Hong Kong Exchanges and Clearing Limited and The Stock Exchange of Hong Kong Limited take no responsibility for the contents of this announcement, make no representation as to its accuracy or completeness and expressly disclaim any liability whatsoever for any loss howsoever arising from or in reliance upon the whole or any part of the contents of this announcement.
Zhaoke Ophthalmology Limited 兆科眼科有限公司 (Incorporated in the British Virgin Islands with limited liability and continued in the Cayman Islands) (Stock Code: 6622)
VOLUNTARY ANNOUNCEMENT – PIVOTAL PHASE III CLINICAL TRIAL OF LEVOBETAXOLOL HYDROCHLORIDE EYE DROPS MET ITS PRIMARY ENDPOINT
This announcement is made by the board of directors (the “Board”) of Zhaoke Ophthalmology Limited (the “Company”) on a voluntary basis.
The Board of the Company is pleased to announce that the pivotal Phase III clinical trial of one of the Company’s generic drug candidates, Levobetaxolol Hydrochloride (“HCl”) eye drops – a β-adrenergic receptor blocker that is used to lower the intraocular pressure (“IOP”) in patients with primary open-angle glaucoma or ocular hypertension, has met its primary endpoint in decreasing the IOP in week 8 compared to the baseline.
The Company’s Levobetaxolol HCl eye drops is potentially the first-to-market generic levobetaxolol targeting glaucoma in China. The patient group receiving Levobetaxolol HCl 0.5% w/v or 25mg/5mL eye drops (b.i.d., one drop each time) has demonstrated superior efficacy with a statistically significant decrease of IOP after 8 weeks of treatment (P<0.01) compared to the patient group receiving Betaxolol HCl (BETOPTIC®S) 0.25% w/v or 12.5mg/5mL eye drops (b.i.d., two drops each time).
Results are expected to be announced at an upcoming medical meeting after completion of detailed statistical analysis.
The Company is developing Levobetaxolol HCl as a generic to Betaxolol HCl Eye Drops. The former contains only the levo enantiomer while the latter is a racemic mixture of both the levo and dextro forms. The levo enantiomer has been shown to be more potent and selective than the dextro form for the b1 adrenergic receptor and is thus more efficacious and better tolerated than the racemic mixture for the treatment of glaucoma.
– 1 – The Levobetaxolol HCl Phase III clinical trial is a Multicenter, Randomized, Open- label, Positive-controlled, Parallel-group and Superiority Clinical Trial of Levobetaxolol Hydrochloride Eye Drops in Patients with Primary Open-angle Glaucoma or Ocular Hypertension to evaluate the safety and efficacy of Levobetaxolol in Chinese patients with primary open-angle glaucoma or ocular hypertension. A total of 366 subjects were enrolled and randomized in a 1:1 ratio between the levobetaxolol HCl eye drops group and the Betaxolol Hydrochloride eye drops group.
The Company plans to submit a new drug application to the National Medical Products Administration for Levobetaxolol HCl eye drops in the first half of 2022. The Company expects to receive approval in 2023 and plans to manufacture the product in-house after regulatory approval. This will be the Company’s 4th application for drug approval in China after Bimatoprost, Bimatoprost Timolol and Epinastine HCl.
Glaucoma is a chronic and progressive disease associated with high intraocular pressure, resulting in optic nerve damage. The IOP is determined by the balance of fluid production versus fluid drainage in the eye. According to China Insights Consultancy (“CIC”), glaucoma is the second largest cause of blindness worldwide, about 25% to 30% of glaucoma patients progress to blindness within 20 years in at least one eye. According to CIC, the prevalence of glaucoma in China is forecast to increase from 15.3 million in 2019 to 20.0 million in 2030, driven by the accelerating aging population. According to the same source, China’s diagnosis rate of glaucoma was only 20.0% in 2019, significantly lower than that of 78.2% in the United States, however, such rate is expected to grow rapidly to 60.6% in 2030, indicating a significant growth potential for the overall glaucoma market. Accordingly, the market size of glaucoma drugs in China is expected to rapidly grow from US$162.7 million in 2019 to US$2.0 billion in 2030, representing a compound annual growth rate of 25.4%. According to the 2020 China Glaucoma Guideline, Beta-blockers can be used as first line treatment in Primary open angle glaucoma.
Cautionary Statement required by Rule 18A.05 of the Rules Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited: The Company cannot guarantee that it will ultimately develop and market Levobetaxolol HCl successfully. Shareholders of the Company and potential investors are advised to exercise caution when dealing with the shares of the Company.
By order of the Board Zhaoke Ophthalmology Limited Dr. Li Xiaoyi Chairman
Hong Kong, September 2, 2021
As at the date of this announcement, the Board of Directors of the Company comprises Dr. Li Xiaoyi and Mr. Dai Xiangrong as executive Directors; Ms. Leelalertsuphakun Wanee, Ms. Tiantian Zhang, Ms. Cai Li and Mr. Chen Yu as non-executive Directors; and Mr. Wong Hin Wing, Prof. Lo Yuk Lam and Dr. Tam Lai Fan Gloria as independent non-executive Directors.
– 2 –