Betting heavily on a less-regulated CMO market, a Chinese company intends to build a massive biologics plant over the next several years to tap into what it predicts will be the country’s rapid move to cell-based drugs.
China's Shandong Sinobioway Biomedicine Co. says it will invest $471.6 million by 2023 on a biologics manufacturing facility that eventually will have 500,000 liters of capacity. In an April filing (PDF), it said construction would begin in mid-April and that the turnkey construction project would be completed in about 18 months. The first phase financing of 280 million yuan comes from a recent public offering the company undertook. It said it would invest another 500 million yuan ($79.9 million) in 2019 and another 1 billion yuan in 2020.
By comparison, the recently completed campus of China’s WuXi Biologics, which claims to have the largest single-use biomanufacturing facility in the country, invested $150 million and has 30,000 liter capacity.
The Sinobioway facility, which will be built on a 15,404 square meter site at the Sinobioway biomedical industry park in Anhui, will include labs, storage and quality control areas, as well as bioreactor capacity.
While some in the industry wondered how the CDMO would generate enough business to fill all of that capacity, Sinobioway's filing references the MAH program that China launched in 2016. The pilot program allows drugmakers to rely on trials conducted outside of China to gain approval and permits them to contract out manufacturing. In the past, approval required that at least part of the trials be conducted in China and the manufacturing be handled by the drugmaker to get approval.
Under a heading in the filing that when translated reads: “Follow the new market opportunities and share the hot industry feast,” Sinobioway Biomedicine projected that China’s CMO market is currently worth about $35 billion, and will reach $50 billion by 2020.
Shandong Sinobioway Biomedicine Co. is a subsidy of China’s Sinobioway. Another of its units, Sinobioway Biomedicine, recently became embroiled in a boardroom fight to gain control of Chinese vaccine maker Sinovac Biotech.