PRESS RELEASES

PRINCETON, N.J., Jan. 23, 2024 – Taiho Oncology, Inc. announces publication of the final results from the pivotal ASCERTAIN clinical trial of fixed-dose oral decitabine and cedazuridine (INQOVI^®) compared to intravenous decitabine in adults with intermediate and high-risk myelodysplastic syndromes (MDS) including chronic myelomonocytic leukemia (CMML).¹

Phase 3 trial will assess progression-free survival of zipalertinib plus chemotherapy versus chemotherapy in adult patients with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer with EGFR exon 20 insertion mutations

Princeton, N.J., and Cambridge, Mass., August 3, 2023 – Taiho Oncology, Inc., Taiho Pharmaceutical Co., Ltd., and Cullinan Oncology, Inc., announced today the launch of the REZILIENT3 trial (NCT05973773, Researching Zipalertinib In EGFR Non-Small Cell Lung Cancer Tumors), a global Phase 3 clinical trial evaluating the combination of zipalertinib and chemotherapy as a potential first-line treatment for adult patients with previously untreated locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring the epidermal growth factor receptor (EGFR) exon 20 insertion mutation and who meet additional criteria.

Results from the primary analysis of the SUNLIGHT trial to be presented at an upcoming scientific conference

Paris - September 12, 2022 – Servier, Taiho Oncology, Inc., and Taiho Pharmaceutical Co., Ltd., announced today that the investigational combination of trifluridine/tipiracil plus bevacizumab showed a statistically significant improvement in the primary endpoint of overall survival (OS) compared to trifluridine/tipiracil alone in a Phase III clinical trial of participants with refractory metastatic colorectal cancer (mCRC) following two chemotherapy regimens.

Taiho obtains exclusive global rights to CLN-081/TAS6417 outside the U.S.; in the U.S., Taiho and Cullinan Oncology to jointly develop and co-commercialize CLN-081/TAS6417

Cullinan Oncology will receive an upfront cash payment of $275 million, with potential to receive up to an additional $130 million in regulatory-based milestone payments

Cullinan Oncology and Taiho will equally share future profits in the U.S.

CAMBRIDGE, Mass., May 12, 2022 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (Cullinan Oncology) (Nasdaq: CGEM) and Taiho Pharmaceutical Co., Ltd. (Taiho) today announced an agreement through which Taiho will acquire Cullinan Pearl Corp. (Cullinan Pearl) and co-develop and co-commercialize Cullinan Oncology’s lead program, CLN-081/TAS6417 (development code in Cullinan Oncology: CLN-081, development code in Taiho: TAS6417), an orally available, differentiated, irreversible EGFR inhibitor that selectively targets cells expressing EGFR exon 20 insertion mutations while sparing cells expressing wild-type EGFR. Subject to customary closing conditions, including expiration or termination of the waiting period under U.S. antitrust laws, the acquisition is expected to close in the second quarter of 2022.

• Study achieved median overall survival of 31.7 months
• Updated efficacy data demonstrated an overall response rate of 62%, with 22% of patients achieving a complete response
• INQOVI is the only oral hypomethylating agent with equivalent exposure to its intravenous (IV) form

Pleasanton, CA, September 23, 2021. Astex Pharmaceuticals, Inc., a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., based in Tokyo, Japan, today announced updated clinical data, including median overall survival (mOS), from the ASCERTAIN phase 3 trial of INQOVI^®, the company’s orally administered fixed-dose combination of decitabine and cedazuridine (ASTX727 or DEC-C) in adults with intermediate and high-risk myelodysplastic syndromes (MDS) including chronic myelomonocytic leukemia (CMML). mOS was 31.7 months.

• Oral drug can be taken at home, which may enable some patients to avoid some hospital visits
• Treatment can induce complete remission and reduce blood transfusion needs for patientsi

OAKVILLE, ON, OCTOBER 8, 2020 – Taiho Pharma Canada, Inc., the Canadian subsidiary of Taiho Pharmaceutical Co., Ltd. (Japan), today announces that Health Canada approved INQOVI® as the first and only orally administered hypomethylating agent for the treatment of adults with intermediate-1, intermediate-2 and high-risk myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML),ii two blood malignancies. INQOVI was developed by Astex Pharmaceuticals, a sister company of Taiho and will be available in Canada.

OAKVILLE, ON, May 19, 2020 – Taiho Pharma Canada, Inc., a Canadian subsidiary of Taiho Pharmaceutical Co., Ltd. (Japan), today announced a positive clinical recommendation by the Institut national d’excellence en santé et en services sociaux (INESSS) recommending that the Minister include LONSURF® (trifluridine and tipiracil [as tipiracil hydrochloride] tablets) on the List of Medications for the treatment of adult patients with metastatic gastric (stomach) cancer or adenocarcinoma of the gastroesophageal junction.ⁱ LONSURF is a treatment for patients who have been previously treated with at least two prior lines of chemotherapy including a fluoropyrimidine, a platinum, and either a taxane or irinotecan and if appropriate with HER2/neu-targeted therapy.ⁱⁱ

Colorectal Cancer Canada “Gives A Shit” about you! www.giveashitnow.ca

Montreal, Mach 2, 2020 –

March is Colorectal Cancer Awareness Month and what better time to support those touched by colorectal cancer and to spread the message that it is Preventable, Treatable, and Beatable!

Colorectal cancer may touch you, your family members, or a friend and it remains the second leading cause of cancer-related deaths in Canada. No matter if you are male or female, young or old, you could be at risk for colorectal cancer. One in 14 men and one in 18 women are expected to develop colorectal cancer during their lifetime. Last year alone, 26,300 Canadians were diagnosed with the disease.

OAKVILLE, ON, Nov. 21, 2019 /CNW/ - Taiho Pharma Canada, Inc., a Canadian subsidiary of Taiho Pharmaceutical Co., Ltd. (Japan), today announced that Health Canada approved LONSURF® (trifluridine and tipiracil [as tipiracil hydrochloride] tablets) for the treatment of adult patients with metastatic gastric (stomach) cancer or adenocarcinoma of the gastroesophageal junction, who have been previously treated with at least two prior lines of chemotherapy including a fluoropyrimidine, a platinum, and either a taxane or irinotecan and if appropriate with HER2/neu-targeted therapy.i LONSURF received a priority review by Health Canada given the high unmet medical need in this patient population. Currently, there is no drug approved in Canada as third-line therapy for metastatic gastric or GEJ carcinoma.

OAKVILLE, ON, AUGUST 19, 2019 – Taiho Pharma Canada, Inc., a Canadian subsidiary of Taiho Pharmaceutical Co., Ltd. (Japan), today announced that Quebec is the first province to make LONSURF accessible with reimbursement under the Régie de l'assurance maladie du Québec (RAMQ).ii This critical listing follows a positive clinical recommendation by the Institut national d’excellence en santé et en services sociaux (INESSS) recommending that the Minister include LONSURF® (trifluridine and tipiracil [as tipiracil hydrochloride] tablets) on the List of Medications for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have failed on previous standard therapies.iii

PRINCETON, N.J., June 7, 2019 – Taiho Oncology, Inc. announces that it has assumed commercialization responsibility from Otsuka Pharmaceuticals Co., Ltd., (Otsuka) for the novel fixed-dose combination of cedazuridine and decitabine (ASTX727) and guadecitabine (SGI-110) in the U.S. and Canada, subject to regulatory approvals. Taiho Pharma Canada, Inc., will commercialize these compounds in Canada.

TORONTO, ON, March 6, 2018 – Taiho Pharma Canada, Inc., a Canadian subsidiary of Taiho Pharmaceutical Co., Ltd. (Japan), today announced that Health Canada approved LONSURF® (trifluridine and tipiracil [as tipiracil hydrochloride] tablets) for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with, or are not candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF biological agents, and, if RAS wild-type, anti-EGFR agents.¹

Otsuka Holdings Co., Ltd. announces that it has signed the CEO Statement of Support for the Women’s Empowerment Principles (WEPs), a set of Principles focusing on corporate action to promote gender equality and women’s empowerment in the workplace, marketplace and community. The WEPs are the result of collaboration between the United Nations Global Compact (UNGC)1 and the United Nations Entity for Gender Equality and the Empowerment of Women (UN Women).²

TORONTO, ON, October 20, 2017 – Taiho Pharma Canada, Inc., a Canadian subsidiary of Taiho Pharmaceutical Co., Ltd. (Japan), today announced that Health Canada accepted for review Taiho’s New Drug Submission (NDS) for trifluridine (FTD) and tipiracil (TPI), and that the NDS has been granted Priority Review status. Health Canada’s review of the NDS under Priority Review is expected to be completed in early 2018.