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康弘药业(002773.SZ):收到药物临床试验补充申请批准通知书
Ge Long Hui A P P· 2025-12-29 04:02
Core Viewpoint - Kanghong Pharmaceutical (002773.SZ) announced that its wholly-owned subsidiary, Chengdu Kanghong Biotechnology Co., Ltd., received approval from the National Medical Products Administration for the clinical trial of Kangbai Xip injection for eye use [1] Group 1: Drug Information - Drug Name: Kangbai Xip Injection for Eye Use [1] - Dosage Form: Injection [1] - Indications: Treatment for neovascular (wet) age-related macular degeneration (nAMD) and vision impairment due to macular edema secondary to retinal vein occlusion (RVO), including branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO) [1] - Acceptance Numbers: CXSB2500193, CXSB2500194 [1] - Approval Conclusion: Permission granted to conduct clinical trials [1]
康弘药业:子公司康柏西普眼用注射液获临床试验补充申请批准
Xin Lang Cai Jing· 2025-12-29 04:02
Core Viewpoint - Kanghong Pharmaceutical's subsidiary, Kanghong Biotech, has received approval from the National Medical Products Administration for clinical trials of its innovative drug, Conbercept, which aims to enhance patient compliance and reduce medical burdens [1] Group 1: Drug Approval and Development - Kanghong Biotech's Conbercept is classified as a Class 1 biological innovative drug with complete independent intellectual property rights [1] - The approval includes the acceptance numbers CXSB2500193 and CXSB2500194, allowing the company to conduct clinical trials [1] - This trial represents an exploration of high-dose applications in clinical settings [1] Group 2: Market Implications - The drug has the potential to improve patient medication adherence, which could lead to a reduction in overall healthcare costs [1] - The development and approval processes for pharmaceuticals carry inherent uncertainties, which may impact investor sentiment [1]
康弘药业:康柏西普眼用注射液收到药物临床试验补充申请批准通知书
Core Viewpoint - Kanghong Pharmaceutical's subsidiary, Kanghong Biotech, has received approval from the National Medical Products Administration for the clinical trial of its eye injection drug, Conbercept, aimed at treating vision loss caused by neovascular (wet) age-related macular degeneration (nAMD) [1] Group 1 - Kanghong Biotech is a wholly-owned subsidiary of Kanghong Pharmaceutical [1] - The approved drug, Conbercept, is specifically indicated for vision impairment due to nAMD [1]
康弘药业:康柏西普眼用注射液收到临床试验补充申请批准通知书
Zhi Tong Cai Jing· 2025-12-29 04:01
Core Viewpoint - Kanghong Pharmaceutical's subsidiary, Chengdu Kanghong Biotechnology Co., has received approval from the National Medical Products Administration for the clinical trial supplement application of Kangbaxip (Kangbaxip eye injection) [1] Group 1: Product Development - Kangbaxip is a class 1 biopharmaceutical innovation drug developed independently by Kanghong Biotechnology, possessing complete intellectual property rights [1] - The drug effectively binds with VEGF in blood and tissues, blocking the signaling pathways that promote neovascularization and growth [1] Group 2: Clinical Application - The current approval marks an exploration of high-dose Kangbaxip eye injection in clinical applications, which is expected to enhance patient medication adherence and reduce medical burden [1]
康弘药业(002773.SZ):康柏西普眼用注射液收到临床试验补充申请批准通知书
智通财经网· 2025-12-29 03:57
Core Viewpoint - Kanghong Pharmaceutical's subsidiary, Chengdu Kanghong Biotechnology Co., has received approval from the National Medical Products Administration for a clinical trial supplement application for its high-dose injection of Conbercept, a first-class biopharmaceutical with independent intellectual property rights [1] Group 1 - The Conbercept eye injection is a self-developed innovative drug that effectively binds to VEGF in blood and tissues, blocking signals that promote neovascularization [1] - The clinical application of high-dose Conbercept is expected to enhance patient compliance and reduce medical burdens [1]
康弘药业(002773) - 关于子公司收到药物临床试验补充申请批准通知书的公告
2025-12-29 03:39
关于子公司收到药物临床试验补充申请批准通知书的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整, 没有虚假记载、误导性陈述或重大遗漏。 成都康弘药业集团股份有限公司 证券代码:002773 证券简称:康弘药业 公告编号:2025-075 二、产品简介 1 / 2 康柏西普眼用注射液是公司全资子公司康弘生物自主研发的具 有完全自主知识产权的 1 类生物创新药,该产品能有效地与血管及组 织中的 VEGF 结合,阻断由 VEGF 介导的促进新生血管出芽和生长的 信号传递。本次为高剂量康柏西普眼用注射液在临床应用上的探索, 有望提升患者用药依从性、减轻医疗负担。 三、对公司的影响 由于药品从研发、临床试验、审评和审批的结果以及时间都具有 一定的不确定性,敬请广大投资者谨慎决策,注意投资风险。 近日,成都康弘药业集团股份有限公司(以下简称"公司")全 资子公司成都康弘生物科技有限公司(以下简称"康弘生物")收到 国家药品监督管理局签发的康柏西普眼用注射液《药物临床试验补充 申请批准通知书》。现将相关情况公告如下: 一、药品基本信息 药品名称:康柏西普眼用注射液 剂型:注射剂 适应症:新生血管性(湿性)年龄 ...
康弘药业:布瑞哌唑片获药品注册证书用于治疗成人精神分裂症
Cai Jing Wang· 2025-12-26 08:57
Core Viewpoint - Kanghong Pharmaceutical (002773) has received the drug registration certificate for Brivaracetam tablets from the National Medical Products Administration, enhancing its product pipeline [1] Group 1: Product Approval - Brivaracetam is indicated for the treatment of schizophrenia, with an unclear mechanism of action potentially involving partial agonist activity at serotonin 5-HT1A and dopamine D2 receptors, as well as antagonist activity at serotonin 5-HT2A receptors [1] - The approved specifications for Brivaracetam tablets are 1mg and 2mg, classified as a chemical drug of category 4 [1] Group 2: Impact on Company - The approval of Brivaracetam tablets enriches the company's product pipeline, indicating a strategic move to expand its offerings in the psychiatric treatment market [1]
12月26日重要公告一览
Xi Niu Cai Jing· 2025-12-26 02:37
Group 1 - 德方纳米 plans annual equipment maintenance to ensure efficient and stable operation, starting January 1, 2026, for one month, with no significant impact on 2026 performance [1] - 达意隆's subsidiary Tianjin Baolong faces a significant decline in OEM orders due to strategic adjustments from core customers, leading to plans to shut down production lines [2] - 天威视讯's subsidiary plans to transfer project assets for 604.3 million yuan to a related party, constituting a related transaction [3] Group 2 - 金龙羽 intends to sign a strategic cooperation framework agreement with an investment institution to establish an industrial merger fund with a planned scale of 1.5 billion yuan [4] - 紫光国微's subsidiary plans to establish a new company with multiple partners, including a subsidiary of CATL, with a registered capital of 300 million yuan [5] - 信隆健康's major shareholder plans to reduce its stake by up to 1% through trading [6] Group 3 - 龙建股份 wins a 612 million yuan EPC contract for a project, which represents approximately 3.27% of the company's audited revenue for 2024 [7] - 复旦张江 receives acceptance for a clinical trial application for a drug aimed at visualizing malignant lesions in lung cancer patients [9] - 博实股份's major shareholder plans to reduce its stake by up to 2.93% [10] Group 4 - 百纳千成 plans to acquire 100% of Zhonglian Century's shares to expand its marketing business and digital advertising solutions [11] - 天铁科技's major shareholder is under criminal detention, but the investigation is unrelated to the company's operations [12] - 海看股份's shareholder plans to reduce its stake by up to 3.6% [13] Group 5 - 智光电气's subsidiary signs a procurement contract worth 148 million yuan for a high-voltage energy storage system [14] - 西藏矿业's attempt to transfer 100% of a subsidiary's equity has not attracted qualified buyers, leading to automatic withdrawal from the trading platform [15] - 英诺激光's major shareholder plans to reduce its stake by up to 3% [16] Group 6 - 福鞍股份's major shareholder plans to reduce its stake by up to 3% [17] - 白云山 receives a drug registration certificate for a rabies vaccine [18] - 华电科工 signs a contract worth approximately 265 million yuan for a power plant project [19] Group 7 - 康弘药业 receives a drug registration certificate for a medication used to treat schizophrenia [20] - 西菱动力's actual controller plans to reduce their stake by 2% [21] - 海希通讯's actual controller plans to reduce their stake by 0.48% [22] Group 8 - 海南机场 plans to transfer 90% of a subsidiary's equity for approximately 500 million yuan, expecting a profit of about 200 million yuan from the transaction [23] - 森远股份 signs a contract for a computing cluster integration project worth 26.78 million yuan [24] - 丽珠集团's subsidiary receives acceptance for a drug registration application for a new treatment for psoriasis [25] Group 9 - 郑州银行 plans to acquire a village bank and convert it into a branch [26] - 方正证券 announces a cash dividend distribution plan for the third quarter of 2025 [27] - 金陵体育 announces a cash dividend distribution plan for the first three quarters of 2025 [29] Group 10 - 紫金银行 announces a mid-term profit distribution plan for 2025 [30] - *ST建艺's major shareholder waives 1.4 billion yuan in debt and donates 400 million yuan to support the company [31] - 万朗磁塑's major shareholder plans to reduce their stake by up to 3% [32] Group 11 - 艾力斯's core product is included in a list of potential breakthrough therapies for lung cancer [33] - 富创精密's shareholder plans to transfer 918.63 million shares [34] - 东阳光's subsidiary plans to increase capital and introduce investors [35] Group 12 - 侨银股份 plans to acquire a 16.67% partnership in a venture capital fund [36] - 尤夫股份 receives a government subsidy of 4.04 million yuan for a technical improvement project [37] - 倍轻松 and its actual controller are under investigation for information disclosure violations [38] Group 13 - 万润新能 plans to reduce production on some lines for maintenance, expecting a reduction of 5,000 to 20,000 tons in lithium iron phosphate output [39]
康弘药业:产品“布瑞哌唑片”取得注册证
Mei Ri Jing Ji Xin Wen· 2025-12-25 12:30
Group 1 - The core point of the article is that Kanghong Pharmaceutical has received a drug registration certificate for Brexpiprazole tablets from the National Medical Products Administration, which is a significant regulatory approval for the company [1] - As of December 25, 2023, Kanghong Pharmaceutical's revenue composition for the first half of 2025 is reported to be 99.97% from the pharmaceutical manufacturing industry and 0.03% from other businesses [1] - The current market capitalization of Kanghong Pharmaceutical is 28.7 billion yuan [2]
康弘药业(002773.SZ):布瑞哌唑片收到药品注册证书
Ge Long Hui A P P· 2025-12-25 11:16
Core Viewpoint - Kanghong Pharmaceutical (002773.SZ) has received the drug registration certificate for Brexpiprazole tablets from the National Medical Products Administration, indicating a significant regulatory approval for a new treatment option for schizophrenia [1] Group 1: Company Developments - The drug registration certificate for Brexpiprazole tablets has been issued with certificate numbers 2025S03922 and 2025S03923, marking an important milestone for Kanghong Pharmaceutical [1] - Brexpiprazole is indicated for the treatment of schizophrenia, which is a critical area in mental health therapeutics [1] Group 2: Drug Mechanism - The exact mechanism of action for Brexpiprazole in treating schizophrenia is not fully understood, but it is believed to involve partial agonist activity at serotonin 5-HT1A and dopamine D2 receptors, along with antagonist activity at serotonin 5-HT2A receptors [1]