星展发布研报称，重申来凯医药"买入"评级，主要因礼来授权引进公司LAE102预防肌肉流失药物的可 能性显著提高。礼来在9月下旬公布的临床试验信息显示，LAE102针对该适应症的竞争优势可能较预期 更为突出。另外，LAE102第一期临床试验预计于9月完成，后续数据公布有望引发礼来及其他国际药企 对授权引进的合作兴趣。 消息面上，来凯医药公布，LAE102针对治疗肥胖症在中国进行的I期多剂量递增研究(MAD研究)取得积 极初步结果。初步结果展现出令人鼓舞的增肌减脂趋势。在第5周时，LAE1026mg/kg剂量组的受试者平 均瘦体重较基线增加了1.7%，同时平均脂肪质量也减少了2.2%。经安慰剂对照组调整后，平均瘦体重 增加达4.6%，而平均脂肪质量则减少了3.6%。此外，近日礼来叫停bimagrumab联用试验，有分析认 为，bimagrumab退出糖尿病试验削弱了潜在竞争，另一方面也凸显了来凯与礼来合作的LAE102管线价 值。 来凯医药-B(02105)再涨超6%，近三个交易日累计涨36%。截至发稿，涨6.11%，报17.55港元，成交额 1.18亿港元。 ...

智通财经APP获悉，来凯医药-B(02105)再涨超6%，近三个交易日累计涨36%。截至发稿，涨6.11%，报 17.55港元，成交额1.18亿港元。 星展发布研报称，重申来凯医药"买入"评级，主要因礼来授权引进公司LAE102预防肌肉流失药物的可 能性显著提高。礼来在9月下旬公布的临床试验信息显示，LAE102针对该适应症的竞争优势可能较预期 更为突出。另外，LAE102第一期临床试验预计于9月完成，后续数据公布有望引发礼来及其他国际药企 对授权引进的合作兴趣。 消息面上，来凯医药公布，LAE102针对治疗肥胖症在中国进行的I期多剂量递增研究(MAD研究)取得积 极初步结果。初步结果展现出令人鼓舞的增肌减脂趋势。在第5周时，LAE1026mg/kg剂量组的受试者平 均瘦体重较基线增加了1.7%，同时平均脂肪质量也减少了2.2%。经安慰剂对照组调整后，平均瘦体重 增加达4.6%，而平均脂肪质量则减少了3.6%。此外，近日礼来叫停bimagrumab联用试验，有分析认 为，bimagrumab退出糖尿病试验削弱了潜在竞争，另一方面也凸显了来凯与礼来合作的LAE102管线价 值。 ...

礼来宣布因"战略业务原因"终止一项2b期肥胖试验，该研究在尚未招募任何参与者前即被叫停。该试验原计划评估礼来以19亿美元收 购Versanis获得的资产bimagrumab，既作为单一疗法，也与其主力GLP-1/GIP药物替尔泊肽联合使用。 整理 | GLP1减重宝典内容团队 公司在今年3月提交了试验申请，计划招募180名肥胖或超重并伴有2型糖尿病的成年人。bimagrumab是一种抗体，通过结合激活素II 型A和B受体来阻断激活素和肌生成抑制素信号通路。研究设计了九个分组，分别测试bimagrumab单用或与替尔泊肽联合，后者正是 Mounjaro和Zepbound的活性成分。 据彭博社首次报道，该试验已被取消。早在6月，ClinicalTrials.gov上的试验状态就从"尚未招募"变更为"进行中但未招募"，引发外界 关注。 本周，该试验状态再次更新为"撤回"。礼来表示，此举是基于业务层面的考虑，公司"会常规性地评估研发管线，以最大化每一款产品 的潜力"。 礼来同时强调，bimagrumab仍在进行中的另一项2期试验中被研究，该试验评估其与替尔泊肽单独或联合在肥胖人群中的疗效。该研 究结果预计将在2026 ...

9月25日，据美国临床试验登记库显示，礼来撤回了ActRIIA/B单抗bimagrumab与司美格鲁肽核心成分tirzepatide联用治疗2型糖尿病患者的IIb期 临床试验，理由是"战略业务原因"。 这项试验原计划为180名既往超重或肥胖并伴有糖尿病的受试者随机给予bimagrumab、tirzepatide或二者联用，监测70周的体重下降及脂肪/肌肉分 布，试验时间自2024年10月21日起、预计2027年1月结束。礼来强调，对所有项目进行例行评估以优化资源，并未透露试验终止的具体原因，外界 普遍解读为公司需要集中资源推进更具前景的肥胖适应症研究。 这一决定并不意味着礼来放弃bimagrumab赛道。公司仍在开展一项针对非糖尿病肥胖成人的II期试验，该试验同样评估bimagrumab与tirzepatide的 联合效果，公司发言人称结果将于2026年读出。 从时间上看，与原计划2027年结束的糖尿病试验相比，肥胖适应症读数提前一年，礼来把精力投向更有望率先获批的肥胖领域。 "高质量减重"依旧重要 bimagrumab由VersanisBio开发，可阻断ActivinⅡ型受体（ActRII），从而抑制肌肉降 ...

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 ...

Group 1 - Eli Lilly has halted an experimental drug study aimed at preventing muscle loss in obese patients due to strategic business considerations [1] - The trial was terminated on June 10, less than a month after its initiation, while a similar study for non-diabetic obese patients remains active [1] - The experimental injection was central to Eli Lilly's strategy for addressing muscle loss in patients undergoing rapid weight loss [1] Group 2 - The terminated trial was intended to follow 180 patients with type 2 diabetes who are obese or overweight for approximately 13 months, focusing on weight loss and fat reduction [1] - Eli Lilly had previously committed around $2 billion to acquire Versanis Bio to obtain bimagrumab, which was to be used in conjunction with its blockbuster drug Zepbound [1] - In a June study, Eli Lilly indicated that bimagrumab could help patients maintain muscle mass while using Novo Nordisk's weight loss drug Wegovy [2] Group 3 - Bimagrumab works by blocking a receptor that typically regulates muscle growth, and it was previously tested by Novartis in a small study involving diabetic patients [2] - In Novartis' early research, one out of 37 patients treated with bimagrumab developed pancreatitis and was hospitalized, raising concerns about the risk of pancreatitis in diabetic patients [2]

Company Developments - Veru Inc. has selected a novel modified-release oral formulation of enobosarm for chronic weight loss management, which aims to enhance fat loss while preserving lean mass [1][4] - The new formulation was developed in collaboration with Laxxon Medical, utilizing proprietary SPID-Technology for advanced oral delivery profiles [2][3] - The modified-release formulation achieved a distinct target product release profile, including a reduction in maximum plasma concentration and a delayed time to maximum plasma concentration [3] - Veru holds a robust patent estate for the new formulation, with protection extending through 2037 and potential expiry of new patent applications expected in 2046 [4] Clinical Study Results - In a Phase 2b clinical study, enobosarm monotherapy reduced weight regain by 46% compared to placebo after discontinuation of semaglutide, while completely preventing fat regain and preserving lean mass [5] Industry Insights - The global anti-obesity drug market was valued at $4.51 billion in 2023 and is projected to grow at a compound annual growth rate of 25.5% through 2032, driven by the increasing prevalence of obesity [6] - Several companies, including Regeneron Pharmaceuticals and Eli Lilly, are advancing obesity treatments, indicating a competitive landscape in the anti-obesity drug market [7][9]

Summary of the Conference Call for LaiKai Pharmaceuticals Company Overview - LaiKai Pharmaceuticals is focused on developing innovative therapies, particularly in the fields of obesity and cancer treatment, with several core products in various stages of clinical development [2][4][5]. Financial Performance - Cash reserves decreased from 700 million RMB in the same period last year to approximately 633 million RMB in the first half of this year, with net cash around 630 million RMB [2][4]. - The net loss slightly reduced from 173 million RMB to 129 million RMB year-over-year [4]. Core Products and Clinical Development - **LQA102**: Currently in Phase I clinical trials, expected to complete MAD (Multiple Ascending Dose) studies by the end of September [2][5]. - **LQA103**: Recently received FDA IND approval, with plans to initiate human trials in the second half of the year [2][5]. - **LAE123**: In the IND enabling stage, with human trials planned for next year [2][5]. - **LAE002**: An AKT inhibitor in Phase III trials for breast cancer in China, with patient enrollment expected to complete in Q4 this year and data readout in the first half of next year [2][5]. Key Clinical Data and Insights - **Bimagrumab**: Data from Eli Lilly indicates a weight loss of over 10% with bimagrumab alone, and over 22% when combined with semaglutide, validating the efficacy of receptor antibodies for obesity treatment [2][8]. - **L2Q a (LQA102)**: Demonstrated significant advantages in weight loss and muscle preservation, with over 41% fat reduction in three weeks during preclinical studies [3][10]. - **AKT Pipeline**: The AKT pipeline is positioned for breast and prostate cancer, with expectations for NDA submission in Q2 next year [12][29]. Market Interest and Strategic Positioning - International market interest is high, as evidenced by Eli Lilly's acquisition of bimagrumab for $1.925 billion and Merck's acquisition of Acero Farm for $11.5 billion, indicating the potential of LaiKai's product portfolio [2][9]. - Multiple multinational corporations (MNCs) are exploring opportunities in the weight loss sector post-ADA conference [9]. Future Directions and Collaborations - LaiKai is actively pursuing partnerships and collaborations, particularly for the 102 and 103 projects, which are expected to enhance business development (BD) opportunities and transaction sizes [18][34]. - The company is also focusing on the development of combination therapies with GLP-1 drugs to address muscle loss associated with obesity treatments [21][27]. Safety and Efficacy Considerations - The MAD study for LQA102 is designed to assess safety and efficacy, with no new safety signals observed thus far [13][14]. - Long-term safety of bimagrumab has shown positive metabolic outcomes, including significant reductions in waist circumference and inflammatory markers [32][33]. Conclusion - LaiKai Pharmaceuticals is positioned at the forefront of innovative drug development in obesity and cancer treatment, with a strong pipeline and significant market interest. The company is focused on advancing its clinical trials and exploring strategic partnerships to maximize shareholder value [35].

Summary of Earnings Call Records Industry Overview - **Industry**: Pharmaceuticals and Biotech Sectors - **Companies Discussed**: AbbVie, Biogen, Bristol Myers Squibb, Bio-Rad Laboratories, Neurocrine Biosciences, Takeda Pharmaceutical, Chugai Pharmaceutical, PeptiDream, Nxera Pharma Key Points by Company AbbVie - **Sales Performance**: Humira sales decreased by 58.1% year-over-year due to biosimilar competition, but this was offset by strong sales of Skyrizi, which increased by 62.2% to $4.4 billion, driven by market share growth in psoriasis and inflammatory bowel disease [1] - **Product Strategy**: Many patients switched from Humira to Skyrizi and Rinvoq instead of biosimilars. AbbVie plans to increase production capacity for Skyrizi in the long term [1] - **New Developments**: The obesity treatment ABBV-295 may address muscle and bone loss when used with other AbbVie drugs [1] Biogen - **Market Share**: Leqembi, an Alzheimer's treatment, maintains a 70% market share despite competition from Eli Lilly's Kisunla [3] - **Testing Growth**: Monthly PET testing for Alzheimer's has increased fivefold, and blood-based biomarker testing has tripled in the past year [3] - **Future Expectations**: Biogen anticipates interim data readout for the AHEAD 3-45 study in 2028 [3] Bristol Myers Squibb - **Sales Growth**: Sales of Opdivo's subcutaneous formulation increased by 7% year-over-year to $30 million, while the intravenous formulation rose to $2.56 billion [6] - **New Product Launch**: Cobenfy, a schizophrenia treatment, generated $35 million in sales with over 2,000 weekly prescriptions [6] - **Direct-to-Patient Model**: The company plans to sell Eliquis directly to patients at a discount of over 50% below the list price [6] Bio-Rad Laboratories - **Sales Performance**: Reported sales of $652 million, up 2% year-over-year, but operating profits fell by 24% to $77 million due to weak demand in biotech and academic research markets [8] - **Market Challenges**: The demand for instruments has been particularly weak, impacting overall sales [8] Neurocrine Biosciences - **Sales Growth**: Total sales reached $688 million, up 16% year-over-year, with operating profits flat at $146 million [10] - **Future Studies**: Plans to initiate a Phase 2 study of NBI-570 in H2 2025, with Phase 1 data readouts expected for NBI-567 and NBI-569 [10] - **Market Positioning**: Neurocrine is exploring differentiation opportunities in muscarinic receptor agonists, which may be better suited for elderly patients [10] Implications for Japanese Companies - **Takeda Pharmaceutical**: Entyvio retains a top share among first-line therapies for ulcerative colitis but is losing market share in second-line settings due to competition [2] - **Chugai Pharmaceutical and PeptiDream**: Both companies are developing myostatin inhibitors to counteract muscle mass loss associated with long-term GLP-1 receptor agonist use [2] - **Nxera Pharma**: The company is positioned positively due to its licensing of muscarinic receptor agonists to Neurocrine, although earnings contributions may not be reflected in share prices until Phase 3 study results are available [11] Additional Insights - **Market Trends**: The aggressive advertising by competitors is impacting market shares of established products like Entyvio [2] - **Direct Sales Models**: There is a growing trend among overseas pharmaceutical companies to adopt direct-to-patient sales models, which Japanese companies have yet to fully embrace [7] This summary encapsulates the key insights and data from the earnings calls of the discussed companies, highlighting their performance, strategies, and implications for the broader industry.

Core Viewpoint - Eli Lilly has shown significant clinical progress and financial results, positioning itself as the largest healthcare player globally, with a market cap of approximately $684 billion as of August 1, and has the potential to reach a $2 trillion valuation within seven years [1]. Group 1: Weight Management Market - The weight management medicines market is rapidly growing, projected to reach $150 billion in sales by 2035, up from $15 billion last year [2]. - Eli Lilly's weight loss therapy, Zepbound, has proven to be highly effective, outperforming its main competitor, Novo Nordisk's Wegovy, in clinical trials, contributing to substantial revenue growth for the company [3][10]. - Eli Lilly is addressing the limitations of Zepbound, such as its weekly injection requirement, by developing orforglipron, an oral GLP-1 medicine, which has shown promising weight loss results in diabetes patients [6][5]. Group 2: Pipeline and Product Diversification - Eli Lilly's pipeline includes innovative products like bimagrumab, which can mitigate muscle loss associated with weight loss therapies, showing significant weight reduction in combination with Wegovy [8]. - The company is also developing retatrutide, which mimics the action of three gut hormones, potentially making it more effective than Zepbound if approved [9]. - Beyond weight management, Eli Lilly has a strong portfolio in diabetes, oncology, and immunology, with products like Mounjaro, Verzenio, and Ebglyss, indicating a diversified and robust pipeline [11][12]. Group 3: Valuation and Market Outlook - Eli Lilly's forward price-to-earnings ratio is around 37, which is high compared to the healthcare industry's average of 16.5, but justified by its rapid sales and profit growth, along with a strong pipeline and dividend program [13]. - The company is expected to outperform the market and achieve the necessary growth to reach a $2 trillion valuation by the end of 2032 [13].