Biosyngen Announces FDA Fast Track Designation for BST02 in Treatment of Liver Cancer

Biosyngen is proud to announce that its latest groundbreaking product, BST02, has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of all types of liver cancer, including hepatocellular carcinoma and cholangiocarcinoma.

Fast track is a process designed to facilitate development, and accelerate the review of drugs to treat serious or life-threatening conditions and fill an unmet medical need. This designation is anticipated to expedite the advancement of clinical trials and the registration of pharmaceutical products for marketing purposes.

BST02 has received approval from the FDA for Phase I/II clinical trial in October 2023 and has also been approved by the Center for Drug Evaluation (CDE) of the China National Drug Administration in January, 2024. This marks the first TIL cell therapy drug for liver cancer to progress to the clinical stage globally. Furthermore, another product from Biosyngen, BRG01, was granted fast track designation in July 2023.

Michelle Chen, co-founder and CEO of Biosyngen, expressed gratitude towards the FDA for acknowledging the company's fourth product. She emphasized the company's commitment to advancing cell therapy for cancer globally and providing innovative treatment solutions for diverse patient populations. Michelle reiterated Biosyngen's dedication to leveraging its advanced technology platforms to offer more effective and accessible treatment options for patients worldwide.

BST02, a T cell therapy based on the expansion of the patient's own tumor infiltrating lymphocytes, falls within the category of adoptive immune cell therapy technology. It holds promise for the treatment of all types of liver cancer, offering new hope for patients. In contrast to traditional TIL therapies, BST02 offers numerous benefits, including the ability to overcome distance constraints due to its cryopreserved form and the reduced need for high doses of interleukin-2.

Biosyngen is dedicated to the R&D of innovative pharmaceutical products aimed at addressing unmet clinical need in oncology. Moving forward, Biosyngen intends to maintain its emphasis on conducting research in this domain for the betterment of patients globally.

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!