据了解，TCR-T是一种通过基因工程技术改造患者自身T细胞，使其特异性识别并杀伤肿瘤细胞的免疫 治疗方法，相较于市场更为熟知的CAR-T疗法在有效性及安全性上均显示出更好的潜力。2024年7月， 公司在研1类新药TAEST16001注射液作为国内首个获得IND批准的TCR-T细胞治疗药物，用于晚期软组 织肉瘤适应症治疗已被CDE纳入突破性治疗品种名单。中报披露，该适应症目前已正式进入确证性临床 试验阶段。若产品后续研发顺利开展并获批上市，有望推动我国细胞治疗水平的提升，帮助香雪制药确 立在免疫细胞治疗领域的行业地位。 更进一步，中报披露，目前子公司香雪生命科学已获得五个关于TCR-T产品的《临床试验通知书》，其 中，TAEST16001注射液已获得三个，适应症分别为晚期软组织肉瘤、晚期食管癌、晚期非小细胞肺 癌。TAEST1901注射液获得两个，适应症为原发性肝癌、晚期胃癌。在该领域，公司已搭建起具有国 际领先水平的前沿生物技术医药研发基地和转化平台，建立起TCR-T完整的技术平台及工艺。 与此同时，公司传统中成药产品仍具备产品及品牌优势。中报指出，香雪抗病毒口服液为全国首个完成 上市后感冒症状随机双盲安慰剂 ...

Core Viewpoint - Guangzhou Xiangxue Pharmaceutical Co., Ltd. and its actual controller Wang Yonghui have been penalized for information disclosure violations, with fines totaling 6 million yuan for the company and 10 million yuan for Wang Yonghui [2][3][10] Group 1: Violations and Penalties - The company failed to recognize losses from the demolition of villas in its 2019 annual report, resulting in an inflated profit of 53.83 million yuan, which accounted for 45.98% of the total profit for that year [4] - The actual controller Wang Yonghui received a warning and was fined 10 million yuan, with 3 million yuan as the directly responsible supervisor and 7 million yuan as the actual controller [2][3] - The company was also found to have significant omissions regarding non-operating fund occupation by related parties, amounting to 4.852 billion yuan from 2016 to 2020 [4] Group 2: Background and Investigation - The investigation into Xiangxue Pharmaceutical began on September 30, 2024, when the company and Wang Yonghui received a notice of case filing from the China Securities Regulatory Commission (CSRC) [3] - The violations were traced back to 2016, with the formal administrative penalty decision being disclosed on August 16, 2025, marking the end of the investigation phase [3][4] Group 3: Financial Performance and Market Impact - The company has reported continuous net losses from 2021 to 2024, with projected revenues for 2024 between 1.613 billion yuan and 2.013 billion yuan, and net losses estimated between 600 million yuan and 862 million yuan [6] - Following the penalties, the company's stock was suspended for one day and subsequently resumed trading under a risk warning, changing its name to "ST Xiangxue" [6] Group 4: Industry Context and Regulatory Environment - The case of Xiangxue Pharmaceutical is not isolated, as similar violations have occurred in the industry, highlighting a trend of increased scrutiny and penalties for information disclosure violations [7][10] - The new Securities Law implemented in 2020 has significantly increased the penalties for disclosure violations, with the company facing a fine of 6 million yuan and individual fines reaching up to 10 million yuan [10]

Core Viewpoint - ST Xiangxue (300147.SZ) reported a decline in revenue and profit for 2024, indicating a low point in business operations, but there are positive aspects in business management, new drug development, and corporate governance that may signal future growth opportunities for investors [1][2]. Business Operations - The company's largest revenue segment, traditional Chinese medicine materials, saw a year-on-year revenue increase of 25.69%, reaching 936 million yuan, contributing 280 million yuan in gross profit [1]. - ST Xiangxue has established a comprehensive industrial chain in the traditional Chinese medicine sector, including production and sales, with cultivation bases in regions such as Ningxia, Sichuan, Yunnan, and Guangdong [1]. New Drug Development - The company is advancing its first-class new drug TAEST16001 injection, which has entered the phase II clinical trial and was presented at the ASCO annual meeting [2]. - TAEST16001 is the first TCR-T cell therapy drug in China to receive IND approval, targeting advanced esophageal cancer and non-small cell lung cancer [2]. - The drug has shown a best response rate of 50% and a median progression-free survival of 5.9 months, indicating significant clinical efficacy and manageable safety [2]. Corporate Restructuring - In April, the company entered a pre-restructuring process, with a temporary administrator appointed to manage debt claims and conduct audits and evaluations [3]. - The restructuring plan aims to improve the company's asset-liability structure and enhance its operational and profitability capabilities, facilitating a return to sustainable and high-quality development [3].