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九典制药两种药品获准开展临床试验
Zhi Tong Cai Jing· 2025-09-24 10:49
Core Viewpoint - The company has received approval from the National Medical Products Administration for clinical trials of two drugs, indicating progress in its research and development efforts [1] Group 1: Clinical Trials - The approved clinical trials include JIZM01 for closed soft tissue contusions and joint sprains [1] - The second trial is for JIZM02, which targets shoulder periarthritis [1]
九典制药(300705.SZ):获得药物临床试验批准通知书
Ge Long Hui A P P· 2025-09-24 10:47
JIZM02功能主治为:祛风除湿、活血通络、行气止痛。用于肩关节周围炎风湿痹痛证,症见肩部疼 痛,肿胀,屈伸不利。肩关节周围炎的治疗原则是针对病症的不同时期或症状严重程度采取相应的治疗 措施,包括药物治疗、物理治疗、针灸、针刀及手术治疗等。常用的治疗药物为非甾体抗炎药及中成药 制剂,如消尔痛酊、蟾马正痛酊、骨痛灵酊等。JIZM02组方精炼,无毒性药材,可为该类患者提供一 种安全有效的治疗方式。 JIZM01和JIZM02获得临床试验资格对公司的财务状况、经营业绩不构成重大影响。根据我国药品注册 相关的法律法规要求,药物在获得药物临床试验批准通知书后,尚需开展临床试验并经国家药监局审 评、审批通过后方可生产上市。 格隆汇9月24日丨九典制药(300705.SZ)公布,近日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》,在完成相关准备工作后将开展临床试验研究。JIZM01功能主治为:活血通络,消肿止痛。 用于闭合性软组织损伤引起的疼痛、肿胀、瘀斑、功能障碍。在临床应用中,软组织损伤主要治疗方式 以局部给药为主,常用药物有云南白药、红花油、活络油、消痛贴膏、少林风湿跌打膏等。 ...
九典制药(300705.SZ)两种药品获准开展临床试验
智通财经网· 2025-09-24 10:45
Core Viewpoint - The company has received approval from the National Medical Products Administration for clinical trials of two drugs, indicating progress in its research and development efforts [1] Group 1 - The company has obtained a clinical trial approval notice for JIZM01, which is intended for the treatment of closed soft tissue contusions and joint sprains [1] - The clinical trial for JIZM02 has been approved, targeting adhesive capsulitis of the shoulder [1]
九典制药:获药物临床试验批准通知书
Core Viewpoint - Jizhen Pharmaceutical has received approval from the National Medical Products Administration for clinical trials of drugs JIZM01 and JIZM02, indicating progress in its research and development efforts [1] Group 1: Company Developments - Jizhen Pharmaceutical announced on September 24 that it has obtained the clinical trial approval for drugs JIZM01 and JIZM02 [1] - JIZM01 is intended for the treatment of closed soft tissue contusions and joint sprains [1] - JIZM02 is aimed at treating periarthritis of the shoulder [1]
九典制药:获得药物临床试验批准通知书
Xin Lang Cai Jing· 2025-09-24 10:32
Core Viewpoint - The company has received approval from the National Medical Products Administration for clinical trials of two drugs, JIZM01 and JIZM02, targeting specific medical conditions [1] Group 1: Drug Information - JIZM01 is intended for the treatment of closed soft tissue contusions and joint sprains [1] - JIZM02 is designed for shoulder periarthritis [1] Group 2: Regulatory Approval - The approval was granted in accordance with the Drug Administration Law of the People's Republic of China and relevant regulations [1] - The company will commence clinical trial research after completing the necessary preparatory work [1]
九典制药(300705) - 关于获得药物临床试验批准通知书的公告
2025-09-24 10:22
| 证券代码:300705 | 证券简称:九典制药 | | | --- | --- | --- | | 债券代码:123223 | 债券简称:九典转02 | 公告编号:2025-068 | 湖南九典制药股份有限公司 关于获得药物临床试验批准通知书的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整,没有虚假 记载、误导性陈述或重大遗漏。 湖南九典制药股份有限公司(以下简称"公司")于近日收到国家药品监督 管理局签发的《药物临床试验批准通知书》,在完成相关准备工作后将开展临床 试验研究。其相关信息如下: 受理号:CXZL2500052、CXZL2500053(同产品不同规格) 申请人:湖南九典制药股份有限公司 拟定适应症:用于闭合性软组织挫伤和关节扭伤 审批结论:根据《中华人民共和国药品管理法》及有关规定,经审查,2025 年 7 月 11 日受理的 JIZM01 临床试验申请符合药品注册的有关要求,同意开展用 于闭合性软组织挫伤和关节扭伤的临床试验。 2、JIZM02 药品名称:JIZM02 注册分类:中药 1.1 类 一、临床试验通知书基本情况 1、JIZM01 药品名称:JIZM01 注册分类 ...
调研速递|湖南九典制药接受投资者网上提问调研,回应股价波动问题
Xin Lang Cai Jing· 2025-09-19 11:28
近日,湖南九典制药股份有限公司举办了2025年湖南辖区上市公司投资者网上集体接待日暨半年度业绩 说明会,通过全景网"投资者关系互动平台"(https://ir.p5w.net)采用网络远程的方式,接受投资者网上 提问。 调研基本信息 在此次说明会上,有投资者提出:"在医药板大涨下,贵公司股价欠佳,近一个月下跌,请问公司经营 是否有大问题"。对此,公司回复称,管理层专注生产经营,一直积极探索维稳措施,如股东增持、股 份回购等。同时强调,二级市场股价波动属市场行为,受宏观经济、市场走势及预期等多重复杂因素影 响,目前公司运营正常,提醒投资者理性对待股价波动,留意投资风险。 声明:市场有风险,投资需谨慎。 本文为AI大模型基于第三方数据库自动发布,任何在本文出现的信 息(包括但不限于个股、评论、预测、图表、指标、理论、任何形式的表述等)均只作为参考,不构成 个人投资建议。受限于第三方数据库质量等问题,我们无法对数据的真实性及完整性进行分辨或核验, 因此本文内容可能出现不准确、不完整、误导性的内容或信息,具体以公司公告为准。如有疑问,请联 系biz@staff.sina.com.cn。 点击查看公告原文>> 责任编辑 ...
九典制药(300705) - 300705九典制药投资者关系管理信息20250919
2025-09-19 10:20
Group 1: Company Overview - Securities Code: 300705, Securities Abbreviation: JiuDian Pharmaceutical [1] - Bond Code: 123223, Bond Abbreviation: JiuDian Convertible 02 [1] - Company Name: Hunan JiuDian Pharmaceutical Co., Ltd. [1] Group 2: Investor Relations Activity - Activity Type: Online collective reception day and semi-annual performance briefing [2] - Date and Time: September 19, 2025, from 14:30 to 17:00 [2] - Location: Conducted via the "Investor Relations Interactive Platform" [2] Group 3: Company Response to Investor Concerns - Investor Inquiry: Concerns about the company's stock price decline despite a surge in the pharmaceutical sector [2] - Company Response: Management is focused on operations and exploring stabilization measures such as shareholder buybacks [2] - Market Behavior: Stock price fluctuations are influenced by multiple factors, including macroeconomic conditions and market expectations [2]
研报掘金丨天风证券:维持九典制药“买入”评级,拓展外用制剂管线+加速创新药转型
Ge Long Hui A P P· 2025-09-19 09:25
Core Viewpoint - Tianfeng Securities report indicates that JiuDian Pharmaceutical achieved a net profit attributable to shareholders of 291 million yuan in the first half of 2025, representing a year-on-year increase of 2.57% [1] - The company is expected to benefit from the increasing demand for transdermal drug delivery and the aging population, which will support its external preparation segment [1] Financial Performance - In the second quarter of 2025, JiuDian Pharmaceutical reported a net profit of 166 million yuan, reflecting a year-on-year growth of 4.54% [1] - The performance growth in the first half of the year met expectations [1] Product Development - As of the first half of 2025, the company holds seven registered external preparation drug certificates and has over 20 external preparation products in development [1] - Key products include Loxoprofen Sodium Gel Patches, Ketoprofen Gel Patches, Anti-inflammatory Pain Relief Plasters, Lidocaine and Prilocaine Cream, and Clotrimazole Vaginal Tablets [1] Strategic Focus - The company is focusing on the innovation of chemical and traditional Chinese medicine drugs, with a core development direction in chemical drug innovation [1] - The primary research areas include pain management (focusing on peptide and small molecule drugs) and oncology (with a focus on PDC drug development) [1] Market Outlook - With the gradual launch of new products and external environmental drivers, the company is expected to maintain sustainable growth in its external preparation segment [1] - Based on changes in the competitive landscape for Loxoprofen Sodium Gel Patches, the profit forecast has been adjusted while maintaining a "Buy" rating [1]
九典制药(300705):公司经营稳健,拓展外用制剂管线+加速创新药转型
Tianfeng Securities· 2025-09-19 06:15
Investment Rating - The investment rating for the company is "Buy" with a target price not specified [7] Core Viewpoints - The company has demonstrated stable operations with a focus on expanding its topical formulation pipeline and accelerating its transformation into innovative drugs [1] - The revenue for the first half of 2025 reached 1.512 billion yuan, representing a year-on-year increase of 10.67%, while the net profit attributable to the parent company was 291 million yuan, up 2.57% year-on-year [1] - The company expects revenue growth of 10-20% and a similar increase in net profit for the full year of 2025 [1] - The gross margin for the first half of 2025 was 74.58%, with a net margin of 19.27% [1] Summary by Sections Financial Performance - In the first half of 2025, the company achieved a revenue of 1.512 billion yuan (YoY +10.67%) and a net profit of 291 million yuan (YoY +2.57%) [1] - The second quarter of 2025 saw a revenue of 816 million yuan (YoY +5.24%) and a net profit of 166 million yuan (YoY +4.54%) [1] - The company maintains a stable expense ratio, with a sales expense ratio of 40.37% and a research and development expense ratio of 8.26% [1] Product Development - As of the first half of 2025, the company holds 7 registered topical formulation products and has over 20 products under development [2] - The topical formulation segment achieved sales revenue of 836 million yuan (YoY +16.96%), driven by the growth of key products [2] - The company anticipates continued growth in its topical formulation pipeline with several products expected to be approved in 2025-2026 [2] Innovation and R&D - The company is transitioning towards innovative drug development, focusing on chemical and traditional Chinese medicine innovations, particularly in pain and oncology [3] - The acquisition of the antibacterial peptide new drug JIJ02 gel for 90 million yuan is a significant step in expanding its innovative drug pipeline [3] - JIJ02 gel is currently in Phase I clinical trials, targeting common acne, and is expected to complete Phase I and initiate Phase II trials by mid-2026 [3] Profit Forecast - The revenue forecast for 2025-2027 is adjusted to 3.281 billion yuan, 3.469 billion yuan, and 3.808 billion yuan respectively, with net profits of 588 million yuan, 628 million yuan, and 729 million yuan [4] - The company maintains a price-to-earnings ratio of 15, 14, and 12 times for the years 2025-2027 [4]