继特朗普政府达成降价协议后，美国联邦医疗保险和医疗补助服务中心(CMS)于周二宣布推出一项自愿 性计划，将GLP-1类减肥及糖尿病治疗药物纳入医疗补助(Medicaid)与联邦医疗保险D部分(Medicare Part D)的承保范围。 据了解，今年11月，美国总统特朗普已与礼来(LLY.US)、诺和诺德(NVO.US)签署协议，承诺大幅降低 热门GLP-1减肥药物在联邦医疗保险、医疗补助计划及自费患者群体的价格。而CMS新推出的计划正是 基于此协议制定，预计最早于2026年5月面向医疗补助计划启动，并于2027年1月扩展至联邦医疗保险。 根据这项"平衡倡议"(BALANCE Initiative)，CMS将通过直接谈判锁定药品净价，制定标准化承保条 款，或对患者自付费用设置上限，并配套提供循证生活方式支持服务。 CMS明确，符合条件的联邦医疗保险参保人每月仅需支付50美元，即可获得GLP-1类药物，其中涵盖诺 和诺德的减肥注射剂Wegovy(司美格鲁肽)与礼来的同类药物Zepbound(替尔泊肽)。 CMS局长Mehmet Oz在社交平台X发文称，该计划"旨在拓宽特定GLP-1类药物的可及性，助力民众养成 ...

为平稳过渡至"平衡倡议"模式，CMS计划于2026年7月启动联邦医疗保险GLP-1药物支付试点项目，届 时参保人可按政府谈判价格购买相关药物。 智通财经APP获悉，继特朗普政府达成降价协议后，美国联邦医疗保险和医疗补助服务中心(CMS)于周 二宣布推出一项自愿性计划，将GLP-1类减肥及糖尿病治疗药物纳入医疗补助(Medicaid)与联邦医疗保 险D部分(Medicare Part D)的承保范围。 据了解，今年11月，美国总统特朗普已与礼来(LLY.US)、诺和诺德(NVO.US)签署协议，承诺大幅降低 热门GLP-1减肥药物在联邦医疗保险、医疗补助计划及自费患者群体的价格。而CMS新推出的计划正是 基于此协议制定，预计最早于2026年5月面向医疗补助计划启动，并于2027年1月扩展至联邦医疗保险。 根据这项"平衡倡议"(BALANCE Initiative)，CMS将通过直接谈判锁定药品净价，制定标准化承保条 款，或对患者自付费用设置上限，并配套提供循证生活方式支持服务。 CMS明确，符合条件的联邦医疗保险参保人每月仅需支付50美元，即可获得GLP-1类药物，其中涵盖诺 和诺德的减肥注射剂Wegovy(司 ...

丨2025年12月19日星期五丨 NO.1 礼来：向FDA提交新型口服减肥药orforglipron的上市申请 12月18日，礼来公司宣布，已向美国食品药品监督管理局（FDA）提交了新型口服减肥药orforglipron的 上市申请。礼来表示，从诺和诺德旗下Wegovy（司美格鲁肽）转用orforglipron的参与者，在转换后平 均维持了此前减重成果的绝大部分，仅平均反弹0.9公斤。 点评：减肥药赛道竞争趋向白热化，口服减肥药orforglipron的上市申请如能获批，将有望凭借积极的临 床数据以及口服制剂的给药优势改变目前的市场格局。 NO.2 复星医药：控股子公司与Clavis Bio达成合作，可获得至多3.63亿美元付款 12月18日，复星医药公告称，公司控股子公司复星医药产业与合作方Clavis Bio签订《合作及选择权协 议》，共同选定靶点并推进临床前开发。Clavis Bio就该等合作项目享有除中国内地、香港、澳门外的 全球范围内开发、生产及商业化独家许可的选择权。 12月18日，百济神州发布公告称，经公司董事会审议通过，同意聘任公司全球研发负责人汪来博士担任 公司总裁，全球研发负责人。聘任生效 ...

Core Viewpoint - Novo Nordisk is seeking accelerated review for a higher dose version of its obesity drug Wegovy (semaglutide) through the FDA's CNPV program, which could lead to approval within one to two months, coinciding with the review of its 25 mg oral semaglutide in Q4 [2][6]. Group 1: Drug Efficacy and Approval Process - The new 7.2 mg dose of semaglutide is expected to provide a more effective weight loss option, with clinical trial results showing an average weight loss of 20.7% over 72 weeks compared to 17.5% for the 2.4 mg group and 2.4% for the placebo group [2][3]. - In the 7.2 mg trial group, 33.2% of participants achieved at least a 25% weight loss, compared to 16.7% in the 2.4 mg group and 0% in the placebo group [3]. - The FDA has issued 15 CNPV designations to date, with Wegovy being among the second batch of drugs selected for this expedited review process [5]. Group 2: CNPV Controversy - Concerns regarding the CNPV program have been raised by lawmakers, questioning its potential to benefit pharmaceutical companies with close ties to the Trump administration and demanding transparency on the beneficiaries and review details [7][10]. - There are fears that the accelerated review process may undermine public trust in FDA decisions, especially in light of staffing cuts within the government [9]. - Reports indicate that the initial CNPV review process excluded the FDA team responsible for evaluations, leading to concerns about the legitimacy and pace of the decision-making [10].

Core Viewpoint - Mangoceuticals (MGRX.US) stock price surged approximately 19% following the announcement of partnerships with pharmaceutical giants Eli Lilly (LLY.US) and Novo Nordisk (NVO.US) to directly offer their popular GLP-1 weight loss medications [1] Company Summary - Mangoceuticals, based in Dallas, Texas, has launched the MangoRx Direct and PeachesRx Direct platforms aimed at self-paying users [1] - The platforms will sell Eli Lilly's Zepbound (tirzepatide) and Novo Nordisk's Wegovy (semaglutide) directly to consumers [1]

Core Viewpoint - Novo Nordisk has reached a final agreement to acquire Akero Therapeutics for up to $5.2 billion, with a cash offer of $54 per share and an additional contingent value right of $6 per share, pending regulatory approval of Akero's drug efruxifermin [1][2] Group 1: Acquisition Details - The total acquisition price is up to $5.2 billion, consisting of $4.7 billion in cash and a $500 million contingent value right [1] - The deal has been unanimously approved by Akero's board and is expected to close by the end of the year [1] - Following the announcement, Akero's stock surged nearly 18%, while Novo Nordisk's stock fell over 1% [1] Group 2: Akero Therapeutics and Efruxifermin - Akero is a clinical-stage biopharmaceutical company focused on developing therapies for patients with severe metabolic diseases [1] - Efruxifermin is currently undergoing late-stage trials aimed at treating patients with moderate to advanced liver fibrosis due to metabolic dysfunction-associated steatohepatitis (MASH) [1] - MASH can progress from metabolic dysfunction-associated steatotic liver disease (MASLD) and is characterized by steatosis, inflammation, and fibrosis, potentially leading to cirrhosis [1] Group 3: Strategic Implications - Novo Nordisk's CEO emphasized the potential of efruxifermin to reverse liver damage and become a cornerstone therapy, either alone or in combination with Wegovy [2] - Akero believes that Novo Nordisk's global leadership in metabolic diseases will accelerate the evaluation and commercialization of efruxifermin [2] - A contingent payment of $6 per share will be made to Akero shareholders if efruxifermin receives full approval from U.S. regulators by June 30, 2031 [2]

Core Viewpoint - Novo Nordisk (NVO.US) shares rose over 4% in pre-market trading following the announcement of positive results from the Oasis 4 Phase 3 trial for its oral weight loss medication Wegovy, which showed an average weight reduction of 16.6% among patients [1] Group 1: Trial Results - The Oasis 4 Phase 3 trial demonstrated that patients taking the oral version of Wegovy (semaglutide) experienced an average weight loss of 16.6% [1] - The trial results indicated improvements in cardiovascular risk factors for patients using Wegovy compared to those on a placebo [1] - These findings are consistent with previous results from trials involving the injectable form of Wegovy [1] Group 2: Stock Performance - Novo Nordisk's stock closed at $58.20, with a pre-market price of $60.62, reflecting a 4.16% increase [1] - The stock's trading volume was 16.809 million shares, with a market capitalization of $258.447 billion [1] - The stock has a 52-week high of $124.107 and a low of $44.548, indicating significant volatility [1]

Group 1 - European stock markets experienced a slight increase, with the healthcare sector being a major support factor [1] - Novo Nordisk's weight loss drug Wegovy demonstrated superior heart protection effects compared to Eli Lilly's competing products, leading to a nearly 3% rise in its stock price [1] - Wegovy was shown to reduce the risk of heart attack, stroke, or death by 57% compared to Eli Lilly's Mounjaro and Zepbound [1] Group 2 - The defense sector in Europe also performed well, with a 1.2% increase, driven by a significant contract announcement from Norway to procure new frigates from the UK, valued at approximately £10 billion (about $13.51 billion) [1]

Group 1 - Novo Nordisk's Wegovy shows significant advantages in reducing the risk of severe cardiovascular events, with a 57% reduction in risk compared to Eli Lilly's Zepbound [1] - The STEER study, based on data from over 20,000 cardiovascular disease patients aged 45 and above, confirms the cardiovascular benefits of GLP-1 drugs for non-diabetic obese patients [1] - The average follow-up period for the Wegovy group was 8.3 months, while the Zepbound group had 8.6 months, indicating sustained effects of the drugs in real-world applications [1] Group 2 - Wegovy is approved in the US and EU not only for obesity treatment but also for reducing the risk of major cardiovascular events in overweight or obese adults with cardiovascular disease [2] - The study data may further solidify Wegovy's leading position in the GLP-1 weight loss drug market and provide new treatment options for millions of obese patients with cardiovascular disease globally [2]

Core Viewpoint - Eli Lilly's Q2 performance exceeded market expectations, but disappointing results from oral GLP-1 drug trials led to a 13% drop in stock price [5][7]. Group 1: Financial Performance - Eli Lilly reported Q2 revenue of $15.56 billion, surpassing Wall Street's expectation of $14.69 billion; earnings per share were $6.31, above the forecast of $5.56 [5]. - U.S. market revenue reached $10.81 billion, with GLP-1 drugs Mounjaro and Zepbound seeing a 46% year-over-year sales increase, although an 8% price reduction limited revenue growth [5]. Group 2: Market Competition - Eli Lilly's Zepbound has outperformed Novo Nordisk's Wegovy in the competitive GLP-1 market, with Zepbound's prescription volume increasing by 225% year-over-year, totaling over 418,000 weekly prescriptions, compared to Wegovy's 35% increase and 281,000 weekly prescriptions [7]. - The oral GLP-1 drug orforglipron showed disappointing results in late-stage trials, with a 25% dropout rate in the highest dosage group, raising concerns about trial design [7]. Group 3: Future Outlook - Eli Lilly plans to submit data for orforglipron to the FDA this year, with hopes for approval and market entry next year [7]. - Novo Nordisk has lowered its 2025 outlook due to competitive pressures, while Eli Lilly holds over 60% of new weight loss prescriptions in the U.S. GLP-1 market [7][8].