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突破性医疗器械认定
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微创脑科学(02172) - 自愿性公告 - APOLLO Dream雷帕霉素靶向洗脱支架系统荣获美...
2026-03-18 09:16
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。 MicroPort NeuroScientic Corporation 微創腦科學有限公司 與傳統藥物支架相比,APOLLO Dream®支架系統能夠更加精準地控制藥物釋放 劑量,在保證療效的同時顯著降低進入人體的總藥物負荷。其藥物塗層採用可 降解材料,在完成藥物釋放後逐步降解,有助於降低遠期血栓形成風險。 – 1 – 突破性醫療器械認定旨在授予針對嚴重威脅生命或導致不可逆功能損害之疾 病而開發,且具有潛在顯著臨床優勢的創新醫療技術。APOLLO Dream®支架系 統是全球首個獲得該項認定的神經介入領域球囊擴張、快速交換式藥物洗脫 支架,該認定標誌著: 未來,本集團將持續推進APOLLO Dream®支架系統的全球臨床研究及註冊進程, 進一步拓展本公司在神經介入創新治療領域的國際影響力,並為全球患者提 供更加先進的治療選擇。 ( 於 開 曼 群 島 註 冊 成 立 的 有 限 公 司 ) (股份代號: ...
百济神州上半年净利润4.5亿元;AI制药最大BD诞生 | 健讯Daily
Group 1: Policy and Regulatory Developments - The Shanghai regulatory authorities issued 18 measures to promote the high-quality development of commercial health insurance, focusing on expanding coverage to include new medical technologies and services [1] - The National Medical Products Administration is seeking public opinion on the draft guidelines for the quality management of medical device online sales, aiming to standardize inspection practices [2] Group 2: Company Announcements and Developments - Heng Rui Medicine announced that its product, injection of Rui Kang Qu Mo Zhu single antibody, received orphan drug designation from the FDA, which may provide policy support for its development and commercialization [3] - Di Zhe Medicine received Fast Track Designation from the FDA for its innovative drug DZD8586, aimed at treating relapsed refractory chronic lymphocytic leukemia [4] - Tuo Jing Life Sciences' subsidiary obtained two medical device registration certificates for diagnostic kits, enhancing its competitiveness in the in vitro diagnostic field [5] - Sino Medical's subsidiary received breakthrough medical device designation from the FDA for its intracranial drug-coated stent system, marking a significant achievement in domestic neurointerventional devices [6] Group 3: Financial Performance - BeiGene reported a net profit of 450 million yuan for the first half of 2025, marking a turnaround with a 45.8% increase in product revenue [7] - Tian Tan Biology's net profit decreased by 12.88% year-on-year, despite a 9.47% increase in total revenue, attributed to declining product prices and reduced interest income [8] Group 4: Investment Activities - Pian Zai Huang plans to invest 200 million yuan in the Gao Xin Run Xin Fund, which targets a total fundraising goal of 1 billion yuan, reflecting the company's strategy in the health industry [9] Group 5: Industry Collaborations - Jing Tai Technology and DoveTree established a collaboration worth 47 billion HKD for AI drug development, setting a new record in the AI pharmaceutical sector [10] Group 6: Shareholder Actions - Qian Hong Pharmaceutical announced plans for shareholders to reduce their holdings by up to 20.9 million shares, representing 1.63% of the total share capital [11] - Shu Yu Ping Min's controlling shareholder plans to reduce their stake by up to 2%, amounting to 804,730 shares [12]