KPM Tech-Telcon RF Pharma "Clinical Application for Domestic Approval of COVID-19 Treatment 'Lenzilumab'"

[Asia Economy Reporter Hyunseok Yoo] KPM Tech and Telcon RF Pharmaceutical are starting clinical trials to verify the safety of a novel coronavirus disease (COVID-19) treatment in Korean subjects.

KPM Tech and Telcon RF Pharmaceutical announced on the 25th that they have submitted a bridging clinical trial plan for Lenzilumab to the Ministry of Food and Drug Safety (MFDS). The trial will be conducted in collaboration with Seoul National University Hospital, CN Research?the largest clinical trial contract research organization (CRO) in Korea?and Meditip, a pharmaceutical regulatory affairs specialist company.

Lenzilumab is a COVID-19 treatment developed by Humanigen (HGEN), a Nasdaq-listed biopharmaceutical company based in the United States. Phase 3 clinical trials are currently underway in the U.S. and Brazil. In the U.S. trial aiming to recruit 515 patients, over 500 have been enrolled so far.

According to interim clinical trial results announced by Humanigen at the end of last year, 92% of severely ill patients treated with Lenzilumab showed symptom improvement, with an average hospital stay of 5 days. This demonstrated more than twice the effectiveness compared to the control group, who were discharged approximately 11 days after admission without treatment.

KPM Tech and Telcon RF Pharmaceutical jointly acquired the domestic and Philippine rights for Lenzilumab from Humanigen last year and are preparing for its introduction in Korea.

This clinical trial will evaluate the safety and tolerability of Lenzilumab in healthy Korean adults. A key objective is to compare the pharmacokinetic characteristics of Lenzilumab between Korean and Western populations.

A bridging clinical trial is generally conducted for imported product approval, allowing domestic import approval applications to be submitted based solely on bridging clinical trial data without additional clinical trials.

A company representative stated, "If safety in Koreans is verified through this bridging clinical trial, it will be possible to apply for domestic import approval based on the results of the U.S. Phase 3 clinical trial without conducting separate domestic clinical trials. We have proactively started the bridging clinical trial domestically before Lenzilumab receives EUA approval in the U.S., aiming to expedite the domestic import approval schedule."

They added, "Even if Lenzilumab obtains EUA approval in the U.S. during the bridging clinical trial, we plan to proceed with conditional domestic import approval applications to ensure there are no delays in the import approval timeline."

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