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一周医药速览(07.07-07.11)
Cai Jing Wang· 2025-07-11 08:29
济川药业:"小儿便通颗粒"获上市许可受理,当前临床尚无治疗小儿便秘的儿童专用中药创新药 济川药业发布关于收到药品注册申请受理通知书的公告。披露全资子公司济川药业集团有限公司收到国家药品监督管 理局签发的"小儿便通颗粒"申报上市许可的《受理通知书》。目前,市场上可用于小儿便秘的同类产品主要用于其他 疾病伴发的便秘症状,临床尚无治疗小儿便秘的儿童专用中药创新药。该产品有望成为指导原则《小儿便秘中药新药 临床研发技术指导原则(试行)》(2024年)发布后的首个用于小儿便秘的中药1.1类儿童专用药。 信达生物官方公众号发布消息。披露首款中国企业自主研发的KRAS G12C抑制剂达伯特®(氟泽雷塞片,Fulzerasib) 已正式获得中国澳门特别行政区药品监管部门批准上市,成为澳门首个获批的中国自主研发KRAS G12C抑制剂,为澳 门KRAS G12C突变型晚期非小细胞肺癌(NSCLC)患者带来全新精准靶向治疗方案。推文介绍,信达生物旗下创新 药物达伯特®,针对携带KRAS G12C基因突变的晚期非小细胞肺癌患者,能够特异性抑制致癌KRAS G12C蛋白,阻断 肿瘤细胞增殖信号,填补了传统治疗手段疗效有限的临床空白。 ...
今年医保目录调整工作方案公布;亚盛医药拿下全球第二个Bcl-2抑制剂 | 医药早参
Mei Ri Jing Ji Xin Wen· 2025-07-10 23:21
每经记者|林姿辰 每经编辑|文多 丨 2025年7月11日 星期五 丨 NO.1 国家医保局公布2025年医保目录调整工作方案 7月10日,国家医保局正式发布《2025年国家基本医疗保险、生育保险和工伤保险药品目录及商业健康 保险创新药品目录调整工作方案》《2025年国家基本医疗保险、生育保险和工伤保险药品目录及商业健 康保险创新药品目录调整申报指南》等文件。此前,今年将新增商保创新药目录一事曾备受关注。 点评:主营业务与非经常性损益共同推动业绩提升,表明公司在全球医药市场竞争力持续增强,业务拓 展与运营效率显著提升。这一业绩将增强投资者信心,提升估值预期,为股价上涨提供有力支撑,进一 步巩固其在行业内的龙头地位,吸引更多长期资金关注。 NO.3 亚盛医药拿下全球第二个Bcl-2抑制剂 7月10日,亚盛医药披露,公司自主研发的新型"B淋巴细胞瘤-2基因"(Bcl-2)选择性抑制剂"利生妥"获 附条件批准上市,用于既往经过至少包含布鲁顿氏酪氨酸激酶(BTK)抑制剂在内的一种系统治疗的成 人慢性淋巴细胞白血病/小淋巴细胞淋巴瘤(CLL/SLL)患者。它成为中国首个上市用于治疗CLL/SLL 的Bcl-2抑制剂,也 ...
港股公告掘金 | 迅销公布前三季度业绩 母公司拥有人应占溢利3390.99亿日圆 同比增长8.4%
Zhi Tong Cai Jing· 2025-07-10 15:11
Major Events - QianShi International (00381) subsidiary FuLao Investment signed a memorandum of understanding with Yanji Municipal Government for potential cooperation in digital economy-related businesses in Hong Kong [1] - Stone Pharmaceutical Group (02005) obtained production registration approval for potassium chloride and sodium chloride injection (500ml and 250ml) [1] - Basilea Pharmaceutica (02616) received approval from the National Medical Products Administration for the domestic production registration application of Prujita® (Pralsetinib capsules) [1] - United BioPharma (03933) received FDA approval for new drug clinical trials for UBT37034 injection [1] - China National Pharmaceutical Group (01177) had the application for the new indication of Kumosil capsules for first-line treatment of breast cancer accepted [1] - Oceanwide Holdings (08476) applied to the Stock Exchange for a transfer listing to the main board [1] Financial Data - Kaison Holdings (00102) reported a loss attributable to shareholders of approximately HKD 740 million for 2023, a shift from profit to loss year-on-year [1] - JiaoGe Friends Holdings (01450) achieved a cumulative GMV of approximately CNY 6.98 billion in the first half of the year, a year-on-year increase of approximately 17.11% [1] - Sunny Optical Technology (02382) reported a smartphone lens shipment of approximately 95.056 million units in June, a month-on-month decrease of 3.1% and a year-on-year decrease of 12.7% [1] - Fast Retailing (06288) announced a profit attributable to the parent company of JPY 339.099 billion for the first three quarters, a year-on-year increase of 8.4% [1] - Jianye Real Estate (00832) reported a total property contract sales of CNY 4.44 billion in the first half of the year, a year-on-year decrease of 1.2% [1] - China Lilang (01234) reported a mid-to-high single-digit year-on-year growth in retail sales of "LILANZ" products in the first half of the year [1]