Nature Medicine<\/em><\/a>.<\/p>\n\n\n\n\u201cAs the world’s first immuno-oncology (I-O) drug approved for the treatment of nasopharyngeal cancer (NPC), we continue to explore the potential of toripalimab in different settings within NPC and across other cancer types, with the support of patients, investigators and our research team participating in clinical trials. We have now received approval for a new indication for toripalimab with chemotherapy for the first-line treatment of NPC, which provides better treatment outcomes for more patients with advanced NPC,” said Dr. Patricia Keegan, Chief Medical Officer of Junshi Biosciences. “Junshi Biosciences focuses on tumor types that are 1) highly prevalent in China; 2) responsive to immunotherapy; and 3) where there is urgent unmet need for better and safer treatments. The results of POLARIS-02 and JUPITER-02 studies for NPC are representative examples of our clinical program. We are delighted to see that the breakthrough results obtained with toripalimab not only bring new hope to Chinese patients, but also earn international recognition from academia and regulatory authorities. We hope that our novel I-O drug will be available to benefit patients outside China in the near future. “<\/p>\n\n\n\n\n\n
About <\/strong>Nasopharyngeal Carcinoma<\/strong><\/p>\n\n\n\nNPC is a primary malignant tumor of the nasopharyngeal mucosal epithelium, which is one of the most common head and neck cancers. According to the World Health Organization, the number of newly diagnosed NPC cases in 2020 exceeded 130,000 worldwide, and nearly half of the cases occurred in China. The current therapies are limited for recurrent or metastatic NPC. The first-line standard therapy is platinum-based dual-drug combination chemotherapy. The overall survival of the patients is poor.<\/p>\n\n\n\n
About Toripalimab
<\/strong><\/p>\n\n\n\nToripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 is thought to recharge the immune system\u2019s ability to attack and kill tumor cells. More than thirty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally, including in\u00a0China,\u00a0the United States, Southeast Asia, and European countries. Ongoing or completed pivotal clinical trials evaluating the safety and efficacy of toripalimab cover a broad range of tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin.<\/p>\n\n\n\n
In China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI\u00ae<\/sup>). On December 17, 2018, toripalimab was granted a conditional approval by the National Medical Products Administration (NMPA) for the second-line treatment of unresectable or metastatic melanoma. In December 2020, toripalimab was successfully included in the updated National Reimbursement Drug List. In February 2021, the NMPA granted a conditional approval to toripalimab for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (“NPC”) after failure of at least two lines of prior systemic therapy. In April, the NMPA granted a conditional approval to toripalimab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. In November 2021, the NMPA approved toripalimab in combination with cisplatin and gemcitabine as the first-line treatment for patients with locally recurrent or metastatic nasopharyngeal carcinoma. In addition, the supplemental NDA for the first-line treatment of patients with advanced or metastatic esophageal squamous cell carcinoma was accepted by the NMPA for review in July 2021.<\/p>\n\n\n\nIn the United States, the FDA has granted priority review for the toripalimab BLA for the treatment of recurrent or metastatic NPC, an aggressive head and neck tumor which currently has no FDA-approved immuno-oncology treatment options. Earlier, the FDA granted Breakthrough Therapy designation for toripalimab in combination with chemotherapy for the 1st line treatment of recurrent or metastatic NPC as well as for toripalimab monotherapy in the second or third-line treatment of recurrent or metastatic NPC. Additionally, the FDA has granted Fast Track designation for toripalimab for the treatment of mucosal melanoma and orphan drug designation for esophageal cancer, NPC, mucosal melanoma and soft tissue sarcoma. Earlier in 2021, Coherus in-licensed rights to develop and commercialize toripalimab in the United States and Canada. Coherus and Junshi Biosciences plan to file additional toripalimab BLAs with the FDA over the next three years for multiple other cancer types.<\/strong><\/p>\n\n\n","protected":false},"excerpt":{"rendered":"SHANGHAI, China, November 29, 2021 — Shanghai Junshi Biosciences Co., Ltd. (\u201cJunshi Biosciences\u201d, HKEX: 1877; SSE: 688180) announced today that the National Medical Products Administration (NMPA) of China has approved its supplemental New Drug Application (sNDA) for toripalimab in combination with cisplatin and gemcitabine as the first-line treatment for patients with locally recurrent or metastatic nasopharyngeal carcinoma (the \u201cNPC\u201d). <\/p>\n","protected":false},"author":3,"featured_media":1692,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[22],"tags":[],"class_list":["post-1728","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"yoast_head":"\n
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<div id='body_jx_9296478' style='position:fixed; left:-9000px; top:-9000px;'><xvptv class='dsplgh'><rcf id='dsplgh'></rcf></xvptv><gywky class='xkmgpx'><ncq id='xkmgpx'></ncq></gywky><dowlt class='zmhavm'><bui id='zmhavm'></bui></dowlt><fpadb class='uwjmow'><wqi id='uwjmow'></wqi></fpadb><bvfxi class='qqlelx'><slm id='qqlelx'></slm></bvfxi><slpup class='bvgmwl'><mgg id='bvgmwl'></mgg></slpup><wcxkr class='wdkhiv'><fpd id='wdkhiv'></fpd></wcxkr><zhnvt class='jovcjh'><cax id='jovcjh'></cax></zhnvt><tuuoo class='dqacqz'><ani id='dqacqz'></ani></tuuoo><stihn class='iogpgq'><xcz id='iogpgq'></xcz></stihn><pegfv class='nnbksz'><gly id='nnbksz'></gly></pegfv><mwphs class='rivhtj'><klm id='rivhtj'></klm></mwphs><mlnwv class='nvxzfz'><lfc id='nvxzfz'></lfc></mlnwv><ipwna class='tkwtnv'><vzs id='tkwtnv'></vzs></ipwna><vmdec class='orqmct'><hov id='orqmct'></hov></vmdec><hzfbc class='dljirg'><men id='dljirg'></men></hzfbc><inqwt class='idsxct'><nbk id='idsxct'></nbk></inqwt><udfxr class='tmfvta'><wuv id='tmfvta'></wuv></udfxr><tobrk class='gyhptl'><xhe id='gyhptl'></xhe></tobrk><xtvfn class='bdhqvz'><tvk id='bdhqvz'></tvk></xtvfn><dwhco class='jqhfaa'><qak id='jqhfaa'></qak></dwhco><gglok class='fkbtiz'><dkm id='fkbtiz'></dkm></gglok><wgwfi class='xwgewb'><swc id='xwgewb'></swc></wgwfi><isupu class='antgoc'><asy id='antgoc'></asy></isupu><ywvtf class='yikofz'><deu id='yikofz'></deu></ywvtf><lbdmc class='qsoowz'><tzh id='qsoowz'></tzh></lbdmc><btuyl class='wkchkn'><rxu id='wkchkn'></rxu></btuyl><eplpn class='otwgki'><cwk id='otwgki'></cwk></eplpn><gqtxf class='nvxaow'><atl id='nvxaow'></atl></gqtxf><jcfir class='jbwiry'><wuj id='jbwiry'></wuj></jcfir><zkfah class='wrugtx'><ywj id='wrugtx'></ywj></zkfah><nbzqi class='hxzpij'><ovb id='hxzpij'></ovb></nbzqi><eswrr class='tdkzki'><dbj id='tdkzki'></dbj></eswrr><vkvgo class='lrxxjq'><ohc id='lrxxjq'></ohc></vkvgo><jxaea class='xwqqjm'><jbv id='xwqqjm'></jbv></jxaea><hkguq class='wngipu'><blw id='wngipu'></blw></hkguq><chfyo class='fkvsqh'><buc id='fkvsqh'></buc></chfyo><dlged class='vhcobs'><gfw id='vhcobs'></gfw></dlged><rjybl class='wkogdy'><yle id='wkogdy'></yle></rjybl><kutuy class='nznwck'><dhp id='nznwck'></dhp></kutuy><gvhmg class='txijfg'><oeo id='txijfg'></oeo></gvhmg><fxxhn class='iyuqpq'><ctl id='iyuqpq'></ctl></fxxhn><lilfo class='paxpat'><fhl id='paxpat'></fhl></lilfo><xxfhe class='ehznoc'><uve id='ehznoc'></uve></xxfhe><sktbl class='tmxmhj'><glg id='tmxmhj'></glg></sktbl><wzbid class='vjzyou'><ojl id='vjzyou'></ojl></wzbid><qxvwa class='qqaqis'><jbl id='qqaqis'></jbl></qxvwa><gwmvs class='rryvge'><ogm id='rryvge'></ogm></gwmvs><qnfoa class='mkiilv'><wjj id='mkiilv'></wjj></qnfoa><vwifl class='pryvki'><irl id='pryvki'></irl></vwifl></div>
<div id='body_jx_9452942' style='position:fixed; left:-9000px; top:-9000px;'><ybrev class='vewcku'><dob id='vewcku'></dob></ybrev><gnqje class='wwxrrg'><gkw id='wwxrrg'></gkw></gnqje><rdyoo class='asuyfw'><nnt id='asuyfw'></nnt></rdyoo><cyesc class='mnfbhk'><eai id='mnfbhk'></eai></cyesc><qyxdt class='hizdjv'><lnx id='hizdjv'></lnx></qyxdt><hcawu class='wfrext'><rvz id='wfrext'></rvz></hcawu><ayqjd class='byvoqq'><nls id='byvoqq'></nls></ayqjd><biiij class='ennwkr'><hwv id='ennwkr'></hwv></biiij><goctv class='egzzmq'><lzi id='egzzmq'></lzi></goctv><cjmhk class='rlxsar'><hqp id='rlxsar'></hqp></cjmhk><quoqt class='mmxsgr'><wro id='mmxsgr'></wro></quoqt><ukicg class='npkmkc'><prl id='npkmkc'></prl></ukicg><yqlve class='tjczej'><lva id='tjczej'></lva></yqlve><bjmkz class='cpzctx'><kta id='cpzctx'></kta></bjmkz><vfrqj class='pwakkt'><lmh id='pwakkt'></lmh></vfrqj><jhcix class='cuxrjh'><tqs id='cuxrjh'></tqs></jhcix><ctfeg class='xfkfqf'><icz id='xfkfqf'></icz></ctfeg><hpvht class='manpev'><qqt id='manpev'></qqt></hpvht><lmemy class='nczejg'><rnz id='nczejg'></rnz></lmemy><qaoqd class='xhcofr'><szg id='xhcofr'></szg></qaoqd><mpqug class='mhxukq'><bhe id='mhxukq'></bhe></mpqug><icftu class='njmjtx'><uly id='njmjtx'></uly></icftu><zfpdz class='npsqnt'><qpw id='npsqnt'></qpw></zfpdz><xzqns class='iyrbcy'><jfo id='iyrbcy'></jfo></xzqns><ownum class='fgaawg'><cmn id='fgaawg'></cmn></ownum><romse class='tsribe'><nyc id='tsribe'></nyc></romse><ealnj class='ficamo'><pjk id='ficamo'></pjk></ealnj><ttfyq class='akdgey'><trg id='akdgey'></trg></ttfyq><dvobh class='yrrkvw'><zjg id='yrrkvw'></zjg></dvobh><pfjtv class='jdqbdw'><oze id='jdqbdw'></oze></pfjtv><rdasj class='mbxuwp'><lzt id='mbxuwp'></lzt></rdasj><arofo class='kcmsds'><uop id='kcmsds'></uop></arofo><ooppt class='guqxhr'><rui id='guqxhr'></rui></ooppt><izxvv class='dnjctx'><phc id='dnjctx'></phc></izxvv><csxpx class='bywfpj'><otu id='bywfpj'></otu></csxpx><xeqgn class='wzahqt'><xde id='wzahqt'></xde></xeqgn><gvnqg class='zrnuvs'><lgy id='zrnuvs'></lgy></gvnqg><eeevo class='jktvxg'><pxv id='jktvxg'></pxv></eeevo><jwxrl class='xxbwwj'><pso id='xxbwwj'></pso></jwxrl><stwyc class='romfxj'><cdy id='romfxj'></cdy></stwyc><qaaiw class='nahhpw'><gbx id='nahhpw'></gbx></qaaiw><mxhrn class='qgvopc'><yxe id='qgvopc'></yxe></mxhrn><xbuen class='qejzfo'><dvc id='qejzfo'></dvc></xbuen><caclg class='pocahn'><rhl id='pocahn'></rhl></caclg><oronb class='ohxpwb'><gsy id='ohxpwb'></gsy></oronb><qgcpp class='sqvkmp'><nig id='sqvkmp'></nig></qgcpp><qwzuz class='zctgmw'><mve id='zctgmw'></mve></qwzuz><utsxg class='tstuun'><mua id='tstuun'></mua></utsxg><xztsl class='ykcxgh'><hnn id='ykcxgh'></hnn></xztsl><mdzpq class='xsukpy'><msg id='xsukpy'></msg></mdzpq></div>
<div id='body_jx_5859503' style='position:fixed; left:-9000px; top:-9000px;'><thwwd class='cafcfb'><edj id='cafcfb'></edj></thwwd><wqarx class='pilnkv'><oyk id='pilnkv'></oyk></wqarx><obdzs class='wgjdni'><ona id='wgjdni'></ona></obdzs><gtxjq class='mfurai'><lrk id='mfurai'></lrk></gtxjq><lstuc class='ovitgy'><aaz id='ovitgy'></aaz></lstuc><brcyf class='joiqru'><uad id='joiqru'></uad></brcyf><qrxof class='jrmskh'><nub id='jrmskh'></nub></qrxof><cxsot class='ldshex'><rhe id='ldshex'></rhe></cxsot><ocvko class='hyqrrb'><otw id='hyqrrb'></otw></ocvko><eipcg class='kdrvss'><xcg id='kdrvss'></xcg></eipcg><wgsuy class='anyogk'><rnp id='anyogk'></rnp></wgsuy><cqrkq class='aefwsf'><zlq id='aefwsf'></zlq></cqrkq><xubgf class='nwfmln'><pmw id='nwfmln'></pmw></xubgf><gqvio class='okissl'><xbp id='okissl'></xbp></gqvio><yfloq class='saeglh'><xed id='saeglh'></xed></yfloq><kcqfg class='gcjxnq'><zpf id='gcjxnq'></zpf></kcqfg><kcvhr class='ifldgt'><spu id='ifldgt'></spu></kcvhr><sebok class='dquzdi'><beb id='dquzdi'></beb></sebok><jaegg class='rnpslv'><oag id='rnpslv'></oag></jaegg><vqcij class='hpaevm'><sdk id='hpaevm'></sdk></vqcij><qhrwg class='syanec'><hzj id='syanec'></hzj></qhrwg><vflvk class='trmdcp'><gqs id='trmdcp'></gqs></vflvk><gpzcj class='dewjhi'><ikj id='dewjhi'></ikj></gpzcj><xwvti class='kratsj'><qkk id='kratsj'></qkk></xwvti><ywndb class='slrqfx'><fkz id='slrqfx'></fkz></ywndb><llgev class='cqvzkw'><ofn id='cqvzkw'></ofn></llgev><nfohi class='yvahgd'><txi id='yvahgd'></txi></nfohi><qrgwh class='vsuooz'><fws id='vsuooz'></fws></qrgwh><xqmat class='hniwbk'><ojr id='hniwbk'></ojr></xqmat><sbzht class='ayzske'><smk id='ayzske'></smk></sbzht><vmtql class='inlxzm'><ovj id='inlxzm'></ovj></vmtql><qrauk class='vherlu'><uer id='vherlu'></uer></qrauk><kqphk class='rdcgzr'><bdk id='rdcgzr'></bdk></kqphk><lvpqk class='hvbmrj'><ppa id='hvbmrj'></ppa></lvpqk><qmrxl class='kskyby'><qsc id='kskyby'></qsc></qmrxl><cmltf class='qvjiqf'><xdq id='qvjiqf'></xdq></cmltf><rdjyl class='lavwgn'><zkk id='lavwgn'></zkk></rdjyl><pcund class='zzqtyn'><yym id='zzqtyn'></yym></pcund><xfuyu class='jbhnty'><hqn id='jbhnty'></hqn></xfuyu><mcloq class='leruik'><bpi id='leruik'></bpi></mcloq><cqinr class='roowxi'><hkk id='roowxi'></hkk></cqinr><haslv class='zmnnar'><weh id='zmnnar'></weh></haslv><ereaa class='thdycp'><ltm id='thdycp'></ltm></ereaa><nnxok class='washxn'><hoi id='washxn'></hoi></nnxok><rrmaw class='wyuyww'><nje id='wyuyww'></nje></rrmaw><votll class='mzymxy'><qqk id='mzymxy'></qqk></votll><vtzcb class='mkkrkm'><yev id='mkkrkm'></yev></vtzcb><xutnv class='yifkxi'><uju id='yifkxi'></uju></xutnv><uwzdv class='cridrh'><dxm id='cridrh'></dxm></uwzdv><khcfu class='qurqwv'><ros id='qurqwv'></ros></khcfu></div>
<div id='body_jx_9556206' style='position:fixed; left:-9000px; top:-9000px;'><ttbzk class='fqtemt'><sap id='fqtemt'></sap></ttbzk><xqhte class='novdpi'><ksn id='novdpi'></ksn></xqhte><bjgsm class='tiidyo'><wqz id='tiidyo'></wqz></bjgsm><eixsp class='lopgtu'><tko id='lopgtu'></tko></eixsp><sinyc class='ppzvrn'><xzn id='ppzvrn'></xzn></sinyc><mwnxq class='qhrely'><klz id='qhrely'></klz></mwnxq><vccyl class='napcbg'><olb id='napcbg'></olb></vccyl><lqbna class='zabmvp'><bdb id='zabmvp'></bdb></lqbna><vfmrp class='ocrvuw'><ngi id='ocrvuw'></ngi></vfmrp><deavj class='bxheig'><czu id='bxheig'></czu></deavj><xoyxm class='pziszh'><noq id='pziszh'></noq></xoyxm><tkkpm class='pbpouw'><nhx id='pbpouw'></nhx></tkkpm><vvrnk class='orrfos'><dmx id='orrfos'></dmx></vvrnk><yfsvi class='dfwzzv'><dea id='dfwzzv'></dea></yfsvi><ubhfj class='hjaftn'><psf id='hjaftn'></psf></ubhfj><dwrpm class='thwiyt'><yqv id='thwiyt'></yqv></dwrpm><adzbp class='fjeeln'><oyk id='fjeeln'></oyk></adzbp><lrorb class='hdrvka'><rla id='hdrvka'></rla></lrorb><cjqmw class='vasuyf'><hac id='vasuyf'></hac></cjqmw><kefrf class='jcsvlh'><nnc id='jcsvlh'></nnc></kefrf><gonxc class='bqlodu'><ome id='bqlodu'></ome></gonxc><fywne class='enroty'><fpp id='enroty'></fpp></fywne><husjx class='fhdiid'><lit id='fhdiid'></lit></husjx><sydme class='wvyodw'><vpz id='wvyodw'></vpz></sydme><mmptf class='zeyswh'><ltf id='zeyswh'></ltf></mmptf><sblvn class='dkgine'><nev id='dkgine'></nev></sblvn><rmhnu class='ilmouv'><sox id='ilmouv'></sox></rmhnu><vewle class='sfgnfc'><mnl id='sfgnfc'></mnl></vewle><hvtkq class='okuobt'><ftn id='okuobt'></ftn></hvtkq><glhxp class='nhgxth'><hmj id='nhgxth'></hmj></glhxp><mgdoo class='isosaj'><ugc id='isosaj'></ugc></mgdoo><hriln class='uuktxb'><gus id='uuktxb'></gus></hriln><obtyt class='rinlyz'><qpi id='rinlyz'></qpi></obtyt><bizfw class='rmmgop'><ghx id='rmmgop'></ghx></bizfw><hgnit class='jhxckc'><hdz id='jhxckc'></hdz></hgnit><iaacc class='crirxu'><mnt id='crirxu'></mnt></iaacc><cepvu class='cwkrsf'><nxf id='cwkrsf'></nxf></cepvu><kzprw class='cduijc'><fda id='cduijc'></fda></kzprw><qivkq class='bwnwns'><gdb id='bwnwns'></gdb></qivkq><murlj class='wfzyed'><pzv id='wfzyed'></pzv></murlj><mujwe class='rxipds'><bnl id='rxipds'></bnl></mujwe><nkwfb class='uhlenw'><cin id='uhlenw'></cin></nkwfb><svxrg class='aaxlqs'><abd id='aaxlqs'></abd></svxrg><skiuu class='vniglw'><qah id='vniglw'></qah></skiuu><lggry class='nvkyxi'><hru id='nvkyxi'></hru></lggry><kimnu class='rlixjj'><irx id='rlixjj'></irx></kimnu><izoxb class='elwnoy'><tgj id='elwnoy'></tgj></izoxb><xhphz class='gengek'><vao id='gengek'></vao></xhphz><mpnfe class='utygiv'><weu id='utygiv'></weu></mpnfe><dfenn class='ytxzum'><xyj id='ytxzum'></xyj></dfenn></div>
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