Zhongxin Jingwei, December 13 (Luo Kun, Wang Yuling) After the opening of the market on the 13th, the Hong Kong-listed company CARsgen Pharmaceutical plunged rapidly, falling 3326%。As of press time, the share was 672 Hong Kong dollars, down 2881%。
On the news side, CARsgen announced on the evening of the 12th Beijing time that the company's subsidiary in the United States, Carsgen Therapeutics Corporation, received a notice from the U.S. Food and Drug Administration (FDA) on the evening of December 11, Beijing time, requesting the suspension of clinical trials of CT053, CT041 and CT071, waiting for the conclusion reached after inspection at the production base in Durham, North Carolina.
Zhongxin Jingwei noticed that on the 12th, the share price of CARsgen was slightly **.
According to CARsgen's official website, CT053 is an autologous BCMA CAR-T cell product candidate for refractory multiple myeloma, and CT041 is a target CLDN18 for gastric cancer, pancreatic cancer and other solid tumors2 autologous CAR-T cell product candidates. Previously, its official website said that CT041 was the world's first solid tumor CAR-T product candidate to enter confirmatory clinical trials.
The announcement also said that the company will conduct a comprehensive review and improvement of the current Good Manufacturing Practice (CGMP) and is committed to working closely with the FDA to resolve the issues identified in the inspection to ensure the smooth progress of clinical trials and marketing applications and high-quality manufacturing.
On the 13th, the relevant person in charge of CARsgen responded to Zhongxin Jingwei that (the FDA's above-mentioned notice) is not for the company's products, but mainly to put forward some places that need to be optimized by the US factory. "We are confident that we will complete (optimization) soon, provide the rectification plan to the FDA, and then maintain communication with the FDA and implement the rectification. The above-mentioned person said.
According to public information, CARsgen is a biopharmaceutical company with operations in China and the United States, mainly focusing on innovative chimeric antigen receptor T cells (CAR-T) for solid tumors and hematologic malignancies**CARsgen was listed in Hong Kong in June 2021. According to the 2023 interim report, CARsgen lost 40.4 billion yuan, with an adjusted net loss of 38.6 billion yuan. (For more reporting clues, please contact the author of this article, Luo Kun: luokun@chinanews.)com.CN) (China-Singapore Jingwei APP).
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