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ST香雪:公司重视TAEST16001的临床价值与市场潜力 正全力推进确证性临床试验筹备阶段的工作
Mei Ri Jing Ji Xin Wen· 2025-11-14 04:50
Group 1 - The company emphasizes the clinical value and market potential of TAEST16001 and is actively advancing the preparatory phase for confirmatory clinical trials [1] - The company has previously disclosed progress in the new drug development stage and will continue to announce updates based on clinical situations in accordance with information disclosure rules [1] - Investors have raised concerns regarding the lack of transparency about the enrollment status of the confirmatory clinical trial, questioning why the company has not provided clear updates [3] Group 2 - The company has received recognition from the CDE for the confirmatory clinical trial plan for TAEST16001, but has not publicly disclosed whether the first patient has been enrolled [3] - Investors are demanding clarity on the enrollment status, indicating that this is a core asset and they have the right to be informed [3]
ST香雪:公司重视TAEST16001的临床价值与市场潜力,正全力推进确证性临床试验筹备阶段的工作
Mei Ri Jing Ji Xin Wen· 2025-11-14 04:45
Core Viewpoint - The company is under scrutiny from investors regarding the status of its clinical trial for TAEST16001, with concerns about transparency in communication and adherence to disclosure rules [1] Group 1: Company Response - The company emphasizes the importance of TAEST16001's clinical value and market potential, stating that it is fully committed to advancing the preparatory phase of the confirmatory clinical trial [1] - The company has previously disclosed progress in the new drug development phase and will continue to provide updates based on clinical developments in accordance with information disclosure regulations [1]
ST香雪:投资者询问TAEST16001入组进度,董秘称看公告
Xin Lang Cai Jing· 2025-10-24 13:01
Core Viewpoint - The company is preparing to enter the confirmatory clinical trial phase for its drug TAEST16001, which has already received approval from the CDE and has undergone expert discussions, indicating readiness for patient enrollment [1] Group 1: Clinical Trial Progress - The company has confirmed that TAEST16001 is set to enter the confirmatory clinical trial phase [1] - The chairman previously mentioned the goal of entering this phase soon, highlighting the urgency of the timeline [1] - The company is aware of the importance of enrollment progress for pipeline advancement, especially in light of ADAP's recent delisting due to insufficient R&D efficiency [1] Group 2: Information Disclosure - The company will disclose the progress of new drug development according to information disclosure rules and actual circumstances through official announcements [1] - Investors are encouraged to pay attention to the company's announcements for updates on enrollment timelines and current progress [1]
ST香雪:行政处罚决定书落地,重整相关工作正顺利进行
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]
ST香雪:公司高度重视TAEST16001的临床价值与市场潜力,正全力推进确证性临床试验筹备阶段工作
Mei Ri Jing Ji Xin Wen· 2025-07-31 09:27
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].
ST香雪:TAEST16001临床试验已明确肿瘤抗原表达检测标准
Jin Rong Jie· 2025-07-31 04:51
Core Viewpoint - The company confirmed that the clinical trial protocol for TAEST16001 includes clear standards for tumor antigen expression detection in target patients, but does not utilize organoid models for patient screening or efficacy validation [1] Group 1 - The clinical trial for TAEST16001 is a TCR-T cell therapy targeting tumor antigens [1] - The company has established specific criteria for detecting tumor antigen expression in patients during the Phase II clinical trial [1] - No organoid models or similar technologies are employed for patient selection or efficacy validation in the related studies [1]
香雪制药:新药获批开展确证性临床试验
Core Viewpoint - The clinical trial for TAEST16001, a groundbreaking TCR-T cell therapy for advanced soft tissue sarcoma, has received official recognition from China's CDE, marking a significant milestone in the field of immunotherapy in China [1][2]. Group 1: Clinical Trial Details - The expert seminar for the confirmatory clinical trial of TAEST16001 was held in Guangzhou, with participation from key stakeholders including principal investigators and investment partners [1]. - TAEST16001 has shown promising results in exploratory Phase II clinical trials, with an objective response rate (ORR) of 62.5% and a median progression-free survival (mPFS) of 5.9 months [3]. - The Phase I trial involved 12 patients with advanced soft tissue sarcoma, showing a good tolerance profile and an ORR of 41.7% [2]. Group 2: Product Significance - TAEST16001 is the first TCR-T cell therapy in China to be included in the breakthrough therapy list by the CDE, representing a significant advancement in the treatment of advanced solid tumors [2]. - The therapy utilizes engineered T cells to target tumor antigens, creating a "cell missile" effect for enhanced tumor destruction [2]. - The successful organization of the expert seminar is expected to facilitate the smooth progress of the confirmatory clinical trial and expedite the product's market launch [3].