ScinoPharm Taiwan on Monday signed a manufacturing and clinical supply contract with TaiGen Biotechnology to provide the API for Burixafor, a potential stem cell treatment.
The API will be manufactured in ScinoPharm’s plant in Changshu, China, though terms of the deal were not disclosed. The plant, built for $133m last year , is apparently the first facility built in China under SFDA manufacturing standards from 2010.
Sabrina Wu, spokeswoman for ScinoPharm, told us that this is a "typical small molecule prepared by organic synthesis."
Burixafor is a stem cell treatment that aims to mobilize bone marrow stem cells and tissue precursor cells to the peripheral blood. It can be used in hematopoietic stem cell transplantation, chemotherapy sensitization and other ischemic diseases. TaiGen is conducting an ongoing Phase II clinical trial in the US, and the drug has received a Clinical Trial Application from China’s FDA for the initiation of a Phase II clinical trial in chemotherapy sensitization.
Burixafor’s annual sales are estimated at $1.1bn, according to the pharmaceutical consultancy company JSB.
According to Ming-Chu Hsu, chairman and CEO of TaiGen, “Burixafor is a 100% in-house developed product that can be used in the treatment of various intractable diseases. The cooperation between TaiGen and ScinoPharm will not only be a win-win for both sides, but will also provide high-quality novel drug for patients from around the world.”
TaiGen has other products in its pipeline and said it hopes to file one IND (investigational new drug) application with the US FDA every 3-4 years to expand its product line.
ScinoPharm currently has accepted over 80 new drug API process research and development plans, of which five new drugs have been launched in the market. In addition, six products have entered Phase III clinical trials. The Changshu plant’s operation is in line with the latest international cGMP plant equipment and quality management standards, the company said.
The company most recently signed on to manufacture topiramate for Maryland-based Supernus . Scinopharm also recently formed a joint venture with a Chinese CRO with the aim of simplifying outsourcing in China.
Jo Shen, president and CEO of ScinoPharma, said, “ScinoPharm’s Changshu Plant provides high-quality API R&D and manufacturing services through its fast, flexible, reliable competitive advantages, effectively assisting clients of new drugs in gaining entry into China, Europe, the US, and other international markets.”