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Japanese drugmakers to start commercial production of new biological medicines

  • January 7, 2016
  • , Nikkei , p. 11
  • JMH Translation

Japan’s leading pharmaceutical firms are planning to start commercial production of biological medicines, which are expected to prove more effective and have fewer side effects than conventional drugs. Daiichi Sankyo will invest several billions of yen to build a production line for anticancer drugs, while Takeda Pharmaceutical will start in-house production of its core new biological medicines within the year. Japanese drugmakers have long prioritized investment in research and development, but they will shift more money into production facilities to turn out new biological medicines that are expected to treat diseases that conventional drugs cannot handle.


To roll out new biological medicines, Daiichi Sankyo will build a production line for raw pharmaceutical ingredients in its Tatebayashi plant in Gunma Prefecture. It has been developing drugs to treat stomach and breast cancer and will seek approval for production and sales by 2020.


The drugs will become Daiichi Sankyo’s first products to be developed in-house. They outperform conventional drugs in attacking cancer cells. The firm’s clinical studies showed that they proved more effective than conventional drugs when administered for stomach and breast cancer patients.


The Tatebayashi factory is currently producing experimental new drugs to confirm their safety and efficacy. Daiichi Sankyo will invest money to turn the Tatebayashi plant into one capable of commercial production. Construction of a new production line will begin in fiscal 2017. It will increase production as soon as it wins the approval. Investment, which includes construction of a new building, is estimated to total several billion yen.


Takeda will start in-house production of its core biological medicines with the year, driven by brisk sales of a new biological drug for ulcerous colitis. It has been outsourcing the production, but it is concerned that it may not able to secure outsourcees in the future due to rising global demand for biological medicines. It will establish a system in which it can meet increased demand and supply products on its own.  


Takeda has installed production equipment in its Hikari factory in Yamaguchi Prefecture. Commercial production will begin after regulatory authorities from the U.S. and Europe, the main destinations of drugs, complete the inspection of the firm’s manufacturing processes. (Abridged)

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