University scientists in Hong Kong get rare US approval for clinical trials of new Chinese medicine

Baptist University’s Centre for Chinese Herbal Medicine Drug Development (CDD) on Sunday said the decision was a major landmark that could lead to its treatment breaking into the global market.

Professor Bian Zhaoxiang, the university’s associate vice-president and the director of the clinical division of the School of Chinese Medicine, said the US trials, approved by the Food and Drug Administration (FDA), would start later this year.

“Authorisation from the FDA is a milestone in the development of Chinese medicine in Hong Kong,” Bian, also the director of the CDD, told the Post.

“The US has an authoritative position in terms of drug approvals. In many cases, the drug will get approved in other countries after being approved in the US. It will help internationalise the medicine.”

Bian said it was hoped to introduce the new medicine, CDD-2101, to the US market in four to six years.

He added no Chinese medicine had been approved by the FDA to be sold in the US market and no more than eight had been approved for clinical trials.

The main ingredients include hemp seed, rhubarb, officinal magnolia bark, bitter apricot seed, bran stir-fried immature orange fruit, and white peony root.

Bian’s team began work to refine the original MaZiRenWan formulation in 2020 with government funding.

The scientists submitted a trials application in collaboration with the University of Chicago and the University of Macau to the FDA in March and got approval a month later.

The first phase of the clinical trial will involve 20 healthy patients in the US and is expected to be completed by 2024.

The second phase will collect safety and effectiveness information from patients with chronic constipation.

The final study will be a large-scale effort to evaluate the medicine’s usefulness and to look for any unanticipated side effects.

Bian said studies had shown that around 14 per cent of people around the world suffered from chronic constipation.

He added that about half of the medicines in the US designed to tackle constipation were ineffective and 60 to 70 per cent of patients were dissatisfied with their treatments.

“It proves that there are clinical needs for new medicines. The available drugs are not able to fulfil the patients’ needs,” Bian said. “We think it is a very good opportunity for Chinese medicine.”

Bian said MaZiRenWan had historically been one of the most widely used Chinese medicines used to treat constipation.

He explained the new formulation was easy to administer with good quality control, an effectiveness of seven to eight weeks per prescription and similar effects as first-line Western treatments.

He said the drug could be given to patients by prescription from Western doctors or Chinese medicine practitioners.

Bian said his team had worked hard to ensure the quality of the medicine – which has a complex mix of active ingredients – met FDA standards.

“The quality of the herbs used in the medicine can differ according to their source and the season that they are harvested,” Bian said.

“But when we are developing a drug with the herbs, we need to set appropriate quality standards.

“Our medicine has six herbs and each of them contains around 1,000 ingredients. How we conduct quality control of these six herbs to ensure each batch of medicine has the same quality is the most challenging part.”

Bian said the team had also consulted a former adjudicator from the FDA, experts from mainland China and directors of pharmaceutical companies.

He added research and development of Chinese medicine in Hong Kong could benefit from the backing of the mainland, government support and the academic experience of research teams.

“We hope that Chinese medicine can go beyond Hong Kong and China,” he said.

“MaZiRenWan is the treasure of Chinese medicine. How can we turn it into a treasure of the world?

“We need a process of internationalisation.”