[Asia Economy Reporter Hyunseok Yoo] KPM Tech and Telcon RF Pharmaceutical are advancing domestic clinical trials of Lenzilumab, a novel coronavirus disease (COVID-19) treatment for which they have acquired domestic distribution rights.
On the 16th, KPM Tech announced that it signed a contract with the clinical research organization (CRO) C&R Research to outsource domestic clinical trials of Lenzilumab.
C&R Research is one of the top CROs in Korea. Recently, it was the only domestic institution to receive certification in Project Management and Data Management/Statistics from the Korea National Enterprise for Clinical Trials (KoNECT) CRO institution certification evaluation.
Lenzilumab is a new drug that suppresses and treats the immune overreaction caused by the cytokine storm, a major cause of death in COVID-19 patients. Phase 3 clinical trials are currently underway in the United States and Brazil.
On the 3rd, KPM Tech and Telcon RF Pharmaceutical signed an exclusive license agreement with Humanigen for the domestic and Philippine territories for Lenzilumab. Both companies secured rights for clinical trials and commercialization of Lenzilumab in these regions.
Meanwhile, Humanigen plans to apply for Emergency Use Authorization (EUA) for Lenzilumab within the first quarter of next year. If the EUA is approved, the domestic and Philippine clinical trials by KPM Tech and Telcon RF Pharmaceutical, who hold the distribution rights, are expected to gain further momentum.
A KPM Tech official stated, “Before the results of the U.S. clinical trials of Lenzilumab are released, we decided to proactively conduct domestic clinical trials to secure safety evaluations,” adding, “We plan to conduct clinical trials at several leading university hospitals in Korea by receiving clinical trial supplies of Lenzilumab from Humanigen.”
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