Microbio received TFDA New Drug Administration (NDA) approval for Herbiron for the treatment of primary dysmenorrhea and iron-deficiency anemia. Microbio plans to launch Herbiron as an OTC in the third quarter of this year.
The Chairman of Microbio, Dr. Willie Lin said in a statement that Herbiron is a self-developed proprietary drug protected by Taiwanese and World patents. Dr. Lin also pointed out that the Phase III clinical trial shows that Herbiron can improve primary dysmenorrhea and iron-deficiency anemia for women between ages 12 to 55 years old. Herbiron significantly elevated serum hemoglobin (*p<0.0001), red blood cell volume, and serum ferritin level. Lin added that reportedly, 5 million of Taiwanese women suffers from menstrual-related symptoms and discomfort, and Herbiron is targeting these population, and based on a 5% market penetration, Herbiron is for a market potential up to 700-800 million TWD annually.
The TFDA has issued four new drug approvals up to date, and Microbio obtained two approvals with Chemo Young and Herbiron. In addition, Microbio and its subsidiary company Oneness biotech has two other drugs in Phase III clinical development. MB-6 is designed to treat colorectal cancer in combination with chemotherapy and ON101 aims to combat diabetic foot ulceration. Oneness Biotech also plans to bring another drug candidate, OB318, to clinical development this year, for treatment of hepatic cancer.
In addition, Fountain Biopharma, another subsidiary company of Microbio group, specializes in the development of monoclonal antibody new drugs for autoimmune diseases. Fountain Biopharma is completing the preclinical studies of FB825 and FB704A to treat severe asthma and rheumatoid arthritis, respectively. Together, the Microbio is becoming an influential player in the pharmaceutical industry of Taiwan.