China's Sinobioway Biomedicine says it will invest nearly $500M in massive biologics site

Flag of China
A Chinese CDMO thinks it can grab a major piece of the contract market that is brewing now that the country has made it easier for drugmakers to get approval for biologic drugs. (daderot/Wikimedia Commons)

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.

Sponsored by Lubrizol Life Science

[Webinar] Cannabinoid Formulation - from Farm to Pharma

Wednesday, June 24, 2020 | 12pm ET / 9am PT

A handful of cannabinoid-based pharmaceutical products are on the market today, and an ever-growing number are in the global development pipeline. This webinar will explore key considerations in developing cannabinoid-based pharmaceutical products, including an overview of global pharmaceutical cannabinoid usage today, common challenges formulating with CBD and other cannabinoids, and more.

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.

RELATED: China pilot eyes easier marketing authorization 

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.

Suggested Articles

Maryland-based Emergent BioSolutions has won a $628 million contract with BARDA to manufacture targeted COVID-19 vaccine hopefuls.

About 76% remdesivir patients had at least one point of clinical improvement on a 7-point scale at day 11, versus 66% of patients on standard care.

Alexion and Amgen reached a deal to put off a biosimilar challenger to Alexion's blockbuster rare disease med Soliris until March 2025.