CMC Contract Manufacturing Outsourcing Expansion

We, Bushu Parmaceuticals (“Bushu”), has been engaged in the pharma contract manufacturing business with domestic and foreign pharmaceutical companies in Japan as the largest independent CMO in Japan. Each day we strive to meet the needs of our customers through the contract manufacturing of commercial drugs and to ensure the highest quality service at the same time. As background, over the past ten years, the need for contract manufacturing by pharmaceutical companies has increased, and we Bushu has benefited from this increase in demand.

However, the trends in the CMO industry have started to change over the last few years due to the external environment, particularly the declining trend of the market for long-term listed drugs. The urgent need for each company is to establish and implement its own strategy. In this context, Bushu has recently reached an agreement with Takeda Pharmaceutical Company Limited (hereinafter referred to as “Takeda Pharmaceutical”) for and partnership in the CMC business area which represents a key element of our core strategy.

The partnership is important for Bushu given the existing CMO relationship with Takada Pharmaceuticals. Through this relationship with Takeda, expect to further refine our techniques through contract services and then expand the CMC-related business with a wide range of other customers in the medium term to contribute to the development of the pharmaceutical industry. Specifically, Bushu will be transform into a one-stop shop CDMO that can offer the entire CMC services from the initial stages of drug development to the approval, application, and launch (process development, formulation design, development of testing methods, manufacturing of clinical trial drugs, new drug approval, application, and auxiliary services, etc.). Bushu is confident that we can respond to better meeting the needs of a wider range of customers through this partnership. Thus Bushu will provide full scope services through the value chain, from drug development to drug manufacturing, instead of conventional contract service involving only manufacturing, packaging, and testing of clinical trial and commercial drugs.

Furthermore, through this partnership nearly 200 employees, including world-class process chemists and specialists in formulation and analysis who have been engaged in CMC activities for many years and who have acquired valuable experience, will pay a major role moving forward. The personnel who are well versed in new drug approval applications in the United States and other countries will support customers’ rapid drug development. Additionally, we will meet customer needs in various fields and in various volumes scales with a full lineup of equipment and devices, including synthesis–related equipment for drug substance process development, cutting-edge manufacturing facilities that can cope with highly potent solid dosages and injectables, and analytical equipment, as well as with our reliable technology.

Through this partnership, the scope of our technology will expand significantly and we will raise our technological capabilities. Bushu will continue to grow to provide enhanced services of an even higher quality for a wider range of customers, including all pharmaceutical companies and Japanese and foreign venture companies, including existing customers. We look forward to our continued business relationships in the future.