[Public Voices] Success Factors for Public-Private Cooperation Models in New Drug Development

'Enblo Tab' Developed in Just 5 Years
A Model Case of Public-Private Collaboration

Lee Chang-jae, CEO of Daewoong Pharmaceutical.

Daewoong Pharmaceutical's SGLT-2 inhibitor class diabetes treatment drug, Enblo Tab 0.3 mg (Inavogliflozin), received marketing authorization from the Ministry of Food and Drug Safety (MFDS) in November last year. It is the 36th domestic new drug. In the pharmaceutical and biotech industry, it takes an average of 15 years for a new drug to be developed from candidate discovery through clinical trials, approval, and launch. Among these, diabetes drugs with a treatment period of 6 to 12 months typically require an average of 7 years from clinical trials to approval. Daewoong Pharmaceutical shortened this period to just 5 years for Enblo Tab. Considering the extremely low final success rate (0.01%), this achievement is even more valuable. The development story of Enblo Tab holds significance in various aspects of the history of domestic new drug development. Enblo Tab was born from the synergy between Daewoong Pharmaceutical's research and development (R&D) capabilities and the MFDS's policy support. It can be seen as the fruit of Daewoong Pharmaceutical's determination to develop new drugs under the strong protection of the MFDS.

Enblo Tab was designated as a priority review drug by the MFDS, accelerating the final approval review process, the last hurdle in the development stage. In particular, quality data for the active pharmaceutical ingredient and finished product prepared before the completion of phase 3 clinical trial results were pre-reviewed using the pre-assessment system to verify the validity of the data in advance. Any data requiring supplementation was continuously communicated and reinforced between Daewoong Pharmaceutical and the MFDS's priority review division even before the marketing authorization application, ensuring completeness.

Public-private cooperation continued even after the marketing authorization application for Enblo Tab in March last year. Meetings to initiate the approval review and supplementary explanation sessions were held to coordinate opinions. After submitting supplementary data, the reviewers and company representatives communicated frequently to promptly resolve any questions. As a result, the approval period, which typically takes more than 10 months on average from application to approval, was shortened to 8 months. This is arguably the most exemplary case of public-private cooperation in the history of domestic new drug development.

Last month, at the 'Innovative Pharmaceutical Companies GIFT (Global Innovative Fast Track) Priority Review Support Meeting' held by the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, Enblo Tab was introduced as a representative success case of priority review product commercialization. Daewoong Pharmaceutical shared with attendees the active support from the MFDS for the successful commercialization of this domestically developed new drug, noting that after submitting supplementary materials, MFDS reviewers and company staff communicated nonstop through all channels, exchanging dozens of emails from 6 a.m. to 11:47 p.m. to discuss opinions.

The shortened approval and review period achieved through the MFDS's support such as priority review and Daewoong Pharmaceutical's efforts enabled early export. In fact, Enblo Tab was able to immediately enter overseas markets such as Brazil, Mexico, and Saudi Arabia. The 'ultra-speed' product commercialization support strategy achieved through public-private collaboration will greatly aid the growth of the domestic pharmaceutical industry in the long term by promoting exports of excellent domestic products. Currently, the MFDS is fully supporting the development of innovative products through the GIFT program. We hope that these efforts by the MFDS will continue to yield results, allowing excellent products developed by domestic companies to be approved quickly and enter overseas markets rapidly. Competition to foster the pharmaceutical and biotech industry is becoming increasingly fierce. It is a time when everyone must participate. In a virtuous cycle where the government and industry push and pull together, the Korean pharmaceutical industry can grow even further. We hope that the success of Enblo Tab, born with the support of the MFDS, will invigorate domestic new drug development.

Changjae Lee, CEO of Daewoong Pharmaceutical

This content was produced with the assistance of AI translation services.