Aribio, developing the oral dementia treatment 'AR1001,' is aiming to enter the Chinese market by partnering with a major Chinese pharmaceutical company following its clinical trial application (IND) to include China in its global Phase 3 clinical trials.
On the 13th, Aribio announced that it signed a strategic cooperation memorandum of understanding (MOU) with Shanghai Pharmaceuticals, one of China's largest pharmaceutical groups and the second-largest pharmaceutical distributor in China. This MOU aims for 'technology transfer or exclusive sales of AR1001 in China' through the clinical development of the oral dementia treatment.
Aribio recently submitted an IND application for the Phase 3 clinical trial of AR1001 to the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) of China. Having already received IND approval in the United States and begun patient dosing in the Phase 3 'Polaris-AD' trial, the plan is to include China alongside Korea and the US. The trial is expected to enroll approximately 1,250 participants, including 100 to 150 from China, about 150 from Korea, 600 from the US, and 400 from Europe. Europe is also planned to submit an IND within this year.
The plan includes collaborative research to successfully complete the Phase 3 trial of AR1001 in China, providing top-tier clinical trial sites such as hospitals through an extensive network, stable commercialization of AR1001 within China via the largest imported pharmaceutical distribution channels, and securing a stable new drug production line using global pharmaceutical manufacturing facilities and production lines that meet excellent Good Manufacturing Practice (GMP) standards.
Shanghai Pharmaceuticals recorded sales of 232 billion yuan (approximately 42 trillion KRW) last year and is ranked among the top 50 pharmaceutical companies worldwide. It has an extensive distribution network covering 31 provinces, municipalities, and autonomous regions in China, serving over 32,000 medical institutions.
Earlier this year, the two companies signed a confidentiality agreement (CDA) and have been conducting a comprehensive technical feasibility review for the strategic partnership. This agreement will mark the start of practical procedures for joint clinical development and full-scale market entry.
Jaejun Jung, CEO of Aribio, stated, “Shanghai Pharmaceuticals, a global pharmaceutical company with clinical development capabilities and an extensive distribution network, is a strong partner. This agreement lays the foundation for the commercialization of AR1001 in China by ensuring the successful completion of the Phase 3 clinical trial and post-approval sales in China.” He added, “This will be recognized as a first step bringing groundbreaking progress in Alzheimer's disease treatment in China, where rapid aging and a surge in dementia patients have prompted national-level countermeasures.”
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