Takeda announced that it has entered into a license and collaboration agreement with Innovent Biologics (HKEX: 01801) for the development, manufacturing and commercialization of two late-stage oncology medicines, IBI363 and IBI343, worldwide outside of Greater China.* 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 Greater China for IBI3001, an early-stage investigational medicine.

“IBI363 and IBI343, two next-generation investigational medicines, have the potential to address critical treatment gaps for patients with a range of solid tumors,” said Teresa Bitetti, President, Global Oncology Business Unit, Takeda. “We are energized by the progress made by Innovent to date and look forward to collaborating to unlock the potential of these programs. Our global research and development expertise and commercialization capabilities will enable us to accelerate the delivery of these investigational medicines to patients. These two programs have the potential to be transformative for our oncology portfolio and significantly enhance Takeda’s growth potential post-2030.”

IBI363 is a potentially first-in-class investigational PD-1/IL-2^α-bias bispecific antibody fusion protein. In early studies where more than 1,200 patients received IBI363 – including patients who were refractory to PD-1/L1 therapy – it has shown promising clinical activity in several solid tumor types, including squamous non-small cell lung cancer (sqNSCLC), non-sqNSCLC and microsatellite stable colorectal cancer (MSS CRC). 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. IBI363 is being studied globally in an ongoing Phase 1/2 and three ongoing Phase 2 clinical trials across patient segments and lines of therapy in NSCLC and MSS CRC. A global Phase 3 study in second-line sqNSCLC is expected to begin in the coming months. Clinical development in additional indications is planned for IBI363. Takeda and Innovent will co-develop IBI363 globally with a 60/40 (Takeda/Innovent) cost split and co-commercialize it in the U.S. with a 60/40 (Takeda/Innovent) profit or loss split. Takeda will lead co-commercialization efforts in the U.S. and will have the exclusive right to commercialize IBI363 outside of the U.S. and Greater China. Takeda will have global manufacturing rights to supply IBI363 outside of Greater China, with such rights being co-exclusive with Innovent for commercial supply in the U.S.

IBI343 is a next-generation investigational antibody-drug conjugate (ADC) that targets the Claudin 18.2 protein, which is often expressed in gastric and pancreatic cancer cells. IBI343 has shown promising clinical activity in studies in gastric cancer and advanced pancreatic cancer, in which more than 340 patients were treated with IBI343. These cancers have among the lowest five-year survival rates. The U.S. FDA has granted Fast Track designation to IBI343 for the treatment of advanced unresectable or metastatic pancreatic ductal adenocarcinoma (PDAC) that has relapsed and/or is refractory to one prior line of therapy. IBI343 is currently being evaluated in an ongoing Phase 3 clinical trial in previously treated gastric cancer in Japan and China and has completed a global Phase 1/2 trial in previously treated pancreatic cancer. Takeda plans to advance the development of IBI343 and expand into the first-line gastric and pancreatic cancer settings. Under the terms of the agreement, Takeda will develop, manufacture and commercialize IBI343 worldwide, outside of Greater China.

“The addition of these programs strengthens our leadership in oncology and enhances Takeda’s late-stage pipeline. Drawing from our deep experience in oncology and the modalities leveraged by IBI363 and IBI343, we are uniquely positioned to partner with Innovent to accelerate and expand the potential of these investigational medicines in a range of solid tumors,” said Andy Plump, President, Research and Development, Takeda. “We are encouraged by the clinical results these investigational medicines have shown and look forward to working with Innovent to deliver these potentially best-in-class medicines to patients with longstanding unmet needs across a wide range of cancers.”

IBI3001 is a potential first-in-class bispecific ADC designed to target both EGFR and B7H3. It is being studied in an ongoing Phase 1 clinical trial in patients with locally advanced or metastatic solid tumors in the U.S., China and Australia. As part of the agreement, Innovent will be solely responsible for clinical development of IBI3001 prior to potential exercise of the option to license. Should Takeda exercise the option, Takeda will develop, manufacture and commercialize IBI3001 worldwide, outside of Greater China.

“We believe that developing innovative immuno-oncology and ADC therapies will be key for redefining cancer treatment worldwide. We look forward to partnering with Takeda to maximize the potential of our pipeline for patients with a wide variety of cancers,” said Dr. Hui Zhou, Chief R&D Officer for Oncology Pipeline at Innovent Biologics. “These investigational therapies, featuring innovative mechanisms of action, have shown promise for patients who currently have limited treatment options. Our collaboration is poised to advance their development and potential commercialization, moving us closer to offering new options to patients in need.”

Innovent will receive a US$1.2 billion upfront payment upon closing of the transaction, which includes an equity investment of US$100 million in Innovent by Takeda. The upfront payment will be funded through cash on hand. Innovent will also be eligible for potential milestones and royalty payments, and a profit or loss split 60/40 (Takeda/Innovent) solely with respect to IBI363 in the U.S., where Takeda will lead the commercialization effort while Innovent will have a co-commercialization right. If Takeda exercises the option for IBI3001, Innovent will be eligible for an option exercise fee and additional potential milestone and royalty payments. The transaction, including any future exercise of the option, is subject to customary closing conditions, including regulatory approvals.