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医药生物行业周报(12月第3周):病理业务发展进入快车道-20251222
Century Securities· 2025-12-22 14:46
Investment Rating - The report does not explicitly state an investment rating for the industry [2]. Core Insights - The pathology business is entering a fast track with the National Healthcare Security Administration issuing guidelines for pricing projects in pathology services, focusing on biopsy sampling, sample processing, and digitalization of pathology data, which is expected to enhance the application of AI in the field [3][11]. - The influenza activity has peaked across the board, with reported cases in southern provinces at 9.7%, down from 11.2% the previous week, but higher than the same period in previous years [3][11]. Market Weekly Review - The pharmaceutical and biotechnology sector fell by 0.14% from December 15 to December 19, outperforming the Wind All A index (-0.15%) and the CSI 300 index (-0.28%). The rebound was weak, with segments like pharmaceutical distribution (5.59%), offline pharmacies (4.69%), and hospitals (4.15%) leading gains, while chemical preparations (-2.1%), vaccines (-0.87%), and medical R&D outsourcing (-0.87%) lagged [3][8]. - Notable stock performances included Huaren Health (55.9%), Luyuan Pharmaceutical (36.8%), and Shuyupingmin (35.7%) with significant gains, while *ST Changyao (-24%), Yipinhong (-23.7%), and Rejing Biology (-16.5%) faced substantial declines [3][11]. Industry News and Key Company Announcements - The National Healthcare Security Administration's guidelines for pathology services are expected to drive high-quality development in the sector and create new scenarios for AI-assisted technology applications [11]. - Significant collaborations and approvals were reported, including Shanghai Jinmante's partnership with Jiangsu Kangning Jerey for a breakthrough therapy designation from the FDA for JSKN003, and Novo Nordisk's submission of a marketing application for CagriSema, which showed a weight loss of 22.7% over 68 weeks in clinical trials [12][13]. - Fosun Pharma's subsidiary received FDA approval to initiate a Phase I clinical trial for HLX18, a biosimilar to Nivolumab, targeting various cancers [13][14].
复星医药(02196.HK)控股子公司药品获美国FDA临床试验批准
Ge Long Hui· 2025-12-19 10:01
HLX18是集团(即公司及控股子公司/单位)自主研发的纳武利尤单抗生物类似药,拟用于黑色素瘤、非小 细胞肺癌、恶性胸膜间皮瘤、肾细胞癌、经典型霍奇金淋巴瘤、头颈部鳞状细胞癌、尿路上皮癌、胃 癌、胃食管连接部癌或食管腺癌、食管癌、结直肠癌、肝细胞癌等原研药已获批的适应症。 截至2025年11月,集团(即公司及控股子公司/单位)现阶段针对HLX18的累计研发投入约为人民币5,253 万元(未经审计)。根据IQVIAMIDAS最新数据1,2024年,纳武利尤单抗于全球范围的销售额约为111亿 美元。 格隆汇12月19日丨复星医药(02196.HK)公告,近日,上海复星医药(集团)股份有限公司(以下简称"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(以下合称"复宏汉霖")获美国 FDA(即美国食品药品监督管理局)批准开展HLX18(即重组抗PD-1人源化单克隆抗体注射液)用于治疗多 种实体瘤的I期临床试验。复宏汉霖拟于条件具备后于美国开展该药品的I期临床试验。 ...