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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]
科兴生物制药股份有限公司 自愿披露关于GB08注射液II期临床试验完成首例受试者入组的公告
Group 1 - The company announced the successful completion of the first subject enrollment and administration in the Phase II clinical trial of "GB08 Injection," developed by its wholly-owned subsidiary, Shenzhen Kexing Pharmaceutical Co., Ltd [1][2] - "GB08 Injection" is the company's first independently developed Class I innovative drug, designed to address the needs of clinical patients with growth hormone deficiency in children, utilizing DNA recombinant technology to enhance safety and patient compliance [1][2] - The clinical trial aims to evaluate the efficacy and safety of "GB08 Injection" in treating children with growth hormone deficiency, with ethical approval obtained from Zhejiang University School of Medicine Affiliated Children's Hospital [2] Group 2 - The successful enrollment of the first subject in the Phase II clinical trial of "GB08 Injection" is not expected to have a significant impact on the company's recent financial status or operating performance [3]
科兴生物制药股份有限公司自愿披露关于GB08注射液II期临床试验完成首例受试者入组的公告
Group 1 - The company announced the successful enrollment of the first subject in the Phase II clinical trial of GB08 injection, which is an innovative drug developed for children with growth hormone deficiency [1][2] - GB08 injection is the company's first self-developed Class I innovative drug, utilizing DNA recombinant technology to enhance safety and patient compliance [1][2] - The clinical trial aims to evaluate the efficacy and safety of GB08 injection in treating children with growth hormone deficiency, with ethical approval obtained from Zhejiang University School of Medicine [2] Group 2 - The successful enrollment of the first subject in the clinical trial is not expected to have a significant impact on the company's recent financial status or operating performance [3]
科兴制药: 自愿披露关于GB08注射液II期临床试验完成首例受试者入组的公告
Zheng Quan Zhi Xing· 2025-09-02 10:25
Group 1 - The core point of the announcement is that Kexing Biopharmaceutical Co., Ltd. has successfully completed the enrollment of the first subject in the Phase II clinical trial of its self-developed GB08 injection, which is aimed at treating children with growth hormone deficiency [1][2] - GB08 injection is the company's first independently developed Class I innovative drug, designed as a long-acting growth hormone based on the needs of clinical patients [1][2] - The clinical trial for GB08 injection has received ethical approval from Zhejiang University School of Medicine Affiliated Children's Hospital, and the trial is a multi-center, randomized, open-label, positive-controlled Phase II/III study [2] Group 2 - The successful enrollment of the first subject in the Phase II clinical trial is not expected to have a significant impact on the company's recent financial status or operating performance [2] - The company will continue to monitor the progress of the GB08 injection and fulfill its disclosure obligations in accordance with relevant regulations [2]
科兴制药(688136.SH)GB08注射液II期临床试验完成首例受试者入组
Ge Long Hui A P P· 2025-09-02 09:48
Core Viewpoint - Company Kexing Pharmaceutical (688136.SH) has successfully completed the first subject enrollment and administration in the Phase II clinical trial of its self-developed GB08 injection for treating pediatric growth hormone deficiency [1] Group 1: Clinical Trial Progress - The Phase II/III clinical trial titled "Evaluation of the Efficacy and Safety of GB08 Injection in Treating Pediatric Growth Hormone Deficiency" has received ethical approval from the Children's Hospital affiliated with Zhejiang University School of Medicine, with approval number 2025-IEC-0009-P-01 [1] - The trial is designed as a multicenter, randomized, open-label, positive-controlled study [1] Group 2: Product Information - GB08 injection is the company's first independently developed Class I innovative drug, designed based on clinical patient needs for pediatric growth hormone deficiency [1] - The product is an Fc fusion protein long-acting growth hormone, and it is being submitted as an "innovative biological product" under the category of therapeutic biological products [1]
科兴制药(688136) - 自愿披露关于GB08注射液II期临床试验完成首例受试者入组的公告
2025-09-02 09:45
公司通过DNA重组技术,将人生长激素(hGH)基因与IgG4亚型Fc段基因连接 后表达,形成具有同源二聚体蛋白结构的创新药物,显著提高了产品安全性及患 者的用药便利性和依从性,未来如成功研发上市将为儿童生长激素缺乏症患者带 来新的治疗手段。 二、"GB08注射液"研究进展情况 证券代码:688136 证券简称:科兴制药 公告编号:2025-072 科兴生物制药股份有限公司 自愿披露关于 GB08 注射液 II 期临床试验 完成首例受试者入组的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏,并对其内容的真实性、准确性和完整性依法承担法律责任。 近日,科兴生物制药股份有限公司(以下简称"公司")全资子公司深圳科 兴药业有限公司(以下简称"深圳科兴")研发的"GB08注射液"II期临床研究 成功完成首例受试者入组给药。现将相关情况公告如下: 一、"GB08注射液"基本情况 GB08注射液是公司首个自主研发的I类创新药,是公司根据临床患者需求、 基于儿童生长激素缺乏症而自主研发的一款Fc融合蛋白长效化生长激素,公司 GB08注射液按治疗用生物制品1类"创新型生物制品"申报。 公 ...
科兴制药(688136.SH):GB08注射液II期临床试验完成首例受试者入组
智通财经网· 2025-09-02 09:41
Core Viewpoint - The announcement highlights the successful completion of the first patient enrollment and dosing in the Phase II clinical study of "GB08 Injection," an innovative drug developed by the company's wholly-owned subsidiary, Shenzhen Kexing Pharmaceutical Co., Ltd [1] Group 1: Product Development - GB08 Injection is the company's first independently developed Class I innovative drug targeting growth hormone deficiency in children [1] - The drug is based on the clinical needs of patients and utilizes DNA recombinant technology to connect the human growth hormone (hGH) gene with the IgG4 Fc segment gene, resulting in a novel drug with a homologous dimeric protein structure [1] - The innovative drug significantly enhances product safety, patient convenience, and adherence to treatment [1] Group 2: Market Potential - If successfully developed and launched, GB08 Injection will provide new treatment options for patients suffering from growth hormone deficiency in children [1]
科兴制药:GB08注射液II期临床试验完成首例受试者入组
Xin Lang Cai Jing· 2025-09-02 09:34
Core Viewpoint - The announcement highlights the successful completion of the first subject enrollment and administration in the Phase II clinical trial of "GB08 Injection," developed by the company's wholly-owned subsidiary, Shenzhen Kexing Pharmaceutical Co., Ltd. [1] Group 1 - The clinical trial aims to evaluate the efficacy and safety of GB08 Injection for treating children with growth hormone deficiency [1] - This trial is a multi-center, randomized, open-label, positive-controlled Phase II/III clinical study [1] - The ethical approval for the trial has been obtained recently, and the first subject has been enrolled and administered [1] Group 2 - The trial is not expected to have a significant impact on the company's recent financial status and operating performance [1]
索拉非尼埃及获批 科兴制药MENA地区商业化添关键成果
Group 1 - The core viewpoint of the news is that Kexing Pharmaceutical has successfully commercialized its product, tolvaptan, in the overseas market, specifically receiving approval from the Egyptian Drug Authority for its marketing [1] - The global market size for sorafenib, a well-known targeted therapy drug, reached 4.889 billion RMB in 2023, indicating significant market potential [1] - Egypt's pharmaceutical market is expected to grow from 152.8 billion EGP (approximately 3 billion USD) in 2024 to 218.1 billion EGP (approximately 4.3 billion USD) by 2028, with a compound annual growth rate of 9.6% [2] Group 2 - Kexing Pharmaceutical has established a subsidiary in Egypt and is focusing on localized operations, which includes the introduction of foreign talent and the registration of key products like bevacizumab and infliximab [3] - The company has introduced nearly 20 overseas commercialized products, and with the successful launch of several major products, its long-term value as a multinational pharmaceutical company is expected to emerge [3] - The collaboration with Beijing Yabao Biological Pharmaceutical Co., Ltd. for the overseas commercialization of tolvaptan has led to significant progress in registration across multiple countries, enhancing the accessibility of this cancer treatment [2][3]
科兴制药引进产品甲苯磺酸索拉非尼获埃及药品管理局(EDA)批准上市
Xin Lang Cai Jing· 2025-09-01 01:43
Group 1 - The core point of the article is that the company, Sinovac Biotech, has received approval from the Egyptian Drug Authority (EDA) for its product, Sorafenib Tosylate Tablets, to be marketed in Egypt [1] - Sorafenib is a well-known targeted therapy drug that has been widely used for the treatment of various tumors, including liver cancer and kidney cancer, since its original approval by the FDA in December 2005 [1]