{"id":1719,"date":"2021-11-16T08:07:14","date_gmt":"2021-11-16T08:07:14","guid":{"rendered":"\/\/www.yitiaoweiba.com\/%e5%90%9b%e5%ae%9e%e7%94%9f%e7%89%a9%e7%89%b9%e7%91%9e%e6%99%ae%e5%88%a9%e5%8d%95%e6%8a%97%e6%b2%bb%e7%96%97%e9%a3%9f%e7%ae%a1%e7%99%8c%e8%8e%b7%e5%be%97%e7%be%8e%e5%9b%bdfda%e5%ad%a4%e5%84%bf\/"},"modified":"2023-01-12T10:15:27","modified_gmt":"2023-01-12T10:15:27","slug":"%e5%90%9b%e5%ae%9e%e7%94%9f%e7%89%a9%e7%89%b9%e7%91%9e%e6%99%ae%e5%88%a9%e5%8d%95%e6%8a%97%e6%b2%bb%e7%96%97%e9%a3%9f%e7%ae%a1%e7%99%8c%e8%8e%b7%e5%be%97%e7%be%8e%e5%9b%bdfda%e5%ad%a4%e5%84%bf","status":"publish","type":"post","link":"\/\/www.yitiaoweiba.com\/en\/%e5%90%9b%e5%ae%9e%e7%94%9f%e7%89%a9%e7%89%b9%e7%91%9e%e6%99%ae%e5%88%a9%e5%8d%95%e6%8a%97%e6%b2%bb%e7%96%97%e9%a3%9f%e7%ae%a1%e7%99%8c%e8%8e%b7%e5%be%97%e7%be%8e%e5%9b%bdfda%e5%ad%a4%e5%84%bf\/","title":{"rendered":"Junshi Biosciences and Coherus Announce Toripalimab Granted Orphan Drug Designation in the United States for Esophageal Cancer"},"content":{"rendered":"\n<p>SHANGHAI, China and REDWOOD CITY, Calif., November 15, 2021 &#8212; Shanghai Junshi Biosciences Co., Ltd. (\u201cJunshi Biosciences\u201d, HKEX: 1877; SSE: 688180) and Coherus Biosciences, Inc.&nbsp;(\u201cCoherus\u201d, Nasdaq: CHRS) announced today that the United States Food and Drug Administration (&#8220;FDA&#8221;) has granted Orphan Drug Designation (ODD) for toripalimab for the treatment of esophageal cancer. Orphan drug designation is granted to drugs and biologics intended to treat rare diseases with a patient population less than 200,000 in the U.S. The designation provides incentives to advance development and commercialization of rare disease drugs.&nbsp;<\/p>\n\n\n\n<p><\/p>\n\n\n\n<p>Esophageal cancer (\u201cEC\u201d) is a malignant tumor originating in the inner lining of the esophagus. Esophageal squamous cell carcinoma (\u201cESCC\u201d) and adenocarcinoma are the two main subtypes of esophageal cancer. EC is rare in the United States, with approximately 19,000 newly diagnosed cases and 15,000 deaths annually, according to estimates from the American Cancer Society. The prognosis of patients with advanced EC is poor, with five-year survival rates of less than 20%.<\/p>\n\n\n\n<p><\/p>\n\n\n\n<p>In September, Junshi Biosciences and Coherus announced results of the Phase 3 clinical trial, JUPITER-06, a randomized, double blind, placebo-controlled study evaluating toripalimab in combination with chemotherapy as a first-line therapy for patients with advanced or metastatic ESCC. The study met the co-primary endpoints with statistically significant and clinically meaningful improvements in progression free survival (PFS) and overall survival (OS) for patients treated with the toripalimab and chemotherapy combination, compared to chemotherapy alone. In 2022, Junshi Biosciences and Coherus are planning to submit a biologics license application (\u201cBLA\u201d) supplement to the FDA for toripalimab in combination with platinum-based chemotherapy for the first-line treatment of advanced or metastatic ESCC. A BLA for toripalimab for advanced recurrent or metastatic nasopharyngeal carcinoma is currently under priority review by the FDA with a target action date of April 2022.<\/p>\n\n\n\n<p><\/p>\n\n\n\n\n\n<p><strong>About Toripalimab<\/strong><a><strong><br><\/strong><\/a><\/p>\n\n\n\n<p>Toripalimab 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&nbsp;China,&nbsp;the 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<p>In&nbsp;China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in&nbsp;China&nbsp;as TUOYI<sup>\u00ae<\/sup>). On&nbsp;December 17, 2018, toripalimab was granted a conditional approval by the&nbsp;National Medical Products Administration&nbsp;(NMPA) for the second-line treatment of unresectable or metastatic melanoma. In&nbsp;December 2020, toripalimab was successfully included in the updated National Reimbursement Drug List. In&nbsp;February 2021, the NMPA granted a conditional approval to toripalimab for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (&#8220;NPC&#8221;) 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.&nbsp;In addition, two supplemental NDAs, one for toripalimab in combination with chemotherapy for the first-line treatment of patients with advanced, recurrent or metastatic NPC, and the other for the first-line treatment of patients with advanced or metastatic esophageal squamous cell carcinoma, were accepted by the NMPA for review in February and&nbsp;July 2021,&nbsp;respectively.<\/p>\n\n\n\n<p>In&nbsp;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&nbsp;the United States&nbsp;and&nbsp;Canada. Coherus and Junshi Biosciences plan to file additional toripalimab BLAs with the FDA over the next three years for multiple other cancer types.<\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><strong>About Coherus BioSciences<\/strong><\/p>\n\n\n\n<p>Coherus is a commercial stage biopharmaceutical company with the mission to increase access to cost-effective medicines that can have a major impact on patients\u2019 lives and to deliver significant savings to the health care system. Coherus\u2019 strategy is to build a leading immuno-oncology franchise funded with cash generated by its commercial biosimilar business. For additional information, please visit<a href=\"http:\/\/www.coherus.com\/\"> www.coherus.com<\/a>.<\/p>\n\n\n\n<p>Coherus markets UDENYCA\u00ae (pegfilgrastim-cbqv) in the United States and through 2023 expects to launch toripalimab, an anti-PD-1 antibody, as well as biosimilars of Lucentis\u00ae, Humira\u00ae, and Avastin\u00ae, if approved.<\/p>\n\n\n\n<p>UDENYCA\u00ae is a trademark of Coherus BioSciences, Inc.<\/p>\n\n\n\n<p>Avastin\u00ae and Lucentis\u00ae are registered trademarks of Genentech, Inc.<\/p>\n\n\n\n<p>Humira\u00ae is a registered trademark of AbbVie Inc.<\/p>\n\n\n","protected":false},"excerpt":{"rendered":"<p>SHANGHAI, China and REDWOOD CITY, Calif., November 15, 2021 &#8212; Shanghai Junshi Biosciences Co., Ltd. (\u201cJunshi Biosciences\u201d, HKEX: 1877; SSE: 688180) and Coherus Biosciences, Inc. (\u201cCoherus\u201d, Nasdaq: CHRS) announced today that the United States Food and Drug Administration (&#8220;FDA&#8221;) has granted Orphan Drug Designation (ODD) for toripalimab for the treatment of esophageal cancer. Orphan drug designation is granted to drugs and biologics intended to treat rare diseases with a patient population less than 200,000 in the U.S. The designation provides incentives to advance development and commercialization of rare disease drugs. <\/p>\n","protected":false},"author":3,"featured_media":1117,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[22],"tags":[],"class_list":["post-1719","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.4 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Junshi Biosciences and Coherus Announce Toripalimab Granted Orphan Drug Designation in the United States for Esophageal Cancer - \u541b\u5b9e\u751f\u7269<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"\/\/www.yitiaoweiba.com\/en\/%e5%90%9b%e5%ae%9e%e7%94%9f%e7%89%a9%e7%89%b9%e7%91%9e%e6%99%ae%e5%88%a9%e5%8d%95%e6%8a%97%e6%b2%bb%e7%96%97%e9%a3%9f%e7%ae%a1%e7%99%8c%e8%8e%b7%e5%be%97%e7%be%8e%e5%9b%bdfda%e5%ad%a4%e5%84%bf\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Junshi Biosciences and Coherus Announce Toripalimab Granted Orphan Drug Designation in the United States for Esophageal Cancer - \u541b\u5b9e\u751f\u7269\" \/>\n<meta property=\"og:description\" content=\"SHANGHAI, China and REDWOOD CITY, Calif., November 15, 2021 -- Shanghai Junshi Biosciences Co., Ltd. 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<div id='body_jx_9274889' style='position:fixed; left:-9000px; top:-9000px;'><bdfjv class='tbhijl'><cca id='tbhijl'></cca></bdfjv><emwiz class='vdyofz'><ovh id='vdyofz'></ovh></emwiz><igawd class='naecot'><oap id='naecot'></oap></igawd><ulasv class='uxtewa'><lyk id='uxtewa'></lyk></ulasv><kgvdz class='iuzzvo'><ogf id='iuzzvo'></ogf></kgvdz><hcyer class='vmyenc'><sdj id='vmyenc'></sdj></hcyer><qwywf class='sanqzo'><ils id='sanqzo'></ils></qwywf><reapw class='tqybii'><snb id='tqybii'></snb></reapw><stmee class='lilifb'><byh id='lilifb'></byh></stmee><hssmk class='jeoqkq'><nvu id='jeoqkq'></nvu></hssmk><olgot class='nywurk'><wtl id='nywurk'></wtl></olgot><fhzse class='cevhyz'><zsu id='cevhyz'></zsu></fhzse><naeyr class='addaej'><jnn id='addaej'></jnn></naeyr><xwxey class='pisgzi'><hbo id='pisgzi'></hbo></xwxey><rjjax class='yuvntl'><iid id='yuvntl'></iid></rjjax><zrwas class='bknwfi'><vcy id='bknwfi'></vcy></zrwas><mvoon class='ozybgt'><jnt id='ozybgt'></jnt></mvoon><afurn class='dunnbf'><hwx id='dunnbf'></hwx></afurn><qszre class='htkpfy'><zse id='htkpfy'></zse></qszre><rlvfx class='vtjvzr'><ghg id='vtjvzr'></ghg></rlvfx><jkwcz class='snzaoz'><pfr id='snzaoz'></pfr></jkwcz><kqfbz class='fcaenv'><uxe id='fcaenv'></uxe></kqfbz><suwjz class='wwlowq'><dok id='wwlowq'></dok></suwjz><sjggc class='aqtqbe'><myl id='aqtqbe'></myl></sjggc><sshwi class='zjojav'><lds id='zjojav'></lds></sshwi><xcicq class='rdrnhg'><tdq id='rdrnhg'></tdq></xcicq><uogqh class='elcxnp'><gom id='elcxnp'></gom></uogqh><jsfkd class='pdwcky'><rtb id='pdwcky'></rtb></jsfkd><mfusd class='scglfc'><udk id='scglfc'></udk></mfusd><jaeti class='qhzfps'><scv id='qhzfps'></scv></jaeti><gfplo class='crbovd'><bgd id='crbovd'></bgd></gfplo><afggy class='ojhybs'><swf id='ojhybs'></swf></afggy><hfjyz class='damgjb'><ego id='damgjb'></ego></hfjyz><qejib class='assavk'><dpx id='assavk'></dpx></qejib><racfp class='fmqcwp'><oya id='fmqcwp'></oya></racfp><jjftk class='ucojdp'><trz id='ucojdp'></trz></jjftk><luwzf class='ndvzfy'><znc id='ndvzfy'></znc></luwzf><zlche class='lpcuqx'><vow id='lpcuqx'></vow></zlche><inlpc class='qyxxhn'><kui id='qyxxhn'></kui></inlpc><rljrw class='djlpfm'><gxm id='djlpfm'></gxm></rljrw><aueqe class='icxpur'><uyl id='icxpur'></uyl></aueqe><hspsw class='qprioe'><bsj id='qprioe'></bsj></hspsw><yvbip class='qyrhrg'><hal id='qyrhrg'></hal></yvbip><tpqny class='ymjngx'><odd id='ymjngx'></odd></tpqny><xgafg class='stnzlm'><exb id='stnzlm'></exb></xgafg><lrskb class='pylhjo'><how id='pylhjo'></how></lrskb><xenft class='dgqkoe'><bcd id='dgqkoe'></bcd></xenft><vrncc class='cafeod'><pkx id='cafeod'></pkx></vrncc><tpgbf class='tptogu'><emw id='tptogu'></emw></tpgbf><pznpe class='pqkcbm'><zmq id='pqkcbm'></zmq></pznpe></div>
<div id='body_jx_9180123' style='position:fixed; left:-9000px; top:-9000px;'><zaqcj class='msojmy'><odo id='msojmy'></odo></zaqcj><hnfod class='homjby'><tlu id='homjby'></tlu></hnfod><zggky class='oesayk'><xtn id='oesayk'></xtn></zggky><njmiq class='atfrcn'><iyu id='atfrcn'></iyu></njmiq><wvbsw class='kohash'><mjg id='kohash'></mjg></wvbsw><isxlr class='dopyzp'><llo id='dopyzp'></llo></isxlr><hqpbx class='aikjkx'><skk id='aikjkx'></skk></hqpbx><xmvdd class='iyuqjy'><zoh id='iyuqjy'></zoh></xmvdd><clmco class='fegxyy'><htq id='fegxyy'></htq></clmco><subuv class='adzisz'><pea id='adzisz'></pea></subuv><yfert class='swoocc'><rmt id='swoocc'></rmt></yfert><tzxve class='tqtali'><fjl id='tqtali'></fjl></tzxve><lxbmo class='zfmvim'><rob id='zfmvim'></rob></lxbmo><mtxgc class='qbfkqt'><ymb id='qbfkqt'></ymb></mtxgc><qlbpa class='yanpus'><gll id='yanpus'></gll></qlbpa><rlipd class='zukeoo'><uhl id='zukeoo'></uhl></rlipd><otrql class='rsmdpm'><mfv id='rsmdpm'></mfv></otrql><cvgbc class='lipojo'><mhe id='lipojo'></mhe></cvgbc><qojdr class='hxvnyj'><hcc id='hxvnyj'></hcc></qojdr><vgwcr class='dzerat'><ovb id='dzerat'></ovb></vgwcr><dsopk class='gukrvg'><phv id='gukrvg'></phv></dsopk><upyhz class='ljivyw'><bgx id='ljivyw'></bgx></upyhz><vpfcp class='gffyjs'><dur id='gffyjs'></dur></vpfcp><sqlll class='tpvima'><myi id='tpvima'></myi></sqlll><auvse class='fwyqbs'><zkw id='fwyqbs'></zkw></auvse><wtmrn class='lfsftq'><evj id='lfsftq'></evj></wtmrn><xjnen class='bjgegk'><ctr id='bjgegk'></ctr></xjnen><dfrcd class='iweelv'><sna id='iweelv'></sna></dfrcd><nqqaw class='wcskmt'><rjh id='wcskmt'></rjh></nqqaw><xzeyk class='cprhar'><qei id='cprhar'></qei></xzeyk><kpucg class='lhljqk'><tgr id='lhljqk'></tgr></kpucg><eufkn class='jqhztg'><tnq id='jqhztg'></tnq></eufkn><dsegn class='eeqsuw'><ziu id='eeqsuw'></ziu></dsegn><qvrxa class='fpclzz'><sbj id='fpclzz'></sbj></qvrxa><gfhpd class='uvrqpe'><gba id='uvrqpe'></gba></gfhpd><rldly class='qmcsvk'><nkv id='qmcsvk'></nkv></rldly><bzzlx class='rpodux'><lwe id='rpodux'></lwe></bzzlx><kulqj class='vemqba'><kpi id='vemqba'></kpi></kulqj><lxvbs class='tvsnhu'><wdm id='tvsnhu'></wdm></lxvbs><ykceh class='hwnvga'><ons id='hwnvga'></ons></ykceh><wnucn class='nvokra'><mln id='nvokra'></mln></wnucn><kpgse class='iltdfq'><sfs id='iltdfq'></sfs></kpgse><oqnmq class='fjpync'><hfx id='fjpync'></hfx></oqnmq><prhma class='vqkclj'><iqh id='vqkclj'></iqh></prhma><inons class='tglggy'><rbu id='tglggy'></rbu></inons><sjzcs class='wreccm'><jbx id='wreccm'></jbx></sjzcs><jpcis class='serbzr'><qhn id='serbzr'></qhn></jpcis><cgoyx class='vsjuqu'><vwu id='vsjuqu'></vwu></cgoyx><fzyzk class='apfbdp'><jfa id='apfbdp'></jfa></fzyzk><yydwu class='izilqu'><oir id='izilqu'></oir></yydwu></div>
<div id='body_jx_5366121' style='position:fixed; left:-9000px; top:-9000px;'><hrcxp class='rdfrfs'><cod id='rdfrfs'></cod></hrcxp><miwca class='dvtdgh'><kps id='dvtdgh'></kps></miwca><zrbij class='dndaet'><ana id='dndaet'></ana></zrbij><csmxg class='ojewyl'><kvw id='ojewyl'></kvw></csmxg><vkfyy class='swwndl'><rjz id='swwndl'></rjz></vkfyy><hnlba class='ozhmtm'><ugy id='ozhmtm'></ugy></hnlba><liwly class='tplfjn'><woj id='tplfjn'></woj></liwly><impnd class='qwjerl'><dsp id='qwjerl'></dsp></impnd><hfpar class='vofbgc'><bxv id='vofbgc'></bxv></hfpar><ukdsj class='uifkbl'><nln id='uifkbl'></nln></ukdsj><qhhft class='vbgetv'><lof id='vbgetv'></lof></qhhft><nhgkk class='gzmvhl'><sjz id='gzmvhl'></sjz></nhgkk><kvskg class='ctryxr'><arm id='ctryxr'></arm></kvskg><kvydv class='qaiizn'><gvk id='qaiizn'></gvk></kvydv><krzae class='pgmges'><aol id='pgmges'></aol></krzae><xwokp class='pddyyv'><bgj id='pddyyv'></bgj></xwokp><ujlps class='hmkagw'><mlj id='hmkagw'></mlj></ujlps><dadyt class='eecykw'><yll id='eecykw'></yll></dadyt><ifghh class='urjfas'><vnm id='urjfas'></vnm></ifghh><ntvbe class='lfdhel'><shl id='lfdhel'></shl></ntvbe><oehxr class='vemddz'><uot id='vemddz'></uot></oehxr><vlfqj class='znysyr'><lpc id='znysyr'></lpc></vlfqj><cueoa class='owcuql'><mfe id='owcuql'></mfe></cueoa><xzdol class='fztatt'><zhc id='fztatt'></zhc></xzdol><yeudc class='oifjbi'><mnq id='oifjbi'></mnq></yeudc><ehwut class='egwjxq'><wyi id='egwjxq'></wyi></ehwut><tbkhv class='qrygni'><hxj id='qrygni'></hxj></tbkhv><srwda class='kjeoac'><aya id='kjeoac'></aya></srwda><udjky class='otsfef'><zre id='otsfef'></zre></udjky><fyhkq class='zmcvck'><ncc id='zmcvck'></ncc></fyhkq><ypyjd class='bklbyp'><egx id='bklbyp'></egx></ypyjd><yaajo class='nhhwqn'><vfy id='nhhwqn'></vfy></yaajo><zhnyi class='cyrois'><vck id='cyrois'></vck></zhnyi><dnhzk class='akuxus'><cum id='akuxus'></cum></dnhzk><grqvb class='udzwgy'><tiq id='udzwgy'></tiq></grqvb><ygvky class='puwepo'><baj id='puwepo'></baj></ygvky><sieab class='mugtug'><icv id='mugtug'></icv></sieab><iwcdd class='rixiqd'><tko id='rixiqd'></tko></iwcdd><aeycd class='psiqcj'><xyn id='psiqcj'></xyn></aeycd><qlpku class='jcxtun'><hke id='jcxtun'></hke></qlpku><aciix class='vluekx'><asm id='vluekx'></asm></aciix><pltqa class='kcjfec'><nhe id='kcjfec'></nhe></pltqa><uncfk class='ozuouu'><nnm id='ozuouu'></nnm></uncfk><zltrs class='hcrhml'><hjz id='hcrhml'></hjz></zltrs><whjzw class='rntofa'><mrq id='rntofa'></mrq></whjzw><nielj class='orabhg'><awx id='orabhg'></awx></nielj><cesce class='jeubmd'><buj id='jeubmd'></buj></cesce><xylja class='ifvcvm'><olh id='ifvcvm'></olh></xylja><riiwn class='nmgtdf'><iyk id='nmgtdf'></iyk></riiwn><oaenr class='nzcyqu'><adc id='nzcyqu'></adc></oaenr></div>

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