2025年4月，一则来自全球临床试验注册平台ClinicalTrials网站的信息显示，港股上市的Biotech公司来凯医药更新了其自研管线LAE102针 对肥胖症在美国的一项I期临床试验(NCT06908707)的相关信息。 一个引人注意的变化是：修订后的临床方案，出现了合作伙伴礼来的名字。 同时，来自ClinicalTrials网站的信息也显示，该研究计划于2025年4月底启动临床入组，预计在2025年8月结束。 LAE102是一款来凯医药自主研发的靶向激活素II型受体A(ActRIIA)的单克隆抗体，也是全球范围内除了礼来的Bimagrumab之外，为数不 多的已经进入临床试验阶段的靶向ActRII的在研管线。 目前来凯LAE102在中国的I期临床试验正全速推进：继单剂量递增部分(SAD研究)之后，2025年3月多剂量递增研究(MAD研究)已完成首 例受试者访视。 根据医药投资部落的数据库显示，去年11月，来凯医药与礼来公司签署了临床合作协议，礼来将负责在美国执行LAE102的一项I期临床试 验并承担相关费用，而来凯医药保留了LAE102的全球权益。 此次来凯医药向FDA提交的临床方案修订版，正是对应于 ...

非常欢迎大家来参加以及多家券商联合主办的莱凯医药2024年一级电话交流会那我们今天也是非常荣幸的邀请到了公司的多位管理层团队来给大家做沟通他们分别是公司的董事长兼首席执行官李向阳博士公司的首席科学官顾湘俊博士公司的这个首席财务官这个周总公司的临床开发的副总裁王俊博士以及公司的这个IRD这个吴总那莱凯医药的话应该也是我们团队从这个去年开始我们对整个 港股包括A股的这个618的这个8月份公司进行系统梳理然后筛选出来重点推荐的这个公司之一那其实公司在尤其在这个减肥领域对吧我觉得应该是做的非常有特色然后呢产品的进来也非常的顺利那我们今天的话也是讲究公司的整体利用情况包括它的发展给大家做一个系统的沟通 我们的交流当中将分为两个部分,第一个部分的话,先邀请公司的这个CFO周总来就公司的整体情况给大家做一个更新,然后之后的话,邻居局各位高管团队的同事将会回答大家交流的问题,大家提出的问题,然后呢,交流问答的环节将由我的同事文信来主持,那周总我就先把这交给你,谢谢。 谢谢杨总 首先谢谢各位投资者朋友参加今天的交换会接下来我们先简单介绍一下莱凯医药在2024年我们整年的一个财务还有业务进展的情况然后我们多预留一些时间然后在介绍 ...

Investment Rating - The report maintains a "Positive" investment rating for the industry [1] Core Insights - The report highlights the significant potential of blocking the Activin receptor (ActR) signaling pathway to promote muscle growth, particularly in treating muscle atrophy-related diseases [4][9] - There is a substantial unmet clinical need for muscle-targeted therapies, especially for patients with spinal muscular atrophy (SMA) and those experiencing muscle loss due to aging or weight management [4][29] - The market for muscle-targeted therapies is projected to be large, with current SMA therapies generating approximately $4.5 billion in sales, indicating a significant opportunity for new treatments [4][33] Summary by Sections 1. ActR Pathway - The ActR pathway plays a crucial role in regulating muscle, blood, and bone through members of the TGFβ superfamily, including Myostatin [9] - Blocking the ActR pathway can effectively treat muscle atrophy by inhibiting Myostatin, which negatively regulates muscle growth [4][10] 2. Clinical Applications of ActR Pathway Blockade: Spinal Muscular Atrophy (SMA) - SMA is a genetic neuromuscular disease caused by mutations in the SMN1 gene, leading to severe muscle atrophy and respiratory failure [22][23] - Current SMA therapies primarily target SMN protein, but they have limitations, highlighting the need for combined therapies that also address muscle atrophy [25][29] 3. Clinical Applications of ActR Pathway Blockade: Weight Management - Muscle loss is a significant issue not only in genetic diseases but also in aging populations, with a 1% annual muscle loss in individuals over 60 [36] - The widespread use of GLP-1RA medications has been linked to 25-40% muscle loss in users, creating a demand for therapies that preserve or enhance muscle mass during weight management [36] 4. Targeted ActRII Pathway Drugs - Apitegromab, developed by Scholar Rock, is a monoclonal antibody targeting latent Myostatin, showing promising results in Phase 3 trials for SMA and expected to submit for FDA approval [38][39] - Taldefgrobep, developed by BIOHAVEN, targets active Myostatin but did not meet primary endpoints in its Phase 2 trial for SMA, although it showed trends of benefit in certain subgroups [57][62] - GYM329, developed by Roche, specifically targets latent Myostatin and is currently undergoing clinical trials for various indications, demonstrating potential for muscle mass increase [69]