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On January 15, 2024, according to the announcement on the CDE official website, Biotheus' third globally pioneering exclusive product pipeline, BRL03 Injection, received approval for new drug clinical trials for the treatment of various advanced solid tumors, including lung cancer and gastric cancer.
September 9th last year,The U.S. FDA Approved the Phase I/II Clinical Trial Application for BRL03(Original link), the NMPA IND application for BRL03 injection has been approved, marking that Biotheus has officially obtained the IND clinical approval for its 7th globally first-in-class product. As the first TCR-T product independently developed by Biotheus to enter clinical trials, IIT studies have shown that BRL03 injection demonstrates good safety and preliminary efficacy in the treatment of solid tumors.In addition, Biotheus’ nasopharyngeal carcinoma and EBV-positive lymphoma pipelines have entered the global Phase I clinical trial stage, with the nasopharyngeal carcinoma indication having completed Phase I clinical enrollment.The IDENTIFIER®自主创新技术平台 of 百吉生物 provides robust support for the discovery and identification of antigens, antibodies, and TCRs. Utilizing a database of TCRs and tumor proteomes from thousands of individuals, 百吉生物 can screen and optimize suitable development assets for various therapeutic needs within two weeks. Through this platform, 百吉生物 identifies TCRs with broad applicability, high specificity, and affinity against multiple solid tumors. Additionally, based on another self-developed platform, MSE-T, BRL03 incorporates additional functional module components that make T cells less prone to exhaustion in the solid tumor microenvironment, thereby exerting more sustained tumor-suppressing efficacy.Biotheus will continue to focus on meeting the unmet clinical needs of patients and providing the best treatment options for cancer patients worldwide.Bioheng is an innovative pharmaceutical company focusing on immune cell therapy with international competitiveness. It brings together top scientific research talents from six countries, and 80% of the Ph.D. research team graduated from universities ranked in the top 50 globally. The company owns the largest private GMP cell production and R&D base in South China located in Guangzhou, as well as the largest private one in Singapore.Globally, there are nearly 20 million new cancer patients each year, of which 90% are patients with solid tumors. The company has four groundbreaking products that have received clinical trial approval from both the Chinese and American drug regulatory authorities. These products are expected to complete clinical trials and enter the market between 2024 and 2026, covering solid tumors such as nasopharyngeal cancer, liver cancer, lung cancer, stomach cancer, and colorectal cancer.
Source of the article:Biosyngen
