KainosMed "Application for Registration of China-Manufactured AIDS Treatment Drug Licensed Out"

[Asia Economy Reporter Yoo Hyun-seok] CNS drug development company Kainosmed announced on the 24th that its Chinese partner has submitted the 'registration application for domestically produced drugs' for an AIDS treatment to the China National Medical Products Administration (CFDA).

Kainosmed, in collaboration with the Korea Research Institute of Chemical Technology, developed the AIDS treatment drug (KM-023) and completed Phase 1 clinical trials in Korea. In 2014, the technology was transferred to Jiangsu Aidi Pharmaceutical in China. Jiangsu Aidi has been developing KM-023 under the substance name ACC007. ACC007 was designated as a Fast Track Review by the CFDA in 2017, accelerating the clinical development process.

Jiangsu Aidi began Phase 3 clinical trials in October 2018. In May, administration to the double-blind treatment patient group for the AIDS treatment was completed.

The company explained, "ACC007 has now completed Phase 3 clinical trials with favorable results and has reached key clinical endpoints. ACC007 was not inferior to the control group (epavirenz, which is commonly used in current frontline clinical treatment methods). In terms of the incidence of various neurological and psychiatric side effects, ACC007 outperformed the control group, indicating its differentiation in safety and tolerability."

Jiangsu Aidi submitted the registration application for domestically produced drugs based on the Phase 3 clinical trial results of ACC007 to the China National Medical Products Administration, which was received on the 23rd. They stated that after ACC007 passes review and approval, a drug approval certificate will be issued, allowing production and sales.

Currently, there are over 1 million AIDS patients in China, with an annual increase of 80,000, showing the highest growth rate among single countries. The Chinese AIDS treatment drug market is estimated to be approximately 2 trillion KRW.

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

A Kainosmed official said, "It is very rare for a domestic bio company’s technology-exported substance to receive overseas regulatory approval for sales, so obtaining sales approval in China this time is expected to be an opportunity for Kainosmed to emerge as a global bio company."

He added, "Given the large Chinese AIDS treatment drug market, it is expected that stable royalty revenue generation will also help stabilize the new drug development business."

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