谈到苏州工业园区，不得不提到由它孵化的苏州生物医药产业园（BioBAY）。政府公开信息显示， 2006年，生物医药及大健康产业就被苏州工业园区视作重点规划、引导和培育的战略新兴产业之一。随 后，园区大力发展生物医药及大健康产业。今年，苏州工业园区市场监管局更是获得了江苏省药监局药 品生产/经营许可证换发事项的正式赋权。 将"BioBAY"这个词汇进行简单的拆解，它可以翻译为"生物港湾"。事实上，作为苏州工业园区发展生 物医药产业的高科技载体，这个于2007年正式启用的园区，也确实在17年间培育了众多生物医药高科技 创新企业，为它们提供了成长的港湾。最新数据显示，BioBAY中的生物医药高科技创新企业数量已经 达到620多家。信达生物制药（苏州）有限公司（下称"信达生物"）就是其中之一。 国内市面上销售的信迪利单抗注射液（达伯舒®）、贝伐珠单抗注射液（达攸同®）、阿达木单抗注射 液（苏立信®）等药物，都是信达生物的产品。目前，公司有18个产品已经获得批准上市，在中国生物 医药领域具备了一定的竞争力。 BioBAY与信达生物之间的故事或许可以用"双向奔赴"来形容。2011年，曾在国内外多家制药公司任职 重要岗位的 ...

登录新浪财经APP 搜索【信披】查看更多考评等级 证券代码：002773 证券简称：康弘药业 公告编号：2025-075 成都康弘药业集团股份有限公司 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 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）年龄相关性黄斑变性（nAMD）、继发于视网膜静脉阻塞（RVO）（视网 膜分支静脉阻塞（BRVO）或视网膜中央静脉阻塞（CRVO））的黄斑水肿引起的视力损伤。 受理号：CXSB2500193、CXSB2500194 审批结论：同意开展临床试验。 二、产品简介 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， ...

登录新浪财经APP 搜索【信披】查看更多考评等级 证券代码：002773 证券简称：康弘药业 公告编号：2025-075 成都康弘药业集团股份有限公司关于 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。 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 受理号：CXSB2500193、CXSB2500194 审批结论：同意开展临床试验。 二、产品简介 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、 ...

康弘药业公告称，其全资子公司康弘生物收到国家药监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》，受理号为CXSB2500193、CXSB2500194，审批结论为同意开展临床试验。该药 品为1类生物创新药，有完全自主知识产权，本次是高剂量药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。但药品研发、审批等有不确定性，提醒投资者注意风险。 ...

康弘药业（002773）(002773.SZ)发布公告，近日,公司全资子公司成都康弘生物科技有限公司(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》。 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。 ...

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。 智通财经APP讯，康弘药业(002773.SZ)发布公告，近日,公司全资子公司成都康弘生物科技有限公司(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》。 ...

Core Insights - Northeast Pharmaceutical, a subsidiary of Liaoning Fangda Group, is focusing on expanding its business in the pharmaceutical and health sectors through three key initiatives: drug research and innovation, development of health food products, and entry into the beauty industry with functional skincare products [2][3]. Group 1: Pharmaceutical Innovation - The company views research and innovation as its "lifeline" and has established a robust R&D system, successfully launching over 20 new raw materials and formulations in recent years [3]. - The recent approval of the DC-TY0801 injection for clinical trials marks a significant advancement in the company's oncology treatment portfolio, specifically targeting EGFRvIII positive recurrent or progressive high-grade glioma [3]. - The company is also expanding its pipeline with multiple tumor-targeted cell therapy products, enhancing its capabilities in the healthcare service sector [3]. Group 2: Health Food Development - Northeast Pharmaceutical is tapping into the health food market by launching a series of health-oriented biscuits, including products made from traditional Chinese medicinal ingredients [4]. - The biscuits are developed in collaboration with local universities, ensuring adherence to national food safety standards and scientific formulation [4][5]. - The product line includes various flavors designed to meet different health needs, showcasing the integration of traditional health concepts with modern food technology [4][5]. Group 3: Expansion into Beauty Industry - The company has launched a functional skincare brand, "Qifangyuan," which combines pharmaceutical standards with skincare innovation [6]. - The skincare products are developed using pharmaceutical-grade raw materials and undergo rigorous safety and efficacy testing [6]. - This move is part of a broader strategy to diversify and meet the growing demand for comprehensive health services, leveraging the company's expertise in pharmaceuticals [6].

Core Viewpoint - Tian Shi Li reported a steady performance in Q3 2025, with revenue of 6.311 billion and a net profit of 984 million, marking a year-on-year growth of 16.88%, defying the industry trend of decline [1] Group 1: Financial Performance - The company achieved a revenue of 6.311 billion in the first three quarters, maintaining stability [1] - The net profit attributable to shareholders reached 984 million, reflecting a year-on-year increase of 16.88% [1] - The pharmaceutical industrial revenue was 5.709 billion, showing steady performance [1] - The cardiovascular/metabolic segment generated 3.186 billion, with a slight year-on-year growth of 1.16% [1] Group 2: Product Development - The key product, Pu You Ke, received approval to expand its indication to treat acute ischemic stroke, which is expected to contribute to future performance [3] - The company’s three major basic drug products are performing well, with the compound Danshen dripping pill expanding its indications to diabetic retinopathy, further driving growth [2] - The company has a rich pipeline of 31 innovative drugs in development, including nearly 20 clinical mid-to-late stage products in traditional Chinese medicine and several in the high-attention biopharmaceutical field [3] Group 3: Market Potential - Analysts predict that Pu You Ke could become a billion-dollar product following its new indication approval, with sales potential expected to exceed 1 billion [3] - The company is focusing on three core disease areas and continuously optimizing its R&D pipeline, which is expected to bring incremental contributions [4]

Core Insights - Tianjin Tasly Pharmaceutical achieved a pharmaceutical industrial revenue of 5.709 billion yuan in the first three quarters, maintaining steady growth, with a net profit attributable to shareholders of 984 million yuan, representing a year-on-year increase of 16.88%, reversing the industry's downward trend [1][2] Group 1: Business Performance - Despite a decline in the national pharmaceutical manufacturing industry, where revenue fell by 2.0% and total profit decreased by 3.9%, Tianjin Tasly's pharmaceutical industrial revenue remained stable [2] - The cardiovascular/metabolic segment generated 3.186 billion yuan in revenue, showing a slight year-on-year growth of 1.16% [2] Group 2: Product Development - The company's key products, including Compound Danshen Dripping Pills, Yangxue Qingnao (granules and pills), and Qishen Yiqi Dripping Pills, are performing well, with the former expanding its indications to diabetic retinopathy, contributing to growth [3] - The innovative drug Puyouke received approval for a new indication for acute ischemic stroke (AIS) treatment, with potential sales exceeding 1 billion yuan due to its unique thrombolytic mechanism and low systemic bleeding risk [4] Group 3: R&D Pipeline - Tianjin Tasly has a robust pipeline with 31 innovative drugs under development, including nearly 20 traditional Chinese medicine products in late-stage clinical trials and several biopharmaceuticals targeting high-interest areas [5] - The company aims to enhance its R&D capabilities as part of the "one body, two wings" strategy of China Resources Sanjiu, focusing on becoming a leading innovative pharmaceutical enterprise in China [5]

Core Viewpoint - Anke Bio announced the presentation of its self-developed biological innovative drug HuA21 at the ESMO annual meeting, showcasing its efficacy in treating HER2-positive advanced gastric/GEJ adenocarcinoma in combination with trastuzumab and chemotherapy [1] Group 1: Study Overview - The study titled "HuA21 combined with trastuzumab and chemotherapy in HER2-positive advanced gastric/GEJ adenocarcinoma: Phase Ib/II dose-escalation and expansion study" was led by researchers from Fudan University and Anhui Medical University [2] - HuA21 is a monoclonal antibody targeting HER2 with a unique amino acid sequence, possessing independent intellectual property rights [2] Group 2: Efficacy and Safety - Early clinical trials indicated that HuA21 demonstrated good safety with no dose-limiting toxicities observed at doses ≤15 mg/kg and significant anti-tumor activity, achieving an objective response rate (ORR) of 63.6% when combined with trastuzumab and chemotherapy [3] - The study enrolled 60 patients with HER2-positive advanced gastric/GEJ adenocarcinoma, using a "3+3" design for dose escalation and expansion [3] - The ORR for the HuA21 (30 mg/kg) group was 80.8%, while the ORR for the HuA21 (20 mg/kg) group was 76.7%, indicating strong anti-tumor activity [4] Group 3: Safety Profile - The overall safety profile was good, with treatment-emergent adverse events (TEAEs) occurring in 100% of the HuA21 (30 mg/kg) group and 96.7% of the HuA21 (20 mg/kg) group, primarily grade 1-2 [4] - Serious adverse events (SAEs) occurred at rates of 6.7% for the HuA21 (30 mg/kg) group and 23.3% for the HuA21 (20 mg/kg) group [4] - Common TEAEs included thrombocytopenia, anemia, neutropenia, leukopenia, and elevated aspartate aminotransferase, all of which were manageable [4] Group 4: Conclusion - The HuA21 (30 mg/kg) group showed a higher ORR of 80.8% compared to the 20 mg/kg group, with a lower incidence of SAEs, supporting the recommendation of 30 mg/kg as the phase III dose for HER2-positive advanced gastric cancer or GEJ cancer [5]