On January 6, Aribio announced that it has signed an exclusive distribution agreement with China’s Fuson Pharmaceutical Group for the oral Alzheimer’s drug candidate AR1001 in 10 ASEAN countries. The contract is valued at approximately 630 billion KRW, bringing the cumulative value of global exclusive distribution agreements for AR1001 to 2.99 trillion KRW.
This agreement includes upfront payments, as well as milestone payments for development, regulatory, and commercialization phases. Additionally, Aribio will receive separate royalties based on net sales after commercialization. Under this deal, Fuson will have exclusive rights to manufacture, obtain regulatory approval, and commercialize AR1001 in 10 ASEAN countries (Singapore, Indonesia, the Philippines, Thailand, Vietnam, Cambodia, Laos, Malaysia, Myanmar, and Brunei).
In this agreement, Aribio has excluded India and left it as a separate subject for future negotiations. The company plans to pursue a contract for India, a major market with a population of 1.4 billion, after the announcement of the global Phase 3 clinical trial top-line results scheduled for the first half of this year, reflecting the clinical outcomes. The strategy is to first establish a foundation for commercialization in the Asian market and maximize negotiation leverage for India once the clinical results are confirmed.
Fuson Pharmaceutical is a company with strong commercialization capabilities, based on its extensive pharmaceutical and distribution network in China. Aribio plans to leverage Fuson’s manufacturing infrastructure, regulatory expertise, and distribution network, which have been built in the Greater China region, to accelerate the early market entry and expansion of AR1001 in the ASEAN market.
With the expansion from the Greater China region to ASEAN, the partnership among Aribio, Newcoparma, and Fuson Pharmaceutical is considered to have become even stronger. Newcoparma serves as a development partner for China and the broader Asia region. Fuson will lead the entire process from regulatory submission to commercialization.
The global Phase 3 clinical trial for AR1001 has completed enrollment of 1,535 patients at over 230 clinical sites across 13 countries, including South Korea, China, North America, and Europe. The company aims to complete the trial and announce the top-line results in the first half of this year.
Jaejun Jung, CEO of Aribio, stated, “Fuson, with its strong commercialization capabilities, signed the agreement based on its confidence in AR1001,” adding, “As our global expansion strategy becomes clearer, the pace of market penetration will accelerate even further.”
Aribio explained that, to date, it has secured distribution agreements totaling 2.99 trillion KRW, including 100 billion KRW in South Korea (Samjin Pharmaceutical), 1.24 trillion KRW in the Middle East and Latin America (UAE Arcellera), 1.02 trillion KRW in the Greater China region (Newcoparma and Fuson), and 630 billion KRW in 10 ASEAN countries (Newcoparma and Fuson).
Fred Kim, head of Aribio’s U.S. office, emphasized, “We will proceed with distribution rights for major markets such as the United States, Europe, and Japan based on the results of the global Phase 3 clinical trial,” and added, “We will ensure that the clinical value and commercial potential of AR1001 are fully reflected in these efforts.”
Meanwhile, Aribio is in the process of merging with Kosdaq-listed company Solux. The scheduled merger date is March 27.
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