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港股午评|恒生指数早盘涨0.49% 黄金股集体走高
智通财经网· 2025-08-04 04:09
Group 1: Market Overview - The Hang Seng Index rose by 0.49%, gaining 119 points to close at 24,627 points, while the Hang Seng Tech Index increased by 0.93%. The morning trading volume in Hong Kong was HKD 126.5 billion [1] Group 2: Gold Stocks - Gold stocks experienced a collective rise due to weaker-than-expected U.S. non-farm payroll data, which led to a significant rebound in gold prices. Analysts suggest that interest rate cut expectations are supporting gold prices. Lingbao Gold (03330) rose by 4%, Chifeng Jilong Gold (06693) increased by 8.7%, and Shandong Gold (01787) saw an 8.8% rise. Laopu Gold (06181) rebounded by 5.5% after a profit warning, with Morgan Stanley predicting strong performance in the second half of the year [1] Group 3: Semiconductor Stocks - Semiconductor stocks led the gains, driven by regulatory concerns over H20 safety risks and the acceleration of domestic AI computing chip production. Hua Hong Semiconductor (01347) rose by 6.46%, Shanghai Fudan (01385) increased by 5.92%, and SMIC (00981) gained 2.8%. InnoCare Pharma (02577) surged over 12% following a partnership with NVIDIA to promote the large-scale implementation of 800 VDC power architecture in AI data centers [1] Group 4: Healthcare Sector - Zhaoke Ophthalmology-B (06622) rose over 7% after its drug Mephalan received orphan drug designation from the U.S. FDA [2] Group 5: Company Performance - Juxing Legend (06683) increased by 4% as the company launched a collaboration plan with numerous trendy artists and formed a strategic partnership with Yushu Technology. China Shipbuilding Defense (00317) rose by 4.3%, supported by verified profit releases from domestic shipbuilding companies and strong new ship order reserves at Huangpu Wenchong [3] - Xinyi Glass (00868) fell over 3% post-earnings due to a continuous decline in the average selling price of float glass products, resulting in a 59.6% year-on-year drop in mid-term net profit [4] - China Resources Medical (01515) dropped by 15.8% after issuing a profit warning, expecting a year-on-year decline of approximately 20% to 25% in mid-term profit attributable to shareholders [5]
兆科眼科-B盘中涨超9% 兆科眼科美法仑获得美国FDA孤儿药资格认证
Zhi Tong Cai Jing· 2025-08-04 03:12
Core Viewpoint - The company Zhaoke Ophthalmology (06622) has seen a significant stock price increase following the announcement of receiving orphan drug designation (ODD) from the FDA for its proprietary formulation, Mephalan, aimed at treating retinoblastoma in children, which could lead to exclusive market rights in the U.S. for seven years if approved [1] Group 1 - Zhaoke Ophthalmology's stock rose over 9% during trading, with a current increase of 5.59%, reaching HKD 3.02, and a trading volume of HKD 12.43 million [1] - The FDA granted orphan drug designation (ODD) for Mephalan, establishing a clear regulatory pathway for the company to submit a new drug clinical trial application in the U.S. [1] - If Mephalan is successfully developed and approved, the company will enjoy seven years of exclusive rights in the U.S. market post-approval, including data exclusivity and market authorization holder status [1] Group 2 - Zhaoke Ophthalmology recently announced a strategic partnership with FAREVA, a leading French pharmaceutical company, to become a trusted partner for drug manufacturing in China [1] - The memorandum of understanding signed with FAREVA indicates Zhaoke Ophthalmology's role as a recommended partner for FAREVA's clients seeking drug production in China [1]
港股异动 | 兆科眼科-B(06622)盘中涨超9% 兆科眼科美法仑获得美国FDA孤儿药资格认证
智通财经网· 2025-08-04 03:10
消息面上,兆科眼科近日公告,美国食品药品监督管理局(FDA)已向公司拥有专利配方、用于治疗儿 童视网膜母细胞瘤(RB,一种罕见的儿童眼癌)的美法仑授出孤儿药资格认证(ODD)。取得ODD为在 美国提交新药临床试验申请(新药试验申请)建立清晰的监管路径。再者,如果美法仑获成功研发并获批 准,公司将在新药上市申请批准后享有七年美国市场独家权利。此项完善保护涵盖上市许可持有人地位 及数据独家权利,尤其重要的是,即使配方有所创新,FDA亦不得批准任何其他以美法仑为基础的RB 适应症产品。 智通财经APP获悉,兆科眼科-B(06622)盘中涨超9%,截至发稿,涨5.59%,报3.02港元,成交额1243.26 万港元。 值得注意的是,据兆科眼科官微消息,7月15日,公司宣布最近与法国领先医药企业FAREVA达成战略 合作。兆科眼科最近与总部位于法国的全球医药用品、化妆品及家用品委托制造商FAREVA签署了谅解 备忘录。根据该备忘录,兆科眼科将成为FAREVA客户在中国寻求药品生产的值得信任的推荐合作伙 伴。 ...
格隆汇公告精选(港股)︱宁德时代(03750.HK)上半年拥有人应占溢利305.12亿元 同比增长33.02%
Ge Long Hui· 2025-07-30 14:51
Group 1 - Ningde Times (03750.HK) reported a net profit attributable to shareholders of 30.512 billion yuan for the first half of 2025, representing a year-on-year increase of 33.02% [1] - The company's revenue for the same period reached 178.9 billion yuan, showing a year-on-year growth of 7.27% [1] - The basic earnings per share for Ningde Times were 6.92 yuan per share, and the company announced an interim dividend of 10.07 yuan per 10 shares (tax included) [1] Group 2 - In the power battery sector, Ningde Times held a global market share of 38.1% from January to May 2025, an increase of 0.6 percentage points compared to the same period last year [1] - In the energy storage sector, the company ranked first globally in battery production from January to June 2025 [1]
兆科眼科-B:用于治疗儿童视网膜母细胞瘤的美法仑取得美国FDA孤儿药资格认证
Zhi Tong Cai Jing· 2025-07-30 11:58
Core Viewpoint - The company has received Orphan Drug Designation (ODD) from the FDA for its proprietary formulation, Mephalan, aimed at treating retinoblastoma (RB), a rare pediatric eye cancer [1] Group 1 - The ODD provides a clear regulatory pathway for the company to submit a New Drug Application (NDA) in the United States [1] - If Mephalan is successfully developed and approved, the company will enjoy seven years of exclusive market rights in the U.S. following the NDA approval [1] - The exclusivity includes marketing authorization holder (MAH) status and data exclusivity, ensuring that the FDA cannot approve any other RB indication products based on Mephalan, even if the formulation is modified [1]
兆科眼科-B(06622):用于治疗儿童视网膜母细胞瘤的美法仑取得美国FDA孤儿药资格认证
智通财经网· 2025-07-30 11:12
Core Viewpoint - The company, Zhaoke Ophthalmology-B (06622), has received Orphan Drug Designation (ODD) from the FDA for its proprietary formulation, Mephalan, aimed at treating retinoblastoma (RB), a rare childhood eye cancer [1] Regulatory Pathway - Obtaining ODD establishes a clear regulatory pathway for the company to submit a New Drug Application (NDA) in the United States [1] - If Mephalan is successfully developed and approved, the company will enjoy seven years of exclusive market rights in the U.S. following the NDA approval [1] Market Exclusivity - The exclusivity includes marketing authorization holder (MAH) status and data exclusivity rights [1] - Importantly, even if the formulation is innovated, the FDA cannot approve any other RB indication products based on Mephalan [1]
兆科眼科-B(06622.HK):用于治疗儿童视网膜母细胞瘤的美法仑取得美国FDA孤儿药资格认证
Ge Long Hui· 2025-07-30 11:12
Core Viewpoint - The company, Zhaoke Ophthalmology-B (06622.HK), has received Orphan Drug Designation (ODD) from the FDA for its proprietary formulation, Mephalan, aimed at treating retinoblastoma (RB), a rare childhood eye cancer [1] Group 1: Regulatory Approval - The ODD provides a clear regulatory pathway for the company to submit a new drug clinical trial application in the U.S. [1] - If Mephalan is successfully developed and approved, the company will enjoy seven years of exclusive market rights in the U.S. post-approval [1] - The exclusivity includes marketing authorization holder (MAH) status and data exclusivity, preventing the FDA from approving any other RB indication products based on Mephalan, even if the formulation is modified [1] Group 2: Drug Mechanism and Current Use - Mephalan is an alkylating agent that interferes with DNA replication and cell division, blocking the growth and spread of cancer cells [1] - Currently, Mephalan is primarily used as a pre-treatment for autologous hematopoietic stem cell transplantation in multiple myeloma patients or for palliative treatment in cases where oral therapy is not applicable [1]
兆科眼科(06622) - 自愿性公佈-用於治疗儿童视网膜母细胞瘤的美法仑取得美国FDA孤儿药资格认...
2025-07-30 11:05
Zhaoke Ophthalmology Limited (於英屬處女群島註冊成立並於開曼群島存續的有限公司) (股份代號:6622) 兆科眼科有限公司 自 願 性 公 告- 用於治療兒童視網膜母細胞瘤的美法侖 取得美國FDA孤兒藥資格認證 本 公 告 乃 由 兆 科 眼 科 有 限 公 司(「本公司」)董 事 會(「董事會」)自 願 作 出。 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 對 因 本 公 告 全部或任何部份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。 取 得ODD為 在 美 國 提 交 新 藥 臨 床 試 驗 申 請(「新藥試驗申請」)建 立 清 晰 的 監 管 路 徑。再 者,如 果 美 法 侖 獲 成 功 研 發 並 獲 批 准,本 公 司 將 在 新 藥 上 市 申 請(「新 藥 申 請」)批 准 後 享 有 七 年 美 國 市 場 獨 家 權 利。此 項 完 善 保 護 涵 蓋 上 市 許 可 持 有 人 (marketing authoriza ...