Core Viewpoint - ST Xiangxue (300147) has received an administrative penalty decision from the China Securities Regulatory Commission (CSRC) due to information disclosure violations, with some penalties being reduced compared to the prior notice [1] Regulatory Actions - The administrative penalty decision no longer imposes a 5-year market ban on the actual controller Wang Yonghui and removes the warning and 500,000 yuan fine against the former independent director Hao Shiming, while other penalties remain consistent with the prior notice [1] Corporate Restructuring - The Guangzhou Intermediate People's Court has agreed to extend the company's pre-restructuring period until October 11, 2025, during which the company will actively cooperate with the temporary administrator and the court [1] - The company has publicly appointed auditing, evaluation, and financial advisory intermediaries, with the auditing and evaluation work progressing smoothly [1] Business Operations - The company emphasizes the clinical value and market potential of TAEST16001 and is fully advancing the preparatory work for confirmatory clinical trials, with updates to be disclosed according to clinical developments and information disclosure rules [1]

Core Viewpoint - The company emphasizes the clinical value and market potential of its new drug TAEST16001 and is actively advancing the preparatory phase of confirmatory clinical trials [2]. Group 1 - The company is committed to keeping investors informed about the clinical progress of TAEST16001 and the status of its pre-restructuring efforts [2]. - The company plans to disclose updates regarding the new drug development and pre-restructuring progress in accordance with information disclosure regulations [2]. - Investors are encouraged to pay attention to the company's announcements for further details [2].

公司回答表示：您好，感谢对公司的关注。TAEST16001的临床试验方案中有明确目标患者的肿瘤抗原 表达检测标准。在相关研究中并未采用类器官模型等技术进行患者筛选或药效验证。谢谢！责任编辑： 栎树 金融界7月31日消息，有投资者在互动平台向ST香雪提问：根据公开资料，TAEST16001是TCR-T细胞 疗法，需针对肿瘤抗原设计。请问在II期临床试验中，是否已明确目标患者的肿瘤抗原表达检测标准？ 针对软组织肉瘤的异质性，是否采用类器官模型等技术进行患者筛选或药效验证？ ...

2025年3月30日，由广州市香雪制药股份有限公司（简称：香雪制药）的控股子公司香雪生命科学技术 （广东）有限公司（简称"香雪生命科学"）作为申办方，北京大学肿瘤医院、中山大学肿瘤防治中心作 为组长单位的TAEST16001治疗晚期软组织肉瘤的确证性临床试验方案专家研讨会在广州召开。参与该 产品I、II期临床试验的PI、投资机构负责人及研究合作伙伴等出席了本次会议。 本报讯 （记者矫月） 香雪生命科学CEO曾仑表示，TAEST16001作为具有突破性和颠覆性的创新药品被国家药品监督管理局 药品审评中心（简称：CDE）纳入突破性治疗药物名单，是中国TCR-T细胞治疗领域的里程碑事件，标 志着其疗效获得CDE的官方认可。 业内人士认为，TAEST16001作为中国首个获批开展确证性临床试验的TCR-T细胞治疗产品，可加快推 进该药成为中国第一款上市的TCR-T细胞治疗药物，对中国免疫细胞治疗创新药的发展具有重要意义。 香雪制药董事长王永辉在致辞时表示：香雪生命科学自主研发的TAEST16001作为中国首个被CDE纳入 突破性治疗名单TCR-T细胞治疗药物，其在探索性II期临床试验中显示了良好的临床疗效，为治疗晚期 ...