格隆汇9月2日丨科兴制药(688136.SH)公布，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。公司子公司深圳科兴开展的临 床试验"评价GB08注射液治疗儿童生长激素缺乏症受试者的有效性和安全性的多中心、随机、开放、阳 性对照的II/III期临床研究"于2025年7月获得临床试验组长单位浙江大学医学院附属儿童医院的伦理批件 （批件号：2025-IEC-0009-P-01），并已于近日完成首例受试者入组给药。 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 ...

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]

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]

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]

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]

Group 1 - A-share companies are increasingly planning to list in Hong Kong, indicating a trend in the market [1] - A total of 29 A-share listed companies have disclosed plans for Hong Kong listings this month [1] - Notable companies involved in this trend include Huaxin Cement, Shengbang Co., Dongcheng Pharmaceutical, and others [1]

Investment Rating - The report maintains a "Buy" rating for the company [10] Core Views - The company reported a revenue of 700 million yuan in the first half of 2025, reflecting a year-on-year decrease of 7.82%, while the net profit attributable to the parent company was 80 million yuan, showing a significant increase of 576.45% [6][10] - The growth in net profit outpaced revenue growth, attributed to improved operational quality and rapid growth in overseas sales, with export revenue reaching 188 million yuan, doubling year-on-year [7][10] - The company is advancing its "global selection and coverage" strategy, with 19 products having obtained overseas commercialization rights and approximately 150 registration applications submitted in over 70 countries/regions [8] - The company has laid out multiple innovative drug pipelines, with 10 innovative drugs disclosed, most of which are global firsts, potentially providing a second growth engine [8] Financial Summary - Total revenue for 2025 is projected at 1.615 billion yuan, with a year-on-year growth rate of 14.8% [5] - The net profit attributable to the parent company is expected to be 108 million yuan in 2025, with a significant year-on-year growth of 244.2% [5] - The company’s gross margin is projected to be 65.3% in 2025, with a return on equity (ROE) of 6.1% [5]

证券日报网讯 8月29日晚间，科兴制药发布公告称，2025年8月29日，公司召开第三届董事会第一次会 议，审议通过了《关于聘任公司审计监察部负责人的议案》，全体董事一致同意聘任陈芳女士为公司审 计监察部负责人。 ...

证券日报网讯 8月29日晚间，科兴制药发布公告称，公司于2025年8月29日召开职工代表大会，审议通 过了《关于选举公司第三届董事会职工代表董事的议案》，同意选举黄凯昆先生为公司第三届董事会职 工代表董事。本次职工代表大会选举产生的职工代表董事，将与公司2025年第一次临时股东会选举产生 的4名非独立董事、3名独立董事共同组成公司第三届董事会。第三届董事会自公司2025年第一次临时股 东会审议通过之日起就任，任期三年。 （编辑 李家琪） ...