丨 2025年11月26日 星期三 丨 11月24日，诺和诺德宣布，其针对司美格鲁肽治疗阿尔茨海默病的两项大型Ⅲ期试验均未达到主要目 标。数据显示，与安慰剂相比，用药患者病情进展未获显著延缓。受此消息影响，公司股价大跌。 港交所官网显示，11月24日，科望医药、明宇制药递表港交所。公开资料显示，两家生物科技公司分别 成立于2017年和2018年，目前均处于临床阶段，未有产品获批上市。 点评：今年以来，港股市场再度成为生物医药企业的"融资港湾"，科望医药、明宇制药递表，也反映出 港股市场在该领域的吸引力正在不断提升。然而，投资者也需保持理性，关注企业研发进展及潜在风 险，避免盲目跟风。 NO.4信达生物玛仕度肽高剂量9mg上市申请获受理 NO.1司美格鲁肽治疗阿尔茨海默病的临床试验失败 点评：阿尔茨海默病的致病机理至今未明确，相关药物研发的失败率一直高居不下，诺和诺德此次宣布 的消息，是对该领域在研药物的又一次打击。不过，中国药企在该领域的研发热情逐年升温，或将给患 者带来新的希望。 NO.2基石药业舒格利单抗的新适应证在欧盟获批 11月25日，基石药业宣布，欧盟委员会（EC）已批准舒格利单抗的新适应证：单药用 ...

丨2025年11月26日星期三丨 NO.1 司美格鲁肽治疗阿尔茨海默病的临床试验失败 11月24日，诺和诺德宣布，其针对司美格鲁肽治疗阿尔茨海默病的两项大型Ⅲ期试验均未达到主要目 标。数据显示，与安慰剂相比，用药患者病情进展未获显著延缓。受此消息影响，公司股价大跌。 点评：阿尔茨海默病的致病机理至今未明确，相关药物研发的失败率一直高居不下，诺和诺德此次宣布 的消息，是对该领域在研药物的又一次打击。不过，中国药企在该领域的研发热情逐年升温，或将给患 者带来新的希望。 点评：今年以来，港股市场再度成为生物医药企业的"融资港湾"，科望医药、明宇制药递表，也反映出 港股市场在该领域的吸引力正在不断提升。然而，投资者也需保持理性，关注企业研发进展及潜在风 险，避免盲目跟风。 NO.4 信达生物玛仕度肽高剂量9mg上市申请获受理 11月25日，信达生物发布公告，宣布玛仕度肽注射液高剂量9mg用于成人中重度肥胖患者长期体重控制 的上市申请，已获中国国家药品监督管理局（NMPA）药品审评中心（CDE）受理。 点评：对于国内中重度肥胖人群，玛仕度肽有望在减重手术之外，提供一个新治疗选择。但随着减肥药 市场竞争日益激烈，该产品的 ...

11月20日，信达生物（1801.HK）宣布，其全球首个GCG/GLP-1双受体激动剂玛仕度肽在中国BMI≥30 中重度肥胖人群的三期临床研究GLORY-2，达成主要终点及所有关键次要终点。数据显示，相较于安 慰剂，玛仕度肽9mg治疗实现显著的体重减轻，特别是在单纯性肥胖受试者中平均体重降幅为20.08%。 当前，玛仕度肽获批的剂量规格主要是2mg、4mg和6mg，对于BMI≥28或24≤BMI＜28并伴有至少一种 肥胖相关并发症的人群。信达生物近期计划向国家药监局递交玛仕度肽9mg用于成人体重控制的上市申 请。 信达生物称，开发玛仕度肽不同剂量和给药方案，玛仕度肽9mg的开发针对中国BMI在大于30，特别是 32.5以上的中重度肥胖患者的减重需求，这部分人群以往只能通过减重手术达到有效的体重管理。（智 通财经记者 李潇潇） ...

来源：市场资讯 （来源：美股情报站） 9月25日，制药巨头礼来公司的股价再次遭受重创，下跌3.67%，这已经是连续第三天出现下跌，总计 跌幅达到5.35%。这一股价波动将其推至自2025年8月以来的最低水平，吸引了诸多投资者和分析师的 关注。 礼来公司通过收购Versanis Bio获得了bimagrumab，这一化合物在此前的概念验证研究中显示出帮助患 者在使用竞争对手药物减重时维持肌肉量的潜力。然而，在更早的研究中，该药物曾导致部分患者出现 胰腺炎的风险，这也为其未来的广泛应用带来了不确定性。 总体来看，礼来在健康领域的战略调整表明公司正在积极应对市场竞争和潜在的安全性问题。对于投资 者而言，关注礼来新的研发管线和市场扩展策略是关键。尽管股价短期内波动较大，但在长期战略布局 明朗化后，可能会为投资者带来更稳定的回报。因此，建议投资者在考虑礼来的投资时，密切关注其在 全球市场的药物批准进展以及潜在的临床合作机会。 礼来近期的下行趋势与其在研发领域所做的战略调整有关。公司已决定终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。据悉，该决定是出于战略性商业考量，而这项临床试验在启动不到一个月 的时间内就被 ...

Core Viewpoint - Pfizer is repositioning itself in the weight loss drug market through a significant acquisition of Metsera, aiming to secure a foothold in a market projected to exceed $100 billion in size [1][4]. Group 1: Acquisition Details - Pfizer is nearing a deal to acquire Metsera for up to $7.3 billion, offering $47.50 per share in cash, with potential additional payments of up to $22.50 per share based on performance milestones [1][5]. - The acquisition price represents a premium of approximately 42.5% over Metsera's closing price of $33.32 on the previous Friday, leading to a surge in Metsera's stock price by over 60% [1][5]. Group 2: Market Context - The global weight loss drug market is expected to reach a value of $150 billion by the early 2030s, indicating strong investor interest in next-generation weight loss therapies [4][6]. - The competition in the weight loss drug market is intensifying, with companies like Eli Lilly and Novo Nordisk leading the GLP-1 class of weight loss drugs, creating high barriers for new entrants [6]. Group 3: Metsera's Profile - Metsera, founded in 2022, is developing obesity treatments based on GLP-1 mechanisms and other biological targets, with its main candidate MET-097i being an injectable drug [5][6]. - Pfizer's shift to an acquisition strategy follows setbacks in its own weight loss drug development, particularly the abandonment of the experimental drug danuglipron due to safety concerns [5][6].

智通财经APP获悉，辉瑞(PFE.US)同意以约49亿美元的企业价值收购肥胖症药物研发初创公司 Metsera(MTSR.US)，此举旨在强化其研发管线。此前，该公司一款关键减肥药研发受挫。 这家美国制药商在周一的声明中表示，将以每股47.50美元的现金收购Metsera，若达成三项特定监管里 程碑，还将额外支付每股最高22.50美元。该交易较Metsera上周五收盘价溢价43%。截至发稿，Metsera 盘前涨59.72%，报53.22美元。 新冠疫情过后，辉瑞正致力于业务重整，将希望寄托于尚未经过验证的新药研发管线，以接替其老化产 品。作为新一代肥胖症药物研发中有望脱颖而出的企业之一，Metsera正在开发多款实验性减肥药物， 其中包括一款注射剂，其给药频率可能低于市场主流产品Wegovy和Zepbound。 该公司研发的药物MET-233i在最近一项研究中，帮助患者在36天内减重高达8.4%。该药物仍处于早期 开发阶段，这意味着距离上市还有数年时间。 彭博行业研究的迈克尔·沙阿表示，MET-233i"可能成为肥胖症治疗领域最具潜力的同类最佳药物"。 ...

Core Viewpoint - Novo Nordisk's new weight loss drug Cagrilintide shows promising results in late-stage clinical trials, leading to a stock price increase of over 2% to $57.12 [1] Group 1: Clinical Trial Results - Cagrilintide demonstrated an average weight loss of 11.8% after 68 weeks in a Phase 3 trial, compared to only 2.3% in the placebo group [1] - The drug is a long-acting insulin analog that increases satiety by mimicking hormones secreted alongside insulin in the pancreas, differing from existing GLP-1 medications [1] Group 2: Company Statements - Martin Holst Lange, Chief Scientific Officer and Executive Vice President of R&D at Novo Nordisk, expressed excitement over the significant weight loss achieved in clinical trials and noted the good tolerability of Cagrilintide [1] - The company anticipates further validation of Cagrilintide's potential in the dedicated Phase 3 RENEW project [1]

Core Viewpoint - The valuation of weight loss drug companies is under scrutiny as the market faces a reality check in 2025, following a period of rapid growth and inflated expectations driven by the success of GLP-1 drugs [1][4]. Group 1: Market Dynamics - The weight loss drug sector has seen intense competition, particularly with the rise of oral small molecule GLP-1 drugs, which are favored for their cost and adherence advantages [1]. - Merck's acquisition of a preclinical oral small molecule GLP-1 from Hansoh Pharma involved an upfront payment of $112 million, with potential milestone payments reaching $1.9 billion [1]. - Metsera, the first biotech company to go public in the weight loss drug space, saw its stock surge nearly 50% on its debut, achieving a market cap of over $3.4 billion within three years of its establishment [1]. Group 2: Clinical Challenges - As clinical sample sizes increase and treatment durations extend, weight loss drugs are revealing significant shortcomings, including side effects and reduced efficacy [2][3]. - Viking's oral GLP-1 drug VK2735 initially showed promising results but faced a 42% stock drop after final clinical results revealed a high dropout rate due to side effects [5][6]. - Eli Lilly's Orforglipron also underperformed expectations, leading to a 14.14% drop in stock price, marking its largest single-day decline since 2000 [6]. Group 3: Safety and Efficacy Concerns - The transition from early clinical trials to larger populations often exposes new safety issues, as seen with Pfizer's decision to halt the development of Danuglipron due to potential liver damage concerns [8]. - Novo Nordisk's downward revision of its 2025 sales growth forecast from 13%-21% to 8%-14% resulted in a 21.8% stock drop, indicating market sensitivity to performance expectations [9]. Group 4: Domestic Market Outlook - Domestic weight loss drug companies are still in the early stages of development, with many relying on promising early data from animal studies to secure funding [10][11]. - The path from animal studies to human trials is fraught with challenges, and the reliance on existing drug frameworks raises concerns about safety and efficacy in later-stage trials [11][14]. Group 5: Future Survival Strategies - The next generation of weight loss drugs will face high standards for efficacy, and slight deviations in performance may not be sufficient to differentiate products in a competitive market [15]. - The industry is moving towards maturity, with ongoing innovation in areas such as weight loss and muscle gain, despite the challenges posed by clinical validation [15][16]. - Companies must prepare for a landscape where only clinically validated therapies can thrive in a market projected to be worth hundreds of billions [17].

Core Insights - Eli Lilly's shares have increased by 3.7% to $720.07 following positive results from a late-stage trial of its weight-loss pill, orforglipron, which helped type 2 diabetes patients lose 10.5% of their body weight over 72 weeks, paving the way for global approval [1] Group 1 - The stock has been on an upward trend since hitting a 52-week low of $623.78 on August 8, achieving its 10th gain in the last 12 sessions [2] - Despite the recent gains, the shares are still down 24.9% year over year and 7.5% year to date [2] - There has been significant options activity, with 50,000 calls exchanged, which is double the intraday average volume, compared to 20,000 puts [2] Group 2 - The popularity of calls has increased over the last 10 weeks, with a 50-day call/put volume ratio of 1.67, ranking higher than 90% of readings from the past year [3]

Group 1 - The core point of the article is that Gilead Sciences-B (01672) announced a share placement to raise funds for clinical trials related to obesity treatments, which has positively impacted its stock price [1] - Gilead plans to place 52.4 million shares at HKD 16.45 each, representing a discount of approximately 9.9% from the previous closing price, with net proceeds expected to be HKD 468 million [1] - Approximately 90% of the funds raised will be allocated to the development of subcutaneous and oral peptide candidates for obesity clinical trials [1] Group 2 - The controlling shareholder and founder, Wu Jinzi, will sell 52.4 million shares at HKD 16.45 each and subsequently subscribe to 28.82 million new shares, resulting in a cash-out of HKD 388 million [1] - Citigroup has highlighted the potential of Gilead's small molecule GLP-1 receptor agonist ASC30, with phase II data expected to be released in Q4 this year, which could serve as a key catalyst for the company [1] - Management has indicated that the safety data from the ASC30 phase II A group blind clinical trial has shown good performance with no cases of discontinuation, and a business development partnership for ASC30 is anticipated by mid-2026 [1]