Zhaoke Ophthalmology Ltd. Announces NMPA Acceptance of New Drug Application for NVK002 to Combat Myopia Progression in Children

Reuters
09 Jul
Zhaoke Ophthalmology Ltd. Announces NMPA Acceptance of New Drug Application for NVK002 to Combat Myopia Progression in Children

Zhaoke Ophthalmology Ltd. has announced that the National Medical Products Administration (NMPA) of China has accepted the New Drug Application (NDA) for NVK002 (Atropine Sulphate Eye Drops 0.02%) for the treatment of myopia progression in children. This acceptance marks a significant step in the regulatory review process for this innovative drug, which is being reviewed as a Class II innovative drug. Previously, an Abbreviated New Drug Application (ANDA) for a 0.01% formulation of the same drug was also accepted by the NMPA. The company aims to address the growing issue of myopia among children and adolescents in China, with this development aligning with the national health objectives outlined by the Chinese government.

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