Will produce Burixafor ingredient at its plant in Changshu, China
ScinoPharm Taiwan, a manufacturer of active pharmaceutical ingredients, has signed a contract with TaiGen Biotechnology for the clinical supply of the API of Burixafor, a new chemical entity discovered and developed by TaiGen.
ScinoPharm will manufacture the ingredient at its plant in Changshu, China.
Jo Shen, President and CEO of ScinoPharm said the cooperation was significant for the domestic pharmaceutical market and indicated that the Taiwanese industry's cumulative research and development momentum 'is paving the way forward'.
Ming-Chu Hsu, Chairman and CEO of TaiGen, added: 'The cooperation between TaiGen and ScinoPharm will not only be a win-win for both sides, but will also provide high-quality novel dug for patients from around the world.'
Burixafor can efficiently mobilise bone marrow stem cells and tissue precursor cells to the peripheral blood. It can be used in hematopoietic stem cell transplantation, chemotherapy sensitisation and other ischemic diseases.
The drug has received a Clinical Trial Application from China's FDA for the initiation of a Phase II clinical trial in chemotherapy sensitisation. ScinoPharm currently has accepted more than 80 new drug API process research and development programs, of which five new drugs have been launched and six products have entered Phase III clinical trials.
The latest international cGMP plant equipment and quality management standards have been installed at the Changshu plant, enabling the company to provide customers with one stop shopping services in R&D, manufacturing and outsourcing, thereby shortening the product development cycle and accelerating the launch of products to the market.
Besides Burixafor, TaiGen is developing the anti-infective, Taigexyn, and an anti-hepatitis C drug, TG-2349. The company hopes to file one IND with the US FDA every three to four years to expand its product line.