Reporter |
On December 1, FiercePharma reported that Eli Lilly and CompanyPharmaceuticalsHas officially abandoned InnoventBiologicalRights to PD-1 inhibitor Tyvyt (sintilimab) outside of China.
Eli Lilly stated in its securities filing for the third quarter that it had terminated the Tyvyt agreement outside of China and returned the drug to Innovent.Biological。
12Month2On the same day, Innovent Biologics confirmed the matter to The Paper. Innovent Biologics stated that its “Recently, Innovent Biologics has proactively and amicably negotiated with Eli Lilly and Company to reclaim the overseas rights of sintilimab. This is a commercial decision.”。Innovent Biologics also stated that this matter is related to "Innovent BiologicsThe cooperation with Eli Lilly in the Chinese market is unaffected, and the Chinese market remains uninfluenced. This will also not impact the strategic partnership established between the two partners over a long period or their collaboration on other products.”。
Eli Lilly and Company, however, did not comment on this.
SintilimabIt is the flagship product of Innovent Biologics and also the first PD-1 inhibitor to be included in China's national medical insurance directory.-1，The product was acquired by Innovent Biologics from an external source in its early years.
In 2015, Innovent Biologics and Eli Lilly and Company reached a licensing cooperation agreement to jointly develop.Sintilimab, with an upfront payment reaching 200 million US dollars, this event was also considered as one of the landmark events in the development process of China's innovative pharmaceutical enterprises at that time. In December 2018, Sintilimab was approved for the first time in China for the treatment of relapsed/refractory classical Hodgkin's lymphoma. In 2020, Eli Lilly paid a prepayment of 200 million US dollars and promised potential milestone payments of up to 825 million US dollars to obtain the overseas rights of Sintilimab.
However, in less than three years, Eli Lilly returned the overseas rights of sintilimab, which was obviously largely related to the previous rejection of sintilimab's U.S. marketing application.
This YearMarch,U.S. Food and Drug Administration (FDA）RejectedSintilimabMarketing application for the treatment of newly diagnosed non-squamous non-small cell lung cancer (NSCLC),And criticized the data and other strategies adopted in Eli Lilly's submission. Subsequently, in this year's mid-year report, Eli Lilly stated that it does not intend to apply to the FDA again.
In addition, it is reported that since this year, Eli Lilly has exited the sales of sintilimab in China, and transferred all related work to Innovent Biologics. Previously, the sales of sintilimab in China were jointly carried out by Eli Lilly and Innovent Biologics. The financial report shows that in the first three quarters of this yearEli Lilly in ChinaSintilimabSales were $236 million, down from $340 million in the same period last year.。
For Innovent Biologics, this incident will further dim the overseas prospects of sintilimab, and this year...May 6, Innovent BiologicsStill rubbingAnnouncement on Withdrawal of Previously Granted Rights to Coherus for the Commercialization of Bevacizumab Biosimilar (IBI-305) in the United States and Canada。