Core Viewpoint - The announcement indicates that the subsidiary Beijing Shengdi Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the clinical trial of SHR-2906 injection, a self-developed therapeutic biological product aimed at weight control and metabolic regulation [1] Group 1: Product Development - SHR-2906 injection is expected to have a synergistic effect in reducing energy intake and promoting energy expenditure, thereby regulating glucose and lipid metabolism and controlling weight [1] - The product aims to improve the metabolic environment in the body and is anticipated to demonstrate clinical efficacy in treating overweight and obesity [1] - Currently, there are no similar drugs approved for market release domestically or internationally [1] Group 2: Financial Investment - The cumulative research and development investment for the SHR-2906 injection project has reached approximately 17.06 million yuan [1]

Core Viewpoint - The announcement highlights that Yabao Pharmaceutical's subsidiary has received approval for clinical trials of GLX002, a new drug aimed at treating pulmonary arterial hypertension (PAH) [1][2]. Group 1: Drug Information - Drug Name: GLX002 [2] - Dosage Form: Tablet [2] - Registration Category: Class 2.2 Chemical Drug [2] - Applicant: Beijing Yabao Biological Pharmaceutical Co., Ltd. [2] - Acceptance Number: CXHL2501089 [2] - Approval Conclusion: The drug meets the requirements for registration and is approved for clinical trials for PAH treatment [1][2]. Group 2: Drug Development and Market Context - GLX002 is a modified new drug based on bosentan dispersible tablets, targeting PAH in patients aged 1 and older [2]. - The drug aims to improve pulmonary vascular resistance (PVR) and enhance exercise capacity in both pediatric and adult patients with WHO functional class II-IV PAH [2]. - In 2024, the sales amount for bosentan dispersible tablets in China is projected to be approximately 20.32 million RMB, with public medical market sales around 17.61 million RMB and retail pharmacy sales about 2.71 million RMB [2]. - Currently, there are no other modified new drugs based on bosentan dispersible tablets available in the domestic or international markets [2]. Group 3: R&D Investment - As of the announcement date, the company has invested approximately 1.6343 million RMB in the R&D of the GLX002 project [3]. - The drug must undergo clinical trials and receive approval from the National Medical Products Administration before it can be manufactured and marketed [3].

传统新药研发平均耗时10-15年，花费超过20亿美元，而失败率高达95%。其根本原因在于，我们一直未能精准分析药物、靶点与机体之间的三重相互作用。面对这一困境，李翛然讲述了自己团队将AI技术与量子计算相结合，构建了“Quantum AIDD”（量子计算+AI药物设计）平台，通过高效求解薛定谔方程，提升药物分子模拟的精度和速度，推动定制化药物设计的故事。 李翛然博⼠是量子计算与AI制药领域的创新先锋，医图⽣科创始⼈兼CEO，CCF会员。他在量子计算和药物研发领域深耕，发表多篇SCI论⽂，拥有数项药物发明全球专利。作为业内先行者；主导医图⽣科的研发与商业化，开展了AI与量子计算在⽣物医药中的研究及应⽤项⽬。他将量子计算融⼊药物设计流程，探索未曾被AI与人类观察到的生物现象，开启“量⼦AI药物设计”时代，为制药⾏业带来全新的变革路径。 This talk was given at a TEDx event using the TED conference format but independently organized by a local community. Learn more at https://ww ...

此外，辉瑞公司最畅销的血液稀释剂Eliquis的价格下调将于明年生效，此前该药被列入拜登时代的《通 胀削减法案》谈判名单。与此同时，辉瑞的关键药物，如肺炎疫苗Prevnar和心脏病治疗药物Vyndaqel， 正面临来自竞争对手的日益激烈的竞争。 这促使Bourla开始寻求收购机会，以帮助辉瑞公司拓展其药物研发管线。该公司最近在与诺和诺德 (NVO.US)的激烈竞购战中胜出，成功收购了肥胖症药物生产商Metsera。 辉瑞斥资100亿美元收购Metsera，使其在这个快速增长的领域获得了一系列极具潜力的新型肥胖症药 物，而此前辉瑞一直难以打入该领域。然而，Metsera的药物仍处于早期研发阶段，这意味着它们可能 还需要数年时间才能上市。 智通财经APP获悉，辉瑞(PFE.US)预测，随着该公司正努力通过一系列昂贵的收购来更新其热门药物产 品线，明年的销售增长将微乎其微甚至没有增长。辉瑞公司周二在一份声明中表示，预计2026年营收将 在595亿美元至625亿美元之间，与华尔街的预期大致相符。今年销售额预计为620亿美元，与该公司11 月初的指引范围一致。该公司预计明年调整后每股收益将位于2.80美元至3美元之间。 ...

撰文丨王聪 编辑丨王多鱼 排版丨水成文 类器官 （ Organoid ） 是从干细胞衍生出的三维 （3D） 结构，能够重现相应组织的关键结构和功能特 征。与传统的二维 （2D） 细胞系相比，人类类器官能提供更贴近人体生理的实验模型。它们能够捕捉人 体组织的复杂性和异质性，从而有助于研究疾病机制、药物疗效和毒性。当由患者来源的生成时，类器官 还能用于评估个体对治疗药物的响应。 近日，"类器官之父" Hans Clevers 教授、 王代松 博士等在 Nature 旗下综述期刊 Nature Reviews Drug Discovery 上发表了题为 ： Human organoids as 3D in vitro platforms for drug discovery: opportunities and challenges 的研究论文。 在这篇综述中，作者们探讨了 类器官在药物发现中的应用 ，概述了当前的生成和维持类器官的方法，考察 了它们在疾病建模、药物筛选和安全性评估方面的应用，并考虑了监管方面以及在药物发现中更广泛采用 所面临的挑战。 在药物研发领域，体外模型发挥着关键作用，为研究细胞对药物的反应提 ...

（文章来源：每日经济新闻） 每经AI快讯，众生药业（002317.SZ）12月16日在投资者互动平台表示，公司昂拉地韦颗粒III期临床试 验正在积极推进中，目前已完成全部参与者入组工作。公司争取早日完成相关研究，申报药物上市，为 广大患者提供更多治疗选择。公司将严格按照相关规则及要求履行决策程序和信息披露义务。 ...

美国密歇根州立大学研究团队利用捐赠的人类干细胞，成功开发出全球首个"人源化"心脏类器官，能在 暴露于炎症环境时表现出心房颤动特征。这一突破为研究心律失常提供了前所未有的活体人体组织模 型，有望打破该领域30多年来无新药问世的僵局。这项发表于《细胞·干细胞》的研究，标志着人类在 对抗心律失常的道路上迈出了关键一步。 心房颤动影响全球约6000万人，但由于缺乏准确的人类心脏模型，药物研发长期停滞。近30多年来，没 有新药物被开发用于治疗心房颤动。现有疗法往往针对症状而非潜在机制，因此人们对这种疾病仍然治 疗不力。 2020年起，密歇根州立大学发育与干细胞生物学部艾托·阿吉雷团队利用捐赠的人类干细胞，培育出直 径约数毫米的三维心脏类器官。这些类器官不仅拥有类似真实心脏的腔室结构和血管网络，还能自主节 律性跳动。而且这些类器官的节律性搏动非常强劲，无需显微镜即可观察到。 类器官大小与扁豆相仿，精确度极高，使团队能够以前所未有的方式研究心脏发育、疾病和药物反应。 此次研究的关键进展在于，团队首次在类器官中引入了免疫细胞。博士后研究员科林·奥罗克发现，当 类器官暴露于炎症环境时，会出现类似房颤的心律失常；而使用抗炎药物后 ...

格隆汇12月12日丨康弘药业(002773.SZ)公布，子公司成都弘基生物科技有限公司（简称"弘基生物"）收 到国家药品监督管理局签发的《药物临床试验批准通知书》，药品名称：KH658眼用注射液。本品适用 于治疗糖尿病黄斑水肿（DME）、糖尿病视网膜病变（DR）。 ...

Core Viewpoint - Dyne Therapeutics is experiencing significant investor interest following a positive analyst upgrade and promising clinical trial results for its investigational drug, leading to a notable increase in stock price [1][2][4]. Group 1: Analyst Upgrade - Jay Olson of Oppenheimer upgraded Dyne's stock recommendation from hold to outperform, nearly quadrupling the price target from $11 to $40 [2]. - The upgrade coincided with the release of positive results from a clinical trial, suggesting a strong potential for the company's drug [4]. Group 2: Clinical Trial Results - Dyne's investigational drug, zeleciment rostudirsen, successfully met both primary and secondary endpoints in a phase 1/2 clinical trial for Duchenne muscular dystrophy (DMD) [4]. - The drug was found to effectively increase the production of dystrophin, a protein crucial for muscle protection [5]. Group 3: Market Performance - Dyne's stock rose by 6.78% to a current price of $19.69, with a market capitalization of $3 billion [6]. - The stock has shown volatility, with a recent secondary stock offering causing initial investor concerns, but the positive trial results have renewed optimism [9]. Group 4: Future Plans - The company aims to submit zeleciment rostudirsen for accelerated FDA approval in the second quarter of 2026, indicating a proactive approach to advancing its drug pipeline [8].

Core Insights - A new study reveals that vertebrates can regenerate a complex lymphoid organ, the thymus, from scratch without any tissue remnants, expanding the understanding of organ regeneration capabilities [1][2] - The research highlights the thymus's critical role in the immune system and its limited repair ability in most animals, which deteriorates with age, leading to decreased immune function [1] Group 1: Research Findings - The study, published in the journal Science Immunology, demonstrates the thymus regeneration ability of the Mexican axolotl, known for its limb regeneration [1] - The research team conducted a series of experiments, including precise thymectomy and high-resolution imaging, confirming the complete dynamic process of thymus regeneration [1] - After 35 days, the axolotl developed a new thymus that matched the original in morphology, cell types, and function [1] Group 2: Mechanisms and Implications - The research team utilized single-cell RNA sequencing to map the stages of thymus regeneration, identifying two signaling pathways as key to initiating this process: bone morphogenetic protein and a lesser-known "regeneration initiator" called midfactor [2] - The findings suggest potential therapeutic avenues for activating similar signaling pathways in humans, which could benefit children who have undergone thymus surgery, patients with specific immune deficiencies, and elderly individuals with declining immune function [2] - The study points to a new drug development pathway, with ongoing exploration of critical issues such as identifying "seed cells" that initiate regeneration, understanding how the size and location of the regenerated organ are precisely regulated, and verifying the effectiveness of related signaling pathways in mammals [2]