· NDA Submission in South Korea by Zhaoke’s local partner, Kwangdong Pharmaceutical, marks the first ex-U.S. regulatory submission for BRIMOCHOL™ PF
· BRIMOCHOL™ PF is designed to be the first and only combination eye drop that can address the loss of near vision associated with presbyopia
HONG KONG, LONDON, SEATTLE and WASHINGTON – 5 November 2025 – Zhaoke Ophthalmology Limited (“Zhaoke Ophthalmology”, “Zhaoke” or the “Company”, SEHK: 6622), a leading ophthalmic pharmaceutical company, is pleased to jointly announce with its strategic partner Tenpoint Therapeutics, Ltd. (“Tenpoint Therapeutics”), a global commercial-ready biotechnology company, that Zhaoke has supported its South Korean partner, Kwangdong Pharmaceutical Co., Ltd. (“KDP”), in submitting a New Drug Application (“NDA”) for BRIMOCHOLTM PF to the Ministry of Food and Drug Safety (“MFDS”) in South Korea. KDP will be responsible for the manufacturing and distribution of BRIMOCHOLTM PF in South Korea.
The NDA submission in South Korea was supported by positive data from the first pivotal Phase 3 BRIO-I study, which demonstrated the benefit of the combination therapy over the individual monotherapy active drug components – a requirement for approval of a fixed-dose combination. In the second vehicle-controlled Phase 3 BRIO-II study, BRIMOCHOLTM PF achieved all primary near vision improvement endpoints with statistically significant three-lines or greater improvement in binocular uncorrected near visual acuity (BUCNVA), without the loss of one line or more in binocular uncorrected distance visual acuity (BUCDVA). In addition, BRIMOCHOLTM PF was well-tolerated with no serious treatment-related adverse events observed in the over 70,000 treatment days monitored in the BRIO-II study.
“We believe BRIMOCHOLTM PF has the potential to become a best-in-class treatment for people with presbyopia, and the NDA filing in South Korea is an important step in our efforts to make it available to patients around the world,” said Henric Bjarke, Chief Executive Officer of Tenpoint Therapeutics. “We appreciate the collaboration with Zhaoke Ophthalmology and KDP that led to this moment and are confident in their highly experienced teams who will continue to manage the MFDS review process and prepare for commercialization in an effort to bring BRIMOCHOLTM PF to market as quickly as possible in South Korea.”
“Together with Tenpoint Therapeutics and KDP, we are excited about this milestone, which marks a critical first step in our broader Asia-Pacific strategy,” said Dr. Li Xiaoyi (Benjamin), Chairman of the Board, Executive Director and CEO of Zhaoke Ophthalmology. “Our partnerships provide us with a strong distribution and commercialization framework, that we believe will enable us to effectively bring BRIMOCHOLTM PF to the millions of presbyopia patients in South Korea and across the Asia-Pacific region.”
In addition to the NDA in South Korea, an NDA for BRIMOCHOLTM PF is under review in the U.S. and Tenpoint Therapeutics has received a Prescription Drug User Fee Act (PDUFA) date from the U.S. Food and Drug Administration (FDA) of January 28, 2026.
About Tenpoint Therapeutics
Tenpoint Therapeutics, Ltd. is a global, commercial-ready biotechnology company developing groundbreaking treatments to rejuvenate vision in the aging eye. Its lead asset, BRIMOCHOL™ PF, is a novel pupil-modulating, investigational therapeutic designed to correct the loss of near vision associated with presbyopia, a condition that afflicts approximately two billion people globally. Tenpoint Therapeutics has completed two large Phase 3 pivotal trials (BRIO-I and BRIO-II) for BRIMOCHOL™ PF, has filed the New Drug Application (NDA) and has received a Prescription Drug User Fee Act (PDUFA) date from the U.S. Food and Drug Administration (FDA) of Jan. 28, 2026. Its pipeline includes paradigm-shifting treatments for ophthalmic indications with the greatest need and global market potential, including presbyopia, cataracts and geographic atrophy. To learn more, visit tenpointtherapeutics.com and connect on LinkedIn.
About Kwangdong Pharmaceutical Co., Ltd.
Kwangdong Pharmaceutical Co., Ltd (009290.KS) is a South Korean human healthcare company founded in 1963 and was listed in the Korean Stock Market, specifically on the Seoul Stock Exchange (KRX) in November of 1989. The company focuses on the development, manufacture, and sale of pharmaceutical products, as well as health drinks and functional foods. The company's business is segmented into Pharmacy Sales, Hospital Sales, Distribution Sales, and Water Sales, each focusing on different aspects of the healthcare market. Kwangdong Pharmaceutical's vision is to become a leading human healthcare brand company with a strong focus on innovation, research, and development. Kwangdong is consistently ranked as one of the top 10 pharmaceutical and healthcare companies in Korea by multiple metrics.
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[4] Tenpoint Therapeutics data on file
[5] GlobalData’s Epidemiology Market Size Search extracted on 18 December 2024.
