Biosyngen announces FDA IND approval of its second product for EBV-positive lymphoma

19 April 2023 | Wednesday | News


Biosyngen Pte Ltd (hereinafter as "Biosyngen") announced that the Company received IND approval for its second product in the pipeline, a T-cell redirection therapy for the treatment of EBV-positive lymphoma. A week prior to this, the IND application of the same therapy has just been approved by China NMPA.
Image Source : Public Domain

Image Source : Public Domain

A few months earlier, the Company's first product (BRG01) targeting relapsed/metastatic nasopharyngeal cancer has been granted IND approval by both the US FDA and China NMPA. Following this IND approval to initiate the phase I/II clinical trials, Biosyngen makes a significant first-step towards the goal to gaining marketing authorization in the US and China. Biosyngen, an innovative biopharmaceutical company, is now the first in the CGT industry to possess dual IND approval from above regulatory bodies for its two products.

At present, Biosyngen's IND application filing to Health Sciences Authority (HSA) is under review. Within 2023, the Company made plans for other IND applications to carry out phase I/II clinical trials for other therapies such as lung cancer, liver cancer and digestive track cancers across key regions – Singapore, the US and China.

Biosyngen broad director & COO, Michelle Chen, "Currently, cell therapy is a key strategy in healthcare development in many countries, including SingaporeChina and the US. It is commonly acknowledged that cell therapy will accelerate human's efforts to better address unconquered diseases to fulfill unmet medical needs and therefore benefit patients around the world".

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