YILING PHARMACEUTICAL(002603)
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以岭药业(002603.SZ):撤回“柴黄利胆胶囊”药品注册申请
Ge Long Hui A P P· 2025-11-27 11:15
Core Viewpoint - Yiling Pharmaceutical (002603.SZ) has withdrawn its drug registration application for "Chaihuang Lidan Capsules" as per the notice from the National Medical Products Administration (NMPA) [1] Group 1: Drug Development and Regulatory Updates - The "Chaihuang Lidan Capsules" is an innovative traditional Chinese medicine developed by Yiling, aimed at treating conditions such as chronic cholecystitis and gastrointestinal issues [1] - The NMPA had accepted the new drug registration application for "Chaihuang Lidan Capsules" in June 2024 [1] - Yiling will enhance the registration materials according to the latest NMPA requirements and will resubmit the drug registration application promptly [1] Group 2: Impact on Company Operations - The withdrawal of the registration application is not expected to have a significant impact on the company's current and future operations and performance [1] - The company emphasizes the importance of drug research and development while strictly controlling R&D costs, acknowledging the high risks and long cycles associated with drug development [1] - Yiling will closely monitor the progress of this drug development matter and fulfill its information disclosure obligations as required [1]
以岭药业:撤回“柴黄利胆胶囊”药品注册申请
Ge Long Hui· 2025-11-27 11:07
格隆汇11月27日丨以岭药业(002603.SZ)公布,全资子公司北京以岭药业有限公司(简称"北京以岭")收 到国家药品监督管理局关于同意其撤回"柴黄利胆胶囊"药品注册申请的通知。柴黄利胆胶囊是公司自主 研制的中药创新药,其功能主治为:清热利湿,疏肝利胆,和胃止痛。用于慢性胆囊炎肝胆湿热、胃失 和降证,症见右上腹胀痛或不适,晨起口苦,口干咽干,脘腹胀满,或伴有恶心欲吐,厌食油腻,纳 呆,嗳气,身重困倦,烦躁易怒,胸闷不舒,小便黄赤,大便不爽或秘结,舌质红,苔黄腻,脉弦滑 数。2024年6月,北京以岭"柴黄利胆胶囊"新药注册申请获国家药监局受理。 北京以岭将根据国家药监局最新要求进一步完善注册资料,并尽快重新提交药品注册申请。北京以岭本 次撤回注册申请预计不会对公司当期及未来的生产经营与业绩产生重大影响。公司重视药品研发,并严 格控制研发成本,但药品研发风险高、周期长,存在诸多不确定性,公司将密切关注该药品研发事项的 后续进展情况,按规定及时履行信息披露义务。 ...
以岭药业:全资子公司撤回“柴黄利胆胶囊”药品注册申请
Xin Lang Cai Jing· 2025-11-27 10:48
Core Viewpoint - Yiling Pharmaceutical announced that its wholly-owned subsidiary, Beijing Yiling, received notification from the National Medical Products Administration to withdraw the drug registration application for "Chai Huang Li Dan Capsule" [1] Group 1: Drug Registration - The drug is an innovative traditional Chinese medicine developed by the company [1] - The new drug registration application was accepted in 2024 [1] - Beijing Yiling will improve the registration materials and resubmit the application as soon as possible [1] Group 2: Impact on Business - The withdrawal is expected not to have a significant impact on the company's current and future production operations and performance [1] - The company will monitor subsequent developments and disclose updates in a timely manner [1]
以岭药业(002603) - 关于全资子公司药品注册申请进展的公告
2025-11-27 10:45
石家庄以岭药业股份有限公司 近日,石家庄以岭药业股份有限公司(以下简称"公司")全资子公司北京 以岭药业有限公司(以下简称"北京以岭")收到国家药品监督管理局关于同意 其撤回"柴黄利胆胶囊"药品注册申请的通知。 柴黄利胆胶囊是公司自主研制的中药创新药,其功能主治为:清热利湿,疏 肝利胆,和胃止痛。用于慢性胆囊炎肝胆湿热、胃失和降证,症见右上腹胀痛或 不适,晨起口苦,口干咽干,脘腹胀满,或伴有恶心欲吐,厌食油腻,纳呆,嗳 气,身重困倦,烦躁易怒,胸闷不舒,小便黄赤,大便不爽或秘结,舌质红,苔 黄腻,脉弦滑数。2024年6月,北京以岭"柴黄利胆胶囊"新药注册申请获国家 药监局受理。 北京以岭将根据国家药监局最新要求进一步完善注册资料,并尽快重新提交 药品注册申请。北京以岭本次撤回注册申请预计不会对公司当期及未来的生产经 营与业绩产生重大影响。公司重视药品研发,并严格控制研发成本,但药品研发 风险高、周期长,存在诸多不确定性,公司将密切关注该药品研发事项的后续进 展情况,按规定及时履行信息披露义务。 敬请投资者谨慎决策,注意投资风险。 特此公告。 证券代码:002603 证券简称:以岭药业 公告编号:2025-04 ...
以岭药业荣膺「阳光」年度杰出药物研发创新企业
Jin Rong Jie· 2025-11-27 07:19
Core Insights - Yiling Pharmaceutical was awarded the title of "Outstanding Drug R&D Innovation Enterprise of the Year" for its continuous innovation and strong R&D capabilities [1] - The company has maintained a high level of R&D investment, with R&D expenses reaching 544 million yuan in the first three quarters of 2025, accounting for 9.27% of its revenue [1] - Yiling Pharmaceutical has cumulatively invested over 5 billion yuan in R&D from 2019 to 2024, leading the industry in R&D spending [1] R&D Achievements - The company has successfully launched its patented traditional Chinese medicine "Qifang Nasal Congestion Tablets" in early 2025, becoming the first registered innovative traditional Chinese medicine in Macau [1] - Yiling Pharmaceutical has a target of producing five new drugs every five years, currently holding 17 innovative traditional Chinese medicine varieties covering eight major disease areas [1] - Among these, 11 varieties are included in the national medical insurance catalog, and 5 are in the national essential drug catalog, indicating broad market and clinical recognition [1] Pipeline and Future Prospects - The company has a rich pipeline with three new traditional Chinese medicine products, including Qigui Luobitong Tablets and Children's Lianhua Qingwen Granules, having submitted applications for market approval [2] - Additionally, five innovative traditional Chinese medicines are in various clinical stages, and one class 1 new chemical drug, Benanilofen Injection, has also submitted for market approval [2] - The company demonstrates a forward-looking layout in diverse drug development, with three class 1 innovative chemical drugs, including XY0206 tablets for solid tumors and leukemia, currently in clinical trials [2] Industry Recognition - The "21st Century Health Industry Competitiveness Research 'Sunshine' Case" aims to discover and promote outstanding enterprises and cutting-edge technologies in the health industry [2] - This year's event focused on seven dimensions, including innovation R&D, business development achievements, innovative drugs and devices, ESG practices, emerging enterprises, digital applications, and corporate health management, showcasing the industry's innovative vitality and exemplary practices [2]
以岭药业养正消积胶囊在泰国获批上市,中医药抗肿瘤获国际认可
Huan Qiu Lao Hu Cai Jing· 2025-11-27 06:51
Core Insights - Yangzheng Xiaojie Capsule is an innovative traditional Chinese medicine developed under the guidance of traditional Chinese medicine theory, targeting the pathological mechanisms of tumors and has been approved for use in primary liver cancer treatment in China [1][2] Group 1: Product Efficacy - Yangzheng Xiaojie Capsule integrates traditional methods with modern anti-cancer drugs, demonstrating a dual action of supporting the body while eliminating pathogens, which aligns with modern cancer treatment goals [1] - Clinical studies indicate that Yangzheng Xiaojie Capsule significantly improves the quality of life for patients with advanced non-small cell lung cancer, with a clinical symptom improvement rate of 83.5% [2] - In a study on primary liver cancer, the combination of Yangzheng Xiaojie Capsule with interventional chemotherapy resulted in a total effective rate of 65.2%, significantly higher than the control group's 36.1% [2] Group 2: Research and Validation - Research led by Professor Jiang Wenguo from Cardiff University found that Yangzheng Xiaojie Capsule can significantly interfere with tumor cell invasion and metastasis by inhibiting the excessive activation of the PI3K/AKT signaling pathway [1] - The same research also indicated that the capsule inhibits the activity of focal adhesion kinase, thereby suppressing tumor angiogenesis, which contributes to tumor starvation [1] Group 3: Market Expansion - Yangzheng Xiaojie Capsule has recently been approved in Thailand, marking a significant milestone in Yiling Pharmaceutical's internationalization strategy and demonstrating the practical application of traditional Chinese medicine in the "Belt and Road" initiative [4] - Yiling Pharmaceutical has successfully registered 17 innovative traditional Chinese medicines in over 50 countries and regions worldwide, indicating strong international market recognition [4]
以岭药业涨2.04%,成交额4.24亿元,主力资金净流出1878.54万元
Xin Lang Cai Jing· 2025-11-26 02:13
Core Viewpoint - Yiling Pharmaceutical's stock has shown a significant increase this year, with a year-to-date rise of 24.44%, indicating strong market performance and investor interest [1][2]. Financial Performance - For the period from January to September 2025, Yiling Pharmaceutical reported a revenue of 5.868 billion yuan, a year-on-year decrease of 7.82%. However, the net profit attributable to shareholders reached 1 billion yuan, reflecting a substantial year-on-year growth of 80.33% [2]. Stock Market Activity - As of November 26, Yiling Pharmaceutical's stock price was 19.55 yuan per share, with a trading volume of 4.24 billion yuan and a market capitalization of 32.662 billion yuan. The stock has experienced a 3.66% increase over the past five trading days and a 20.83% increase over the past 60 days [1]. - The company has appeared on the "Dragon and Tiger List" once this year, with a net buy of 64.05 million yuan on January 6, contributing to a total buy of 233 million yuan, which accounted for 14.28% of total trading volume [1]. Shareholder Information - As of September 30, 2025, Yiling Pharmaceutical had 152,700 shareholders, a decrease of 10.22% from the previous period. The average number of circulating shares per shareholder increased by 11.38% to 9,013 shares [2]. - The company has distributed a total of 4.455 billion yuan in dividends since its A-share listing, with 1.838 billion yuan distributed in the last three years [3]. Institutional Holdings - Among the top ten circulating shareholders as of September 30, 2025, Hong Kong Central Clearing Limited is the third-largest shareholder with 25.704 million shares, an increase of 8.1119 million shares from the previous period. Meanwhile, the Southern CSI 500 ETF has reduced its holdings by 256,900 shares [3].
2025长三角健康大会共绘中医药协同发展新篇章
Xin Hua Ri Bao· 2025-11-25 23:51
Core Insights - The 2025 Yangtze River Delta Health Conference aims to promote high-quality development in health and wellness in the region, aligning with national strategies for "Healthy China" and regional integration [1][2][3] Group 1: Conference Overview - The conference is themed "Co-construction and Sharing, Inheritance and Innovation," focusing on collaborative health development and the promotion of traditional Chinese medicine (TCM) [1][2] - The event is organized by various health and media organizations, highlighting the importance of TCM as a unique health resource and economic asset [1][2] Group 2: Keynote Addresses and Insights - Notable speakers, including Chinese Academy of Engineering member Zhang Boli, emphasized the significance of TCM in modern health services and its role in achieving a "Healthy China" [2][3] - The conference highlighted the need for institutional alignment in regional cooperation and the integration of TCM into modern health systems [3] Group 3: Innovation and Collaboration - The conference facilitated the signing of several key TCM research projects, marking a significant step in translating research into clinical applications [4] - A collaborative mechanism for the inheritance of traditional TCM skills was established, aiming to integrate resources and cultivate talent in the region [4] Group 4: Publications and Academic Exchange - The launch of the book "The Health Code in Medicinal Paste" aims to make TCM knowledge accessible to the public, promoting understanding and benefits of TCM practices [5] - The conference also initiated the 2025 Jiangsu Province TCM Academic Annual Conference, fostering further academic exchange [5] Group 5: Industry Participation and Innovations - The event showcased a diverse range of industry leaders and innovations, including companies like Kangyuan Pharmaceutical and Huazhong Sanjiu, highlighting a complete industry chain from drug development to specialized medical foods [7] - The conference featured a technology transfer area where innovative TCM products were presented, demonstrating the transition from traditional remedies to modern healthcare solutions [7]
以岭药业扬帆出海:从“走出去”到“走进去”再到“走上去”
Quan Jing Wang· 2025-11-25 09:38
Core Insights - The article highlights the successful global registration and commercialization of 17 innovative traditional Chinese medicine (TCM) products by Yiling Pharmaceutical, marking a significant step in the internationalization of TCM [1][5][6] - Yiling Pharmaceutical has established a clear pathway for TCM's global integration, moving from physical expansion to cultural integration and value leadership [1][5] Group 1: Global Expansion of TCM - Yiling Pharmaceutical has successfully registered its innovative TCM products in over 50 countries and regions, demonstrating the global reach of Chinese medicine [1][5] - The company emphasizes the importance of theoretical foundations in TCM's internationalization, having developed a comprehensive theory system around "Luo disease" over 33 years [5][6] - The establishment of various international academic exchange platforms has facilitated the global dissemination and research of Luo disease theory [6][9] Group 2: Cultural Integration and Market Strategies - Yiling Pharmaceutical adopts a differentiated market strategy, tailoring its approach to meet the specific medical needs and cultural contexts of different regions [7][8] - In developed countries, the focus is on high-level clinical research to gain trust from the academic and regulatory communities, while in emerging markets, the company integrates its products into local healthcare systems [7][8] - The successful inclusion of Tongxinluo capsules in Vietnam's healthcare system exemplifies the company's effective local integration strategy [7] Group 3: Evidence-Based Medicine and Research - Yiling Pharmaceutical leads in evidence-based research, establishing a robust research framework that supports the clinical efficacy of its TCM products [9][10] - The company has conducted over 40 high-quality evidence-based studies on its innovative TCM products, with significant findings published in prestigious international medical journals [10][12] - This research not only validates the safety and efficacy of TCM but also presents its benefits in modern scientific language, enhancing its global acceptance [10][12] Group 4: Future Outlook and Challenges - Despite the progress, Yiling Pharmaceutical acknowledges ongoing challenges in cultural recognition and regulatory policies, particularly in non-Belt and Road countries [12] - The company believes that collaboration among government, industry, academia, and research institutions is essential to overcome these barriers and further the global impact of TCM [12]
以岭药业:推动中医药与现代科技交融,以开放的姿态融入全球健康治理
Zheng Quan Shi Bao Wang· 2025-11-25 07:19
在近期发布的中共中央关于"十五五"规划的建议中,"推进中医药传承创新,促进中西医结合"再度被提 及。近年来,中医药作为"民族瑰宝"不仅需要传承,更需要与时俱进推动创新,走向全球,已逐渐成为 越来越多业界人士的共识。 众多上市公司中,专利中药龙头公司以岭药业(002603.SZ)正是中医药现代化的践行者。近日,以岭 医药研究院副院长、中药研究院院长魏聪及以岭药业国际贸易中心负责人孙学非接受媒体采访,阐述了 以岭药业在中医药现代化及国际化层面的贡献。 孙学非介绍,在东南亚市场,通心络胶囊等通络中药以药品身份进入医保目录;而在东欧某些国家,受 限于当地法规,只能以保健品类别销售。针对这种情况,企业采取"本土化适配"策略:在越南,联合当 地医院开展临床观察;在非洲,与传统医学机构合作进行药物特性研究。孙学非回忆,这种"入乡随 俗"的严谨态度,让通心络胶囊成为该国首批以"草药与天然药物"身份获批进入医院销售的中国中成 药。 "如今,在加拿大温哥华的连锁药房、肯尼亚内罗毕的中医诊所,以岭药业的产品已不再是陌生面孔。 更值得关注的是,其自主研发的酸枣仁油软胶囊获得百余个国际批文。"孙学非表示,这种转变背后, 是中医药从"文 ...