[Asia Economy Reporter Yoo Hyun-seok] Kainosmed, a company developing central nervous system (CNS) drugs, announced on the 5th that it recently completed the 48-week double-blind treatment administration for the patient group in the clinical Phase 3 trial of the AIDS treatment drug KM-023, which is currently underway in China through technology transfer to the Chinese pharmaceutical company Jiangsu Idea.
Jiangsu Idea is currently conducting statistical analysis on the efficacy results. To shorten the final new drug approval period, they have decided to begin documentation work this summer for the New Drug Application (NDA) during the open follow-up period.
With this result, Kainosmed has taken a step closer to the commercialization of KM-023. Jiangsu Idea’s target commercialization timeline is 2021?2022.
Kainosmed transferred the technology of KM-023, which completed Phase 1 clinical trials in Korea, to Jiangsu Idea in China in 2014. KM-023 was designated as a Fast Track Review by the China Food and Drug Administration (CFDA) in 2017, accelerating the clinical development process.
During the Phase 3 clinical trials, KM-023 showed a lower dropout rate due to side effects compared to competing drugs, raising expectations for its safety. Jiangsu Idea expects that KM-023’s excellent safety profile will allow it to replace existing drugs such as Efavirenz and Rilpivirine.
Jiangsu Idea, which received the technology transfer, holds the Chinese domestic sales rights for KM-023, while Kainosmed retains the global sales rights. In 2017, Kainosmed received the full milestone payment in advance from Jiangsu Idea and will receive 2% royalties on future single-combination drug sales.
A Kainosmed official stated, "We look forward to Jiangsu Idea’s swift NDA process in China," and added, "We plan to enter emerging markets in the future based on joint clinical data."
Meanwhile, Kainosmed is completing a SPAC merger with Hana Financial No.11 SPAC and plans to list the merged new shares on KOSDAQ on the 8th. End.
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