Belief BioMed (BBM), a China-based global biotech company, announced on Monday that it has entered into an exclusive collaboration agreement with Grand Life Sciences Group Co Ltd, a pharmaceutical and healthcare enterprise group.

Under the agreement, Belief BioMed will grant Grand Life Sciences the rights to commercialise its investigational product, BBM-H803, in Mainland China, Hong Kong China, Macau China, and Taiwan China. The collaboration is intended to leverage the companies' respective strengths and resources in their respective fields, to accelerate the product's commercialisation process, help haemophilia A patients access innovative treatment option, and jointly promote the development of the gene therapy industry.

BBM-H803 is an AAV-based gene therapy with independent intellectual property rights owned by Belief BioMed. It is administered intravenously to deliver the coagulation factor VIII gene into the body of patients with haemophilia A, thereby improving and maintaining the coagulation factor level in the patient's body for a long time, for the prevention of bleeding. BBM-H803 uses liver-tropic capsid and highly efficient gene expression cassette, and the drug production uses the company's independently developed serum-free suspension culture process, which meets the requirements of the Good Manufacturing Practice for Pharmaceuticals.

In December 2022, BBM-H803 was granted Orphan Drug Designation (ODD) by the US Food and Drug Administration (FDA). In July 2023, the Investigational New Drug (IND) application for BBM-H803 was approved by China's National Medical Products Administration (NMPA). In October 2024, the drug received Rare Pediatric Disease Designation (RPDD) from the FDA.