Global business expansion and international launches

「Overseas product sales increased by ¥6.1 billion, or 44.8%, year on year to ¥19.8 billion.」

「Until now, the company's business model was to conduct clinical development and sales in Japan, South Korea and Taiwan, while generally licensing out novel drug candidates for Europe, the US and other regions. It is now shifting that model and working to conduct clinical development and sales itself in Europe and the US. As part of this effort, it acquired US-based Deciphera in June 2024, strengthening its clinical development structure in Europe and the US and acquiring a sales network covering more than 40 countries worldwide.」

「In September this year, the company obtained approval in Europe for ROMVIMZA (DCC-3014), a CSF-1 receptor inhibitor, for the indication of tenosynovial giant cell tumor causing clinically significant loss of physical function and for which surgery is not expected to provide benefit or may result in unacceptable morbidity or disability.」

「To expand and accelerate its overseas business, the company acquired Deciphera, strengthening its pipeline and R&D capabilities while acquiring a sales base in Europe and the US. It will also use Deciphera as its hub for operations in Europe and the US, reorganizing and consolidating the functions previously maintained in the US and the UK.」

「Sales of Qinlock, a gastrointestinal stromal tumor treatment acquired through the acquisition of Deciphera, totaled ¥8.1 billion from July to September.」

「Through this acquisition, the company will expand its solid tumor pipeline, and the acquisition of QINLOCK® and Vimseltinib is expected to increase group earnings over the short to medium term. It will also acquire Deciphera's development and sales capabilities in Europe and the US, strengthening its direct-sales structure in those markets.」

「The company began a Phase I trial in the United States of the iPS cell-derived HER2 CAR-T cell therapy ONO-8250 for HER2-positive solid tumors.」

「By strengthening its clinical development capabilities in Europe and the US, the company is establishing a structure capable of conducting clinical trials globally, in Japan, the US and Europe.」

「At Ono Pharma USA, Inc., following the relocation of its office to Cambridge, Massachusetts, in April 2021, the company is building a competitive organizational structure by recruiting talented personnel with extensive experience in the pharmaceutical industry. In Europe, it is also considering establishing its own medical affairs, marketing and sales organizations in light of the status of ongoing clinical trials.」

「Note 1: The company obtained approval in Japan and Taiwan for the combination of Opdivo and Yervoy and the combination of Opdivo and chemotherapy for the indication of unresectable advanced or recurrent esophageal cancer.」

「The company is working toward direct overseas sales so that it can provide its novel drugs worldwide. It has already established local subsidiaries in South Korea and Taiwan and begun selling its own products there. With a view to future direct sales activities in Europe and the US, it is advancing the development of multiple projects, including the development in the US of ONO-4059 (Belexibru tablets), a Bruton tyrosine kinase inhibitor, while working to establish its sales organization.」

「Note 2: The company obtained approval in South Korea for the BTK inhibitor Belexibru tablets for the indication of relapsed or refractory primary B-cell central nervous system lymphoma.」

「In June this year, the company obtained approval in South Korea for combination therapy with chemotherapy including fluoropyrimidine- and platinum-based agents for the indication of advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma. In October this year, it obtained approval in Taiwan for the same combination therapy for the indication of advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma without HER2 overexpression.」

「The company obtained approval in South Korea in April last year and in Taiwan in June last year for the indication of unresectable advanced or recurrent esophageal squamous cell carcinoma that is refractory or intolerant to chemotherapy including fluoropyrimidine- and platinum-based agents. In December last year, it obtained approval in South Korea for the combination with Yervoy for the indication of advanced or recurrent non-small cell lung cancer negative for EGFR or ALK gene mutations. In February this year, it obtained approval in Taiwan for the same combination therapy.」

「Note 1: The company obtained approval in Japan and South Korea for the combination of Opdivo and Yervoy for the indication of unresectable advanced or recurrent non-small cell lung cancer.」

「In April this year, the company obtained approval in South Korea for the indication of unresectable advanced or recurrent esophageal squamous cell carcinoma that is refractory or intolerant to chemotherapy including fluoropyrimidine- and platinum-based agents. In June this year, it obtained approval in Taiwan for the indication of unresectable advanced or recurrent esophageal squamous cell carcinoma with disease progression after combination therapy including fluoropyrimidine- and platinum-based agents.」

「To provide its internally developed novel drugs worldwide, the company is working toward direct overseas sales of specialty products, particularly antineoplastic agents. It has already established local subsidiaries in South Korea and Taiwan and begun selling its own products there. In Europe and the US, it is working to establish and strengthen its organization, including development capabilities, with a view to future direct sales activities.」

「In May this year, the company obtained approval in Taiwan for the indication of adjuvant therapy in patients with melanoma with lymph node metastasis after complete resection or metastatic melanoma.」

「Opdivo received approval in Taiwan for the indication of metastatic colorectal cancer with high microsatellite instability (MSI-H) or deficient DNA mismatch repair (dMMR) that has progressed after treatment with a fluoropyrimidine, oxaliplatin and irinotecan.」

「Note 5: The company obtained approval in Taiwan for a partial change to the import marketing authorization for the combination of Opdivo and Yervoy for the indication of previously untreated intermediate- and poor-risk advanced renal cell carcinoma.」

「In June this year, Bristol Myers Squibb obtained import marketing approval in China for Opdivo for the indication of locally advanced or metastatic non-small cell lung cancer after chemotherapy including platinum agents. In October this year, it obtained approval in South Korea for a partial change to the import marketing authorization for the combination of Opdivo and Yervoy for the indication of previously untreated intermediate- and poor-risk advanced renal cell carcinoma.」

「In April this year, Bristol Myers Squibb obtained approval in the US for a partial change to the marketing authorization for the combination of Opdivo and Yervoy for the indication of previously untreated intermediate- and poor-risk advanced renal cell carcinoma.」

「Opdivo received approval for a partial change to its import marketing authorization for the indication of advanced or recurrent gastric cancer or gastroesophageal junction cancer after 2 or more lines of chemotherapy.」

「In April this year, Opdivo received approval in Taiwan for a partial change to its import marketing authorization for the indication of advanced renal cell carcinoma in patients previously treated with an antiangiogenic therapy. / In August this year, Opdivo received approval in Taiwan for a partial change to its import marketing authorization for the indication of recurrent or metastatic head and neck squamous cell carcinoma in patients previously treated with platinum-based therapy. / In September this year, Bristol Myers Squibb obtained approval in the US for a partial change to the marketing authorization for Opdivo for the indication of hepatocellular carcinoma in patients previously treated with sorafenib.」

「To provide its internally developed novel drugs worldwide, the company is working toward selling its specialty products, particularly anticancer drugs, directly overseas. It has already established local subsidiaries in South Korea and Taiwan and begun selling its own products there, and will also consider sales activities in Europe and the US while working to establish and strengthen its development structure.」

「Opdivo I.V. Injection received approval in the US for a partial change to its marketing authorization for the indication of recurrent or metastatic head and neck squamous cell carcinoma with disease progression during or after platinum-based therapy. / Opdivo I.V. Injection received approval in Europe for a partial change to its marketing authorization for the indication of relapsed or refractory classical Hodgkin lymphoma after autologous hematopoietic stem cell transplantation and treatment with brentuximab vedotin.」

「In May this year, Bristol Myers Squibb obtained approval in Europe for a partial change to the marketing authorizations for Opdivo and Yervoy for the indication of unresectable or metastatic melanoma. / In May this year, Bristol Myers Squibb obtained approval in the US for a partial change to the marketing authorization for Opdivo for the indication of classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation and treatment with brentuximab vedotin.」

「Opdivo I.V. Injection received approval in the US for a partial change to its marketing authorization for the indication of classical Hodgkin lymphoma in patients who have received prior therapy. / Opdivo I.V. Injection was submitted in Europe and the US for approval of a partial change to its marketing authorization for the indication of recurrent or metastatic head and neck squamous cell carcinoma in patients who have received prior therapy.」

「The company is advancing its global business expansion so that it can provide its internally developed novel drugs worldwide. Alongside actively pursuing clinical development overseas, it aims to launch its internally discovered compounds in overseas markets through partner companies.」