中药创新药研发
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悦康药业递表港交所 为一家涉及四种核心模式的生物制药公司
Zhi Tong Cai Jing· 2025-12-30 00:21
据港交所12月29日披露,悦康药业集团股份有限公司(简称:悦康药业(688658.SH))向港交所主板提交上市申请,中信证券为其独家保荐人。 公司简介 招股书披露,悦康药业是一家生物制药公司,专注于研究、开发、生产和商业化四种模式的疗法:寡核苷酸、信使核糖核酸(mRNA)疫苗、多肽和中药创新 药。公司利用商业化产品组合、跨模态研发技术平台和能力、药品生产质量管理规范(GMP) 认证的生产系统及遍布全国的商业化网络等综合优势,为拥有 大量未满足需求及长期增长潜力的主要治疗领域推进候选产品的差异化创新管线。 | | | | 截至12月31日止年度 | | | | | 截至7月31日止七個月 | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | 2022年 | | 2023年 | | 2024年 | | 2024年 | | 2025年 | | | | (人民幣于元) | 8 | (人民幣于元) | ક | (人民幣于元) | હ | (人民幣于元) | હુર | (人民幣于元) | 多 | | | | | | | ...
湖南方盛制药股份有限公司关于投资者接待日活动召开情况的公告
Zheng Quan Shi Bao· 2025-12-21 18:10
本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏,并对其内容 的真实性、准确性和完整性承担法律责任。 近日,养血祛风止痛颗粒通过国家医保谈判,首次纳入《国家基本医疗保险、生育保险和工伤保险药品 目录(2025年)》。为使广大客户、投资者与行业分析师更深入了解该产品及公司发展动态,湖南方盛 制药股份有限公司(以下简称"公司")于2025年12月21日(周日)举办"养血祛风止痛颗粒新品上市发 布会暨投资者接待日"活动。现将有关情况公告如下: 一、活动基本情况 1、召开时间:2025年12月21日(周日),9:00-12:00; 2、召开地点:公司研发大楼一楼大礼堂(长沙市国家高新技术产业开发区嘉运路299号); 3、参会人员:董事长兼总经理周晓莉女士、党委书记兼董事长助理张庆华先生、董事兼副总经理陈波 先生、董事萧钺先生、董事会秘书何仕先生等公司领导及相关行业专家代表; 4、来访人员:天风证券、中泰证券、华源证券、华泰证券、国联民生证券、开源证券、中邮证券、东 北证券、东吴证券、西部证券、华创证券、财信证券、鑫巢资本、金石投资、创富启航及个人投资者与 部分媒体。(排名不分先后) 二、 ...
远大医药盘中涨超3% 中药创新药GPN01360国内II期临床达到终点
Zhi Tong Cai Jing· 2025-12-11 03:45
远大医药(00512)盘中涨超3%,截至发稿,涨2.59%,报8.32港元,成交额3337.37万港元。 消息面上,远大医药近日公布,用于治疗抑郁症的中药创新药GPN01360在中国开展的Ⅱ期临床研究达 到临床终点。据悉,GPN01360是一款用于治疗抑郁症(肝郁脾虚证)的1.1类中药创新药,基于古代经典 方剂"逍遥散",通过现代药理学与临床研究筛选优化而成,处方由柴胡、郁金、佛手等12味中药组成, 具有疏肝健脾、解郁安神的功效。 远大医药表示,积极的临床研究数据为GPN01360后续的研发奠定了基础,并有望解决现有西药因副作 用导致患者依从性差的难题,从而提高长期治疗的持续性和有效性,为提升抑郁症的临床治愈率带来新 的方案。同时,GPN01360也将为中医药治疗抑郁症此类精神类疾病提供有力的循证医学证据,验证中 成药的独特优势与科学价值。 ...
远大医药:公司用于治疗抑郁症的中药1类创新药II期临床达到终点
Cai Jing Wang· 2025-12-09 03:16
近日,远大医药集团发布公告称,公司用于治疗抑郁症的中药创新药GPN01360在中国开展的II期临床 研究成功达到临床终点。 该研究是一项随机、双盲、安慰剂平行对照、多中心的II期临床研究,入组148例抑郁症患者,口服给 药8周,旨在初步评价该药相较于安慰剂治疗抑郁症(肝郁脾虚证)的有效性和安全性。结果表明,该 药在抑郁症的治疗方面有较好的安全性和有效性,且对抑郁伴焦虑、失眠等症状的改善也较为明显。 ...
远大医药:中药1类创新药GPN01360在中国开展的II期临床研究成功达到临床终点
Zhi Tong Cai Jing· 2025-12-08 11:52
GPN01360 是一款用于治疗抑郁症(肝郁脾虚证)的1.1类中药创新药,基于古代经典方剂"逍遥散",通过 现代药理学与临床研究筛选优化而成,处方由柴胡、郁金、佛手等12 味中药组成,具有疏肝健脾、解 郁安神的功效。该中药主要用于治疗肝郁脾虚型抑郁症,其典型症状包括情绪低落、思维迟缓、意志活 动减退、心烦焦虑、失眠健忘、食少纳呆及神疲乏力等。前期近百人的人用经验研究表明,GPN01360 在改善抑郁症状、缓解焦虑失眠及调理脾胃功能方面表现出良好疗效与安全性。 抑郁症也称抑郁障碍,是一种常见的精神障碍,可影响患者的工作、学习和社会生活,严重时可导致自 杀,且复发率高达75%-90%,是一种终生性疾病,是全球精神障碍所致疾病负担的首要原因,也是全球 重大的公共卫生问题。根据世界卫生组织(WHO)最新统计数据,全球大约有3.32亿人患有抑郁症,总患 病率约4.0%,其中成人患病率达5.7%。抑郁症是全球范围内全因伤残引起的健康寿命损失年(years lived with disability,"YLDs")的第二大因素,其中在15-29岁年龄组中,是YLDs的首要因素,为全球社会生 产力带来了巨大负担,抑郁与焦虑每 ...
远大医药(00512) - 自愿性公告: 本集团中药1类创新药GPN01360在中国开展的II期临床...
2025-12-08 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之內容概不負責,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。 Grand Pharmaceutical Group Limited 遠大醫藥集團有限公司* ( 於百慕達註冊成立之有限公司 ) (股份代號:00512) 自願性公告 本集團中藥 1 類創新藥 GPN01360 在中國開展的 II 期臨床研究成功達到臨床終點 -1- 0.05);PSQI 展現出明顯的治療趨勢。此外,GPN01360 安全性和耐受性較好,在整個 試驗期間未發現明顯的毒副作用。以上研究結果表明,GPN01360 在抑鬱症的治療方面 有較好的安全性和有效性,且對抑鬱伴焦慮、失眠等症狀的改善也較為明顯。 GPN01360 是一款用於治療抑鬱症(肝鬱脾虛證)的 1.1 類中藥創新藥,基於古代經典 方劑「逍遙散」,通過現代藥理學與臨床研究篩選優化而成,處方由柴胡、郁金、佛手 等 12 味中藥組成,具有疏肝健脾、解鬱安神的功效。該中藥主要用於治療肝鬱脾虛型 抑鬱症,其典型症狀包括情緒低落、思維遲緩、意 ...
片仔癀(600436):研发积极推进 储备潜力品种
Xin Lang Cai Jing· 2025-11-23 02:27
Company Updates - The company announced the completion of the first subject enrollment in the PZH2108 Phase IIa clinical trial on November 20. Additionally, the company announced the completion of the first subject enrollment in the Phase III clinical trial for Wen Dan Pian on October 17 [1] New Drug Development - The company is actively advancing two new drug projects and 18 ongoing new drug research initiatives, including five traditional Chinese medicine (TCM) Class 1 drugs, one TCM Class 1.2 drug, and four chemical Class 1 drugs by October 2025. Among these, TCM Class 1 drug PZH1219 has received clinical approval, and PZH1215 has completed subject enrollment for Phase IIa. The chemical Class 1 drug PZH2111 has completed subject enrollment for Phase I. This strategy is expected to establish a solid product reserve for the company [2] - PZH2108 is an innovative Class 1 chemical drug with independent intellectual property rights, intended for the treatment of cancer pain. The company has completed Phase I clinical trials, showing good safety and tolerability across various dosage groups in healthy subjects in China [2] - Wen Dan Pian is an innovative Class 1 TCM compound formulation derived from the classic formula Wen Dan Tang, aimed at treating mild to moderate generalized anxiety disorder (Phlegm-Heat Disturbance Syndrome). The clinical trial seeks to confirm its efficacy and safety. According to the Drug Intelligence Network database, the sales scale of anti-anxiety drugs in Chinese hospitals is expected to reach 2.444 billion yuan in 2024 [2] Traditional Chinese Medicine Development - The company has achieved significant results in the secondary development of TCM. By October 2025, it has completed 100% subject enrollment for three projects involving the use of Pizhuan for primary liver cancer post-surgical recurrence reduction, as well as four studies on the anti-influenza effects of compound Pizhuan tablets, and published 12 academic papers. This indicates potential for further expansion of indications in the future [3] Profit Forecast and Valuation - The company maintains net profit forecasts of 2.431 billion yuan and 2.674 billion yuan for 2025 and 2026, respectively. The current stock price corresponds to a price-to-earnings ratio of 43.7 times for 2025 and 39.7 times for 2026. The company maintains an outperform rating and a target price of 240 yuan, indicating a potential upside of 36.2% from the current stock price [4]
沉寂三年的云南白药,见底了吗?
Ge Long Hui· 2025-11-14 09:01
Core Viewpoint - The market value of Yunnan Baiyao is under pressure due to the overall downturn in the traditional Chinese medicine industry, despite its stable revenue and profit growth. The company is facing challenges in maintaining growth momentum and diversifying its product offerings [1][3][19]. Financial Performance - Yunnan Baiyao reported a revenue of 30.65 billion yuan for the first three quarters, a year-on-year increase of 2.47% [3][5]. - The net profit attributable to shareholders reached 4.78 billion yuan, reflecting a year-on-year growth of 10.41% [3][5]. - The company's basic earnings per share increased by 10.74% to 2.68 yuan [5]. Revenue Composition - The company's revenue is heavily reliant on commercial sales, which account for 60% of total revenue but have a low gross margin of only 6% [6]. - Industrial sales, which make up less than 40% of revenue, are the main profit contributors, particularly from products like aerosol sprays and toothpaste [6]. Market Position and Challenges - Yunnan Baiyao holds a dominant market share in several product categories, including a 91.8% share in the aerosol market for muscle and joint pain relief [6]. - Despite its strong market position, the company faces challenges in growth as sales in pharmaceuticals and health products have slowed down in recent years [7]. Diversification Efforts - In recent years, Yunnan Baiyao has explored various side businesses, including tea and industrial hemp, and previously engaged in stock trading, which led to significant losses [8][14]. - The company has since reduced its trading financial assets significantly, indicating a shift in strategy towards safer investments [10][11]. Strategic Developments - Yunnan Baiyao has announced plans to focus on both traditional Chinese medicine and innovative pharmaceuticals, aiming for both internal and external growth [26][27]. - The acquisition of 聚药堂 for 660 million yuan is part of its strategy to enhance its product portfolio and market reach, despite concerns over the high premium paid [28][30]. Innovation and R&D - The company is actively pursuing innovation in its product lines, with ongoing projects in traditional Chinese medicine and health supplements [32][36]. - Yunnan Baiyao is also working on developing new drugs, although the process is lengthy and costly, posing risks to timely market entry [36]. Market Outlook - Despite recent challenges, Yunnan Baiyao has maintained a high dividend payout ratio, making it attractive to investors [36]. - The company's current valuation is below the industry average, suggesting potential for future growth, although caution is advised before making investment decisions [36].
以岭药业(002603) - 2025年10月28日投资者关系活动记录表
2025-10-29 09:06
Group 1: Company Overview and Market Position - Yiling Pharmaceutical is recognized as the company with the most approved innovative traditional Chinese medicine (TCM) products since 2020 [2] - The company has established a comprehensive management system for intellectual property and trade secrets to protect its innovations [2] Group 2: Product Promotion Strategies - In the hospital market, the company is enhancing specialized promotion efforts based on five national key research projects [3] - In the external market, the company focuses on brand strategy, aiming to strengthen brand building and improve customer compliance with products [3] Group 3: Innovative Drug Development - The company has multiple innovative drugs in clinical stages, including XY0206 for acute myeloid leukemia and XY03-EA for ischemic stroke [6] - Future R&D plans include over ten products in respiratory, endocrine, digestive, gynecological, and pediatric fields [4] Group 4: Sales Expectations and Strategies - The BaZi Kidney Supplement Capsule is expected to enhance immune function and improve aging-related symptoms, with research published in high-impact journals [7][8] - The company is increasing sales efforts through retail and e-commerce channels, focusing on brand building and customer relationship management [8] Group 5: Market Potential and Financial Outlook - The market for diabetic retinopathy treatment is promising, with approximately 116.4 million diabetes patients in China and a DR prevalence rate of about 34.6% [11] - The company anticipates a recovery in gross profit margins due to declining prices of traditional Chinese medicinal materials and internal efficiency improvements [12]
片仔癀:前三季度实现收入74.42亿元,1.1类新药有望填补中药焦虑用药空白
Zheng Quan Shi Bao Wang· 2025-10-17 12:29
Core Viewpoint - The company reported a slight decline in performance for the first three quarters of 2025, with operating revenue and net profit attributable to shareholders reaching 7.442 billion yuan and 2.129 billion yuan respectively, due to adverse factors such as a temporary contraction in the consumer market and high raw material costs [1] Group 1: Financial Performance - The company's operating revenue for the first three quarters of 2025 was 7.442 billion yuan, while the net profit attributable to shareholders was 2.129 billion yuan [1] - The management is actively investing in brand, channel, research and development, and external investments to support future business recovery [1] Group 2: Raw Material Costs - The price of natural bull gall has been decreasing, dropping from 1.65 million yuan per kilogram at the beginning of the year to 1.45 million yuan, which is expected to further improve cost conditions [1] Group 3: R&D and Clinical Trials - The company announced the completion of the first subject enrollment in the Phase III clinical trial for the innovative traditional Chinese medicine, Wen Dan Pian, which targets mild to moderate generalized anxiety disorder [1][2] - Wen Dan Pian is based on the classic formula Wen Dan Tang and has been used clinically since 2007, classified as a 1.1 category innovative traditional Chinese medicine [2] - The Phase III clinical trial aims to confirm the efficacy and safety of Wen Dan Pian in treating mild to moderate generalized anxiety disorder, with 606 subjects expected to be recruited [4] Group 4: Market Demand and Opportunities - The patient base for generalized anxiety disorder (GAD) is large, with a lifetime prevalence of 7.6% among Chinese adults and an annual prevalence of 5.0% [3] - The market for anti-anxiety medications in hospitals in China is projected to reach 2.444 billion yuan in 2024 [3] - There is a significant unmet clinical need for traditional Chinese medicine treatments for GAD, particularly for the phlegm-heat disturbance type, which the company's product aims to address [3][4] Group 5: Industry Trends - The Chinese government has emphasized the importance of innovation in traditional Chinese medicine, encouraging the development of new drugs and children's medications [4] - The company has been actively promoting the research and development of innovative drugs, with 18 new drug research projects underway in the first half of 2025 [4]