CUHK Clinical Trial Centre: Hong Kong’s early clinical research fast-tracked for approval and commencement

19 September 2025

The CUHK Clinical Trial Centre (CUHK CTC) has announced a breakthrough in the field of early clinical trials (Phase 1 clinical trials) in Hong Kong: it initiated a First-in-Human (FIH) clinical study in a short period, quickly completing approvals and recruiting the world’s first batch of Chinese patients.

The development fully demonstrates Hong Kong’s outstanding capabilities as an international clinical research hub to attract more pharmaceutical companies to conduct clinical research in the city, bringing new treatment options to patients and contributing to the city’s economic development.

This study, led by Professor Brigette Ma of the Department of Clinical Oncology, is developing cutting-edge innovative therapies for patients with advanced RAS gene mutated colorectal cancer, pancreatic cancer and lung cancer. The study obtained full approval from the Department of Health and the Ethics Committee in just two months, far surpassing the average approval time of six to nine months or longer for past Phase 1 clinical trials.

The CUHK Phase 1 Clinical Trial Centre also successfully recruited the world’s first two Chinese patients to participate in the FIH study on 8 and 16 July respectively. The recruitment time was significantly shortened compared to previous Phase 1 clinical trials.

The Clinical Trial Centre stated that the achievement was inseparable from the government’s committed support for and reforms of clinical research policies in recent years, as well as close collaboration among local institutions.

The company leading this clinical trial is supported by the Hong Kong government’s Office for Attracting Strategic Enterprises, which aims to attract leading international pharmaceutical companies to expand their operations in Hong Kong. Mr Peter Yan, the Director-General of the Office, stated: “We strive to facilitate the enterprises’ collaboration with local universities and research institutions, conducting clinical trials in Hong Kong to fully leverage research excellence.”

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