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海思科医药集团股份有限公司关于获得创新药HSK47388片新适应症《药物临床试验批准通知书》的公告
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2025-09-03 22:59
Group 1 - The core point of the article is that Haikang Pharmaceutical Group has received approval from the National Medical Products Administration for clinical trials of its innovative drug HSK47388 for a new indication related to autoimmune diseases [1][4] - HSK47388 is an orally administered, potent, and highly selective drug developed by the company, showing significant efficacy in preclinical studies on rat models of enteritis, with good tolerability and a large safety window [1][4] - The approval for clinical trials represents a new opportunity for HSK47388 in the treatment of autoimmune diseases, potentially providing a new therapeutic option for patients [1]
9连板天普股份明起停牌核查;永安药业董事长陈勇解除留置丨公告精选
2 1 Shi Ji Jing Ji Bao Dao· 2025-09-03 14:19
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]
9月3日晚间重要公告一览
Xi Niu Cai Jing· 2025-09-03 10:18
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]
海思科(002653.SZ):获得创新药HSK47388片新适应症的药物临床试验批准通知书
Ge Long Hui A P P· 2025-09-03 08:15
Core Viewpoint - The company has received approval from the National Medical Products Administration for the clinical trial of HSK47388, a drug developed for the treatment of autoimmune diseases [1] Group 1: Drug Development - HSK47388 is an orally administered, potent, and highly selective drug [1] - Preclinical studies have shown significant dose-dependent efficacy in rat models of enteritis [1] - The drug demonstrates good tolerability and a large safety window, indicating strong development potential [1] Group 2: Market Implications - The clinical trial application represents a new indication for HSK47388 in the field of autoimmune diseases [1] - The drug is expected to provide a new treatment option for patients suffering from autoimmune diseases [1]
海思科: 关于获得创新药HSK47388片新适应症《药物临床试验批准通知书》的公告
Zheng Quan Zhi Xing· 2025-09-03 08:10
Group 1 - Company has received the "Drug Clinical Trial Approval Notice" from the National Medical Products Administration for the innovative drug HSK47388, which is intended for the treatment of autoimmune diseases [1] - HSK47388 is an orally administered, potent, and highly selective drug that has shown significant efficacy in preclinical studies, particularly in rat models of enteritis, demonstrating dose-dependent effects and good tolerability [1] - The application for HSK47388 represents a new clinical trial for an additional indication in the field of autoimmune diseases, potentially providing a new treatment option for patients [1] Group 2 - The clinical trial application for HSK47388 was accepted in June 2025, indicating compliance with the relevant drug registration requirements [1] - The drug is classified as a tablet form and is aimed at treating autoimmune diseases, with the registration number CXHL2500600 for domestic production [1]
海思科:HSK47388片新适应症药物临床试验获批
Zheng Quan Shi Bao Wang· 2025-09-03 08:09
Core Viewpoint - The company received approval from the National Medical Products Administration for clinical trials of HSK47388 tablets, which are intended for the treatment of autoimmune diseases [1] Group 1 - The clinical trial approval was granted for HSK47388 tablets, which are a self-developed oral medication with high selectivity and potency [1] - The application represents a new indication for HSK47388 in the field of autoimmune diseases, potentially providing a new treatment option for patients [1] - The approval was based on the compliance of HSK47388 with drug registration requirements as of June 2025 [1]
海思科:HSK47388片新适应症获药物临床试验批准
Xin Lang Cai Jing· 2025-09-03 08:04
Core Viewpoint - The company has received approval from the National Medical Products Administration for clinical trials of its self-developed drug HSK47388, aimed at treating autoimmune diseases [1] Group 1: Drug Development - HSK47388 is an oral, potent, and highly selective drug [1] - Preclinical studies have shown significant efficacy in a rat model of colitis [1] - The drug demonstrates good tolerability and a large safety window [1] Group 2: Market Implications - This application represents a new indication for HSK47388 in the field of autoimmune diseases [1] - The drug is expected to provide a new treatment option for patients suffering from autoimmune diseases [1]
海思科(002653.SZ)获得创新药HSK47388片新适应症《药物临床试验批准通知书》
智通财经网· 2025-09-03 08:04
Core Viewpoint - The company has received approval from the National Medical Products Administration for clinical trials of HSK47388 tablets, a drug developed for the treatment of autoimmune diseases [1] Company Summary - HSK47388 tablets are an orally administered, potent, and highly selective drug developed by the company [1] - The drug has shown significant efficacy in preclinical studies, particularly in a rat model of colitis, demonstrating dose-dependent effects [1] - HSK47388 exhibits good tolerability and a large safety window, indicating its potential for further development [1] Industry Summary - The approval for clinical trials represents a new indication for HSK47388 in the field of autoimmune diseases, potentially providing a new treatment option for patients [1]
海思科(002653) - 关于获得创新药HSK47388片新适应症《药物临床试验批准通知书》的公告
2025-09-03 08:00
| 药品名称 | 剂型 | 适应症 | 申请事项 | 受理号 | | --- | --- | --- | --- | --- | | HSK47388 | 片剂 | 拟用于自身免 | 境内生产药品 | CXHL2500600 | | | | 疫疾病的治疗 | 注册临床试验 | CXHL2500601 | 根据《中华人民共和国药品管理法》及有关规定,经审查,2025 年 6 月受理的 HSK47388 片符合药品注册的有关要求,同意本品开展 临床试验。 证券代码:002653 证券简称:海思科 公告编号:2025-097 海思科医药集团股份有限公司 关于获得创新药 HSK47388 片新适应症 《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内容的真实、准确、完整, 没有虚假记载、误导性陈述或重大遗漏。 海思科医药集团股份有限公司(以下简称"公司")于近日收到 国家药品监督管理局下发的《药物临床试验批准通知书》,相关情况 如下: 海思科医药集团股份有限公司董事会 2025 年 9 月 4 日 2 一、研发项目简介 HSK47388片是公司自主研发的口服、强效、高选择性的药物,拟 用于自身免疫 ...
海思科获得创新药HSK47388片新适应症《药物临床试验批准通知书》
Zhi Tong Cai Jing· 2025-09-03 07:58
Core Viewpoint - The company, HaiSiKe (002653.SZ), has received approval from the National Medical Products Administration for clinical trials of its self-developed drug HSK47388, which is intended for the treatment of autoimmune diseases [1] Group 1: Drug Development - HSK47388 is an oral, potent, and highly selective drug developed by the company [1] - The drug has shown significant dose-dependent efficacy in preclinical studies using rat models of enteritis [1] - HSK47388 demonstrates good tolerability and a large safety window, indicating strong development potential [1] Group 2: Clinical Trial Approval - The approval allows HSK47388 to proceed with clinical trials for a new indication in the field of autoimmune diseases [1] - This development is expected to provide a new treatment option for patients suffering from autoimmune diseases [1]