Kilde;
Hvilken checkpoint blocker vil bli brukt i kombinasjons TG i Kina, kineserne er ute med sin første CPI PD-L1 (Tuoyi) produsert av Shanghai Junshi og flere er på vei. Både Merck og BMS sin CPI er godkjent i Kina og prisene er droppet med 60% i forhold til US, men de er fortsatt ikke konkurransedyktig sammenlignet med lokal produsert CPI. Den er godkjent for treatment of melanoma, en liten ønskedrøm kunne vært Oncos + Tuoyi i melanoma.
And what really shook things up was the pricing of the third entrant, Shanghai Junshi’s Tuoyi: a 70% discount to Opdivo’s China cost, or an incredible 90% less than the US list price.
On December 17, China’s National Medical Products Authority (NMPA) conditionally approved the listing of the first locally developed programmed cell death-1 (PD-1) checkpoint inhibitor, Tuoyi (toripalimab) monoclonal antibody injection for the treatment of melanoma.
The product of the Chinese biotech firm Shanghai Junshi Biosciences could be the first locally developed PD-(L)1 drug launching in China in competition with the already approved global market-leading PD-(L)1 drug, Keytruda (pembrolizumab). The approval is an important turning point in the history of Chinese drug development, which is moving away from producing “me-too” drugs aimed at the domestic market to independently develop brands that will compete with Western developers’ drugs.
Two PD-1 inhibitors, Bristol-Myers Squibb’s (BMS’) Opdivo (nivolumab) and Merck’s Keytruda received approval in China in June and in July 2018, respectively, lagging years behind US approvals. Similarly to Keytruda, the NMPA approved Tuoyi as a second-line treatment in patients with unresectable or metastatic melanoma following first-line treatment failure. Junshi’s application for Tuoyi was accepted by the State Drug Administration in March 2018 for listing, and was included in the priority review and approval category for accelerated review and approval.
