The Chinese University of Hong Kong Clinical Trial Centre (CUHK CTC) has announced a breakthrough in the field of early clinical trials (Phase 1 clinical trials) in Hong Kong. With policy support from the government in recent years, the Phase 1 Clinical Trial Centre under the CUHK CTC has successfully 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. This fully demonstrates Hong Kong’s outstanding capabilities as an international clinical research hub, attracting more pharmaceutical companies to conduct clinical research in the city, bringing new treatment options to patients and contributing to Hong Kong’s economic development. The company leading this clinical trial is supported by the Hong Kong government’s Office for Attracting Strategic Enterprises (OASES), which aims to attract leading international pharmaceutical companies to expand their operations in Hong Kong.

This study is developing cutting-edge innovative therapies for patients with advanced RAS gene mutated colorectal cancer, pancreatic cancer and lung cancer. The study, led by Professor Brigette Ma, Professor in the Department of Clinical Oncology at CUHK’s Faculty of Medicine (CU Medicine), highlights Hong Kong’s efficiency in clinical research.

• Unprecedented approval speed: 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. This demonstrates a significant acceleration and flexibility in Hong Kong’s medical approval processes.
• Global first Chinese patients enrolled: The CUHK Phase 1 Clinical Trial Centre successfully recruited the world’s first two Chinese patients to participate in this critical FIH study on 8 and 16 July, respectively. The time required for patient recruitment was also significantly shortened compared to previous Phase 1 clinical trials.
• CUHK’s leadership and excellence: The exceptional leadership and operational efficiency of Professor Ma and her team at the CUHK Phase 1 Clinical Trial Centre were key to this success. This achievement highlights CUHK’s powerful capabilities and agility in early clinical research, further solidifying Hong Kong’s position as a hub for medical expertise.

Hong Kong’s advantages in clinical research development and the contributions of CUHK CTC

The CUHK CTC stated that this groundbreaking achievement is 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 government has created unprecedented advantages for Hong Kong clinical research by introducing multiple policies, including the establishment of the Greater Bay Area International Clinical Trial Institute. At the same time, the Hospital Authority has also cooperated by establishing the Central Clinical Research and Innovation Office and Cluster Clinical Research Support Offices in various clusters to provide support for frontline healthcare professionals, effectively streamlining research processes and accelerating approval procedures and times. This policy, combined with the outstanding capabilities of the CUHK CTC, is the key to the centre’s ability to efficiently complete the FIH clinical trial and successfully recruit the world’s first batch of Chinese patients.

Since its establishment, the CUHK CTC has been committed to promoting high-quality and efficient clinical research. The centre’s Phase 1 Clinical Trial Centre has an experienced, multi-disciplinary professional team with comprehensive capabilities to conduct clinical trials from Phase I to IV. With advanced laboratory facilities, a rigorous quality management system and extensive cooperation with top academic institutions and pharmaceutical companies worldwide, the CUHK Phase 1 Clinical Trial Centre has successfully completed numerous internationally influential clinical studies, including multiple global or regional first-patient-enrolled projects, accumulating valuable experience for the development and clinical application of new drugs worldwide. This wealth of experience and these outstanding achievements enable the centre to quickly respond to the latest global research needs, ensuring that research projects can be promoted efficiently and precisely.

Greater government support expected to attract global pharmaceutical companies to Hong Kong

The successful initiation of this FIH clinical study provides compelling evidence that Hong Kong can secure more high-end medical R&D investment. CUHK CTC earnestly hopes that the Hong Kong government will continue to increase its support for clinical research, especially by providing more attractive incentives at the policy level to attract top pharmaceutical companies from around the world to conduct clinical research in Hong Kong. This includes but is not limited to providing more competitive R&D funding and tax incentives, establishing an effective patient recruitment system and accelerating the subsequent registration and application of drugs. This will help Hong Kong consolidate its position as an international clinical research hub, accelerate the R&D and transformation of new drugs globally, and make greater contributions to the city’s innovation, technological development and human health and well-being.

The CUHK CTC will continue to play a leading role in medical research in Hong Kong and looks forward to working with more local and international partners to jointly promote the development of clinical research in the city.

The Office for Attracting Strategic Enterprises (OASES) was established by the Hong Kong government in 2022 and is responsible for attracting representative and high-potential strategic enterprises from around the globe. Mr Peter Yan, the Director-General of the OASES, stated: “Life and health technology is an industry of strategic importance. Many of the enterprises we introduce are industry leaders with world-class research and development capabilities and innovative potential. We strive to facilitate their collaboration with local universities and research institutions, conducting clinical trials in Hong Kong to fully leverage research excellence.”

About CUHK CTC

The CUHK CTC is committed to promoting high-quality clinical research, covering trials from early to late stages. The centre has an experienced professional team and top-notch research facilities, aiming to provide a leading research platform for the development of global drugs and medical technologies, and is committed to enhancing Hong Kong’s influence in the clinical research field globally.

CUHK Phase 1 Clinical Trial Centre