{"id":19710,"date":"2021-12-03T12:56:01","date_gmt":"2021-12-03T12:56:01","guid":{"rendered":"https:\/\/pr.asianetpakistan.com\/?p=83536"},"modified":"2021-12-03T12:56:01","modified_gmt":"2021-12-03T12:56:01","slug":"junshi-biosciences-announces-two-additional-indications-for-toripalimab-included-in-chinas-national-reimbursement-drug-list","status":"publish","type":"post","link":"https:\/\/myanmarnewswire.com\/junshi-biosciences-announces-two-additional-indications-for-toripalimab-included-in-chinas-national-reimbursement-drug-list\/","title":{"rendered":"Junshi Biosciences Announces Two Additional Indications for Toripalimab Included in China\u2019s National Reimbursement Drug List"},"content":{"rendered":"

–the only anti-PD-1 monoclonal antibody in the NRDL for melanoma and nasopharyngeal carcinoma<\/h4>\n

SHANGHAI, China, Dec. 03, 2021 (GLOBE NEWSWIRE) — Junshi Biosciences (HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced today that the company\u2019s product toripalimab continues to be included in Category B in the National Drug List for Basic Medical Insurance, Work-Related Injury Insurance and Maternity Insurance (2021 Edition) (the \u201cNRDL\u201d) upon negotiations, with two additional indications including the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma after failure of at least two lines of prior systemic therapy and patients with locally advanced or metastatic urothelial carcinoma after failure of platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. In December 2020, the second-line treatment of unresectable or metastatic melanoma was included in the NRDL for the first time. Toripalimab is the only anti-PD-1 monoclonal antibody included in the NRDL for the treatment of melanoma and nasopharyngeal carcinoma.<\/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 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

In\u00a0China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in\u00a0China\u00a0as TUOYI\u00ae<\/sup>). On\u00a0December 17, 2018, toripalimab was granted a conditional approval by the\u00a0National Medical Products Administration\u00a0(NMPA) for the second-line treatment of unresectable or metastatic melanoma. In\u00a0February 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.\u00a0In 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

In\u00a0December 2020, toripalimab was successfully included in the updated National Reimbursement Drug List for the indication of the second-line treatment of unresectable or metastatic melanoma. In December 2021, two additional indications were included on the list: recurrent or metastatic nasopharyngeal carcinoma after failure of at least two lines of prior systemic therapy and locally advanced or metastatic urothelial carcinoma after failure of platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.<\/p>\n

In\u00a0the 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\u00a0the United States\u00a0and\u00a0Canada. 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

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 45 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 antibody for solid tumors was the first in the world to be approved for clinical trials by the FDA and NMPA and its anti-PCSK9 monoclonal antibody was the first in\u00a0China\u00a0to be approved for clinical trials by the NMPA. In early 2020, Junshi Biosciences joined forces with the\u00a0Institute of Microbiology of Chinese Academy\u00a0of Science and Eli Lilly to co-develop JS016 (etesevimab), China\u2019s first neutralizing fully human monoclonal antibody against SARS-CoV-2. JS016 administered with bamlanivimab has been granted Emergency Use Authorizations (EUA) in 15 countries and regions worldwide. The JS016 program is a part of our continuous innovation for disease control and prevention of the global pandemic. Junshi Biosciences has over 2,500 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing and Guangzhou). For more information, please visit:\u00a0http:\/\/junshipharma.com<\/a>.<\/p>\n

Junshi Biosciences Contact Information<\/strong>
\nIR Team:
\nJunshi Biosciences
\ninfo@junshipharma.com<\/a>
\n+ 86 021-2250 0300<\/p>\n

Solebury Trout
\nBob Ai
\nbai@soleburytrout.com<\/a>
\n+ 1 646-389-6658<\/p>\n

PR Team:
\nJunshi Biosciences
\nZhi Li
\nzhi_li@junshipharma.com<\/a>
\n+ 86 021-6105 8800<\/p>\n","protected":false},"excerpt":{"rendered":"

\u2013the only anti-PD-1 monoclonal antibody in the NRDL for melanoma and nasopharyngeal carcinoma SHANGHAI, China, Dec. 03, 2021 (GLOBE NEWSWIRE) \u2014 Junshi Biosciences (HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced today that the company\u2019s product toripalimab continues to be included in Category [\u2026]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[14],"tags":[],"yoast_head":"\nJunshi Biosciences Announces Two Additional Indications for Toripalimab Included in China\u2019s National Reimbursement Drug List - Myanmar Newswire<\/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:\/\/myanmarnewswire.com\/junshi-biosciences-announces-two-additional-indications-for-toripalimab-included-in-chinas-national-reimbursement-drug-list\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Junshi Biosciences Announces Two Additional Indications for Toripalimab Included in China\u2019s National Reimbursement Drug List - 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