Japanese firms form monoclonal antibody manufacturing JV with an eye on biosims

By Gareth Macdonald contact

- Last updated on GMT

Desire for Made in Japan biologics prompt Niigata-based mAb JV (iStock/.kanuman)
Desire for Made in Japan biologics prompt Niigata-based mAb JV (iStock/.kanuman)

Related tags: Monoclonal antibody, Monoclonal antibodies

Mitsubishi Gas Chemical and Nippon Kayaku have said they will start making monoclonal antibody drugs at a site in Niigata, Japan within two years.

The firms formed Cultivecs - a biopharmaceutical joint venture - this month, explaining that the plan is to develop therapeutic antibody products and biosimilars and provide contract manufacturing services for such products.

Manufacturing operations will be based at Mitsubishi’s facility in Niigata using technology and knowhow gained from the firm’s 2014 collaboration with GlycoNex.

Nippon Kayaku entered the biologics space in 2010​ when it teamed up with Korean firm Celltrion to develop a infliximab biosimilar. The product was approved in Japan in 2014.

A year later Nippon and Celltrion started development of a trastuzumab biosimilar.

Mitsubishi Gas Chemical and Nippon Kayaku – which share ownership of Cultivecs 55%/45% - cited Japan’s dependence on imported monoclonal antibodies as the main motivation for establishing local production capacity.

The growth of biologics, particularly monoclonal antibodies, is very prominent in domestic and global pharmaceutical markets.

Japan is highly dependent on import of biologics, which is estimated to exceed $5bn every year” ​they continued, adding that “Made-in-Japan biologics of high quality with stable supply security system are highly required​.”

Cultivecs will also develop and manufacture biosimilars according to Mitsubishi Gas Chemical and Nippon Kayaku.

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