Medication already in use in Hong Kong may be approved in mainland China more quickly with the help of real world data harnessed by a research centre set to be established in collaboration with Shenzhen, the health minister has said.

The use of Hong Kong data showing the drugs’ effectiveness would speed up the approval process over the border, especially for medications for serious or rare diseases on the mainland, Secretary for Health Lo Chung-mau told the Post.

“This will be very influential,” he said, explaining the plan would benefit more patients. “Real world data are created when some drugs have been used preliminarily in clinical settings but are not registered yet. [The companies] can supplement data from clinical trials with the real world data and submit them to a regulatory authority.”

Lo said the research centre would be established under the Greater Bay Area International Clinical Trial Institute located in a new innovation and technology cooperation zone at the border.

The institute would be ready by the third quarter of this year at the earliest, the minister said.

Authorities earlier said the facility would act as a “one-stop clinical trial support platform for medical research institutions” and coordinate clinical trial resources in Hong Kong’s public and private healthcare sectors, including researchers, data banks and laboratories.

The government announced in its 2023 policy address its goal to develop Hong Kong into a health and medical innovation hub. Under the plan, authorities hoped to attract more pharmaceutical corporations to conduct research and development, and clinical trials in the city.

Lo said the research centre would mostly target Hong Kong-registered drugs that were approved for urgent clinical use at designated healthcare institutions in the Greater Bay Area under a measure introduced in collaboration with mainland authorities in 2021.

The bay area refers to Beijing’s plan to link Hong Kong, Macau and nine cities in Guangdong province into a hi-tech economic powerhouse.

He said only drugs for serious conditions and with few alternatives were accepted into the 2021 measure.

“While mainland authorities have not given its full approval, the drugs are allowed to be used among a certain group of people. Can we make use of the data derived from the usage under this special measure?” he said. “As we can prove its quality, safety and efficacy, in addition to the clinical trial data, the time required for approval can be shortened.”

He said the centre could also be beneficial to medications under the city’s Named Patient Programme, in which doctors can apply to use an unregistered drug for a specific patient with urgent needs.

Professor Ian Wong Chi-Kei, former head of the University of Hong Kong’s department of pharmacology and pharmacy, supported Lo’s plan, saying the centre could help pharmaceutical corporations save on the time required to conduct another clinical trial on the mainland.

He said there was a gap in data involving the Chinese population as clinical trials for most drugs were conducted in Western countries.

That gap could be filled by the centre using real world data in Hong Kong, Wong added.

“We have the local knowledge and connection, which is sufficient enough for international companies to come to us, as well as to convince regulators,” he said.

In 2020, Wong said his team helped an American pharmaceutical company apply to use one of its drugs on postmenopausal women with osteoporosis at high risk for fractures on the mainland, leveraging Hong Kong’s real world data.

“Hong Kong had been using the drugs for around five years so they did not need to run another clinical trial for five to six years to get approved,” he said. “Both the company and the mainland authorities were very happy about it.”

He suggested the research centre could serve as a platform to coordinate resources and streamline the data extraction process from public hospitals, given there might be more private companies helping pharmaceutical corporations write studies on real world data in the future.

Wong said the centre could also lead to more drugs being registered in Hong Kong, boosting the city’s development into a biomedical hub.