Celltrion's Wuhan Plans on Hold Amid Coronavirus Outbreak

Being the epicenter of the coronavirus outbreak has not been auspicious for Wuhan’s ambitions in the global biosimilars market. The region is now part of a massive coronavirus quarantine implemented by the Chinese government and also by global private and public sector institutions that are pulling back out of caution.

In recent years, Wuhan has figured broadly into China’s ambitions for a large share of the rapidly growing biosimilars market.

In late January, Incheon, Korea-based company Celltrion announced plans to build its first overseas manufacturing plant in Wuhan. The company forecast an April groundbreaking for the $514 million biologics plan, which would manufacture drugs for the Chinese market and do contract manufacturing for other companies.

“While we remain strongly committed to the project, it is difficult to say how the ongoing outbreak will affect our plans at this moment,” said company representative Taegyun Kim, in response to a query from The Center for Biosimilars^®.

“We are closely monitoring the situation and will continue to communicate with the officials of Hubei province,” Kim said.

The company has recalled its employees from Wuhan until the outbreak is brought under control, as have many other outside companies and government agencies with workers in the Chinese market affected by the coronavirus.

Kim said each of Celltrion’s recalled employees has undergone a medical checkup, and none appear to have contracted the virus. They have been back in Korea since January 21. Until conditions in Wuhan stabilize, the factory development will be managed from the company’s Korea base of operations, he said.

As the epicenter of the coronavirus outbreak, Wuhan, a city of 11 million, is being watched closely. Media have reported that hospitals are overwhelmed with patients and government-imposed restrictions on mobility have brought the city to a virtual standstill.

Wuhan is already home to a JHL Biotech biosimilars manufacturing plant that began development in 2013.

Constructed in partnership with GE Healthcare Life Sciences, the JHL Biotech factory was designed for the production of biosimilars and monoclonal antibodies for late-stage clinical trials and commercial supply.

After completion, the JHL Biotech plant was considered the largest such plant in Asia, with 2400 square meters of floor space and bioreactors with 2000-liter-capacity single-use bioreactors. Celltrion’s factory would eclipse that with a 120,000-liter capacity.

Recognizing huge market potential for oncology medicines, China has sought to develop this aspect of its pharmaceutical market. A report in April 2019 by McKinsey and Company predicted year on year biosimilar market growth in China of 20% to 25%. It said the biosimilar market in China would reach $8.1 billion in size by 2025, up from $2 billion in 2018.

There is enormous room for growth in the biologics market in China, based on statistics from McKinsey and Company. The report said 20% to 25% of patients with breast cancer are treated with biologics, versus 70% of patients with breast cancer in the United States.

It said fewer than 10% of patients with colorectal cancer are treated with biologics in China, as opposed to 55% of this population in the United States. For rheumatoid arthritis, the corresponding shares are less than 5% and 25%, the report said.

Last year, through an agreement with 3SBio, a Chinese biotech, Samsung Bioepis launched plans to expand its biosimilar business into mainland China. The agreement covered biosimilar candidates from Samsung Bioepis, including SB8, which references Roche’s oncology drug Avastin (bevacizumab).

3SBio specializes in oncology, autoimmune diseases, nephrology, metabolic diseases and dermatology.

In early January 2020, Samsung Bioepis and AffaMed Therapeutics announced that the China National Medical Products Administration (NMPA) had cleared the start of a phase 3 trial for SB12, a biosimilar eculizumab referencing Soliris.