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科济药业美国临床试验暂停已被FDA解除

The clinical trial suspension of Keji Pharmaceutical in the USA has been lifted by the FDA.

PR Newswire ·  Nov 1, 2024 09:16

shanghai, November 1, 2024 / USA Today / -- Koji Pharma (Stock Code: 2171.HK), a company mainly focused on innovative CAR-T cell therapy for treating hematologic malignancies and solid tumors, announced that the Food and Drug Administration ("FDA") has lifted the clinical trial suspensions in the United States for zevor-cel injection (zevor-cel, CT053, an autologous CAR-T cell product targeting BCMA), satri-cel injection (satri-cel, CT041, an autologous CAR-T cell product targeting Claudin18.2), and CT071 (an autologous CAR-T cell product targeting GPRC5D).

About Koji Pharmaceuticals

SciClone Pharmaceuticals (stock code: 2171.HK) is a biopharmaceutical company with business in China and the USA, primarily focused on innovative CAR-T cell therapies for the treatment of hematological malignant tumors and solid tumors. The company has established a CAR-T cell research and development platform ranging from target discovery and innovative CAR-T cell development, clinical trials, and commercial-scale production. The company aims to address major challenges facing current CAR-T cell therapies, such as improving safety, increasing efficacy in treating solid tumors, and reducing treatment costs, by independently developing new technologies and possessing a global product pipeline. The mission of SciClone Pharmaceuticals is to become a global leader in the biopharmaceutical field, providing innovative and differentiated cell therapies to cancer patients worldwide and enabling cancer to be cured.

Forward-looking statements

All statements in this press release that are not historical facts or are irrelevant to current facts or conditions are forward-looking statements. Such forward-looking statements express the current views, forecasts, beliefs, and expectations of the Group as of the date of this press release regarding future events. These forward-looking statements are based on assumptions and factors beyond the Group's control. Therefore, they are subject to significant risks and uncertainties, and actual events or results may differ materially from these forward-looking statements, and the forward-looking events discussed in this press release may not occur. These risks and uncertainties include but are not limited to detailed content under the heading "Major Risks and Uncertainties" in our recent annual reports, interim reports, and other announcements and reports posted on our company's website. We make no representations or warranties regarding the realization or reasonableness of any forecasts, targets, estimates, or predictions in this press release.

Contact SciClone Pharmaceuticals

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