Eli Lilly & Co’s (NYSE: LLY) Q3 2022 SEC filing released last month revealed that the US major has decided to end its license to develop the programmed death-1 (PD-1) inhibitor Tyvyt (sintilimab) in markets outside of China. In a single sentence, Lilly noted that the license deal signed with China’s Innovent Biologics Inc. (HKG: 1801) in 2020 for geographies outside of China was terminated and rights reverted to Innovent in October 2022.
Tyvyt’s Regulatory Journey
Lilly and Innovent’s Tyvyt became the first China-sourced PD-1 inhibitor to be judged for approval in the US, filed as a first-line therapy for non-squamous non-small cell lung cancer (NSCLC). However, that filing was met with a Complete Response Letter (CRL) in March of this year, following scathing criticism of the lack of US data and comparison to US standard treatment for NSCLC during the preceding Oncologic Drugs Advisory Committee (ODAC) review.
Financial and Market Impact
Lilly first paid USD 56 million and promised up to USD 400 million in milestone payouts to co-develop Tyvyt in China in a 2015 deal. Tyvyt went on to win a first indication approval in China in December 2018 in classic Hodgkin’s lymphoma, and Lilly came back to take ex-China rights in 2020 for a further USD 200 million upfront and up to USD 825 million in potential milestone payouts. Lilly is thought to have paid only the USD 200 million upfront to Innovent in relation to ex-China development.
In China, Lilly’s Q3 report reveals the heightened market pressures on Tyvyt, which faced reimbursement-related price cuts in China with effect from the beginning of 2022. The drug generated USD 235.8 million in revenues recognized by Lilly during the first nine months of the year, down from USD 340.2 million during the same period in 2021. That was also reflected in Lilly’s overall China market revenues, which reached USD 1.102 billion over Q1-Q3, down from USD 1.285 billion the year before.
Innovent’s New Partnership
Notably, Innovent in August this year signed a separate deal with Sanofi SA (NASDAQ: SNY) focused on pairing Tyvyt with two of the French firm’s oncology pipeline for China market development and commercialization. That included a EUR 300 million (USD 315.8 million) equity investment in Innovent by Sanofi.-Fineline Info & Tech
