Sunhawk Vision’s Ophthalmic Drug SHJ002 was designated an Index Case by Taiwan FDA and Center for Drug Evaluation. This recognition will facilitate fast-track approval pathway and expedite market entry.
Sunhawk Vision has successfully passed the evaluation by the TFDA for its innovative ophthalmic drug currently under development, SHJ002, and has received official approval for its inclusion in the Drug Project Regulatory Counseling Program.
Through this government-established counseling mechanism, promising new drug development projects are facilitated in engaging directly with professional regulatory review authorities, thereby enhancing the efficiency of R&D and regulatory submission planning. Sunhawk Vision simultaneously proceeding with the contract signing process with the Center for Drug Evaluation (CDE), aiming to leverage this mechanism to accelerate the clinical development and regulatory strategy planning for SHJ002.
