Casi to create ‘key asset’ manufacturing facility in China
Casi Pharmaceuticals continues its push into the Chinese market with plans to develop a manufacturing facility in Jiangsu Province, China.
The firm has already in-licensed three US Food and Drug Administration (FDA) approved products from Spectrum Pharmaceuticals specifically for China. It also holds a Beijing-based subsidiary and R&D operations in the country.
A spokesperson for Casi told us the facility will take three to five years to complete construction work, receive FDA approval and then scale up production.
“The project will be completed in phases. For the first phase, we expect to file with the FDA for changing manufacturing site approvals of our first key ANDA (abbreviated new drug application) product in two years,” the spokesperson continued.
Construction of the facility will begin in mid-2019 and the firm said in a statement that it will be “a key asset supporting Casi’s growth and commercialisation plans with further agreements to be finalised”.
In terms of the cost of the facility, the company will invest $21m (€18.4m) and will receive $20m from an undisclosed “joint venture partner”, the spokesperson said.
It will also invest several ANDA products into the joint venture, which the company values at, or above, $30m.
The spokesperson was unable to confirm which products will be produced at the site but said that the company is “evaluating the market potential” of 30 ANDA products to be produced at the site – with China and the US the intended markets.
At the beginning of the year, Casi acquired a portfolio of 25 ANDA products from Sandoz, a subsidiary of Novartis, with the intention of producing these assets for the Chinese market.
