BioGend Therapeutics Co., Ltd. announced that company's Hsinchu factory has passed the domestic medical device quality management system (QMS) manufacturing license. The TFDA sent inspector to the factory for an on-site inspection on February 27, 2024. On May 28, 2024 BioGend received notification from the FDA that BioGend's Hsinchu factory complies with the requirements of Taiwan's Quality Management System for Medical Devices (QMS) and has been granted a manufacturing license.

The license number is QMS2268.