BioGend Therapeutics was established in July 2016 with a noble vision to be an innovative solutions provider for holistic medical care to restore bone and joint functions. We are committed to develop regenerative orthobiologic products that fulfill unmet clinical needs. We strive to be a trusted healthcare partner helping people maintain a healthy and active life style.
The project management teams at BioGend Therapeutics are led by seasoned product development managers with team members from different functional areas. Each development project is carefully planned following the phase-gate process for effective and efficient execution. For highly regulated biomedical devices, the expertise in regulatory affairs and pre-clinical and clinical development is essential in order to gain regulatory approval and to realize the potential value of innovative bio-technologies. Through the development of innovative bio-orthopaedic products and the establishment of world class GMP processes, we hope to elevate Taiwan's biomedical industry to a new level. The BiG-001, BiG-006 and BiG-009 are currently the main products under development at BioGend Therapeutics.
BiG-001 and BiG-006, an osteoinductive bone graft substitute composing of an osteoinductive factor (OIF), a morphogenetic protein similar to rhBMP-2 expressed in Escherichia coli bacteria, and a tricalcium phosphate (TCP) bioceramic. CHO cells produced rhBMP-2 has been shown to be very effective in stimulating bone growth clinically. However, there continues to be a great need for improving its safety profile and reducing the cost. The use of TCP as a carrier for OIF significantly improves the release efficiency of OIF. The preclinical studies of OIF/granular TCP (BiG-001) in a critical ulnar defect rabbit model, and of OIF/block TCP (BiG-006) in a lumbar spine fusion sheep model, have demonstrated the highly potent bone regenerative capabilities even at a much lower dosage compared to Infuse Bone Graft currently used in surgery. The internal GMP manufacturing process has been developed to produce consistently the high quality OIF. Human clinical feasibility studies are scheduled to take place in 2020.
BiG-009, a one-step autologous cartilage repair system originally developed at the Industrial Technology and Research Institute (ITRI) in collaboration with Department of Orthopaedic Surgery at the National Taiwan University Hospital. The biphasic cartilage repair implant (RevoCart) is a simple one-step and effective treatment for articaular cartilage defects requiring no cumbersome and costly in vitro cell culture and expansion. RevoCart has completed a pivotal randomized controlled clinical study and has gained the premarket approval from the Taiwan FDA in April 2020. RevoCart is currently available for clinical use in Taiwan. The patients in a small pilot study continue to show good clinical outcome at 5 years followup.
BioGend Therapeutics, a regenerative bioengineering company, dedicates to the development of high-value-added and regulatory demanding combination bioproducts through a strategic partnership with critical suppliers. The current product technology focus is for bone and joint restoration based on the proprietary know-how in cartilage tissue and bone tissue repair/regeneration. BioGend strives to lead the vertical integration of the supply chains facilitating the advancement of the biomedical industry in Taiwan to a new higher level.
Innovator and full service provider for healthy bone and joints.
•Develop high-end and high-quality bio-orthopaedic products for bone and joints repair and regeneration
•Provide high-quality services to promote healthy bone and joints
Providing superior bio-orthopaedic products and services to patients and the general public is the responsibility of BioGend Therapeutics and the cornerstone for corporate sustainability.
Culture and Responsibility
At BioGend Therapeutics, we see opportunities that others have yet to identify. We have the vision and determination to explore new technological frontiers, and transform ideas previously considered impossible into reality. We strive to find breakthrough solutions to fulfill unmet clinical needs to benefit patients and the general public.