Biosyngen Secures Seventh Global First-in-Class IND Approval in China for Its Fourth-Generation TCR-T Therapy BRL03 Following FDA Clearance
Biosyngen
Developer of Innovative Immune Cell Technology Products
Biosyngen's World-First Fourth-Generation TCR Pipeline for Lung Cancer and Other Solid Tumors Approved for Clinical Trials by NMPA
On January 15, 2024, according to the announcement on the CDE official website, BioGend Biologics' third globally first-in-class product pipeline, BRL03 Injection, received approval for clinical trials as a new drug. It is intended for the treatment of various advanced solid tumors, including lung cancer and gastric cancer.
On September 9 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 Bio-Gene Biotech has officially obtained the IND clinical approval for its 7th world's first product.As the first TCR-T product independently developed by BioGend to enter clinical trials, IIT studies have shown that BRL03 injection has good safety and preliminary efficacy in the treatment of solid tumors.
In addition,Two pipelines of Baiji Bio for nasopharyngeal carcinoma and EBV-positive lymphoma indications have entered the global Phase I clinical trial stage, with the nasopharyngeal carcinoma indication having completed Phase I clinical enrollment.
Baiji Bio's self-innovative technology platform IDENTIFIER® provides strong support for the discovery and identification of antigens, antibodies, and TCRs.Using a database of TCRs and tumor proteomes from thousands of individuals, Biotheus can screen and optimize suitable development assets for different therapeutic needs within two weeks. Through this platform, Biotheus has identified TCRs with broad applicability, high specificity, and affinity against various solid tumors.In addition, based on another self-developed MSE-T platform, BRL03 also has additional functional module components, making T cells less prone to exhaustion in the solid tumor microenvironment, thereby exerting anti-tumor efficacy more durably.
Biotheus will continue to focus on meeting the unmet clinical needs of patients, providing the best treatment options for cancer patients worldwide.
About BioGevity
Biohundred 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 doctoral research team graduated from universities ranked in the top 50 globally. It owns the largest private GMP cell production and R&D base in South China in Guangzhou, as well as the largest private one in Singapore.
Globally, there are nearly 20 million new cancer patients each year, 90% of whom have 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, gastric cancer, and colorectal cancer.
The company has established long-term and close research cooperation relationships with multiple top domestic and international scientific research institutions and medical institutions, such as the Stanford University School of Medicine in the United States, Gustave Roussy Cancer Center (the largest cancer center in Europe and ranked 4th worldwide) in France, the Agency for Science, Technology and Research (A*STAR) in Singapore, Helmholtz Zentrum München in Munich, Germany, Hannover Medical School in Germany, Queensland Institute of Medical Research in Australia, Sun Yat-sen University Cancer Center in China, and Fudan University Shanghai Cancer Center. The extensive clinical resources cover the globe.
As a benchmark enterprise of Sino-Singapore cooperation, the company has attracted the attention of both governments. In March 2023, Prime Minister Lee Hsien Loong visited Guangzhou, and BioGend was the only biotech company invited to present a report to him. In April 2023, Governor Wang Weizhong led a team to conduct research at BioGend. In July 2023, Secretary Huang Kunming conducted an inspection in Huangpu District, and BioGend attended as one of the representative companies to report its work.
To learn more about BioSyngen, please visit the official website at www.biosyngen.com
Tel: +65 6908 0398 (Singapore); +86 020 6631 1128 (Guangzhou)
Email: info@biosg.com
