On April 24, Hyundai Bioscience, the parent company of Penetrium Bioscience, announced that Chief Executive Officer (CEO) Bae Byeong-jun will join the president’s economic delegation to Vietnam.
The previous day, Bae attended the Korea-Vietnam Business Forum and memorandum of understanding (MOU) signing ceremony at the JW Marriott Hotel in Hanoi.
Hyundai Bioscience formally signed a comprehensive cooperation MOU with Vietnamese pharmaceutical company Bepharco for the authorization, import, distribution, and supply of antiviral drugs in Vietnam.
This MOU outlines the key principles and roadmap for jointly advancing regulatory approvals and supply projects for the products in Vietnam. Bepharco will support activities related to authorization, import, distribution, and supply within local legal limits.
The companies agreed to establish an executive-led joint working committee with regular meetings. Through this committee, they aim to develop practical cooperation initiatives, such as initial patient referrals, leveraging Bepharco’s local medical and pharmacy network.
Hyundai Bioscience plans to accelerate clinical development of dengue treatments in Vietnam and prepare for commercialization by aligning approval strategies, market access, and supply roadmaps.
Additionally, Hyundai Bioscience signed an MOU with Smart Scientific Research Support Service Corporation, a Vietnamese regulatory and clinical development support organization, for a feasibility study and local clinical development cooperation on a multinational Phase 2 trial of an anti-cancer drug.
Smart Scientific Research, Vietnam’s first Ministry of Health-approved clinical trial organization (CRO), leads local clinical development with extensive experience and hospital networks compliant with global Good Clinical Practice (GCP) standards.
Key collaboration areas include evaluating trial site infrastructure, identifying principal investigators, analyzing patient populations and unmet medical needs, and reviewing biomarker testing and specimen export regulations during the clinical feasibility study phase.
For subsequent clinical development stages, the partnership will cover protocol localization, regulatory submissions, monitoring and data management, clinical trial drug logistics and customs, and patient recruitment, encompassing the entire clinical lifecycle.
CEO Bae emphasized that this economic delegation to Vietnam goes beyond event attendance and MOU signings. It concretely defines follow-up tasks for authorization, distribution, supply, and acceleration of cancer and dengue clinical trials. It’ll quickly advance these efforts to achieve tangible results with the Vietnamese partners.
Recently, Hyundai Bioscience received final approval from the Ministry of Food and Drug Safety (MFDS) for amendments to the clinical trial plan (IND) for Penetrium, its universal environmental normalizer, in combination therapy for prostate cancer.
Relevant documents will be submitted to Seoul National University Hospital’s Institutional Review Board on April 21, followed by a site initiation visit in mid-May, after which patient recruitment and dosing will commence.
The global oncology and pharmaceutical communities are closely watching this world-first clinical trial combining the innovative drug candidate Penetrium with targeted cancer therapies.
