新药研发
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GLP-1/GIP长效激动剂及MUC-17 ADC齐传捷报 华东医药研发实力再获验证
Zheng Quan Ri Bao Wang· 2025-12-15 13:15
Core Viewpoint - East China Pharmaceutical's subsidiary, Hangzhou Sino-American East China Pharmaceutical Co., Ltd., has achieved positive results in the Phase II clinical trial of its innovative dual-target long-acting agonist HDM1005 for weight management, showcasing the company's strong R&D capabilities in metabolic diseases [1][2]. Group 1: HDM1005 Development - HDM1005 is a novel class of chemical drug that acts as a dual-target long-acting agonist for GLP-1 and GIP receptors, with preclinical studies indicating its potential to improve metabolic functions, reduce oxidative stress, and enhance cardiovascular adaptability [1]. - The clinical development of HDM1005 is progressing systematically, with the Phase III trial for weight management expected to complete the first subject enrollment by October 2025, and the Phase II trial for diabetes having completed subject enrollment by July 2025 [2]. - Applications for clinical trials of HDM1005 in multiple indications, including metabolic-associated fatty liver disease (MAFLD) and metabolic-associated fatty liver inflammation (MASH), have been approved in both China and the United States, indicating a comprehensive global clinical development strategy [2]. Group 2: HDM2012 Development - HDM2012, a novel antibody-drug conjugate targeting MUC-17, has received orphan drug designation from the FDA for gastric cancer and pancreatic cancer, highlighting the international recognition of the drug's innovative R&D [2]. - HDM2012 is the first ADC product targeting MUC-17 and is currently the only ADC drug in clinical research for this target, which is highly expressed in gastric, colorectal, and pancreatic cancers but has limited expression in normal organs [2]. - Preclinical results for HDM2012 demonstrate good drug-like properties, safety, and efficacy, with clinical trials in China and the U.S. receiving approval in July and June 2025, respectively, for advanced malignancies [3].
一个创新强国的绿色崛起
Ren Min Ri Bao Hai Wai Ban· 2025-12-15 06:10
近日,法国总统马克龙访华之际,《回声报》、《费加罗报》、法新社等法国媒体均聚焦中国,其中, 中国在科技创新和绿色发展领域取得的成就成为关注焦点。事实上,最近,《金融时报》《经济学人》 等多家外媒关注中国成为创新强国,并纷纷探究其中原因。报道称,中国已从"世界工厂"变身,西方国 家需要在竞争中迎头赶上。 中国作为技术强国的崛起已无可置疑 "创新"已成为中国经济社会发展的关键词。不久前党的二十届四中全会通过的"十五五"规划建议中,有 61次提及"创新"。近年来,中国重大科创成果密集涌现,全球创新指数排名从2012年的第34位升至2025 年的第10位。 "中国几乎在所有领域都占据优势地位"。这是法国外交及中国问题专家伊曼纽尔·林科特近日接受《费 加罗报》专访时做出的判断。文章指出,在当前全球技术格局中,特别是在电动汽车、人工智能等关键 领域,中国作为技术强国的崛起已无可置疑。中国近年来主动引导全球标准设定、技术创新推进,已进 入价值链高端。 澳大利亚广播公司12月8日文章引用澳大利亚智库最新发布的一份报告指出,中国在8个人工智能类别中 的7个,全部13个先进材料和制造技术类别,所有7个国防、太空、机器人和交通类别 ...
拨康视云-B成功举行CBT-004的第2期临床试验后会议
Zhi Tong Cai Jing· 2025-12-12 08:43
拨康视云-B(02592)公布,于2025年12月10日,公司全资附属公司Cloudbreak USA与美国食品及药物管 理局成功举行第2期临床试验后会议,该会议涉及CBT-004的临床开发,而CBT-004为一种潜在的同类首 创无防腐剂滴眼液,适用于治疗血管化睑裂斑,该病症常见于紫外线照射过度者及年长者。 于第2期临床试验后会议上,美国食品及药物管理局就下列事项提供意见回馈:药物稳定性及规格研 究、支持向美国食品及药物管理局提交拟议新药申请所需的非临床研究,以及CBT-004第3期临床研究 的设计及终点。其中,美国食品及药物管理局与Cloudbreak USA就以下事项达成共识:将充血症状减轻 作为CBT-004获批的主要终点,其统计学及临床意义,并将症状缓解作为潜在的共同主要终点。 第2期临床试验后会议乃基于2025年5月完成的第2期临床试验结果及2025年7月完成的临床试验报告而举 行,该报告显示CBT-004在受试者中具有安全性且耐受性良好,并达到主要疗效终点及若干次要疗效终 点。尤其是,第2期临床试验结果显示CBT-004在减轻结膜充血方面具疗效,首次用药后最快7天即可见 效。于28天治疗期间,亦观 ...
中国抗体(03681) - 自愿公告SM17新药研究申请获国家药品监督管理局药品审评中心受理
2025-12-11 09:51
香 港 交 易 及 結 算 所 有 限 公 司 及 香 港 聯 合 交 易 所 有 限 公 司 對 本 公 告 的 內 容 概 不 負 責,對其準確性或完整性亦不發表任何聲明,並明確表示概不就因本公告全部或 任何部分內容而產生或因倚賴該等內容而引致的任何損失承擔任何責任。 SM17新藥研究申請獲國家藥品監督管理局藥品審評中心受理 茲提述中國抗體製藥有限公司(「本公司」,連同其附屬公司統稱「本集團」)所刊發 日 期 為 二 零 二 二 年 二 月 十 六 日 、 二 零 二 二 年 三 月 十 四 日 、 二 零 二 二 年 六 月 十 五 日 、 二 零 二 三 年 五 月 二 十 二 日 、 二 零 二 三 年 六 月 十 二 日 、 二 零 二 三 年 八 月 十 四 日、二零二三年九月十一日、二零二三年十一月二十七日、二零二四年六月十一 日、二零二五年四月七日及二零二五年十月十四日的過往公告,內容有關本集團 主要產品之一SM17研發進展。 本公司董事會(「董事會」)欣然宣佈,於二零二五年十二月十一日,一項SM17針對 炎 症性 腸病(「IBD」)的 新藥 研究 申 請(「IND」), 已 提交 予中 國 ...
迪哲医药连亏6年3季度 A股募38.99亿IPO中信证券保荐
Zhong Guo Jing Ji Wang· 2025-12-11 07:47
中国经济网北京12月11日讯 迪哲医药(688192.SH)近日发布2025年第三季度报告显示,2025年 第三季度,公司实现营业收入2.31亿元,同比增长71.46%;归属于上市公司股东的净利润-2.03亿元; 归属于上市公司股东的扣除非经常性损益的净利润-2.11亿元。 2025年前三季度,公司实现营业收入5.86亿元,同比增长73.23%;归属于上市公司股东的净利 润-5.80亿元;归属于上市公司股东的扣除非经常性损益的净利润-6.31亿元;经营活动产生的现金流量 净额为-4.24亿元。 | | | | | HATTA A SAMILA 年初至报告期 | | --- | --- | --- | --- | --- | | | | 本报告期比上 | | 末比上年同期 | | 项目 | 本报告期 | 年同期增减变 | 年初至报告期末 | | | | | 动幅度(%) | | 增减变动幅度 | | | | | | (%) | | 营业收入 | 231,299,714.08 | 71.46 | 586,301,134.90 | 73.23 | | 到海总额 | -203.910.752.21 | 不适用 | - ...
港股异动 昭衍新药(06127)再涨超7% 实验猴价格迎来暴涨 供需缺口或持续放大
Jin Rong Jie· 2025-12-11 02:13
Core Viewpoint - The stock price of Zhaoyan New Drug (06127) has increased by over 7%, reaching HKD 18.56, with a trading volume of HKD 42.5682 million, driven by a surge in the price of experimental monkeys [1] Group 1: Company Overview - Zhaoyan New Drug is the largest supplier of experimental monkeys globally [1] - The company's stock performance reflects market optimism regarding its position in the experimental monkey supply sector [1] Group 2: Industry Dynamics - The price of experimental monkeys has skyrocketed, with the cost of 3-5 year old macaques reaching HKD 140,000 each, indicating a supply-demand imbalance [1] - According to estimates from Founder Securities, the supply of experimental monkeys is projected to be around 49,000 to 52,400 per year from 2025 to 2027, while demand is expected to be between 51,300 to 62,600 per year [1] - The short-term increase in demand for experimental monkeys is driven by a resurgence in new drug development, while supply-side improvements are expected to be challenging, potentially widening the supply-demand gap [1]
昭衍新药早盘涨逾7%实验猴价格迎来暴涨 供需缺口或持续放大
Xin Lang Cai Jing· 2025-12-11 01:47
Group 1 - The core point of the article highlights a significant increase in the price of experimental monkeys, with the price for 3-5 year old macaques rising to 140,000 yuan each, indicating a supply-demand imbalance in the market [1][3] - Zhaoyan New Drug (06127) is identified as the largest supplier of experimental monkeys globally, benefiting from the rising prices and demand [1][3] - According to estimates from Founder Securities, the supply of experimental monkeys is projected to be around 49,000 to 52,400 per year from 2025 to 2027, while demand is expected to be between 51,300 and 62,600 per year, suggesting a persistent supply-demand gap due to challenges in improving supply [1][3]
华通证券国际:首次覆盖君圣泰医药-B予“推荐”评级 目标价为5.78港元
Zhi Tong Cai Jing· 2025-12-10 15:16
Group 1 - The commercialization process of the core product HTD1801 is expected to accelerate within the year, with the NDA stage anticipated by the end of 2025 [1] - The company forecasts revenues of 0 million, 0 million, and 2.53 billion for the years 2025, 2026, and 2027 respectively [1] - A target price of 5.78 HKD per share is set for the next six months, with an initial "recommend" investment rating [1] Group 2 - HTD1801 is a globally innovative oral anti-inflammatory and metabolic regulator, granted two Fast Track designations by the FDA [2] - The product operates through a unique dual mechanism, aiming to treat cardiovascular and metabolic diseases comprehensively, showing significant efficacy in improving blood glucose metabolism and other health markers [2] - Clinical trial data indicates HTD1801 can significantly reduce HbA1c levels by -1.1% to -1.3%, outperforming the leading drug Dapagliflozin in achieving ideal HbA1c control [2] Group 3 - HTD1801 shows potential in chronic kidney disease (CKD) treatment, with clinical studies indicating it can improve eGFR levels in early-stage patients [3] - The drug demonstrated a significant improvement in eGFR compared to placebo in patients with mild kidney function impairment [3] - HTD1801 may also have a trend of reducing eGFR in patients with high renal filtration [3]
研报掘金丨西部证券:首予百奥赛图“买入”评级,临床前产品和服务高速增长
Ge Long Hui· 2025-12-10 07:22
格隆汇12月10日|西部证券研报指出,百奥赛图是一家创新技术驱动新药研发的国际性生物技术公司, 致力于成为全球新药发源地。基于底层基因编辑技术,百奥赛图自主研发了RenMice(RenMab、 RenLite、RenNano、RenTCR mimicTM)平台,用于全人治疗性单克隆抗体、双/多特异性抗体、双抗 ADC、纳米抗体和类TCR抗体的发现。公司临床前产品和服务高速增长,全球化运营海外MNC 认证, 已实现规模化动物模型销售。全球新药早研竞争激烈,"千鼠万抗"货架模式提升开发效率,抗体授权推 动业绩弹性。公司抗体业务始于2020年,全年收入0.41亿元,而2025年上半年收入达到1.63亿元(同比 +37.8%)。随着后续分子进一步临床推进,公司平台价值有望进一步放大。首次覆盖,给予"买入"评 级。 ...
N百奥上午收盘涨135.38% 半日成交12.44亿元
Zheng Quan Shi Bao Wang· 2025-12-10 05:14
Group 1 - The company N Bai Ao (688796) was listed today, opening with a rise of 117.39%, and by midday, the increase expanded to 135.38% with a trading volume of 20.49 million shares and a turnover of 1.244 billion yuan, resulting in a turnover rate of 57.10% [2][3] - The company specializes in providing innovative model animals and preclinical pharmaceutical research and development services based on its self-developed gene editing technology, utilizing its RenMice platform for large-scale drug discovery and development targeting over a thousand potential drug targets in the human body [2] - After over a decade of development, the company has established itself with four technical platforms: gene-edited model animal preparation, innovative model animal breeding and supply, preclinical pharmacology and efficacy evaluation, and antibody drug discovery, aiming to provide high-quality products and services for new drug development [2] Group 2 - The total number of shares issued by the company is 47.5 million, with an online issuance of 11.461 million shares at a price of 26.68 yuan per share, resulting in an issuance price-to-earnings ratio of 519.12, compared to the industry average of 39.31 [3] - The final online issuance success rate was 0.02801388%, and the total fundraising amount from the initial public offering (IPO) is 1.267 billion yuan, primarily directed towards early drug development service platform construction, working capital supplementation, preclinical and clinical research projects, and antibody drug research and evaluation projects [3]