Tirzepatide

Welcome to another edition of Endpoints Weekly — and happy spring! The weather may not feel very spring-like here in NYC (outside that false start a couple weeks ago), but we’re grateful the sidewalk snowbanks are gone, at the very least. Let’s dive into the headlines. This week we had AI news from Roche and Nvidia, who want to build the industry’s leading “AI factory” — though details on cost and timeline remain scarce. We also reported on how the biopharma industry is looking to cushion the effect of “most favored nation” drug pricing policy, oral GLP-1 data from Structure Therapeutics, Verily’s latest fundraise, and a federal court decision on RFK Jr.’s vaccine policies. Have a great weekend! — Max Gelman The AI race in biopharma is heating up. Roche and Nvidia partnered on what they’re calling the “largest announced hybrid-cloud AI factory” in the industry. The announcement comes just a few months after Eli Lilly unveiled plans for its own AI-powered supercomputer, which Lilly claimed would be biopharma’s most powerful. Roche’s Genentech originally signed a deal with Nvidia in 2023. The newly expanded agreement covers the broader Roche enterprise, spanning its drugs and diagnostics businesses and areas like discovery, manufacturing and sales. The computing power will be used to train and run AI models across those functions. Financial details were not disclosed . In an interview with Endpoints’ Andrew Dunn, Genentech’s head of research and early development Aviv Regev also declined to offer a timeline beyond “quick” for building out the capacity. On the hardware side, Roche is adding 2,716 of Nvidia’s Blackwell GPUs, bringing its total to over 3,500 Blackwell chips — compared with the 1,016 chips in Lilly’s supercomputer. 🌎 Drugmakers are looking for ways to mitigate the potential effect of the Trump administration’s “most favored nation” US drug pricing policy on future launches, Anna Brown reported this week . Lawyers say they’re receiving inquiries about whether amending licensing contracts could be a way to do so. MFN is at the forefront of companies’ minds when looking to enter a new licensing deal, according to Adam Golden, an M&A and IP transactions lawyer at Freshfields. A typical licensing agreement might involve a drug developer licensing an asset to a large commercial partner in territories where the developer can’t execute the launch itself. Now, lawyers are getting questions about whether biotechs can ask their overseas partners to delay launches to avoid having a reference price that could lower the price in the US. Established licensing deals are also being reviewed , but they may be difficult to change, especially if pharma companies want to reduce royalties, Golden told Endpoints. So far, 16 large pharma companies have agreed to MFN deals with the White House. An Eli Lilly spokesperson told Endpoints that MFN has no impact on the drugmaker’s licensing deals. A Roche spokesperson said that business is continuing as normal, despite geopolitical factors and a rapidly changing operating environment. Anna has the full story here. Structure Therapeutics may have a serious GLP-1 contender on its hands. The biotech’s once-daily pill, aleniglipron, produced a placebo-adjusted average weight loss of 16.3%, or about 39 pounds, at the 180 mg dose after 44 weeks. Results came from a Phase 2 study in patients with obesity or overweight with at least one weight-related comorbidity. Patients on the higher 240 mg dose saw a placebo-adjusted weight loss of 16%. It’s a major milestone for Structure, which has been one of the most-watched small biotechs in the obesity space. The company intends to move into Phase 3 in the second half of 2026 as it aims to compete with Novo Nordisk and Eli Lilly — and it intends to do so without a partner, at least for now. That said, a big pharma alliance could be key to unlocking aleniglipron’s full potential; CEO Raymond Stevens called such a partnership “really, really important” at an investor conference last year. 💰 Verily has raised $300 million in outside funding that ends parent company Alphabet’s controlling position in the healthcare innovation company, Endpoints’ Shelby Livingston learned exclusively this week. Alphabet remains a significant minority investor. But Verily CEO Stephen Gillett said the move marks the company’s “next phase of growth.” Verily has been making moves to step out of Alphabet’s shadow, with plans to eventually go public. It’s been divesting business units, including its insurance business Granular, and sharpening its focus. Most recently, it’s zeroed in on an AI healthcare platform, called Pre, that powers all Verily solutions. The new funds will accelerate Verily’s healthcare platform strategy to bring data together into personal health records, speed up clinical research and deliver personalized care. Shelby has more details here . 💉 A federal judge issued a stay on the agency’s January decision to downgrade recommendations for six vaccines on the childhood vaccine schedule. He also suspended the appointments of 13 members on the CDC’s reconstituted vaccine advisory panel, and stayed the votes taken by those members. The American Academy of Pediatrics and several other health organizations filed the lawsuit in July over changes to Covid-19 vaccine recommendations for kids and pregnant women, and have since amended the complaint multiple times to challenge additional actions, including the January changes to the childhood vaccine schedule and HHS Secretary Robert F. Kennedy Jr.’s reconstitution of the Advisory Committee on Immunization Practices. Plaintiffs said in an amended complaint that the agency failed to consider whether changes to the childhood vaccine schedule “would lead to increases in serious illness and death due to vaccine-preventable illnesses.” But attorneys for HHS argued in court documents that the changes to the childhood vaccine schedule were “reasonable and reasonably explained.” Read more about the case here. DON’T MISS:

前言PREFACE 2026年3月20日，诺和诺德所持有的司美格鲁肽中国核心分子专利正式届满，宣告国产仿制药研发的法律壁垒全面清零。作为GLP-1赛道的"王牌单品"，司美格鲁肽的商业化潜力早已吸引国内药企布局，目前已有10家药企递交12款仿制药上市申请，专利到期的信号枪响后，国产司美格鲁肽的市场争夺战正式拉开帷幕。 专利清零：首仿格局初显 PART 01 1 十企扎堆申报 专利保护期结束后，此前受限于专利的国产司美格鲁肽上市申请正式进入审评流程。据国家药监局数据，目前已有九源基因、新北江制药（丽珠集团）、齐鲁制药等10家国内药企，递交了12款司美格鲁肽仿制药的注册申请，申报适应症主要聚焦2型糖尿病，九源基因等少数企业已启动体重管理适应症的申报工作，国产药企的卡位竞速全面展开。 2 注册类别差异 国产司美格鲁肽申报呈现出2.2类化学药品改良新药与3.3类治疗用生物制品仿制药两种路径，这一差异成为首仿争夺战的关键。2.2类申报在试验要求、样本量、研发成本上远低于3.3类，齐鲁制药、百克生物选择该路径率先进入首仿决赛圈；九源基因、丽珠集团等则以3.3类申报，虽研发门槛更高，但布局更早。其中齐鲁制药2024年9月率先提交2型糖尿病适应症2.2类申请，百克生物则率先布局体重管理适应症，二者成为首仿最有力竞争者。 审评竞速：减重上市尚远 PART 02 1 头部药企进度分化，降糖赛道双雄领跑 当前所有申报药企均未获得上市批文，头部企业进度呈现明显分化，降糖与减重适应症推进节奏差异显著。 九源基因2024年3月率先递交糖尿病适应症3.3类NDA，虽原计划2025年下半年获批的进度有所延迟，但仍与2024年6月申报的丽珠集团共同处于降糖适应症审评第一梯队；减重适应症方面，九源基因2026年2月刚递交NDA进入审评，丽珠集团仍处于三期临床阶段，其余企业尚未启动减重适应症申报。 2 审批周期明晰，上市时间线基本确定 结合CDE审评节奏与企业申报进度，国产司美格鲁肽上市时间线已清晰。乐观估计2026年下半年，首批糖尿病适应症仿制药有望落地；减重适应症因申报进度滞后、临床要求更高，仿制药规模化上市则要等到2027年以后。即便进度最快的九源基因，其降糖与减重双适应症获批也预计在2027年上半年，中美华东等紧随其后的企业则或于2027年下半年拿到上市资格。 市场变局：减重赛道爆发 PART 03 1 国产入局再拉降幅 司美格鲁肽价格下行趋势已不可逆，原研药此前已完成首轮大幅降价，降糖规格1.34mg/mL（1.5mL预充）从1120元/支降至478.8元/支，减重规格2.27mg/mL（3mL预充）从1893.67元/支降至987.48元/支，降幅均超50%。 参考利拉鲁肽仿制药上市经验，业内预计国产司美格鲁肽上市后，减重适应症自费价格将再降60%-70%，原研月均1600元的减重用药成本，将随国产药入局落入大众可承受区间。 2 减重市场迎爆发节点 国内减重市场正迎来全方位的爆发契机，成为药企布局的核心焦点。一方面，原研药减重适应症未纳入医保，院外自费市场存在巨大替代空间，2025年司美格鲁肽大中华区减重销售额仅8.35亿元，远低于降糖领域的56.45亿元，与海外2:1的销售结构形成鲜明对比； 另一方面，国内减重门诊快速普及，截至2025年全国245家三甲医院开设减重门诊，广东等省份计划2026年将二级以上医院减重门诊设置率提升至80%以上，医生规范化诊疗提升了市场对减重药物的接受度；同时，我国超重及肥胖人口突破5.3亿，体重管理纳入国家战略，全民健康需求推动减重药物市场需求持续释放。 国产司美格鲁肽面临三重竞争挑战 PART 04 1 同靶点仿制药的内部角逐 司美格鲁肽仿制药内部的竞争已进入白热化。除目前已申报的10家企业外，华润双鹤、翰宇药业等十几家药企正以2.2类新药开展临床试验。 其中翰宇药业降糖与减重适应症三期临床已进入收尾阶段，预计2026年底至2027年初申报上市，仿制药市场将很快迎来扎堆上市的局面，卷价格、卷渠道成为必然。 2 其他GLP-1药物的直接冲击 替尔泊肽、玛仕度肽等已上市GLP-1类药物成为司美格鲁肽最直接的竞争对手，其中替尔泊肽2025年已将司美格鲁肽赶下药王宝座，这类药物靶点更具优势，临床效果突出，已在市场形成一定的品牌认知，将分流国产司美格鲁肽的潜在市场。 3 迭代管线的长期围堵 一大批GLP-1迭代药物已进入临床后期，成为司美格鲁肽的长期威胁。这些药物针对性弥补司美格鲁肽的短板，或采用口服剂型、或叠加多靶点、或开发长效制剂，如礼来Retatrutide、恒瑞医药HRS-9531等均已进入三期临床，上市后将对司美格鲁肽形成全方位的市场挤压。 司美格鲁肽专利到期，是国产GLP-1仿制药赛道的发令枪，却远非终点线。对于国产药企而言，抢下首仿、快速完成医院准入与市场教育，是占据竞争优势的关键；而在减重市场爆发的当下，如何在同靶点仿制药、同类GLP-1药物、迭代管线的三重竞争中找到自身定位，才是决定市场地位的核心。这场GLP-1赛道的争夺战，才刚刚开始。