛道持续火热，罗氏、葛兰素史克等药企纷纷者这一领域加大布局。值得注意的是，国内Biotech舜景医药的创新性双特异性抗体SGT003在JPM大会惊艳亮相，临床前研究数据显示，SGT003可显著减少Tregs和TAMs的数量。在更低的剂量作用下，SGT003对比已上市抗PD-1单抗和抗CTLA-4单抗的抑制肿瘤效果更显著，且不刺激TNF-α等因子释放，引发行业关注。 当然，JPM大会的热闹过后，国内Biotech又将回到资金窘迫的环境中耕耘。那些带着交易任务远赴旧金山的企业代表中，或许能够带着交易的意向返程并不多。但美元基金抛出的橄榄枝、跨国药企对新产品的迫切需求，都让国内Biotech有了走下去的信心和可能性。 *封面图片来源：123rf 如果您认同文章中的观点、信息，或想进一步讨论，请与我们联系；也可加入动脉网行业社群，结交更多志同道合的好友。 近 期 推 荐 声明：动脉网所刊载内容之知识产权为动脉网及相关权利人专属所有或持有。未经许可，禁止进行转载、摘编、复制及建立镜像等任何使用。 动脉网，未来医疗服务平台