Chung Mei Biopharma Co Ltd (中美生技醫藥) yesterday inked a technology transfer agreement with the Development Center for Biotechnology (DCB, 生物技術開發中心) to commercialize DCB-BO130, a new botanical drug for melanoma, the most dangerous type of skin cancer.
The drug is made from extracts of Crassocephalum crepidioides, a common herb also known as fireweed.
The herb’s anti-inflammatory properties were discovered by Academica Sinica researchers, who passed their findings on to the center for further research, Chung Mei Biopharma chairman Lin Ben-yuan (林本源) said, adding that the transfer represents the nation’s biggest-ever technology transfer agreement.
The US Food and Drug Administration (FDA) on March 20 approved DCB-BO130’s phase 1b/2a clinical trials, the company said, adding that it plans to seek permission from local health authorities to begin clinical trials before the end of the year.
The drug is expected to gain New Drug Application approval from the FDA in the third quarter of 2024, the company said.
To speed up commercialization efforts, Chung Mei Biopharma is planning to apply for Orphan Drug Designation from the FDA next year to gain prioritized clinical trial reviews and other benefits such as tax exemptions and 10-year exclusivity, the company said.
In addition, Chung Mei Biopharma is to develop DCB-BO130 as a combination treatment for melanoma and develop supplement products based on the herb’s anti-inflammatory attributes, it said.
The company hopes to offer the drug at a more accessible price than existing melanoma treatments, which can cost from NT$100,000 to NT$1.28 million (US$3,315 to US$42,432) per month, it said.
Botanical drugs have significantly lower toxicity and less side effects than conventional, small-molecule drugs, and their market potential remains relatively untapped, DCB president and chief operating officer Lawrence Gan (甘良生) said.
The market for botanical drugs is expected to reach US$26.6 billion by the end of this year, while the market for melanoma treatments is expected to surge from US$1.34 billion to US$5.64 billion by 2023, Gan said.
Founded in 2014, Chung Mei Biopharma is an affiliate of Chung Mei Enterprise Group (中美集團), which is headed by its flagship unit, Chung Mei Pharmaceutical Co Ltd (中美兄弟製藥), a drug manufacturer that was founded in 1936 and produces Taiwan’s top-selling stool softeners and treatments for parasitic roundworm.
Lin, who is also president of Chung Mei Pharmaceutical, said that Chung Mei Biopharma is seeking to make its debut on the local bourse through its new drug development affiliate.
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