Successful Completion of Phase 1 Clinical Trial for DW1021 in Vietnam
First Korean Pharmaceutical Company to Conduct Phase 1 Trial in Vietnam
Paving the Way for Entry into the Southeast Asian Pharmerging Market
Daewon Pharmaceutical announced on August 21 that it has successfully completed Phase 1 clinical trials in Vietnam for DW1021, a combination analgesic that merges Korea's 12th domestically developed new drug, Pelubi Tab, with tramadol. This marks the first time a Korean pharmaceutical company has conducted a Phase 1 clinical trial in Vietnam.
Daewon Pharmaceutical
This clinical trial serves as a stepping stone for entering the Vietnamese market and is also part of a broader strategy to expand into the global pharmerging market, including Southeast Asia. The term "pharmerging" is a combination of "pharmacy" and "emerging," referring to emerging pharmaceutical markets that are attracting industry attention due to their higher growth potential and lower labor costs compared to advanced markets.
This clinical trial was supported by the Ministry of Trade, Industry and Energy's project for the "Development of Global Market-Oriented Formulation Technology-Based Improved Medicines." The initiative aims to support the overseas expansion of technology-based medicines (TBM) that are differentiated from existing products in terms of formulation technology and medication compliance. The pharmerging market has posed challenges for Korean pharmaceutical and biotech companies due to the lack of established TBM regulations and approvals, as well as difficulties in securing local networks and infrastructure.
Building on the successful experience of Pelubi Tab-which is Korea's 12th domestically developed new drug and the top-prescribed NSAID-Daewon Pharmaceutical embarked on the development of a tramadol combination drug to achieve more potent pain relief. DW1021 is a compound that combines the two active ingredients in an ionic bond, enhancing their synergistic effect. The goal is to provide sufficient analgesic efficacy with a lower dose of tramadol, thereby reducing tramadol consumption and minimizing side effects.
This clinical trial, approved by the Ministry of Health (MoH) of Vietnam, was conducted from April at the Clinical Trial and Bioequivalence Research Center (HPMP) of Hai Phong University of Medicine and Pharmacy. The study, which targeted Vietnamese adults, evaluated the bioavailability and food effect of DW1021. The results confirmed that the bioavailability in Vietnamese subjects was similar to that in Koreans. Additionally, despite being an extended-release formulation, DW1021 showed no food effect, and demonstrated excellent tolerability and safety.
Based on the successful completion of Phase 1, Daewon Pharmaceutical plans to conduct subsequent clinical trials and obtain marketing approval for DW1021 in Vietnam. A company representative stated, "This clinical trial will serve as an important milestone for Daewon Pharmaceutical's entry into the pharmerging markets, including Southeast Asia," adding, "We aim to widely promote the excellence of Korean new drugs and establish successful cases of overseas expansion."
Meanwhile, as of 2023, the pharmaceutical market size of the six major Southeast Asian countries (Indonesia, Vietnam, the Philippines, Thailand, Malaysia, and Singapore) is estimated at approximately $20 billion (about 26 trillion KRW). Among these, the Vietnamese market alone is estimated at around $7 billion, and has rapidly expanded with an average annual growth rate of 7.3% over the past decade.
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