Becoming The Third Gmp Inspection That The Company Has Passed This Year

HONG KONG, 13 September 2021 – Zhaoke Ophthalmology Limited (“Zhaoke Ophthalmology” or the “Company”, SEHK: 6622), a leading ophthalmic pharmaceutical company dedicated to the research, development and commercialization of therapies that address significant unmet medical needs, is pleased to announce that one of the Company’s drug candidates, Adapalene Clindamycin Combination Gel (“ACCG”) passed the on-site inspection for drug registration by the Center for Food and Drug Inspection of the National Medical Products Administration (the “NMPA”). The inspection verified the original records and information on the research and development as well as the manufacturing processes of ACCG. This is the third on-site inspection the Company has passed this year following the on-site inspections of Bimatoprost Timolol eye drop and Epinastine HCl eye drop in May 2021, and is an important step for the final approval of ACCG.

The Company also passed the Good Manufacturing Practice (“GMP”) compliance inspection of the production line of topical gel conducted by the Guangdong Medical Products Administration. It confirms that the Company has put in place a GMP management framework, a core team, a complete set of analytical instruments, equipment and facilities, a well-managed documentation system and proper operations of the production and quality systems. This is the Company’s second production line that has passed GMP Inspection.

Adapalene is a retinoic acid receptor (RAR) agonist that stimulates skin growth and clindamycin is an antibiotic that blocks bacterial protein synthesis. The Company has successfully completed the pivotal Phase III trial of ACCG in China. The results from the pivotal Phase III trial show that the study has met its primary endpoint, demonstrating ACCG’s superiority over either the Adapalene Gel or Clindamycin Phosphate Gel alone with highly significant statistical difference (P<0.0001).

ACCG demonstrated significant improvement in the primary endpoint when compared to that of the two individual components alone: the percentage change in total lesion counts from baseline was 68.5% for the ACCG group versus 52.8% (P<0.0001) and 59.5% (P<0.0001) for the Adapalene Gel group and Clindamycin Phosphate Gel group, respectively.

In February 2021, the new drug application of ACCG submitted by the Company was accepted by the NMPA. A patent on ACCG, “Dispersion process of Adapalene in a gel preparation”, has been granted in both China (patent application number: 201711392438.9) and the United States (patent application number: 16228808).

The Company and the licensee, Lee’s Pharmaceutical International Limited and Zhaoke Pharmaceutical (Guangzhou) Limited (collectively the “Lee’s Pharm Group”) entered into the License Agreement in October 2020, pursuant to which, the Company agreed to outlicense ACCG by granting exclusive rights to the Lee’s Pharm Group to commercialize ACCG, in the greater China region. In consideration, the Lee’s Pharm Group agreed to pay an upfront payment upon signing of the agreement and a milestone payment after obtaining the relevant regulatory approval for the new drug application of ACCG in China, and to share with the Company the profit derived from the sale of ACCG.