The Centre for Chinese Herbal Medicine Drug Development of Hong Kong Baptist University (HKBU) has received the orphan drug designation from the US Food and Drug Administration (FDA) for its new Chinese medicine drug, CDD-2107.
The medicine is made using effective components of a Chinese herbal medicine, Chaenomelis Fructus, to treat a rare disease, myofibrillar myopathy.
According to HKBU, CDD-2107 is the first botanical drug in Hong Kong to receive this designation.
The university believes that the orphan drug status will accelerate the approval procedure of the drug.
This includes expediting the review process, waiver of the marketing authorisation charge, and seven years of market exclusivity for the authorised drug.
HKBU’s research team aims to file an Investigational New Drug application to the US FDA in two years to conduct clinical studies.
Centre for Chinese Herbal Medicine Drug Development director and associate VP Bian Zhaoxiang said: “CDD-2107 is the fruit of the integration of Chinese medicine theory and modern technology.
“Receiving the orphan drug designation by the FDA for CDD-2107 is an encouraging milestone and recognition of our team’s dedication to scientific innovation.”
“We plan to submit an Investigational New Drug application in two years, which will be a crucial milestone in establishing CDD-2107 as an internationally recognised, safe, and effective treatment for Bag3opathy.
“Our ultimate goal is to obtain FDA approval for selling CDD-2107, benefiting more patients.”
Currently, myofibrillar myopathy has no viable treatment and patients are severely impacted by the enormous expense of care.
The researchers are currently investigating and assessing potential therapy modalities.
The Centre for Chinese Herbal Medicine Drug Development developed CDD-2107 by focusing on myofibrillar myopathy caused by BAG3 gene mutation.
HKBU said the centre referred to clinical cases and integrated Chinese medicine theory with modern scientific technology.
