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迈威生物9MW0813注射液上市许可申请获得受理
Bei Jing Shang Bao· 2025-09-19 09:07
公告显示,9MW0813注射液是阿柏西普(艾力雅®)的生物类似药,为VEGFR—1和VEGFR—2胞外区 结合域与人免疫球蛋白Fc段重组形成的融合蛋白,可与VEGF—A和PlGF结合。 北京商报讯(记者 王寅浩 实习记者 宋雨盈)9月19日,迈威生物发布公告称,公司近日收到国家药品 监督管理局核准签发的《受理通知书》,9MW0813注射液的上市许可申请获得受理,用于糖尿病性黄 斑水肿(DME)和新生血管(湿性)年龄相关性黄斑变性(nAMD)。 ...
复星医药子公司两个地舒单抗注射液获欧盟注册批准
Bei Jing Shang Bao· 2025-09-19 09:07
Core Viewpoint - Fosun Pharma's subsidiary Shanghai Fuhong Hanlin Biotech has received approval from the European Commission for the marketing authorization applications (MAAs) of two biosimilar products, BILDYOS® and BILPREVDA® [1] Group 1 - The approved products are both injections of dezhushe monoclonal antibody, with specifications of 60mg/mL for BILDYOS® and 120mg/1.7mL for BILPREVDA® [1] - The marketing authorization allows for the sale of these products in all EU member states as well as in Iceland, Liechtenstein, and Norway, which are part of the European Economic Area [1]
复星医药:两个地舒单抗注射液产品获欧盟注册批准
Zhi Tong Cai Jing· 2025-09-19 08:32
Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., has received approval from the European Commission for the marketing authorization applications (MAAs) of two biosimilar products, BILDYOS® and BILPREVDA® [1] Group 1: Company Developments - The approved products, BILDYOS® (60 mg/mL) and BILPREVDA® (120 mg/1.7 mL), are biosimilars of denosumab, intended for the treatment of osteoporosis in postmenopausal women at high risk of fractures [1] - The marketing authorization allows for the sale of these products across all EU member states, as well as in Iceland, Liechtenstein, and Norway [1] Group 2: Industry Implications - The approval of HLX14 represents a significant advancement in the biosimilar market, particularly for osteoporosis treatments, which is a growing area of need in the healthcare sector [1]
欧林生物:获得政府补助464万元
Mei Ri Jing Ji Xin Wen· 2025-09-19 08:31
每经头条(nbdtoutiao)——"25基点太少,50基点太多":美联储降息"走钢丝","特朗普代言人"投下唯 一反对票 (记者 张喜威) 每经AI快讯,欧林生物(SH 688319,收盘价:26.8元)9月19日晚间发布公告称,近期,成都欧林生物 科技股份有限公司"重组多重耐药金黄色葡萄球菌疫苗研制与产业化"项目入选四川省2025年第二批省级 科技计划,公司于2025年9月19日收到政府补助款项共计人民币464万元,其中324.8万元为公司所获政 府补助;其余139.2万元为项目合作单位所获政府补助。 2024年1至12月份,欧林生物的营业收入构成为:医药制造业占比99.53%,其他业务占比0.47%。 截至发稿,欧林生物市值为109亿元。 ...
北交所上市公司锦波生物大宗交易折价14.86%,成交金额100.8万元
Sou Hu Cai Jing· 2025-09-19 08:23
(记者 曾健辉) 免责声明:本文内容与数据仅供参考,不构成投资建议,使用前核实。据此操作,风险自担。 每日经济新闻 每经讯,2025年9月19日,北交所上市公司锦波生物(832982,收盘价:295.98元)发生一笔大宗交易,成交价252元/股,成交 数量4000股,成交金额100.8万元,折价14.86%。买入营业部是国金证券股份有限公司上海静安区南京西路证券营业部,卖出营 业部是国金证券股份有限公司深圳分公司。 ...
迈威生物(688062.SH):9MW0813注射液上市许可申请获得受理
智通财经网· 2025-09-19 07:50
智通财经APP讯,迈威生物(688062.SH)发布公告,近日,公司收到国家药品监督管理局核准签发的 《受理通知书》,9MW0813注射液的上市许可申请获得受理,用于糖尿病性黄斑水肿(DME)和新生血 管(湿性)年龄相关性黄斑变性(nAMD)。 据悉,9MW0813注射液是阿柏西普(艾力雅®)的生物类似药,为VEGFR-1和VEGFR-2胞外区结合域与人 免疫球蛋白Fc段重组形成的融合蛋白,可与VEGF-A和PlGF结合。 ...
科前生物实控人续签一致行动人协议,巩固公司控制权
Xin Lang Cai Jing· 2025-09-19 07:49
Core Points - The announcement indicates that the actual controllers of Keqian Bio, He Qigai, Wu Bin, Fang Liurong, and Wu Meizhou, have renewed the "Consistent Action Agreement" on September 17, 2025, which was originally set to be renewed on September 20, 2024 [1] - The new agreement clarifies the purpose of consistent action and decision-making mechanisms, extending its validity until September 21, 2026 [1] - As of the announcement date, the four individuals collectively hold 27.48% of the company's shares, ensuring stability in the company's control and maintaining strategic and operational continuity [1] - The renewal of the agreement is expected to promote healthy and sustainable development without harming the interests of minority investors [1]
劲方医药登陆香港联交所,华兴资本担任联席账簿管理人及联席牵头经办人
Xin Lang Cai Jing· 2025-09-19 07:39
Group 1 - The core viewpoint of the article is that Jinfang Pharmaceutical Technology (Shanghai) Co., Ltd. has successfully listed on the Hong Kong Stock Exchange with a base issuance scale of approximately $230 million, potentially increasing to $270 million with full exercise of the over-allotment option [1][2] - Jinfang Pharmaceutical is a biopharmaceutical company with a global vision and operations, having already received approval for its first innovative drug. The company focuses on innovation and advanced treatment methods to meet various medical needs [1] - As of September 2, the company has established a competitive and innovative product pipeline consisting of eight candidate products, five of which are in clinical development. The pipeline primarily targets treatments related to the RAS family of genes [1] Group 2 - One of the core products, GFH925 (fulzerasib, marketed as Daberu®), has been commercially approved in China for the treatment of advanced non-small cell lung cancer (NSCLC). The company is also exploring treatments for autoimmune and inflammatory diseases, as well as other cancer-related therapies [1] - Huaxing Capital played a significant role in the underwriting process, successfully introducing several internationally renowned long-term funds as cornerstone investors, reflecting strong market recognition of the company's R&D capabilities and growth prospects [2] - The president of Huaxing International expressed pride in supporting Jinfang Pharmaceutical's listing, highlighting the company's leading R&D strength and clear global strategy, which positions it as an excellent representative of Chinese innovative pharmaceutical companies [2]
益方生物股价连续5天下跌累计跌幅6.99%,国投瑞银基金旗下1只基金持8.57万股,浮亏损失21.85万元
Xin Lang Cai Jing· 2025-09-19 07:35
9月19日,益方生物跌1.14%,截至发稿,报33.93元/股,成交3.51亿元,换手率2.46%,总市值196.23亿 元。益方生物股价已经连续5天下跌,区间累计跌幅6.99%。 责任编辑:小浪快报 国投瑞银上证科创板200指数发起式A(023518)成立日期2025年3月18日,最新规模7007.47万。成立以 来收益32.43%。 国投瑞银上证科创板200指数发起式A(023518)基金经理为赵建、钱瀚。 截至发稿,赵建累计任职时间11年362天,现任基金资产总规模38.48亿元,任职期间最佳基金回报 172.91%, 任职期间最差基金回报-88.73%。 钱瀚累计任职时间2年37天,现任基金资产总规模9.36亿元,任职期间最佳基金回报36.41%, 任职期间 最差基金回报1.33%。 风险提示:市场有风险,投资需谨慎。本文为AI大模型自动发布,任何在本文出现的信息(包括但不 限于个股、评论、预测、图表、指标、理论、任何形式的表述等)均只作为参考,不构成个人投资建 议。 资料显示,益方生物科技(上海)股份有限公司位于中国(上海)自由贸易试验区李冰路67弄4号210室,成 立日期2013年1月11日,上市 ...
港股异动 | 创胜集团-B(06628)午后涨超6% 此前宣布配股筹资 用于开发TST001等核心管线资产
智通财经网· 2025-09-19 06:59
Core Viewpoint - Chuangsheng Group-B (06628) has seen a significant stock price increase following the announcement of a share placement to fund clinical development and operational expenses [1] Group 1: Financial Actions - Chuangsheng Group plans to place 14.4 million shares at a price of HKD 4.33 per share, raising approximately HKD 59.34 million [1] - The allocation of the net proceeds includes 40% for clinical development of pipeline assets TST001 and TST002, 30% for advancing promising preclinical pipeline assets such as TST801, TST013, and TST786, and 30% for working capital and general purposes [1] Group 2: Clinical Developments - Recent breakthroughs in research and clinical trials have been reported, particularly for TST001, which has shown a median overall survival (mOS) of 20.4 months in a study involving 82 patients with gastric cancer [1] - TST001 is set to initiate a global Phase III clinical trial for gastric and gastroesophageal cancer upon receiving regulatory approval [1] - The osteoporosis drug Blosozumab (TST002) has entered Phase II clinical trials in China with positive early results [1]