China’s new Marketing Authorization Holder (MAH) program, which allows drugmakers to contract production instead of building their own plants, appears to have set off a biologics production race of sorts, leading CMOs in China to invest hundreds of millions in new plant projects.
China’s WuXi Biologics said on Wednesday that it would build an R&D and clinical and commercial production center in Shijiazhuang that will eventually employ 1,000 workers.
The company will invest $240 million in the new facility, which will have 48,000 liter bioreactor capacity. Work is to begin next year and the first phase completed in 2020.
“We are very pleased to establish the largest biologics center in northern China, which will enable local companies to more effectively develop and manufacture biologics and in the meantime provide a robust supply chain network for our global clients,” said WuXi CEO Chris Chen in a statement. “This expansion will allow us great access to local talents, markets and government support."
WuXi already has seven manufacturing facilities in the country, including one that it boasts is the largest single-use bioreactor manufacturing facility in the country. The plant in Wuxi City has about a 30,000 liter bioreactor capacity.
Its latest announcement comes just days after China's Shandong Sinobioway Biomedicine Co. said it will invest $471.6 million by 2023 on a biologics manufacturing facility that eventually will have 500,000 liters of capacity. The Sinobioway facility, which is slated to 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 wonder how the companies can generate enough business to fill all of that planned capacity, both companies cited China’s new Marketing Authorization Holder program. The test program allows drugmakers to contract out manufacturing. In the past, approval required that manufacturing be handled by the drugmaker.
Most Big Pharma players have already built their own biologics plants to produce drugs in the country but the new regs removed a huge financial burden from smaller players. When the pilot program was announced in 2016, the Ropes & Gray law firm advised drugmakers and contractors to take advantage.
"The MAH system demonstrates China’s strong momentum to unleash innovation in the pharmaceutical sector," the law firm said. "Both local and foreign players should consider leveraging the regulatory flexibility of the pilot program to acquire or spin off assets and to utilize GMP-certified contract manufacturing arrangements. Contract manufacturers are also advised to revisit potential opportunities in the Chinese market."
The regulatory shift has drawn players from outside as well as inside China. Germany’s Boehringer Ingelheim is among those. Last year it opened a biologics plant with one single-use bioreactor, but the plant was designed to install additional 2000-L single-use bioreactors and fill/finish capabilities if demand calls for that.
WuXi’s has found demand robust for its facilities. CEO Chen pointed out the company already is working on dozens of biologic drugs for clients.
"With this investment and current 161 biologics programs that WuXi Biologics will manufacture, we will quickly and cost-effectively expand our manufacturing capacity to meet our partners' needs and become one of the global CMO leaders."
In March it won FDA approval to produce a novel HIV med for Taiwan-based TaiMed Biologics at its original plant for cell-based drugs near Shanghai. While WuXi figures many of its clients will be domestic drugmakers, it also is looking to draw in global players.
It is so confident of its capabilities that it is now building a facility in Europe to address the European market directly. The €325 million ($392 million) biologics facility in Dundalk, Ireland, its first outside of China, is slated to be complete in 2021 and to employ 400 workers.