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复宏汉霖:地舒单抗注射液在欧盟获批上市 覆盖原研所有适应症
Zheng Quan Ri Bao· 2025-09-22 13:15
本报讯 (记者金婉霞)9月19日,上海复宏汉霖生物技术股份有限公司(以下简称"复宏汉霖")的微信 公众号显示,公司60mg/mL和120mg/1.7mL两规格的地舒单抗注射液已获得欧盟委员会(EC)的上市许 可,适应症覆盖了原研产品在欧盟已获批的所有适应症。 复宏汉霖首席商务发展官兼高级副总裁曹平表示,此次获批是复宏汉霖与合作伙伴强强联合、共同满足 欧洲患者和医疗系统需求的又一重要成果。"凭借对科学卓越与产品质量的始终坚守,我们在美国获批 的基础上不断前行,将这些生物类似药治疗方案带给全球更多有需要的患者。"曹平称。 (文章来源:证券日报) ...
第11批集采文件发布;我国创新药上半年对外授权近660亿美元
Policy Developments - The National Healthcare Security Administration (NHSA) released the 11th batch of national drug centralized procurement documents, emphasizing principles of "stabilizing clinical use, ensuring quality, preventing collusion, and countering internal competition" [2] - The new procurement strategy optimizes "anchor prices" by not simply selecting the lowest bid but using the higher value between the average of "comparable unit prices" and the lowest "comparable unit price" at 50% [2] Drug and Device Approvals - Fosun Pharma announced that its subsidiary, Fuhong Hanlin, received EU approval for two drugs, BILDYOS® and BILPREVDA®, for treating osteoporosis in high-risk patients [4] - Renfu Pharma's subsidiary received a tentative FDA approval for Oxcarbazepine extended-release tablets, aimed at treating partial seizures in patients aged 6 and above, with a total R&D investment of approximately 15 million RMB [5] Capital Markets - LuKang Pharmaceutical plans to acquire a 1.9231% stake in Shandong Lukang Hecheng Pharmaceutical Co., with the final amount to be determined through bidding [7] - GE Healthcare responded to rumors about selling its Chinese business, stating its commitment to providing high-quality medical services in China [8] Industry Events - The NHSA announced the interim results of expert reviews for the 2025 National Basic Medical Insurance Directory and commercial insurance innovative drug directory adjustments [10][11] - In the first half of 2025, China's innovative drug licensing transactions reached nearly $66 billion, indicating a significant increase in international recognition and commercial value of Chinese innovative drugs [12] - The National Medical Products Administration established a review center in the Beijing-Tianjin-Hebei region to enhance drug and medical device evaluation services [13] - Approximately 100 rare disease drugs have been included in the basic medical insurance directory, covering 42 types of rare diseases [14]
上海复星医药(集团)股份有限公司 关于控股子公司药品获欧盟注册批准的提示性公告
Overview - Shanghai Fosun Pharmaceutical (Group) Co., Ltd. has received approval from the European Commission for its subsidiaries' biosimilar products BILDYOSR and BILPREVDAR, which are based on denosumab [2][3] - The approval allows these products to be marketed in all EU member states as well as Iceland, Liechtenstein, and Norway [2] Product Information - HLX14, the biosimilar denosumab, is intended for the treatment of osteoporosis in postmenopausal women at high risk of fractures, along with other indications aligned with the reference products Prolia and XGEVA [2] - The cumulative R&D investment for HLX14 is approximately RMB 323 million as of July 2025 [4] Market Impact - The approval in the EU follows a previous approval in the US, enhancing the company's international market presence [5] - The global sales of denosumab injection products are projected to be approximately USD 7.463 billion in 2024 [4] - Commercial rights for HLX14 outside of China were granted to Organon LLC in June 2022, allowing for milestone and sales commission rights following the EU approval [5]
消费“白马股”突发爆雷!下周一停牌戴帽 | 盘后公告精选
Jin Shi Shu Ju· 2025-09-19 14:23
登录新浪财经APP 搜索【信披】查看更多考评等级 09月19日,消费"白马股"绝味食品(维权)突发爆雷!因信披违规将被ST,股票下周一停牌一天;医 药出海再传捷报,龙头药企复星医药旗下产品获欧盟批准上市;物联网芯片公司泰凌微旗下端侧AI芯 片已获头部客户采用并实现量产。 以下是盘后公告精选: 绝味食品:因收到行政处罚事先告知书公司股票将被实施其他风险警示 绝味食品公告称,公司于2025年9月19日收到中国证券监督管理委员会湖南监管局下发的《行政处罚事 先告知书》,根据《事先告知书》载明的内容,公司股票将被实施其他风险警示,A股简称将变更 为"ST绝味",证券代码仍为603517。实施起始日为2025年9月23日,停牌日期为2025年9月22日。公司 将追溯调整相关财务报表,加强内部控制流程建设,并积极争取尽快申请撤销风险警示。 复星医药:复宏汉霖药品获欧盟批准上市 复星医药公告,控股子公司复宏汉霖及其控股子公司自主研发的地舒单抗注射液产品BILDYOS(规格 60mg/mL)和BILPREVDA(120mg/1.7mL)的上市许可申请获欧盟委员会批准。该产品适用于骨折高 风险的绝经后妇女及男性骨质疏松症治疗、 ...
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]
复星医药:控股子公司两个地舒单抗注射液产品获欧盟注册批准
Group 1 - The core point of the article is that Fosun Pharma's subsidiary, Fuhong Hanlin, has received approval from the European Commission for the marketing authorization applications (MAAs) of two products, BILDYOS® and BILPREVDA® [1] - BILDYOS® (60mg/mL) and BILPREVDA® (120mg/1.7mL) are both injection products containing dexsilone, which are now approved for sale in all EU member states as well as Iceland, Liechtenstein, and Norway [1]
复星医药(600196.SH):控股子公司药品获欧盟注册批准
Ge Long Hui A P P· 2025-09-19 08:16
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 monoclonal antibody injection products, BILDYOS® and BILPREVDA® [1] Group 1 - The approved products, BILDYOS® (60 mg/mL) and BILPREVDA® (120 mg/1.7 mL), are based on the project code HLX14 [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]
港股异动丨旗下地舒单抗成功出海、股东大额增持!复宏汉霖收涨4.94% 年内累涨超2.4倍
Ge Long Hui· 2025-09-03 09:17
Core Viewpoint - The article highlights the strong performance of Fuhong Hanlin (2696.HK) amidst a general decline in the Hong Kong stock market, driven by the approval of its biosimilar products by the FDA, indicating significant growth potential for the company [1] Group 1: Company Performance - Fuhong Hanlin's stock rose by 4.94% to HKD 80.8, approaching its historical high of HKD 85.95 reached on August 21 [1] - The company's stock has increased over 2.4 times year-to-date, significantly outperforming the Hang Seng Index, which has risen by over 26% in the same period [1] Group 2: Regulatory Approval - The FDA approved the market applications for two biosimilar products: BILDYOS® (denosumab-nxxp) and BILPREVDA® (denosumab-nxxp), which are biosimilars to PROLIA® and XGEVA® respectively [1] - This approval marks another milestone for Fuhong Hanlin in gaining regulatory recognition for its self-developed and self-manufactured biosimilars in the U.S. market [1] Group 3: Shareholder Confidence - Point72 Associates, LLC increased its stake in Fuhong Hanlin by approximately HKD 20.37 million, acquiring 243,800 shares, raising its total holdings to 8.24 million shares [1] - Following this purchase, the ownership percentage increased from 4.89% to 5.04%, reflecting strong confidence from shareholders in the company's long-term growth and investment value [1]
首款“中国籍”地舒单抗成功出海 获美国FDA批准上市
Mei Ri Jing Ji Xin Wen· 2025-09-02 10:45
Core Viewpoint - The approval of two products of Dazhu Single Antibody Injection by the FDA marks a significant milestone for the company, being the first domestically produced Dazhu Single Antibody to be approved overseas [2] Company Summary - The company, Fuhong Hanlin, has announced that its Dazhu Single Antibody Injection products (60mg/mL and 120mg/1.7mL) have received FDA approval for eight indications, including osteoporosis and bone-related events [2] - With this approval, the company now has three products approved in the United States [2]