KainosMed Nears Completion of Phase 3 Clinical Trial for AIDS Treatment in China

[Asia Economy Reporter Hyunseok Yoo] Kainosmed, which is pursuing a merger listing with Hana Financial No.11 SPAC, announced on the 28th that the Phase 3 clinical trial of the AIDS treatment drug (KM-023), licensed to the Chinese pharmaceutical company Jiangsu Idea, is progressing smoothly and is about to administer the last patient in the first half of this year.

Kainosmed believes that KM-023 has a competitive safety profile and expects it to replace existing drugs such as Efavirenz and Rilpivirin. Unlike existing AIDS treatments that show side effects related to birth defects and degenerative brain diseases, KM-023 showed no related side effects in Phase 1 clinical trials and demonstrated excellent antiviral effects. Additionally, the fact that it shows the same effect as existing drugs at 25% of the dosage is also a positive factor.

The company completed Phase 1 clinical trials of KM-023 domestically and licensed the technology to Jiangsu Idea in China in 2014. Considering the increasing number of patients giving up treatment due to high treatment costs, the China Food and Drug Administration (CFDA) designated KM-023 as a Fast Track Review candidate in 2017. After analyzing the Phase 1 clinical trial results, the CFDA recognized its outstanding efficacy as a treatment and conducted a simplified Phase 2a trial.

Currently, Jiangsu Idea, which received the technology transfer, holds the domestic sales rights for KM-023 in China, while Kainosmed holds the global sales rights. Kainosmed received the full milestone payment of $1.7 million from Jiangsu Idea in 2017 and will receive a 2% royalty on sales of single-combination formulations in the future.

A Kainosmed official stated, “The ongoing Phase 3 clinical trial is showing a very low dropout rate, raising expectations for Phase 3 approval,” and added, “As KM-023 is part of the Chinese government’s pharmaceutical innovation policy and will be sold under the government’s active support and management, we aim to achieve a 30% market share within three years after launch.”