U.S. markets may be shaken by domestic Chinese immune checkpoint inhibitors

Now there is a fifth deal between Coherus Bio­Sciences and Shang­hai Jun­shi Bio­sciences for Junshi’s PD‑1 inhibitor named Tuoyi (tori­pal­imab), the US or EU com­pa­nies and Chi­nese PD‑1/L1 devel­op­ers. With six check­point inhibitors orig­i­nal­ly devel­oped in Chi­na and now part­nered with the US/EU com­pa­nies vying for approval in the US, this could lead to aggres­sive dis­count­ed prices and com­pet­i­tive pres­sure on the estab­lished check­point inhibitors, shak­ing up the US mar­ket in com­ing years, says Glob­al­Da­ta, a lead­ing data and ana­lyt­ics company.
Jes­si­ca McCor­ma­ck, PhD, Oncol­o­gy and Hema­tol­ogy Ana­lyst at Glob­al­Da­ta, com­ments: “When Chi­nese PD‑1 inhibitors Tuoyi and Tyvyt (sin­til­imab) (from Innovent/Eli Lil­ly), launched in Chi­na they did so at con­sid­er­ably low­er price points than rival PD‑1 inhibitors, Keytru­da and Opdi­vo. A sim­i­lar cut in pric­ing in the US mar­ket could see new entries from Chi­na real­ly start­ing to com­pete with the big names. Look­ing ahead, this strat­e­gy could be even more suc­cess­ful in more cost-con­scious countries.”
All six of the check­point inhibitors that have part­ner­ships with the US/EU firms are in late stage devel­op­ment and come with some com­pelling clin­i­cal data. Tuoyi is already approved in Chi­na for the treat­ment of sec­ond line melanoma patients and also comes with both break­through ther­a­py and orphan des­ig­na­tions for nasopha­ryn­geal can­cer, and orphan des­ig­na­tion for soft tis­sue sar­co­ma. Tyvyt is in a sim­i­lar posi­tion, hav­ing been approved in Chi­na in 2019 for third line relapsed or refrac­to­ry clas­sic Hodgkin’s lym­phoma. The com­pa­ny demon­strat­ed pos­i­tive results in a Phase III tri­al in non-small cell lung can­cer (NSCLC) in Chi­na. How­ev­er, its US-based Phase III tri­al is explor­ing Tyvyt in esophageal cancer.
McCor­ma­ck con­tin­ues: “Coherus and Jun­shi have indi­cat­ed that they intend to file a Bio­log­ics License Appli­ca­tion for the use of Tuoyi in nasopha­ryn­geal can­cer lat­er this year. While the US tri­als are now under­way, the major­i­ty of clin­i­cal data will be com­ing from Asia and it remains to be seen how the FDA will han­dle this. The most advanced can­di­date is tislelizum­ab. Orig­i­nal­ly devel­oped by BeiGene and now part­nered with Novar­tis, there are cur­rent­ly 13 US-based clin­i­cal tri­als fea­tur­ing tislelizum­ab, includ­ing six in Phase III, so this could be a good bet for a first US approval.”
Pos­i­tive inter­im results with tislelizum­ab have been report­ed from both the Ratio­nale 302 and Ratio­nale 303 tri­als in pre­vi­ous­ly treat­ed esophageal and NSCLC patients, respec­tive­ly. BeiGene has indi­cat­ed that an FDA fil­ing is like­ly in the near term, though it is not known which indi­ca­tion will be pur­sued first.
McCor­ma­ck con­cludes: “NSCLC is dom­i­nat­ed by Merck’s Keytru­da (pem­brolizum­ab). In con­trast, Keytru­da and Bris­tol Myers Squibb’s Opdi­vo (nivolum­ab) were approved recent­ly for esophageal can­cer. This could make this rel­a­tive­ly small indi­ca­tion a more appeal­ing ini­tial approval for BeiGene and pave the way for oth­er Chi­nese-made PD‑1 inhibitors to enter the US market.”