Eli Lilly and Company and Innovent Biologics, a Suzhou, China-based biopharmaceutical company, have announced a global expansion of their strategic alliance for TYVYT (sintilimab), an anti-PD-1 monoclonal antibody immuno-oncology medicine, in a deal worth up to $1.025 billion. Lilly and Innovent co-developed the drug.

In 2019, Lilly and Innovent began commercializing TYVYT in China after being granted marketing approval for relapsed or refractory classic Hodgkin’s lymphoma after at least two lines of systemic chemotherapy. Under the expanded license agreement, Lilly will obtain an exclusive license for TYVYT for geographies outside of China and plans to pursue registration of TYVYT in the US and other markets. In return, Innovent will receive an upfront payment of $200 million and will be eligible for up to $825 million in potential development and commercial milestones as well as tiered double-digit royalties on net sales. Both companies will also retain the right to study TYVYT in combination with other medicines as part of their own clinical programs.

The two companies are also studying TYVYT as a potential therapy in non-squamous non-small cell lung cancer (NSCLC) and several other types of cancer. Earlier this month (August 2020), the two companies released interim Phase III results evaluating TYVYT in combination with Lilly’s Alimta (pemetrexed) and platinum chemotherapy for treating advanced or recurrent non-squamous NSCLC without sensitizing EGFR (epidermal growth factor receptor) mutations or ALK (anaplastic lymphoma kinase) rearrangements. A supplemental new drug application for this indication is under regulatory review in China.

Source: Eli Lilly and Company and Innovent Biologics