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金陵药业:噁拉戈利片获批开展Ⅲ期临床研究
Core Viewpoint - Jinling Pharmaceutical (000919) has received approval from the National Medical Products Administration for the clinical trial of Olaragoli tablets, which are intended for the treatment of moderate to severe pain associated with endometriosis [1] Company Summary - Jinling Pharmaceutical's subsidiary, Jinling Pharmaceutical Factory, has been granted a Clinical Trial Approval Notice for Olaragoli tablets [1] - The clinical research will be conducted in Phase III, indicating a significant step towards potential market introduction [1] Industry Summary - The approval of Olaragoli tablets highlights ongoing advancements in the pharmaceutical industry, particularly in addressing women's health issues such as endometriosis [1]
金陵药业(000919.SZ): 金陵制药厂的噁拉戈利片获批开展Ⅲ期临床研究
Ge Long Hui A P P· 2025-09-03 09:20
Core Viewpoint - Jinling Pharmaceutical has received approval from the National Medical Products Administration for the clinical trial of Olaragolix tablets, marking a significant step in the development of a treatment for moderate to severe pain associated with endometriosis [1] Group 1 - Jinling Pharmaceutical's subsidiary, Jinling Pharmaceutical Factory, has been granted a Clinical Trial Approval Notice for Olaragolix tablets to conduct Phase III clinical research [1] - Olaragolix is an oral gonadotropin-releasing hormone (GnRH) antagonist primarily used for treating moderate to severe pain related to endometriosis [1] - Olaragolix tablets are included in the National List of Encouraged Generic Drugs, indicating potential market advantages [1]
金陵药业(000919) - 金陵药业股份有限公司关于分公司收到药物临床试验批准通知书的公告
2025-09-03 09:15
证券代码: 000919 证券简称:金陵药业 公告编号:2025-065 金陵药业股份有限公司 关于分公司收到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。 金陵药业股份有限公司(以下简称"公司")于 2025 年 6 月 24 日披露了《关于分公司收到噁拉戈利片受理通知书的公告》(公告编 号:2025-042),公司分公司金陵药业股份有限公司南京金陵制药厂 (以下简称"金陵制药厂")收到国家药品监督管理局下发的噁拉戈 利片临床试验申请受理通知书。近日,金陵制药厂收到国家药品监督 管理局核准签发的《药物临床试验批准通知书》,批准噁拉戈利片开 展Ⅲ期临床研究。现将相关情况公告如下: 一、《药物临床试验批准通知书》的主要内容 产品名称:噁拉戈利片 注册分类:化学药品 3 类 申请事项:临床试验申请 受理号:CYHL2500117、CYHL2500118 规格:150mg、200mg 申请的适应症:用于治疗与子宫内膜异位症相关的中度至重度疼 痛。 申请人:金陵药业股份有限公司南京金陵制药厂 审查结论:根据《中华人民共和国药品管理法》及有 ...
金陵药业:分公司收到噁拉戈利片Ⅲ期临床试验批准通知书
Xin Lang Cai Jing· 2025-09-03 09:12
Core Viewpoint - Jinling Pharmaceutical has received approval for the Phase III clinical trial of Olaragolix, which is intended for the treatment of moderate to severe pain associated with endometriosis [1] Group 1: Company Developments - Jinling Pharmaceutical's subsidiary, Nanjing Jinling Pharmaceutical Factory, has been granted the clinical trial approval by the National Medical Products Administration [1] - Olaragolix is included in the National "Second Batch of Encouraged Generic Drug List" [1] Group 2: Industry Context - The pharmaceutical industry is characterized by high technology and high risk, with lengthy and complex processes from research and development to clinical trial approval and production [1] - The development of pharmaceutical products is susceptible to various uncertainties, which can impact the timeline and success of drug approval [1]
金陵药业:公司已关注到人工智能应用对医药行业影响
Zheng Quan Ri Bao Wang· 2025-09-02 13:14
Group 1 - The company, Jinling Pharmaceutical, has acknowledged the impact of artificial intelligence applications on the pharmaceutical industry [1] - The company plans to research potential applications of artificial intelligence based on industry development and needs [1]
金陵药业(000919.SZ):2025年中报净利润为4833.35万元、同比较去年同期下降14.08%
Xin Lang Cai Jing· 2025-08-28 02:30
Core Insights - Jinling Pharmaceutical (000919.SZ) reported a total operating revenue of 1.601 billion yuan for the first half of 2025, ranking 32nd among disclosed peers, which represents a decrease of 113 million yuan or 6.62% year-on-year [1] - The net profit attributable to shareholders was 48.33 million yuan, ranking 65th among peers, down by 7.92 million yuan or 14.08% compared to the same period last year [1] - The net cash inflow from operating activities was 15.84 million yuan, ranking 91st among peers, a decrease of 5.52 million yuan or 25.82% year-on-year [1] Financial Ratios - The latest debt-to-asset ratio is 20.34%, ranking 45th among peers, an increase of 0.79 percentage points from the previous quarter and 3.73 percentage points from the same period last year [3] - The latest gross profit margin is 19.43%, ranking 113th among peers, with a slight increase of 0.07 percentage points from the previous quarter but a decrease of 1.54 percentage points year-on-year [3] - The latest return on equity (ROE) is 1.28%, ranking 84th among peers, down by 0.09 percentage points compared to the same period last year [3] Earnings Per Share and Turnover Ratios - The diluted earnings per share is 0.08 yuan, ranking 77th among peers, a decrease of 0.02 yuan or 21.59% year-on-year [3] - The latest total asset turnover ratio is 0.26 times, ranking 35th among peers, a decrease of 0.02 times year-on-year [3] - The latest inventory turnover ratio is 5.02 times, ranking 1st among peers, an increase of 0.56 times or 12.49% year-on-year [3] Shareholder Structure - The number of shareholders is 35,400, with the top ten shareholders holding 322 million shares, accounting for 51.58% of the total share capital [3] - The largest shareholder is Nanjing New Industry Investment Group Co., Ltd., holding 41.59% of the shares [3]
金陵药业:2025年半年度净利润约4833万元
Mei Ri Jing Ji Xin Wen· 2025-08-27 22:56
Company Performance - Jinling Pharmaceutical reported a revenue of approximately 1.601 billion yuan for the first half of 2025, representing a year-on-year decrease of 6.62% [1] - The net profit attributable to shareholders of the listed company was approximately 48.33 million yuan, down 14.08% year-on-year [1] - The basic earnings per share were 0.0777 yuan, reflecting a year-on-year decline of 21.59% [1]
金陵药业(000919.SZ):上半年净利润4833.35万元 同比下降14.08%
Ge Long Hui A P P· 2025-08-27 12:47
Group 1 - The core viewpoint of the article is that Jinling Pharmaceutical (000919.SZ) reported a decline in both revenue and net profit for the first half of 2025 compared to the same period last year [1] Group 2 - The company achieved operating revenue of 1.601 billion yuan, representing a year-on-year decrease of 6.62% [1] - The net profit attributable to shareholders of the listed company was 48.33 million yuan, down 14.08% year-on-year [1] - The net profit attributable to shareholders after deducting non-recurring gains and losses was 35.51 million yuan, reflecting a year-on-year decline of 21.55% [1] - The basic earnings per share were reported at 0.0777 yuan [1]
金陵药业(000919) - 2025年半年度财务报告
2025-08-27 12:35
金陵药业股份有限公司 二○二五年半年度财务报表附注 金陵药业股份有限公司 二○二五年半年度财务报表附注 (除特殊注明外,金额单位均为人民币元) 一、 公司基本情况 金陵药业股份有限公司(以下简称"公司"或"本公司")是经中国人民解放军总后勤 部[1998]后生字第 261 号文批准,由南京金陵制药(集团)有限公司、南京军区福州总医院企 业管理局、南京军区后勤部苏州企业管理局、南京军区后勤部南京企业管理局一分局、南京 军区后勤部徐州企业管理局分别将其所属的南京金陵制药厂、福州梅峰制药厂、浙江天峰制 药厂、南京金威天然饮料公司、合肥利民制药厂以 1997 年 12 月 31 日为评估基准日经评估 确认后的净资产投入,采用发起设立方式成立的股份有限公司。1998 年 9 月 8 日,公司在 南京市工商行政管理局领取企业法人营业执照,注册号 24979447-5,注册资本人民币 20,000.00 万元。 经中国证券监督管理委员会证监发行字[1999]42 号文核准,公司于 1999 年 8 月 27 日在 深圳证券交易所采用"上网定价"发行方式,发行 8,000.00 万股人民币普通股,每股发行价 8.40 元,发 ...
金陵药业(000919) - 金陵药业股份有限公司关于2025年半年度募集资金存放与使用情况的专项报告
2025-08-27 12:35
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。 证券代码:000919 证券简称:金陵药业 公告编号:2025-064 金陵药业股份有限公司 关于2025年半年度募集资金存放与使用情况的专项报告 一、募集资金基本情况 根据中国证券监督管理委员会(以下简称"中国证监会") 《上市公司募集资金监管规则》《深圳证券交易所上市公司自律监 管指引第 1 号——主板上市公司规范运作》以及《深圳证券交易 所上市公司自律监管指南第 2 号——公告格式》的相关规定,金 陵药业股份有限公司(以下简称"公司")就 2025年半年度募集 资金存放与使用情况作如下专项报告: 经中国证监会《关于同意金陵药业股份有限公司向特定对象发 行股票注册的批复》(证监许可〔2024〕41号)核准,公司向特定 对象发行人民币普通股(A 股) 117,924,528股,每股面值人民币 1.00 元 , 每 股 发 行 价 格 为 人 民 币 6.36 元 , 共 计 募 集 资 金 749,999,998.08元。本次发行涉及相关费用为7,367,708.75元(不 含税),实际募集资金净额为人民币74 ...