Signifying Government Recognition in The Company’s Quality Manufacturing System
Zhaoke Ophthalmology Limited (stock code: 6622), an ophthalmic pharmaceutical company dedicated to the research, development and commercialization of therapies that address significant unmet medical needs, announced that on 13 May 2021, two pharmaceutical products of the Company, namely Bimatoprost Timolol eye drop (a potential first-to-market generic drug in China targeting glaucoma, a fixed dose combination of a prostaglandin analogue and a beta-blocker) and Epinastine HCl eye drop (a potential first-to-market generic drug in China targeting allergic conjunctivitis with a dual mechanism of action of anti-histamine and mast cell stabilization), passed the on-site inspection for drug registration of the Greater Bay Area Center for Drug Evaluation of NMPA.
The inspection verified the original records and information on the research and development as well as the manufacturing processes of the above two drug products.
The Company also passed the Good Manufacturing Practice (GMP) compliance inspection 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.
Passing the on-site inspection for drug registration and GMP compliance is a major milestone for the Company. The positive result of the on-site inspection for drug registration of the Company as the first by any enterprise to complete such inspection conducted by the Greater Bay Area Center for Drug Evaluation of NMPA signifies NMPA’s approval of the capacity of the Company’s drug research and development system as well as the quality management system. It also validates that such systems can produce products compliant with the registration requirements in a sustained and consistent fashion.
The Company’s manufacturing facility occupies approximately 7,600 sq.m. in Nansha New District, Guangzhou. It is designed and built for ophthalmic drugs in compliance with cGMP requirements of China, the United States and the EU with full manufacturing capability and ready for commercial-scale production. The Company is currently expanding its manufacturing capacity and expects to complete the expansion by the end of 2022.
Dr. Li Xiaoyi, Chairman of the Board, Executive Director and CEO of Zhaoke Ophthalmology, said, “The eye is a very sensitive organ of the human body, so we attach great importance to our production quality and safety, and strive to provide patients with the safest and highest quality products. Quality manufacturing is one of the core pillars of Zhaoke, passing the on-site inspection by the NMPA is a strong accreditation for the Company. It affirms all the hard work that we have put in over the years to ensure a quality manufacturing system.”
The Company has submitted the abbreviated new drug application (ANDA) for both of the aforementioned generic drugs (Bimatoprost Timolol eye drop and Epinastine HCl eye drop) to NMPA. The Company expects to commence commercialization of these two products upon receiving their regulatory approvals in 2022. Their commercialization is expected to address the unmet needs by glaucoma patients and help the Company forge a close bond with downstream strategic channels such as partners, key opinion leaders, ophthalmologists and hospitals.
About Zhaoke Ophthalmology Limited
Zhaoke Ophthalmology Limited is an ophthalmic pharmaceutical company dedicated to the research, development and commercialization of therapies that address significant unmet medical needs in China. The Company has built a comprehensive ophthalmic drug pipeline of 25 candidates, comprising 13 innovative drugs and 12 generic drugs, that covers most major ocular indications affecting the front and the back of the eye, through either in-house development or in-licensing. The Company has developed internal capabilities in key aspects of ophthalmic drug development. The Company’s specialized in-house research, development, clinical and regulatory capabilities have enabled it to concurrently advance multiple innovative and generic drug candidates through the preclinical and clinical stages. The Company has established a commercial-scale advanced manufacturing facility, which is designed and built for ophthalmic drugs in compliance with cGMP requirements of China, the United States and the European Union. The Company is led by an international management team with decades of industry experience and a track record of research and development, clinical operations, manufacturing, regulatory communications, business development and commercialization of ophthalmic therapies.
Zhaoke Ophthalmology has received strong endorsement from blue-chip pre-IPO investors, including GIC, Hillhouse Capital, TPG, Loyal Valley Capital, Orbimed and Aier Eye Hospital. The Company recently completed its HK IPO with cornerstone investors including CaaS Capital, GIC, Golden Valley, Jennison, Mass Ave, Matthews Asia, OrbiMed and VMS Investment.
Issued by Porda Havas International Finance Communications Group for and on behalf of Zhaoke Ophthalmology Limited. For further information, please contact:
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