Phase 1 clinical trial of the novel anti-diabetic drug candidate DBPR108 completely led by Institute of Biotechnology and Pharmaceutical Research (IBPR), National Health Research Institutes from drug discovery to drug development was completed in June. DBPR108 was approved for the Phase 1 clinical trial carried out in China by China Food and Drug Administration (CFDA) in March this year through the promotion by the industry alliance consisting of Genovate Biotechnology (Genovate), China Chemical & Pharmaceutical Co., Yungshin Pharm, Taiwan Biotech, TTY Biopharm and Nang Kuang Pharmaceutical Co. This is the first case proceeding to the clinical trial in China after development by domestic industries and received Gold in Technology Transfer for the 2015 Taipei Biotech Award.
DBPR108 research has received Gold in 2013 National Invention and Creation Award and 9th Yung Shin TienTe Lee Excellent Medicine Technology Award successively. This time again won Gold in Technology Transfer Award for technology transfer to domestic/foreign biotechnology companies or industry-academia cooperation indicating that DBPR108 is not only under drug discovery but also makes efforts on counseling domestic companies transition to the investment of high added value biotechnology and promoting the industrialization of domestic research achievements which are highly expected and recognized.
DBPR108, a DPP4 inhibitor, as a novel small molecule drug candidate for Type 2 diabetes is the most eminent drug candidate in development among more than 500 new compounds in-house synthesized by NHRI research team. NHRI with six domestic pharmaceutical companies composing the industry alliance implemented the project “Contribution to the Successful Biotechnology Investment Cases” under the support of Executive Yuan Science Development Foundation in December 2008. Single dose (Phase 1a) clinical trial was initiated in the beginning of 2012 and completed repeated dose (Phase 1b) clinical trial in June 2015.
Base on the results of oral dose Phase 1 clinical study, absorption of DBPR108 was linear at both high and low dose and displayed good pharmacokinetic properties of oral drug without drug accumulation. Adverse side effects were not observed with good tolerance. The most important thing is that DBPR108 has great and continuous inhibition to DPP4 protease activity suitable for once daily dosing which is comparable with the inhibitors developed by international pharmaceutical companies.
Since a huge number of patients is required for Phase 2 and Phase 3 clinical trials, implementation of the clinical study at several medical centers in multiple countries is needed for the aim and marketing drug soon. Therefore Genovate started planning the layout of the market in China and licensed the patent in China and related rights in the end of 2012. Genovate promoted the new drug of diabetes to the market in China and hoped to expedite the progress of DBPR108 development by taking advantage of the signed Cross-Strait Cooperation Agreement on Medicine and Public Health Affairs and the development trend.
According to the statistics from International Diabetes Federation, 382 million people worldwide had diabetes in 2013 and an estimate of 2035 will reach 592 million by rising 55%. Diabetes is 4th Taiwan’s 10 leading causes of death. China has been called” Diabetes Capital” and the population is 100 million with annual growth rate of 20% indicating great potential of the market for anti-diabetic drugs.
To seize market opportunities development strategy of DBPR108 with the advantage of high activity and safety will focus on high potential markets such as China to provide benefits to patients with diabetes in Chinese regions as the developmental niche. This case establishes a good developmental mode of promoting cross-strait cooperation on medicine and public health affairs for the Government.
Gradually rising prevalence in diabetes is the important problem that all countries in the world are confronted with and thereby diabetes is considered a great topic of the policy for public health. IBPR, NHRI is the only research institute covering the upstream fundamental medical research, genomic research, target identification, pharmacological mechanism investigation and drug discovery to the midstream pre-clinical development and clinical medicine by now. IBPR will support the Phase 2 and 3 clinical trials in China continuously and hope to provide the safest drug for patients with diabetes by developing global market.