{"id":71082,"date":"2022-07-06T12:06:03","date_gmt":"2022-07-06T12:06:03","guid":{"rendered":"https:\/\/pr.asianetpakistan.com\/?p=94466"},"modified":"2022-07-06T12:06:03","modified_gmt":"2022-07-06T12:06:03","slug":"junshi-biosciences-and-coherus-announce-fda-acceptance-of-resubmission-of-bla-for-toripalimab-for-the-treatment-of-nasopharyngeal-carcinoma","status":"publish","type":"post","link":"https:\/\/indonesiatribune.com\/junshi-biosciences-and-coherus-announce-fda-acceptance-of-resubmission-of-bla-for-toripalimab-for-the-treatment-of-nasopharyngeal-carcinoma\/","title":{"rendered":"Junshi Biosciences and Coherus Announce FDA Acceptance of Resubmission of BLA for Toripalimab for the Treatment of Nasopharyngeal Carcinoma"},"content":{"rendered":"
\n

–<\/em> FDA has set a target action date of December 23, 2022 for the toripalimab BLA –<\/em><\/p>\n

– Toripalimab will be the first and only immuno-oncology agent for NPC in\u00a0U.S., if approved\u00a0–<\/em><\/p>\n

SHANGHAI, China and REDWOOD CITY, Calif., July 06, 2022 (GLOBE NEWSWIRE) — Shanghai Junshi Biosciences Co., Ltd. (\u201cJunshi Biosciences\u201d, HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc.\u00a0(\u201cCoherus\u201d) announced today that the United States Food and Drug Administration (“FDA”) has accepted for review the Biologics License Application (\u201cBLA\u201d) resubmission for toripalimab in combination with gemcitabine and cisplatin as first-line treatment for patients with advanced recurrent or metastatic nasopharyngeal carcinoma (\u201cNPC\u201d) and for toripalimab monotherapy for the second-line or later treatment of recurrent or metastatic NPC after platinum-containing chemotherapy.<\/p>\n

The FDA has set a Prescription Drug User Fee Act (“PDUFA”) action date for\u00a0December 23, 2022. The Agency earlier communicated that the review timeline for the BLA resubmission would be six months, as onsite inspections in China would be required. Travel restrictions related to the COVID-19 pandemic previously hindered the FDA\u2019s ability to complete required inspections. Coherus plans to launch toripalimab in the United States in the first quarter of 2023, if approved.<\/p>\n

\u201cAlthough the COVID-19 pandemic has created tremendous challenges for everyone, our dedication to bring better treatment options to patients around the world remains steadfast,\u201d said Dr. Patricia Keegan, Chief Medical Officer of Junshi Biosciences. \u201cThrough our concerted efforts with our partner, Coherus, we have made continual progress towards obtaining toripalimab\u2019s first marketing authorization outside of China. Over the next several months, we will work closely with the FDA to facilitate the review of this novel drug.\u201d<\/p>\n

\u201cToripalimab would address a critical unmet medical need for patients with nasopharyngeal carcinoma, an aggressive cancer for which there are currently no FDA-approved immunotherapy treatments. We collaborated closely with our partner, Junshi Biosciences, to complete the quality process changes requested by the FDA and facilitate the rapid resubmission of the toripalimab BLA,\u201d said Dr. Theresa LaVallee, Chief Development Officer of Coherus.<\/p>\n

\u201cFor Coherus, the toripalimab resubmission is one of several key development and commercialization milestones we are sharply focusing on over the next twelve months, and we are pleased with the Company\u2019s execution and progress on all of them,\u201d said Denny Lanfear, CEO of Coherus. \u201cWe now look forward to the August 2, 2022 target action date for our BLA for CIMERLI\u2122, our Lucentis\u00ae<\/sup> biosimilar, followed by product launch which we are confident will be very successful. The toripalimab December 2022 PDUFA date follows directly, and the projected toripalimab launch in Q1 2023 will formally mark our entry into immuno-oncology, where Coherus will be one of just a handful of companies with a proprietary PD-1 as a foundation stone to build its oncology franchise upon. Lastly, twelve months from now, in July 2023, we expect to begin marketing our Humira\u00ae<\/sup> biosimilar, YUSIMRY\u00ae<\/sup>, which was approved by the FDA in December 2021. Preparations for that commercial launch are going very well. Biosimilar market execution is a demonstrated Coherus competency, and we believe that our commercialization strategy provides a robust framework against which we can successfully execute to meet our market expectations and share projections.\u201d<\/p>\n

Following approval of toripalimab for NPC, Coherus\u2019 strategy in the US includes evaluating toripalimab\u2019s ability to deliver substantial clinical benefit in significant indications, in combination with other cancer drugs and immunotherapies, through co-development agreements.<\/p>\n

About Toripalimab in NPC<\/strong>
\nNPC is a type of aggressive cancer that starts in the nasopharynx, the upper part of the throat behind the nose and near the base of skull. Due to the location of the primary tumor, surgery is rarely an option, and patients with localized disease are treated primarily with radiation and chemotherapy. In\u00a0the United States, there are presently no immunotherapies approved for the treatment of NPC.<\/p>\n

The toripalimab BLA is supported by the results from JUPITER-02, a randomized, double blind, placebo-controlled, international multi-center Phase 3 clinical trial, as well as POLARIS-02, a multi-center, open-label, pivotal Phase 2 clinical study. The JUPITER-02 results were first presented in June 2021 in a plenary session of the\u00a0American Society of Clinical Oncology\u00a0(\u201cASCO\u201d) annual meeting (#LBA2) and subsequently published in detail as the cover article of the\u00a0September 2021\u00a0issue of\u00a0Nature Medicine<\/a>. The POLARIS-02 results were published online in\u00a0January 2021\u00a0in the\u00a0Journal of Clinical Oncology<\/a>.<\/p>\n

The FDA has granted Breakthrough Therapy designation (\u201cBTD\u201d) for toripalimab in combination with chemotherapy (gemcitabine and cisplatin) for the 1st<\/sup>\u00a0line treatment of recurrent, locally advanced or primary metastatic non-keratinizing NPC and for toripalimab monotherapy for patients with recurrent or metastatic non-keratinizing NPC with disease progression on or after platinum-containing chemotherapy.\u00a0Additionally, the FDA has granted Orphan Drug designation for toripalimab for NPC.<\/p>\n

In China, the National Medical Products Administration (\u201cNMPA\u201d) in 2021 approved toripalimab for two NPC indications.<\/p>\n

About Toripalimab <\/strong>
\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 promotes the immune system\u2019s ability to attack and kill tumor cells. In\u00a0China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in\u00a0China\u00a0as TUOYI\u00ae<\/sup>). Currently, there are five approved indications for toripalimab in\u00a0China.<\/p>\n

About Junshi Biosciences<\/strong>
\nFounded in\u00a0December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative therapeutics. The company has established a diversified R&D pipeline comprising over 50 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for anti-PD-1 monoclonal antibody in China. Its first-in-human anti-BTLA monoclonal antibody for the treatment of various cancers is the first in the world to be approved for clinical trials by the FDA and NMPA and has since entered Phase Ib\/II trials in both\u00a0China\u00a0and the US. Its anti-PCSK9 monoclonal antibody was the first in\u00a0China\u00a0to be approved for clinical trials by the NMPA.\u00a0In the face of the COVID-19 pandemic, Junshi Biosciences responded swiftly and strongly, joining forces with Chinese and international scientific research institutions and enterprises to develop an arsenal of drug candidates to combat COVID-19, taking the initiative to shoulder the social responsibility of Chinese pharmaceutical companies by prioritizing and accelerating COVID-19 R&D. Among the many drug candidates is JS016 (etesevimab), China\u2019s first neutralizing fully human monoclonal antibody against SARS-CoV-2 and the result of the combined efforts of Junshi Biosciences, the\u00a0Institute of Microbiology\u00a0of the\u00a0Chinese Academy\u00a0of Science and Lilly. JS016 administered with bamlanivimab has been granted Emergency Use Authorizations (EUA) in over 15 countries and regions worldwide. Meanwhile, VV116, a new oral nucleoside analog anti-SARS-CoV-2 drug designed to hinder virus replication, is in global Phase III clinical trials. The JS016 and VV116 programs are a part of the company\u2019s continuous innovation for disease control and prevention of the global pandemic.<\/p>\n

Junshi Biosciences has more than 2,800 employees in\u00a0the United States\u00a0(San Francisco\u00a0and\u00a0Maryland) and\u00a0China\u00a0(Shanghai,\u00a0Suzhou,\u00a0Beijing\u00a0and\u00a0Guangzhou). For more information, please visit:\u00a0http:\/\/junshipharma.com<\/a>.<\/p>\n

About\u00a0Coherus BioSciences<\/strong>
\nCoherus is a commercial stage biopharmaceutical company building a leading immuno-oncology franchise funded with cash generated by its FDA-approved products. In 2021, Coherus in-licensed toripalimab, an anti-PD-1 antibody, in\u00a0the United States\u00a0and\u00a0Canada. The resubmission of the BLA for toripalimab for the treatment of NPC was accepted by the FDA in July 2022. Toripalimab is also being evaluated in pivotal clinical trials for the treatment of rare and highly prevalent cancers. Coherus markets UDENYCA\u00ae<\/sup> (pegfilgrastim-cbqv), a biosimilar of Neulasta\u00ae<\/sup> in\u00a0the United States, and expects to launch the FDA-approved Humira\u00ae<\/sup> biosimilar YUSIMRY\u2122 (adalimumab-aqvh) in\u00a0the United States\u00a0in 2023. The FDA is currently reviewing the biologics license application for CIMERLI\u2122, a biosimilar of Lucentis\u00ae<\/sup> (ranibizumab injection), with a target action date of\u00a0August 2022.<\/p>\n

Forward-Looking Statements<\/strong>
\nExcept for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding Coherus\u2019 ability to build its immuno-oncology franchise to achieve a leading market position; Coherus\u2019 ability to generate cash; Coherus\u2019 investment plans; Coherus\u2019 expectations for the launch dates of toripalimab, CIMERL\u2122 and YUSIMRY\u2122; Coherus\u2019 plans to file additional BLAs for toripalimab and pursue co-development agreements for other indications; beliefs about toripalimab\u2019s ability to address an unmet need for patients; expectations about the success and timing of the FDA review of toripalimab and CIMERLI\u2122; and Coherus\u2019 ability to meet market expectations and share projections in the future.<\/p>\n

Such forward-looking statements involve substantial risks and uncertainties that could cause Coherus\u2019 actual results, performance or achievements to differ significantly from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the risks and uncertainties inherent in the clinical drug development process; risks relating to the COVID-19 pandemic; risks related to our existing and potential collaboration partners; risks of the drug development position of Coherus\u2019 competitors; the risks and uncertainties of the regulatory approval process, including the speed of regulatory review, international aspects of Coherus\u2019 business, and the need to have the FDA finish inspections in\u00a0China\u00a0during a COVID-19 pandemic; the risk of FDA review issues; the risk of Coherus\u2019 execution of its change in strategy from a focus on biosimilars to a strategy using cash from its portfolio to fund an immuno-oncology franchise; the risk that Coherus is unable to complete commercial transactions and other matters that could affect the availability or commercial potential of Coherus\u2019 drug candidates; and the risks and uncertainties of possible litigation. All forward-looking statements contained in this press release speak only as of the date of this press release. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the significant risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus\u2019 business in general, see Coherus\u2019 Quarterly Report on Form 10-Q for the fiscal quarter ended\u00a0March 31, 2022, filed with the\u00a0Securities and Exchange Commission\u00a0on\u00a0May 5, 2022, including the section therein captioned \u201cRisk Factors\u201d and in other documents Coherus files with the\u00a0Securities and Exchange Commission.<\/p>\n

UDENYCA\u00ae<\/sup>, CIMERLI\u2122 and YUSIMRY\u2122, whether or not appearing in large print or with the trademark symbol, are trademarks of Coherus, its affiliates, related companies or its licensors or joint venture partners, unless otherwise noted. Trademarks and trade names of other companies appearing in this press release are, to the knowledge of Coherus, the property of their respective owners.<\/p>\n

Junshi Biosciences Contact Information:<\/strong>
\nIR Team:<\/strong>
\nJunshi Biosciences
\ninfo@junshipharma.com<\/a>
\n+ 86 021-6105 8800<\/p>\n

PR Team:<\/strong>
\nJunshi Biosciences
\nZhi Li
\nzhi_li@junshipharma.com<\/a>
\n+ 86 021-6105 8800<\/p>\n

Coherus Contact Information:<\/strong>
\nIR Contact:<\/strong>
\nMcDavid Stilwell
\nChief Financial Officer
\nCoherus BioSciences, Inc.
\nIR@coherus.com<\/a><\/p>\n

Media Contact:<\/strong>
\nKelli Perkins
\nRed House
\nkelli@redhousecomms.com<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

\u2013 FDA has set a target action date of December 23, 2022 for the toripalimab BLA \u2013 \u2013 Toripalimab will be the first and only immuno-oncology agent for NPC in\u00a0U.S., if approved\u00a0\u2013 SHANGHAI, China and REDWOOD CITY, Calif., July 06, 2022 (GLOBE NEWSWIRE) \u2014 Shanghai Junshi Biosciences Co., Ltd. (\u201cJunshi Biosciences\u201d, HKEX: 1877; SSE: 688180) [\u2026]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"yoast_head":"\nJunshi Biosciences and Coherus Announce FDA Acceptance of Resubmission of BLA for Toripalimab for the Treatment of Nasopharyngeal Carcinoma - Indonesia Tribune<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/indonesiatribune.com\/junshi-biosciences-and-coherus-announce-fda-acceptance-of-resubmission-of-bla-for-toripalimab-for-the-treatment-of-nasopharyngeal-carcinoma\/\" \/>\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 FDA Acceptance of Resubmission of BLA for Toripalimab for the Treatment of Nasopharyngeal Carcinoma - Indonesia Tribune\" \/>\n<meta property=\"og:description\" content=\"\u2013 FDA has set a target action date of December 23, 2022 for the toripalimab BLA \u2013 \u2013 Toripalimab will be the first and only immuno-oncology agent for NPC in\u00a0U.S., if approved\u00a0\u2013 SHANGHAI, China and REDWOOD CITY, Calif., July 06, 2022 (GLOBE NEWSWIRE) \u2014 Shanghai Junshi Biosciences Co., Ltd. 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