TCR - T细胞治疗
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ST香雪:目前整体经营情况正常 创新药研发取得新突破
Zhong Zheng Wang· 2026-01-30 12:02
在面临短期经营挑战的同时,ST香雪在创新药研发领域持续取得重要进展。近日,公司公告披露 控股子公司香雪生命科学技术(广东)有限公司研发的TCR-T细胞治疗产品"XLS-103注射液"获批临 床,用于治疗基因型为HLA-A*11:01,肿瘤新生抗原KRAS G12V突变阳性的晚期非小细胞肺癌和晚期 胰腺癌。这是香雪生命科学基于现有TCR-T细胞治疗核心技术和研发平台获得的第六个和第七个临床试 验批件。 中证报中证网讯(记者 傅苏颖)1月30日晚间,ST香雪发布2025年年度业绩预告称,公司预计2025 年归母净利润亏损6.35亿元至9.34亿元。业绩变动主要受市场竞争加剧、流动性危机、财务费用高企及 资产减值等因素影响。公司目前整体经营情况正常,将继续努力提升盈利能力,实现可持续的稳健经 营。 根据公司近期披露公告,香雪生命科学已形成覆盖抗原肽发现、TCR亲和力优化、全流程开发的平 台体系,旗下三款TCR-T产品(TAEST16001、TAEST1901和XLS-103)适应症涉及软组织肉瘤、食管 癌、肝癌、胃癌等多类实体瘤。 ...
ST香雪(300147.SZ):XLS-103注射液获得药物临床试验批准
智通财经网· 2025-12-23 10:45
Core Viewpoint - ST Xiangxue's subsidiary, Xiangxue Life Science, has received clinical trial approval for its new drug XLS-103 injection from the National Medical Products Administration, marking a significant milestone in its TCR T-cell therapy development [1] Group 1 - Xiangxue Life Science has obtained two clinical trial approval notices for XLS-103 injection, with notification numbers 2025LP03514 and 2025LP03515 [1] - The approval of XLS-103 injection is the sixth and seventh clinical trial notices related to TCR-T products developed by Xiangxue Life Science [1]
ST香雪:XLS-103注射液获得药物临床试验批准
Mei Ri Jing Ji Xin Wen· 2025-12-23 10:10
Core Viewpoint - ST Xiangxue announced that its subsidiary, Xiangxue Life Sciences, received clinical trial approval for the new drug XLS-103 injection, aimed at treating advanced non-small cell lung cancer and advanced pancreatic cancer with specific genetic mutations [1] Group 1 - The new drug is intended for patients with the HLA-A*11:01 genotype and KRAS G12V mutation [1] - This marks the sixth and seventh clinical trial notifications for TCR-T products obtained by Xiangxue Life Sciences based on its existing TCR-T cell therapy technology and R&D platform [1] Group 2 - The R&D of new drugs is characterized by long cycles, significant investment, high risks, and high added value [1] - The process involves many unpredictable factors, including technical and process challenges, leading to uncertainties in clinical trial progress and results [1]
ST香雪:预重整进程稳步推进,子公司已获5个TCR-T产品IND批件
Zheng Quan Shi Bao Wang· 2025-08-27 12:20
Group 1 - The company reported a net loss of 234 million yuan in the first half of 2025, with total revenue of 818 million yuan, impacted by underperformance in traditional Chinese medicine sales, high financial costs, heavy asset burdens, and impairment provisions [1] - The company is focusing on R&D as a breakthrough point, particularly in the development of TCR-T products, which may help transition from traditional Chinese medicine to innovative pharmaceuticals, establishing a new competitive advantage in R&D [1] - TCR-T therapy, which modifies patients' T cells to target and kill tumor cells, shows better potential in efficacy and safety compared to the more familiar CAR-T therapy [1] Group 2 - The company’s subsidiary, Xiangxue Life Sciences, has received five clinical trial notifications for TCR-T products, with TAEST16001 injection approved for three indications: advanced soft tissue sarcoma, advanced esophageal cancer, and advanced non-small cell lung cancer [2] - The company has established a leading-edge biopharmaceutical R&D base and a complete TCR-T technology platform and process [2] - Traditional Chinese medicine products still hold significant brand and product advantages, with Xiangxue antiviral oral liquid being the first in the country to complete randomized double-blind placebo-controlled clinical research for cold symptoms [2] Group 3 - The company is currently progressing steadily in its pre-restructuring process, with auditing and evaluation work proceeding smoothly [3] - Entering the pre-restructuring program facilitates early communication with creditors and potential investors, allowing the company to gather feedback and develop a feasible restructuring plan [3] - The company will continue to manage daily operations actively, regardless of whether it enters the restructuring process [3]