ZHAOKE OPHTH's partners have submitted a new drug application for BRIMOCHOL PF to the South Korean Ministry of Food and Drug Safety

ZHAOKE OPHTH (06622.HK) and its strategic partner, global commercial biotechnology company Tenpoint Therapeutics, Ltd., jointly announced that ZHAOKE OPHTH has assisted its Korean partner Kwangdong Pharmaceutical Co., Ltd. (KDP) in submitting a New Drug Application (NDA) for BRIMOCHOL PF to the Korean Ministry of Food and Drug Safety (MFDS). KDP will be responsible for the production and sales of BRIMOCHOL PF in Korea.

The submission of this NDA in Korea is based on positive data from the first pivotal Phase III trial "BRIO-I," which confirmed that the combination therapy is superior to a single active drug component in efficacy, a necessary condition for the approval of fixed-dose combination formulations. In the second placebo-controlled Phase III clinical trial "BRIO-II," BRIMOCHOL PF achieved all primary endpoints for near vision improvement, with binocular uncorrected near visual acuity (BUCNVA) improving by three lines or more, and binocular uncorrected distance visual acuity (BUCDVA) not decreasing by one line or more. Additionally, BRIMOCHOL PF was well tolerated, with no treatment-related serious adverse events observed during over 70,000 treatment days monitored in the BRIO-II study.

In addition to the NDA submitted in Korea, the NDA for BRIMOCHOL PF in the United States is also under review, and Tenpoint Therapeutics has previously received the Prescription Drug User Fee Act (PDUFA) date from the U.S. Food and Drug Administration (FDA), which is January 28, 2026.

BRIMOCHOL PF is a preservative-free once-daily pupil-regulating eye drop used to correct near vision loss due to presbyopia, with effects lasting six to eight hours. BRIMOCHOL PF is a fixed-dose combination of carbachol (choline preparation) and bromonidine tartrate. This new therapy causes pupil constriction, creating a pinhole effect, allowing only centrally focused light to enter the eye, thereby sharpening images at medium to short distances