The National Health Research Institutes have written a new chapter in drug development in Taiwan
Diabetes drug DBPR108 granted New Drug Approval
- Date: 2025-01-21
- Update: 2025-01-21
- Source: 國家衛生研究院
- Views: 105
According to market research reports, the global diabetes drug market size was approximately US$79.25 billion in 2023 and is expected to grow to US$153.98 billion by 2032, with a CAGR of 7.0%. By 2030, the global type 2 diabetes treatment market size will reach US$91.9 billion, with an average CAGR of 6.9% from 2024 to 2030. According to the 10th edition of the IDF Diabetes Atlas report of the International Diabetes Federation (IDF), global diabetes-related medical expenditures reached US$966 billion in 2021, accounting for 9% of global health expenditures, and this figure is expected to continue to rise. As the number of diabetes patients continues to rise worldwide, the diabetes treatment market is growing rapidly.
The National Health Research Institutes (NHRI) independently developed a new anti-diabetic drug DBPR108 (prusogliptin). With the support of major government programs such as the National Research Program for Biopharmaceuticals (NRPB) and the Biotechnology Success Investment Case Program, NHRI developed DBPR108 and licensed to the industry alliance composed of 6 Taiwan local pharmaceutical companies headed by Genovate Biotechnology Co., Ltd. (Genovate), and then sub-licensed to Zhongqi Pharmaceutical Technology (Shi-Jia-Zhuang) Co. Ltd. of CSPC Pharmaceutical Group Co., Ltd. Finally, on January 10, 2025, DBPR108 was granted the New Drug Approval (NDA) by the National Medical Products Administration (NMPA) to launch in China as a new treatment for type 2 diabetes. This major breakthrough marks a new milestone for the NHRI in drug discovery and development and also provides great recognition for Taiwan's capabilities for new drug researches.
NHRI harnesses cross-disciplinary R&D synergy: DBPR108 is a successful example from “Bench to Bedside” commercialization
New drug discovery and development is different from general industries. Each stage requires the involvement of people with different expertise, and is a type of scientific research that relies heavily on teamwork. The Institute of Biotechnology and Pharmaceutical Research (IBPR), under the impetus of former Director Dr. Yu-sheng Chao, who retired from Merck Pharmaceuticals in the United States, initiated the anti-DPP-4 diabetes drug discovery project in 2002. Chemist Dr. Weir-Torn Jiaang and his laboratory team were responsible for drug design, biologist Dr. Xin Chen and her team conducted biological activity evaluation, Dr. Su-Ying Wu and her team conducted molecular structure analysis, pharmacologist Dr. Chiung-Tong Chen and his team conducted animal pharmacology and toxicity assessments, and pharmacokineticist Dr. Teng-Kuang Yeh and his team conducted pharmacokinetics and drug metabolism studies. After years of hard work and the input of nearly 30 devoted research scientists, DBPR108, with patent novelty, was claimed as a drug candidate in 2008.
For drug development of DBPR108, the IBPR team then co-developed with the industry alliance led by Genovate, including other five domestic pharmaceutical companies, China Chemical & Pharmaceutical Co., Ltd., Nang Kuang Pharmaceutical Co., Ltd., Yung Shin Pharmaceutical Industrial Co., Ltd., TTY Biopharm Co., Ltd., and Taiwan Biotech Co., Ltd., to jointly implement The Executive Yuan National Science and Technology Development Fund's "Biotechnology Success Investment Case Program". This program was co-hosted by Dr. Low-Tone Ho of the Department of Medical Education and Research (now are two departments) of Taipei Veterans General Hospital, and supported by several experts retired from well-known foreign pharmaceutical companies, including the toxicology expert Dr. Robert Hsu, the pharmacokinetics expert Dr. Shih-Jung Lan, the formulation expert Dr. Tsong-Toh Yang, and the clinical expert Mrs. Grace Woo, and the IBPR drug development team of more than 20 people, successively completed the First-in-Human phase I single ascending dose and multiple ascending dose clinical trials in Taiwan at the Taipei Municipal Wanfang Hospital and Taipei Medical University Hospital, which were the first cases of chronic disease treatment clinical trials in Taiwan. DBPR108 exhibited good tolerability and no serious adverse reactions were observed.
DBPR108 was awarded the 2013 National Invention and Creation Award Gold Medal, the 9th YungShin Tien De Lee "Excellent Medical Technology Award", and the 2015 Taipei Biotechnology Award, Technology Transfer Cooperation Award Gold Medal, highlighting IBPR’s efforts to engage with domestic companies to transform and invest in high value-added biotechnology and to promote the industrialization of local R&D products.
To accelerate the commercialization phase of DBPR108’s development, NHRI then transferred the DBPR108 to the industry alliance consisted of 6 domestic pharmaceutical companies. DBPR108 was then sub-licensed to the CSPC Zhongqi Pharmaceutical Technology (Shi-Jia-Zhuang) Co., Ltd., who successfully completed the Phase I to III clinical trials and new drug application.
The global challenge of diabetes and the breakthrough of DBPR108: a new generation of long-acting and safe DPP-4 inhibitor
According to IDF estimates, as of 2021, approximately 537 million adults (20-79 years old) worldwide have diabetes, and the number of people with diabetes is expected to increase to 643 million by 2030. The study noted that the prevalence of diabetes varies significantly between regions, with the Western Pacific region being one of the worst affected. There were approximately 2.46 million people with diabetes in Taiwan in 2021, and this number is expected to rise to 3.03 million by 2045.
DBPR108 is a novel oral DPP-4 inhibitor with high selectivity and long-lasting effects. DBPR108 increases glucagon-like peptide-1 (GLP-1) level through inhibiting DPP-4, thereby enhancing the sensitivity of pancreatic β cells and α cells to glucose, promoting insulin secretion, and inhibiting glucagon release to achieve the purpose of controlling blood sugar.
Phase III clinical trial of DBPR108 showed that it has a long-lasting blood sugar-lowering effect and is not likely to cause hypoglycemia or weight gain. In addition, DBPR108 has low incidence of adverse reactions and interactions with other drugs and no dose adjustment for patients with mild to moderate renal impairment. The efficacy and safety profile of DBPR108 were established to demonstrate its market potential as a new generation of DPP-4 inhibitor.
NHRI-Industry Cooperation: Promote the Successful Launch of DBPR108
During the development of DBPR108, NHRI worked together with different teams within the organization and partnered with various contract development and manufacturing organizations (CDMOs), contract research organizations (CROs), and medical centers in Taiwan. With support from the industry alliance, Genovate played a key role in helping develop the clinical formulation for DBPR108 and worked closely with CSPC. This collaboration ultimately led to the successful approval for marketing DBPR108.
The successful launch of DBPR108 shows the determination and creativity of the NHRI’s team in discovering and developing new drugs. Looking ahead, NHRI will keep focusing on researching, developing, and promoting high-quality new medications to address major global health challenges and fulfill its mission of "Research Innovation for the Benefit of the People."
NHRI, Institute of Biotechnology and Pharmaceutical Research
The NHRI was established in 1996 and is Taiwan's only mission-oriented medical and health research institution, which is dedicated to "strengthen medical and health research and improve the health and well-being of the people." The Institute of Biotechnology and Pharmaceutical Research (IBPR) was established in 1998. It conducts cross-disciplinary applied research and development of innovative drugs for important disease areas, and continuously seeks industry, academia, research, and medical partners for new drug development. So far, IBPR has successfully developed 23 drug candidates for the disease areas of cancer, metabolism, etc. 13 were licensed to domestic and overseas companies, of which 6 are in the clinical development stages, 1 is in the marketing, fully demonstrating the key role of the NHRI in promoting the progress of Taiwan's biotech industry.
This article was translated and written by Ms. Yi-Fang Li, co-PM of DBPR108 and proofread by Dr. Yu-Sheng Chao and Dr. Kelvin Lun Tsou. We sincerely appreciate their valuable contributions.