The Hong Kong Baptist University Traditional Chinese Medicine Innovation and Development Center (HKBU Traditional Chinese Medicine Innovation and Development Center) has previously conducted research on the ancient Chinese medicine formula "Mazi Ren Wan" and developed a new Chinese medicine compound for the treatment of refractory constipation. The experimental new drug application submitted by the center to the US Food and Drug Administration (FDA) for this drug has been approved and will begin the first phase of clinical trials in the United States this year.
At a press conference held in Hong Kong on the 25th by the Innovation and Research Center for Traditional Chinese Medicine at Baptist University, the reporter received the above information. This is also the first time a new drug based on Chinese herbal medicine has been developed in Hong Kong and approved for clinical trials in the United States.
It is understood that the first phase of clinical research on the compound new drug will begin within this year. The research and development team will recruit 20 healthy individuals in the United States to participate in a randomized, double-blind, and placebo-controlled manner to evaluate the safety, tolerability, and pharmacokinetics of the drug. The team is expected to take three to five years to complete the second and third phases of clinical research, and will then submit a new drug registration application to the FDA.
Bian Zhaoxiang, Associate Vice President of Baptist University (Development of Traditional Chinese Medicine) and President of Traditional Chinese Medicine Innovation and Research Center, stated that traditional Chinese medicine compound therapy has a good clinical effect in treating constipation, but it has not been recognized by the international market. This drug has been approved by the FDA for clinical trials, which is a full affirmation of the development of traditional Chinese medicine in Hong Kong and also builds confidence in the development of traditional Chinese medicine in Hong Kong.
Bian Zhaoxiang continued that integrating the advantages of mainland China and Hong Kong in the development process of traditional Chinese medicine products is very important for promoting the internationalization of traditional Chinese medicine. I hope to leverage the platform of the Traditional Chinese Medicine Innovation and Research Center to further cooperate with other regions in the mainland and globally in the development of traditional Chinese medicine products.
The President of Baptist University, Wei Bingjiang, stated that in 2020, Baptist University was funded by the "InnoHK Innovation Hong Kong R&D Platform" from the Hong Kong Innovation and Technology Department to establish a Traditional Chinese Medicine Innovation and Research Center, greatly enhancing the comprehensive strength of Baptist University's traditional Chinese medicine research and development. This approval to conduct clinical trials in the United States will provide more valuable experience for the future.
At a press conference held in Hong Kong on the 25th by the Innovation and Research Center for Traditional Chinese Medicine at Baptist University, the reporter received the above information. This is also the first time a new drug based on Chinese herbal medicine has been developed in Hong Kong and approved for clinical trials in the United States.
It is understood that the first phase of clinical research on the compound new drug will begin within this year. The research and development team will recruit 20 healthy individuals in the United States to participate in a randomized, double-blind, and placebo-controlled manner to evaluate the safety, tolerability, and pharmacokinetics of the drug. The team is expected to take three to five years to complete the second and third phases of clinical research, and will then submit a new drug registration application to the FDA.
Bian Zhaoxiang, Associate Vice President of Baptist University (Development of Traditional Chinese Medicine) and President of Traditional Chinese Medicine Innovation and Research Center, stated that traditional Chinese medicine compound therapy has a good clinical effect in treating constipation, but it has not been recognized by the international market. This drug has been approved by the FDA for clinical trials, which is a full affirmation of the development of traditional Chinese medicine in Hong Kong and also builds confidence in the development of traditional Chinese medicine in Hong Kong.
Bian Zhaoxiang continued that integrating the advantages of mainland China and Hong Kong in the development process of traditional Chinese medicine products is very important for promoting the internationalization of traditional Chinese medicine. I hope to leverage the platform of the Traditional Chinese Medicine Innovation and Research Center to further cooperate with other regions in the mainland and globally in the development of traditional Chinese medicine products.
The President of Baptist University, Wei Bingjiang, stated that in 2020, Baptist University was funded by the "InnoHK Innovation Hong Kong R&D Platform" from the Hong Kong Innovation and Technology Department to establish a Traditional Chinese Medicine Innovation and Research Center, greatly enhancing the comprehensive strength of Baptist University's traditional Chinese medicine research and development. This approval to conduct clinical trials in the United States will provide more valuable experience for the future.