地舒单抗生物类似药HLX14
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港股开盘:恒指跌0.44%、科指跌0.51%,科技股及新汽车多数走低,新消费概念股走高
Jin Rong Jie· 2025-12-03 01:37
12月3日,港股集体低开,恒生指数跌0.44%报25980.89点,恒生科技指数跌0.51%报5595.53点,国企指 数跌0.55%报9132.53点,红筹指数跌0.24%报4267.46点。 盘面上,大型科技股多数走低,阿里巴巴跌0.76%,腾讯控股跌0.16%,京东集团跌0.34%,网易跌 1.52%,快手跌1.38%,哔哩哔哩跌1.08%。汽车股继续分化,蔚来汽车、小鹏汽车继续走低,濠赌股、 食品饮料股、三桶油普跌。另外,核电股、建材水泥股、新消费概念股多数上涨,此外,新股金岩高岭 新材高开超27%。 复宏汉霖(02696.HK):地舒单抗生物类似药HLX14的上市注册申请获国家药品监督管理局受理。2024年 度,同类产品于全球范围内的销售额约为74.63亿美元。 企业新闻 德琪医药-B(06996.HK):ATG-022联合KEYTRUDA®(帕博利珠单抗)±化疗的IB/II期研究于中国获授予 IND批准。 加科思-B(01167.HK):订立的增资协议及股权转让协议,已收到海松资本支付的人民币1.25亿元的首付 款。将为集团后续创新肿瘤疗法管线研发的推进提供助力。 金辉集团(00137.HK):附 ...
智通港股早知道 特朗普称哈塞特为“潜在的”美联储主席 苹果(AAPL.US)续创历史新高
Jin Rong Jie· 2025-12-03 00:07
Group 1: Federal Reserve Leadership and Economic Outlook - President Trump has named Kevin Hassett as a potential candidate for the next Federal Reserve Chair, with plans to announce the selection in early 2026, increasing speculation about the Fed's future leadership [1] - According to CME's FedWatch tool, there is an 89.2% probability of a 25 basis point rate cut in December, and a 66.6% probability of a cumulative 25 basis point cut by January 2024 [1] - The OECD predicts that developed economies will end their current rate-cutting cycle by the end of 2026, indicating limited policy easing space for major central banks despite potential economic slowdowns [1] Group 2: Stock Market Performance - U.S. stock markets saw gains, with the Dow Jones Industrial Average rising by 185.13 points to 47,474.46, a 0.39% increase, and the S&P 500 up by 16.74 points to 6,829.37, a 0.25% increase [2] - Apple shares rose over 1%, marking a seventh consecutive day of gains and reaching a new all-time high [2] - Chinese concept stocks mostly declined, with the Nasdaq Golden Dragon China Index falling by 0.65% [2] Group 3: Economic Growth Forecasts - The OECD has raised its 2025 economic growth forecast for China to 5%, up from a previous estimate of 4.9% [3] - Global economic growth is projected at 3.2% for 2025 and 2.9% for 2026, remaining unchanged from prior forecasts [3] Group 4: Semiconductor Market Insights - Morgan Stanley forecasts that the humanoid robot semiconductor market will reach $305 billion by 2045, with demand expected to grow by approximately 15% from 2025 to 2030, followed by a 40% increase thereafter [4] Group 5: Strategic Partnerships and Collaborations - EVE Energy has signed a comprehensive strategic cooperation agreement with China Gas, focusing on energy storage technology innovation and the large-scale application of clean energy [8] - Sunny Optical Technology is the exclusive supplier of camera lenses and main camera telephoto modules for the Doubao mobile assistant engineering prototype [6] Group 6: New Product Launches and Approvals - Xpeng Motors and Huawei jointly launched the next-generation DriveONE range extender generator, achieving a power density of 1.88 kW/kg and an industry-leading efficiency of ≥92% [5] - Daqi Pharmaceutical has received IND approval for its ATG-022 combined with KEYTRUDA® and chemotherapy in China [9] Group 7: Corporate Acquisitions and Stock Movements - JD.com has acquired approximately 59.8% of Ceconomy’s equity and voting rights, with total holdings expected to reach 85.2% after the transaction [10] - Black Sesame Intelligence plans to invest approximately RMB 400 million to 550 million to acquire a majority stake in Zhuhai Yizhi Electronics Technology [14]
智通港股早知道 | 特朗普称哈塞特为“潜在的”美联储主席 苹果(AAPL.US)续创历史新高
Zhi Tong Cai Jing· 2025-12-02 23:30
Group 1: Federal Reserve and Economic Outlook - President Trump has named Kevin Hassett as a potential candidate for the next Federal Reserve Chair, with an announcement expected in early 2026 [1] - The probability of a 25 basis point rate cut by the Federal Reserve in December is 89.2%, while the probability of maintaining the current rate is 10.8% [1] - The OECD predicts that developed economies will end their current rate-cutting cycle by the end of 2026, indicating limited policy easing space for major central banks despite potential economic slowdowns [1][3] Group 2: Stock Market Performance - U.S. stock markets saw gains, with the Dow Jones Industrial Average rising by 185.13 points to 47,474.46, a 0.39% increase [2] - Apple Inc. continues to reach new historical highs, marking its seventh consecutive day of gains, while Intel and Nvidia also saw significant increases [2] Group 3: Economic Growth Projections - The OECD has raised its 2025 economic growth forecast for China to 5%, up from a previous estimate of 4.9% [3] Group 4: Semiconductor Market Insights - Morgan Stanley forecasts that the humanoid robot semiconductor market will reach $305 billion by 2045, with a demand growth of approximately 15% from 2025 to 2030, followed by a 40% increase thereafter [4] Group 5: Strategic Partnerships and Innovations - EVE Energy has entered into a comprehensive strategic cooperation agreement with China Gas, focusing on energy storage technology innovation and the large-scale application of clean energy [8] - XPeng Motors and Huawei have jointly launched the next-generation DriveONE range extender generator, achieving a power density of 1.88 kW/kg and an efficiency of over 92% [5][8] Group 6: Corporate Developments - JD.com has acquired approximately 59.8% of Ceconomy’s equity and voting rights, with total holdings expected to reach 85.2% after the transaction [10] - Black Sesame Intelligence plans to invest approximately RMB 400 million to RMB 550 million to acquire a majority stake in Zhuhai Yizhi Electronic Technology [14]
上海复星医药(集团)股份有限公司2025年第二次临时股东会决议公告
Shang Hai Zheng Quan Bao· 2025-12-02 18:32
Group 1 - The company held its second extraordinary general meeting of shareholders in 2025, with no resolutions being rejected [2][3] - The meeting was conducted in compliance with the Company Law and the company's articles of association, with a total of 2,639,554,073 shares eligible for voting [2][3] - The meeting was attended by 8 out of 11 directors, including the chairman and CEO, while 3 directors were absent due to other commitments [3] Group 2 - The company announced that its subsidiary, Suzhou Er Ye Pharmaceutical Co., Ltd., received acceptance for its drug registration application for Heparin Sodium Injection from the National Medical Products Administration [8] - The drug is intended for various medical uses, including the prevention and treatment of venous thromboembolism and anticoagulation during surgeries [9][10] - As of October 2025, the cumulative R&D investment for this drug was approximately RMB 8.61 million, with projected sales in China for 2024 estimated at RMB 1.386 billion [10] Group 3 - The company’s subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., received acceptance for its drug registration application for HLX14, a biosimilar of Denosumab [13] - HLX14 has been approved in the US and EU, with a cumulative R&D investment of approximately RMB 320 million as of the announcement date [15] - Global sales for Denosumab products are projected to be around USD 7.463 billion in 2024 [16] Group 4 - The company is involved in a private equity investment fund, the Dalian Star Future Fund, which focuses on investing in early-stage medical technology companies [20] - A recent agreement was made for a transfer of partnership shares within the fund, maintaining the company's shareholding percentage at 51% [21][23] - The new partner, Dalian Jinyun, has no prior relationship with the company and does not hold any shares in it [24]
复星医药:控股子公司地舒单抗生物类似药HLX14获国家药监局受理
Hua Er Jie Jian Wen· 2025-12-02 15:17
Core Points - The subsidiary of Fosun Pharma, Fuhong Hanlin, has received acceptance for the drug registration application of the biosimilar HLX14, a drug similar to Dexamethasone, by the National Medical Products Administration [1] - The application is classified as a Class 3.3 therapeutic biological product, with indications based on all approved indications of the reference drug Prolia in China [1] Product Information - HLX14 has been approved for marketing in the United States, European Union, and the United Kingdom, covering all indications of the original product [1] - The application for marketing registration was accepted by Health Canada in September 2024 [1] - Cumulative R&D investment is approximately 320 million yuan (unaudited) as of October 2025 [1] Market Outlook - According to IQVIA data, the global sales of Dexamethasone products are projected to be approximately 7.463 billion USD in 2024 [1]
复宏汉霖(02696):地舒单抗生物类似药HLX14的上市注册申请获国家药品监督管理局受理
Zhi Tong Cai Jing· 2025-12-02 10:53
本次HLX14的上市注册申请(NDA)主要基于HLX14对比其参照药(Prolia)产生的数据,包括分析相似性研 究、非临床和临床比对研究。这些数据都充分证明了HLX14与其参照药在质量、安全性和有效性方面 的高度相似。 HLX14是本集团自主研发的地舒单抗生物类似药,2025年下半年,HLX14两个产品(美国及欧洲商品 名:BILDYOS以及BILPREVDA)分别于美国、欧盟及英国批准上市,获批适应症覆盖其原研产品(Prolia 与XGEVA)于当地已获批的所有适应症。2024年9月,HLX14的上市注册申请(NDSs)获加拿大卫生部 (Health Canada)受理。 根据IQVIA MIDASTM的最新数据(由IQVIA提供,IQVIA是全球医药健康产业专业信息和战略咨询服务 提供商),2024年度,地舒单抗产品于全球范围内的销售额约为74.63亿美元。 (原标题:复宏汉霖(02696):地舒单抗生物类似药HLX14的上市注册申请获国家药品监督管理局受 理) 智通财经APP讯,复宏汉霖(02696)发布公告,近日,本集团自主研发的地舒单抗生物类似药HLX14(重 组抗RANKL全人单克隆抗体注射液) ...
复星医药子公司地舒单抗生物类似药HLX14药品注册申请获受理
Bei Jing Shang Bao· 2025-12-02 10:36
北京商报讯(记者 丁宁)12月2日晚间,复星医药(600196)发布公告称,公司控股子公司上海复宏汉 霖生物技术股份有限公司及其控股子公司自主研发的地舒单抗生物类似药HLX14(即重组抗RANKL全 人单克隆抗体注射液)的药品注册申请获国家药品监督管理局受理。本次申报适应症为其参照药普罗力 (英文商品名:Prolia)于中国境内1已获批上市的所有适应症。 ...
复宏汉霖(02696) - 自愿公告 - 地舒单抗生物类似药HLX14(重组抗RANKL全人单克隆抗...
2025-12-02 10:32
A. 緒言 本公告由上海復宏漢霖生物技術股份有限公司(「本公司」,連同其附屬公司 統稱「本集團」)自願作出,以告知本公司股東及潛在投資者本公司最新業務 更新。 本公司董事會(「董事會」)欣然宣佈,近日,本集團自主研發的地舒單抗生物 類似藥HLX14(重組抗RANKL全人單克隆抗體注射液)(「HLX14」)的上市註 冊申請(NDA)獲國家藥品監督管理局(NMPA)藥品審評中心受理。本次上市 註冊申請(NDA)涉及其參照藥普羅力® (英文商品名:Prolia®)於中國境內(不 包括港澳台地區,下同)已獲批上市的所有適應症,包括:用於骨折高風險 的絕經後婦女的骨質疏鬆症;在絕經後婦女中,本品可顯著降低椎體、非椎 體和髖部骨折的風險;用於骨折高風險的男性骨質疏鬆症;及用於骨折高風 險的糖皮質激素誘導的骨質疏鬆症。 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責,對其準確性 或完整性亦不發表任何聲明,並明確表示概不就因本公告全部或任何部分內容而產生或因倚賴 該等內容而引致的任何損失承擔任何責任。 Shanghai Henlius Biotech, Inc. 上海復宏漢霖生物技術股份有限公司 (於 ...
欧加隆中国总裁吴泽发:坚定“立中国,惠中国,益世界”,将继续加大在中国的投资
Zhong Guo Xin Wen Wang· 2025-10-30 07:01
Core Insights - The company, Eurofins, emphasizes its commitment to the Chinese market with the guiding principle of "Establishing China, Benefiting China, and Enriching the World" [1][10] - Eurofins has been actively participating in the China International Import Expo (CIIE) for four consecutive years, viewing it as a vital platform for connecting with potential partners and expanding collaboration [2][10] - The company is focusing on increasing investments in China, particularly in innovative drug development and local partnerships to enhance its product pipeline [3][5][10] Investment Strategy - Eurofins plans to deepen its exploration of early-stage innovative drug assets in China, recognizing the high value of Chinese innovation in the pharmaceutical sector [2][5] - The company has already established a collaboration project and is actively seeking local partners in nine therapeutic areas to drive commercialization in the Chinese market [3][5] Product Development - Eurofins is set to launch a new lipid-lowering combination drug in China by July 2024, further expanding its product offerings in the cardiovascular health sector [6][10] - The company has a strong historical presence in lipid management, having introduced several first-in-class products to address unmet medical needs in this area [6][7] Market Challenges - Despite high awareness of hypertension and diabetes, awareness of dyslipidemia remains low in China, with only 11.7% of adults aware of their lipid levels, leading to a significant treatment gap [7][10] - Eurofins is working to improve the accessibility of quality products through collaborations with various healthcare institutions and enhancing the capabilities of healthcare professionals [7][9] Future Outlook - The company aims to explore more collaborations in areas affecting family health, including women's health and chronic diseases, while adapting to the evolving Chinese market [10] - Eurofins is committed to leveraging the CIIE as a key platform to showcase its health solutions and contribute to the high-quality development of China's population [10]
复宏汉霖绩后涨超7%再创新高 国际化战略持续推进 上半年海外产品利润实现超2倍增长
Zhi Tong Cai Jing· 2025-08-26 02:10
Core Viewpoint - The company Fuhong Hanlin (02696) experienced a significant stock price increase of over 7%, reaching a historical high of 85.95 HKD following the release of its interim results, indicating positive market sentiment towards its performance and growth prospects [1] Financial Performance - For the first half of the year, the company reported revenue of 2.82 billion RMB, representing a year-on-year increase of 2.67% [1] - Gross profit reached 2.199 billion RMB, showing a year-on-year growth of 10.47% [1] - Shareholder profit attributable to the company was 390 million RMB, reflecting a slight increase of 0.99% year-on-year [1] International Expansion - The company's overseas product sales generated approximately 40.6 million RMB, with profits from these products more than doubling compared to the same period last year, driven by the company's internationalization strategy and increased sales in the U.S. market [1] - In February, the company's Hanshu Zhuang joint chemotherapy for extensive-stage small cell lung cancer (ES-SCLC) was approved for marketing in the EU, marking the second product approved in this market, showcasing international recognition of the company's innovative products [1] - In July, the biosimilar HLX14 (recombinant anti-RANKL fully human monoclonal antibody injection) received a positive review from the European Medicines Agency (EMA), paving the way for its market entry in Europe [1]