Global Business
In order to deliver pharmaceuticals discovered and developed by our company to patients around the world, we are building a system that enables us to develop and market our own products on a global basis. In recent years, we have been strengthening our global pipeline not only for our own products but also for globally in-licensed products. First, we are working on products in niche areas that do not require a large sales organization, with the aim of selling them ourselves overseas.
Steps for Growing as a Global Company
We have defined three steps that will transform us into a global company. Currently, we are in step two working to establish our own marketing operations in the U.S. and Europe for our niche products that do not require large-scale sales organizations.
Step 1 ：Globalizing our marketing organizations
Steadily increasing our presence in Asia, and establishing our own marketing organizations in South Korea and Taiwan
Our global expansion began in earnest with the establishment of ONO PHARMA KOREA CO., LTD. located in South Korea in FY2013 followed by ONO PHARMA TAIWAN CO., LTD. in FY2014, both of which are wholly owned subsidiaries of ONO. The subsidiaries established their own sales organizations, and we started our own sales operations for OPDIVO in South Korea in FY2015 and in Taiwan in FY2016, respectively. To date, OPDIVO has been approved for 10 cancers in South Korea and 11 cancers in Taiwan (as of the end of June 2023). In addition, VELEXBRU received approval and began our own marketing in South Korea in FY2021 and in Taiwan in FY2022 for the indication of relapsed or refractory primary B-cell CNS lymphoma. Furthermore, since FY2021 BRAFTOVI has been marketed by our own sales organization in South Korea for the indication of advanced or relapsed colorectal cancer with BRAFV600E mutation, and the Company is steadily increasing its presence in Asia
| Year | Progress |
|---|---|
| 2013 | Establishment of ONO PHARMA KOREA CO., LTD. |
| 2014 | Establishment of ONO PHARMA TAIWAN CO., LTD. |
| 2015 | Started own sales of OPDIVO in South Korea （as of June 2023 approved for 10 cancers） |
| 2016 | Started own sales of OPDIVO in Taiwan （as of June 2023 approved for 11 cancers） |
| 2021 | Started own sales of VELEXBRU and BRAFTOVI in South Korea |
| 2022 | Started own sales of VELEXBRU in Taiwan |
Step 2 ：alization of our own sales organizations in the U.S. and Europe
Strengthening our systems for marketing and development
ONO Pharma USA, Inc. is taking the opportunity of its office relocation to Cambridge, Massachusetts in April 2021 to acquire talented human resources with extensive experience in the pharmaceutical industry and create a competitive organizational structure. In addition to expanding our development structure for new compounds such as ONO-4059, we will strengthen our system for bringing products to market by hiring human resources from Commercial, Pharmacovigilance, and Medical to establish our own sales system.
| Year | Progress |
|---|---|
| 1998 | Establishment of ONO PHARMA UK LTD. in the UK Establishment of ONO PHARMA USA, INC. in the U.S. |
| 2023 | Started clinical trials in the USA （as of the end of June, 2023, six products in trials） |
| 2023 | Started clinical trials in the UK （as of the end of June, 2023, six products in trials） |
As of the end of June, 2023, we have been conducting clinical trials the U.S. and Europe for 6 products and are aiming to establish a PoC (Proof of Concept : PoC studies are an early stage of clinical drug development to confirm whether the drug candidates demonstrate the clinical safety and efficacy expected during the drug discovery phase） for development products following ONO-4059. In Europe, we currently have an organization of about 60 people, mainly in development, but we will continue to improve and strengthen the organization, including development, to build a development structure so we will be able to do the work from late-stage clinical trials to regulatory filings, in-house. In addition, in light of the status of ongoing clinical trials, we are also moving forward with the establishment of our own sales system.
Building a business foundation in the U.S. believing in Ono Pharma’s R&D strength and limitless potential
Kunihiko Ito
President & CEO, ONO PHARMA USA, INC.
In order to successfully establish operations in the U.S. for the first time, we drew up a medium- to long-term vision and strategy, and opened a new office in Cambridge, Massachusetts in 2021. In the U.S., we aim to continue to bring first-in-class products to market. Currently, we are hiring strong leaders, building our organization, and working on development and product launch preparatory activities. Believing in our R&D strength and limitless potential, we are establishing a platform for our business foundation in the U.S. in each value chain. We aim to be a global specialty pharma that truly benefits patients. This is a big dream that requires all hands on deck.
Aiming at a Global Specialty Pharma
Archana Sondhi
Vice President, Sales & Marketing, ONO PHARMA USA, INC.
At ONO US, we believe that one of the key steps towards doing the best for patients with unmet needs is to hire passionate people. We have built a formidable US leadership team with extensive experience in Oncology and continue to hire exceptional talent to achieve our goals. We are leveraging Ono’s leadership and commercial success in Japan to bring first-in-class drugs to the US and make them accessible to patients. We are building a robust commercial, access and operational infrastructure including best-in-class omnichannel strategy for effective stakeholder engagement. With our functional and market expertise, we feel confident in our capabilities to launch our drug pipeline in the US.
Step 3 ：Becoming a true global company
Growing market share by continuously introducing new drugs and expanding sales network to China and ASEAN
In the regions where we established sales bases by proceeding up to Step 2, we will continue to introduce new drugs that satisfy further unmet needs, and we will consider expanding our sales network to China, ASEAN, and other regions.
Overseas sites
- The photo shows the buildings where our local subsidiaries are located.