Group 1 - The company, Jinling Pharmaceutical, announced on September 3 that its subsidiary, Nanjing Jinling Pharmaceutical Factory, received a clinical trial application acceptance notice for Olaragol tablets from the National Medical Products Administration [1] - The company has also received the approval notice for the clinical trial, allowing the commencement of Phase III clinical research for Olaragol tablets [1]

Core Viewpoint - Jinling Pharmaceutical (000919.SZ) has received approval from the National Medical Products Administration for the clinical trial of Orelizumab tablets, marking a significant step in its development pipeline [1] Group 1: Company Developments - Jinling Pharmaceutical's subsidiary, Nanjing Jinling Pharmaceutical Factory, has been granted a clinical trial application acceptance notice for Orelizumab tablets [1] - The company has also received the Drug Clinical Trial Approval Notice, allowing the commencement of Phase III clinical research for Orelizumab tablets [1] Group 2: Product Information - Orelizumab is an oral GnRH antagonist primarily used for treating moderate to severe pain associated with endometriosis [1] - The product is included in the National "Second Batch of Encouraged Generic Drug List" [1]

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]

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]

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 ...

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]

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]

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]

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]

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]