Catalent, Inc.

Welcome back to Endpoints Weekly, and thanks for starting your Saturday morning with us! It’s officially autumn, but the weather here in NYC hasn’t cooled off just yet. Here’s hoping we get a few more days of 70-degree temps before the season fully turns. We had another busy week in biopharma, with no bigger headline than Pfizer jumping back into the obesity space. Our reporters had this story covered from every angle this week, so be sure to read all our in-depth articles in case you missed them earlier! There was more news out of Washington, as President Donald Trump held a press conference to claim, despite conflicting evidence, that Tylenol use during pregnancy may cause or contribute to autism. Trump also threatened pharmaceutical tariffs against companies who don’t manufacture their drugs in the US, and his administration is expected to make a major drug pricing announcement next week. Elsewhere, we have stories on a drug rejection and the end of Biogen’s AAV gene therapy work. Be sure to dive on in, and thanks again for reading. — Max Gelman No, it isn’t teaming up with Taylor Swift or the baseball team from Queens. Rather, Pfizer acquired the GLP-1 biotech Metsera this week for $4.9 billion. The size of the deal can increase to $7.3 billion if all the milestones are reached. Metsera’s most advanced drug, a GLP-1 receptor agonist called MET-097i, is in Phase 2b testing. A once-weekly version of MET-097i is slated to enter Phase 3 in the first half of next year, and a once-monthly formulation is anticipated to begin in the second half of 2026. The biotech is also working on oral peptides. The deal immediately makes Pfizer relevant in obesity again after it sidelined an in-house drug earlier this year due to intolerable side effects. Pfizer will once again aim to take on the market’s GLP-1 leaders in Eli Lilly and Novo Nordisk, and they’ll likely need the Metsera programs to perform as well as their competitors , senior biopharma journalist Elizabeth Cairns writes. Could the buyout also spark M&A from other companies? That’s the question biotech correspondent Kyle LaHucik posed to analysts this week in the wake of Pfizer’s deal. Larger biopharmas much prefer acquisitions to licensing deals, one told Kyle, and it’s possible the industry could see such companies “tiptoeing” into more obesity deals. Read more here . President Donald Trump said on Thursday night that drugmakers have until Oct. 1 to break ground on their manufacturing promises, or face a 100% tariff on brand-name pharma products. In a post on Truth Social, he said the tariff would be imposed next week unless a company is “‘breaking ground’ and/or ‘under construction’” in the US. At the end of the week, the biopharma industry was still trying to assess the situation. Leerink analyst David Risinger said that “many large-cap biopharmaceutical companies should not be exposed because they are engaged in some sort of US facility construction activity, but it is difficult to predict which smaller US biopharma companies may face exposure.” Meanwhile, Endpoints News’ Max Bayer and Drew Armstrong reported on Thursday that the White House could make an announcement as soon as next week about its efforts to reduce drug prices, which could include an update on its most favored nation plan and other price policies. Stay tuned for more. The FDA rejected Scholar Rock’s experimental spinal muscular atrophy drug apitegromab after issues were found at a Novo Nordisk manufacturing site in Indiana. The company said the issues were not specific to apitegromab and that there were no concerns about the safety or efficacy of the drug. It plans to resubmit its application once the issues have been resolved. Novo acquired the Catalent site from Novo Holdings last year. Earlier this year, Regeneron received a complete response letter for Eylea HD after issues were found at the same Indiana site. At the time, Regeneron CEO Leonard Schleifer said the issues were “process” and “procedural” related, without going into much detail. Read more from Anna Brown here. The FDA is calling on GSK to update the label for a drug it stopped selling more than 28 years ago, Zachary Brennan reported this week. The agency claimed a review of medical literature shows the now-generic drug, called leucovorin, might help with autism. During a press conference on Monday, Trump and HHS Secretary Robert F. Kennedy Jr. also claimed that, despite conflicting evidence, Tylenol use during pregnancy may be associated with autism. Patricia Zettler, a professor at Ohio State University and former FDA lawyer, told Endpoints that the “FDA seems to be asking the NDA sponsor to add an indication to this drug, and from what we can tell from what is public, FDA is basing that request on information that seems quite different from what the agency would normally consider to be ‘substantial evidence’ of effectiveness, even for rare diseases.” GSK told Endpoints that it would update the label, at the FDA’s request. But the company said it had no plans to restart manufacturing. The big biotech will end its work on gene therapies that use adeno-associated viruses, following in the footsteps of other companies like Pfizer, Roche, Takeda and Vertex. AAV capsids are expensive to manufacture, and the therapies often carry multimillion-dollar price tags. Some also come with only modest efficacy. It’s not the first time Biogen has cut back on gene therapy. In 2023, early in CEO Chris Viehbacher’s tenure, the company deprioritized its preclinical AAV gene therapy work. But it didn’t scrap all of its early in-human programs. As recently as May, Biogen researchers presented the design of new viral vectors at a gene therapy conference.

全球医疗行业每日重点资讯 文 | 苏丁 企业动态 默克集团（Merck KGaA）正式宣布，现任电子业务CEO Kai Beckmann将自2026年5月1日起接任Belén Garijo，担任集团执行董事会主席兼首席执行官。Garijo将按计划在2026年4月底完成任期，以确保管理层平稳过渡。Beckmann即日起将担任副CEO，并继续负责电子业务直至继任者确定。Belén Garijo在默克任职15年，其中6年担任医疗健康业务CEO，自2021年起担任集团执行董事会主席兼CEO。在中国市场，Garijo大力拓展了默克医疗健康业务的布局。卸任后，她将继续活跃于医疗健康领域，专注于满足患者需求。 美国生物技术公司莫德纳新尖端研究中心在英国牛津郡启用。作为与英国政府十年战略合作的组成部分，莫德纳将向英国研发投资超过10亿英镑：以发现新疗法、创造就业机会，并增强疫情应对能力。 美国医疗用品制造商麦朗(Medline)正考虑最快于10月底提交首次公开募股(IPO)申请，若顺利推进，此次上市有望成为今年美国规模最大的IPO交易。麦朗此次IPO拟募资约50亿美元，其背后投资方包括黑石集团、凯雷集团与Hellman & Friedman。麦朗估值或最高达500亿美元。Medline主要生产医院与医疗机构使用的医疗用品，涵盖手套、手术衣、检查床等品类，目前在全球拥有超过4.3万名员工，2024年净销售额约为255亿美元。 Harbor Health从VillageMD收购了32家诊所，继续扩大其在德克萨斯州的临床足迹。该交易将公司的业务范围扩大到三个新市场：圣安东尼奥、埃尔帕索和达拉斯。Harbor Health还扩大了其在总部奥斯汀的既定临床足迹。此次收购使Harbor Health的临床业务几乎翻了两番，诊所总数从11家增加到43家，并增加80多名临床医生。 合同开发与制造组织（CDMO）Catalent Pharma Solutions宣布其位于美国佛罗里达州坦帕市的新全球总部正式启用。年初，Catalent宣布将从美国新泽西州萨默塞特的前总部迁出，在新泽西州布里奇沃特开设公司办公室，并在坦帕建立新的公司总部。此次进驻坦帕体现了公司在佛罗里达州的战略扩张。新总部毗邻位于圣彼得堡的50万平方英尺生产基地，该生产基地在当地深耕多年，拥有逾630名员工，是公司在北美地区主要的软胶囊研发与生产基地。 西门子医疗宣布参与CRISPR诊断specialist VedaBio的2500万美元A轮扩展融资并签署战略合作协议。这是VedaBio短期内完成的第二轮重磅融资。在此之前，该公司已在初始A轮融资中斩获4000万美元，由OMX Ventures独家领投。本次A轮扩展融资西门子医疗作为战略投资方强势入局，将融资总规模进一步扩大至6500万美元。 欧林生物公告，正在筹划发行境外股份(H股)并申请在香港联合交易所有限公司挂牌上市事宜。成立之初，公司便确立了“仿创结合、双轮驱动”的发展战略：一方面通过仿制药快速进入市场积累资本，另一方面聚焦创新疫苗研发以构筑核心竞争力。5月份，该公司重组金黄色葡萄球菌疫苗取得重要进展。 产业动态 瑞士制药商罗氏(Roche)的一种实验性减肥药已进入后期试验阶段，该公司表示，其目标是成为全球前三大减肥药生产商，与诺和诺德和礼来形成竞争。罗氏目前还没有任何批准上市的减肥药，该公司的目标是到2030年推出全套治疗方案。罗氏本周早些时候表示，其CT-388减肥注射剂已进入三期试验，这是公司寻求监管部门批准前的最后阶段。这标志着罗氏在肥胖症及相关疾病治疗方面的最新进展。 礼来已停止一项旨在防止肥胖患者肌肉过度流失的实验性药物研究，理由是出于战略性商业考量。此外，礼来还计划在印度推出其实验性减肥药orforpligron。该公司认为，在这个全球人口最多的国家，此类产品具有发展空间。 礼来公司宣布，欧盟委员会已批准其阿尔茨海默病治疗药物Kisunla（donanemab）上市，该药物用于治疗早期症状性阿尔茨海默病的特定情况。 百时美施贵宝将以优惠价格向符合条件的患者提供其中重度斑块状银屑病药物Sotyktu，价格比其当前标价低80%。此前该公司亦宣布针对抗凝血药Eliquis的折扣计划，以回应特朗普政府要求制药行业降低药品价格。 药明生物推出定点整合CHO细胞株开发平台TrueSite TI，凭借对抗体及复杂药物分子细胞株质量的显著优化、工艺放大的卓越稳定性，以及研发周期的大幅缩短，为创新生物药研发提供更具竞争优势的全新解决方案。定点整合是一种以精准化为核心的细胞工程技术，能够将目的蛋白导入宿主细胞中预先确定且经过严格验证的位点。TrueSite TI是药明生物WuXia第四代细胞株开发平台。 美国总统特朗普宣布从10月1日起对一批进口商品加征关税。其中，进入该国的“任何品牌或专利药品”将被征收100%的关税，但不适用于在美国当地建造制药厂的公司，涉及已动工或正在建设项目的公司将被豁免。 联系美通社 +86-10-5953 9500 info@prnasia.com

此次搬迁彰显了公司在美国佛罗里达州的战略扩张，毗邻位于圣彼得堡的常驻生产基地，新总部旨在支持创新、协作与业务增长。 Catalent, Inc. 作为药品开发与供应领域的行业领导者，助力全球患者获得更优质的治疗方案。近日，公司宣布其位于美国佛罗里达州坦帕市的新全球总部正式启用。该尖端设施旨在彰显创新精神、协作理念与卓越品质，未来将支持公司呈现优质的服务和“患者至上”的企业理念，持续为制药、生物技术及消费者健康领域的客户创造价值。 Catalent 全球总部新貌 年初，Catalent宣布将从美国新泽西州萨默塞特的前总部迁出，在新泽西州布里奇沃特开设公司办公室，并在坦帕建立新的公司总部。此次进驻坦帕体现了公司在佛罗里达州的战略扩张。新总部毗邻位于圣彼得堡的50万平方英尺生产基地，该生产基地在当地深耕多年，拥有逾630名员工，是公司在北美地区主要的软胶囊研发与生产基地。 Catalent总裁兼首席执行官Alessandro Maselli表示:  “我们在坦帕市设立新全球总部，标志着公司发展历程中的重要里程碑，既体现了我们持续增长的雄心，也彰显了我们作为一家立足创新、卓越服务与诚信经营的企业所秉承的传统理念。” 近半个世纪以来，我们始终深耕坦帕地区。如今在圣彼得堡基地，我们提供从早期研发到大规模商业化生产的全流程服务。我们非常高兴能在此区域进一步拓展业务版图。" （全球总部剪彩仪式） Catalent公司同时还举行了剪彩仪式，庆祝新全球总部落成。出席活动的嘉宾包括Catalent高管及州、地方官员，其中有佛罗里达州商务厅厅长J. Alex Kelly、坦帕市市长Jane Castor、坦帕湾经济发展委员会主席兼首席执行官Craig Richard，以及圣彼得堡经济发展公司总裁兼首席执行官Mike Swesey。 Catalent新全球总部设立于美国银行广场41层，该42层甲级写字楼由Banyan Street Capital持有，坐落于坦帕市中心商务区核心地带，地址为佛罗里达州坦帕市肯尼迪大道东101号（邮编33602）。 关于Catalent（康泰伦特） Catalent是一家全球领先的合同开发与制造组织（CDMO），致力于药品开发、生产和供应，助力人们生活的更美好、更健康。我们专注于为制药、生物技术及消费健康领域的客户提供无与伦比的服务，支持产品开发、上市及全生命周期供应。凭借在开发科学、给药技术及多模式生产领域深耕多年的丰富经验，Catalent每年助力加速开发项目进程，推动逾百种新产品上市。依托遍布全球的40余家生产基地和数千名科研人员与技术专家，以及最先进的技术平台，Catalent每年为患者提供数十亿剂改善健康、挽救生命的治疗药物。更多信息请访问www.catalent.com。