Our first pipeline Neu-001,Neu-001, an innovative first-in-class small-molecule drug for treating amblyopia (commonly known as lazy eye), has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA). This milestone achievement was unveiled at a press conference held on December 17 at the Hong Kong Science Park, marking the first FDA approval for a novel chemical drug developed under Hong Kong’s prestigious InnoHK research platform.
The press conference was hosted by Professor Guangjin Pan, Director of the Centre for Regenerative Medicine and Health, Hong Kong Institute of Science & Innovation, Chinese Academy of Sciences. Key attendees at the event included Ms Lillian Cheong Man-lei, JP, Under Secretary for Innovation, Technology and Industry, HKSAR Government; Professor Anderson Shum Ho-Cheung, Vice-President (Research) of the City University of Hong Kong; Ms Yan Wu, Deputy Director-General of the Bureau of International Cooperation, Chinese Academy of Sciences; and Mr Albert Wong, Chief Executive Officer of the Hong Kong Science and Technology Parks Corporation (HKSTP).
This FDA approval represents a significant step forward in the treatment of amblyopia. This important milestone also paves the way for the next phase of Neu-001’s development, with Phase I clinical trials scheduled to commence by mid-2025. The trials will follow a multi-center design, simultaneously conducted across various locations including Hong Kong and Guangzhou. This advancement marks a crucial step toward the ultimate goal of bringing Neu-001 to market, offering new hope for patients affected by amblyopia.
“Founders of NeuDirection Prof. Micky Tortorella (left) and Prof. Jufang He (right) announcing milestone FDA IND approval for Neu-001: A breakthrough moment in amblyopia treatment development”