Core Viewpoint - Jinling Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the clinical trial of Orelagol tablets, which are intended for the treatment of moderate to severe pain associated with endometriosis [1][2]. Group 1: Clinical Trial Approval - The clinical trial application for Orelagol tablets was accepted on June 20, 2025, and has been approved to proceed with Phase III clinical research [2]. - The product is classified as a Class 3 chemical drug and is available in dosages of 150mg and 200mg [1][3]. - Orelagol is a GnRH antagonist used primarily for treating moderate to severe pain related to endometriosis [3]. Group 2: Regulatory Compliance - The application for the clinical trial meets the requirements set forth by the Drug Administration Law of the People's Republic of China [2]. - The approval signifies compliance with the relevant drug registration regulations [2]. Group 3: Product Information - Orelagol tablets are included in the second batch of encouraged generic drug lists in China [3].

Key Points - Tianpu Co., Ltd. announced a suspension of trading for stock verification due to multiple instances of abnormal trading fluctuations from August 22 to September 3, with a reminder for investors about market risks [1] - China Shipbuilding Industry Corporation announced a share exchange ratio of 1:0.1339 for the merger with China Shipbuilding, with the stock ceasing to be listed from September 5, 2025 [2] - Chengdu Huamei reported that its 40G high-precision RF ADC chip is still in the trial production stage and has not achieved mass sales, indicating market demand uncertainty [2] - Taihe Technology's sulfide solid electrolyte project is currently in the trial production phase and has not generated sales revenue [3] - Robotech signed a contract worth approximately €946.50 million for fully automated silicon photonic packaging equipment, expected to positively impact the company's future performance [4] - Wento Holdings reported that its cinema and gaming businesses are still in the recovery phase post-restructuring, with potential uncertainties in future operations [5] - Xibu Muye's fresh milk production increased by 4.8% month-on-month in August [6] - China Shipbuilding announced the implementation of a share exchange merger with China Heavy Industry [6] - Gansu Energy plans to invest CNY 40.89 billion in a wind-solar integrated project [6] - Xinhua Medical's endoscope cleaning workstation received a Class II medical device registration certificate [6]

（文章来源：证券日报） 证券日报网讯 9月3日晚间，金陵药业发布公告称，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》，公司分公司金陵药业股份有限公司南京金陵制药厂（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。 ...

Core Viewpoint - Jinling Pharmaceutical has received approval for the Phase III clinical trial of Orelagol, a GnRH antagonist for treating moderate to severe pain associated with endometriosis, indicating a significant step in its product development pipeline [1] Group 1: Company Overview - Jinling Pharmaceutical's main business includes pharmaceutical and medical device manufacturing, as well as health care services [1] - The company’s product range covers cardiovascular, iron supplements, gastrointestinal medications, and oncology supportive drugs [1] - The company has a strong competitive advantage in the iron supplement market with its key product, Succinic Acid Iron Tablets [1] Group 2: Recent Financial Performance - In the first half of 2025, the company reported revenue of 1.6 billion yuan, a decrease of 6.6% year-on-year [1] - The net profit attributable to shareholders was 48.33 million yuan, down 14.08% year-on-year [1] - The net profit excluding non-recurring items was 35.51 million yuan, reflecting a decline of 21.6% year-on-year [1] Group 3: Business Strategy and Innovation - The company emphasizes the synergy between its pharmaceutical and health care platforms to support stable and high-quality development [2] - The pharmaceutical segment plays a crucial role, focusing on growth stabilization, cost reduction, structural adjustment, and capacity enhancement [2] - R&D investment increased by 20.51% year-on-year to 45.34 million yuan, with progress in product development and patent applications [2]

Group 1 - Shengtun Mining plans to repurchase shares worth between 500 million and 600 million yuan, with a maximum repurchase price of 11.82 yuan per share, aimed at employee stock ownership plans or equity incentives [1] - Kangnbei received a drug registration certificate for Linggui Shugan Granules, which is derived from traditional Chinese medicine and is used for treating phlegm and dampness due to Yang deficiency [2] - Zhangjiang Hi-Tech intends to publicly transfer 100% equity and related debts of Shanghai Jixin Rui Construction Technology Co., Ltd. with a total price not less than 151 million yuan [3] Group 2 - Shankai Intelligent won a bid for a metering device procurement project worth 13.318 million yuan from Hohhot Water Supply Company [4] - Hason Co. plans to jointly establish a supply chain company with a registered capital of 10 million yuan, in which Hason will hold a 10% stake [5] - Pudong Construction's subsidiaries won multiple major projects with a total amount of 1.271 billion yuan [6] Group 3 - Jinling Pharmaceutical received approval for the Phase III clinical trial of Olaratogrel tablets, which are used for treating moderate to severe pain associated with endometriosis [8] - Menohua's subsidiary obtained a drug registration certificate for Mosapride Citrate Tablets, aimed at improving gastrointestinal symptoms [10] - Shapuaisi's major shareholder plans to reduce holdings by up to 2% of the company's shares due to personal financial needs [11] Group 4 - Changyuan Power reported an August electricity generation of 3.771 billion kWh, a year-on-year decrease of 6.03% [15][16] - Xibu Livestock's August fresh milk production increased by 4.8% month-on-month but decreased by 7.27% year-on-year [19] - Yong'an Pharmaceutical's actual controller and chairman had their detention lifted, allowing them to resume normal duties [20] Group 5 - Jinkai Intelligent's director resigned due to work adjustments [22] - Xinhua Medical received a Class II medical device registration for an endoscope cleaning workstation [23] - Haishi Science and Technology's innovative drug HSK47388 received approval for a new indication clinical trial [25] Group 6 - Baotai Co. plans to participate in a land use rights auction in Baoji City with a starting price of 57.34 million yuan [26] - Minfeng Special Paper received a government subsidy totaling 11.2 million yuan [27] - Jiuchang Bio obtained a medical device registration for a heparin-binding protein assay kit [29] Group 7 - Jingao Technology plans to repurchase shares worth between 200 million and 400 million yuan, with a maximum price of 17.36 yuan per share [31] - Youxunda won a bid for a metering equipment project from China Southern Power Grid worth approximately 161 million yuan [32] - Qianli Technology reported an August vehicle sales increase of 168.55% year-on-year [32] Group 8 - Guangzhou Port expects an August container throughput increase of 1.2% year-on-year [32] - Kexing Pharmaceutical's GB08 injection completed the first subject enrollment for Phase II clinical trials [33] - Wu Ming Pharmaceutical plans to transfer 98.9% of its subsidiary's shares to a newly established wholly-owned subsidiary [34] Group 9 - Shanghai Electric's acquisition of K-Electric Limited shares has not yet completed the transfer [35] - Fulai New Materials plans to raise no more than 710 million yuan through a private placement [36] - Huaren Health's drug registration application for a new type of potassium ion competitive acid blocker has been accepted [37]

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]

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]