In the document, the contract manufacturing organisation (CMO) describes itself as a gateway to China’s “booming” biologics market adding that it plans to expand through in-house R&D and acquisitions.
The initial public offering (IPO) prospectus does not set an expected value or date for the move. However, it does show Wuxi Biologics generated revenue of RMB697m ($101m) in the nine months to September 30, which is up 91% on the comparable period in 2015.
The firm's profit for the nine months to the end of September was RMB136m, up from RMB9.7m generated in the first nine months of 2015. For comparison, revenue and profit in 2014 were RMB331m and RMB42m, respectively.
Customer base
In addition to sharing details of its finances, Wuxi Biologics’ IPO prospectus also gives potential investors a glimpse of the firm’s customer base.
Wuxi names AstraZeneca, Genentech, Momenta Pharmaceutical, Amicus Therapeutics and Johnson & Johnson as important non-Chinese customers. It also revealed that is works with Taiwan-based TaiMed Biologics, Israel’s OPKO Biologics, Hong Kong’s CStone Pharmaceutical.
The firm’s Chinese customer base includes Harbin Gloria Pharmaceuticals, Zhejiang Medicines Co and Chia Tia Tianqing Pharmaceutical.
Manufacturing growth
Wuxi Biologics manufacturing and development infrastructure consist of three sites: a facility in Wuxi that uses single-use disposable technology; a plant in Shanghai that focuses on drug discover; and a biosafety testing laboratory in Suzhou.
The firm is also expanding its Wuxi site to support protein and monoclonal antibody (mAb) drug production. The expansion will up capacity from 5,000L to 35,000L and is expected to be operational at the end of the year.
Wuxi also plans to add mammalian culture based manufacturing capacity at its Shanghai site in a project expected to start in June.
The IPO confirms speculation that Wuxi Biologics’ parent company Wuxi PharmaTech (Cayman) Inc. was planning to take the contract manufacturing organisation which emerged last February.
Chinese regulations
The IPO prospectus comes six months after China’s State Council started trialling a new drug marketing authorization holder (MAH) system (here in Chinese) that permitted some applicants to use contract manufacturing organisations (CMOs).
Current MAH rules require that applicants must own a GMP-compliant manufacturing company to make the drugs.
Under the pilot scheme – plans for which were announced in November 2015 – firm’s seeking approval in ten of the country’s 34 provinces have the option of hiring a CMO. The scheme is due to run until November 2018.