Company: TAK
Filing Date: 2025-10-30
Form Type: 6-K
Source: 0001395064-25-000154
Chunk: 29

Company: TAKEDA PHARMACEUTICAL CO LTD
Filing Date: 2025-10-30
Form: 6-K
Chunk 29
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inant coronavirus (SARS-CoV-2) vaccine

– In August 2025, Takeda announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved a partial change to the manufacturing and marketing authorization for NUVAXOVID formulated to target Omicron LP8.1 lineage for which the application was submitted in June 2025. The approval is based on data related to the change of the antigen strain, as well as non-clinical data in which NUVAXOVID was shown to induce neutralizing antibodies against recent SARS-CoV-2 variants (LP.8.1, LP.8.1.1, JN.1, KP.3.1.1, XEC, XEC.4, NP.1, LF.7 and LF.7.2.1).

Building a sustainable research platform / Enhancing R&D collaboration

In addition to our concentrated efforts to increase our in-house R&D capabilities, external partnerships with third-party partners are a key component of our strategy for enhancing our R&D pipeline. Our strategy to expand and diversify our external partnerships allows us to take part in research of a wide variety of new products and increases the chances that we will be able to take part in a major research-related breakthrough.

– In October 2025, Takeda announced that it entered into a license and collaboration agreement with Innovent Biologics for the development, manufacturing and commercialization of two late-stage oncology medicines, IBI363 and IBI343, worldwide outside of Mainland China, Hong Kong, Macau and Taiwan. IBI363 is being evaluated in non-small cell lung and colorectal cancers and has shown potential efficacy in additional solid tumor types. IBI343 is being evaluated in gastric and pancreatic cancers. Takeda will also receive an exclusive option to license global rights outside of Mainland China, Hong Kong, Macau and Taiwan for IBI3001, an early-stage investigational medicine. IBI363 is a potentially first-in-class investigational PD-1/IL-2 α-bias bispecific antibody fusion protein. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to IBI363 for the treatment of patients with unresectable, locally advanced or metastatic sqNSCLC that has progressed following anti-PD-(L)1 therapy and platinum-based chemotherapy. IBI343 is a next-generation investigational antibody-drug conjugate (ADC) that targets the Claud