{"id":2933,"date":"2024-10-15T16:16:37","date_gmt":"2024-10-15T08:16:37","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%e5%9c%a8%e5%8d%b0%e5%ba%a6%e5%92%8c%e4%b8%ad%e5%9b%bd%e9%a6%99%e6%b8%af%e8%8e%b7%e6%89%b9%e4%b8%8a%e5%b8%82\/"},"modified":"2024-11-29T16:19:12","modified_gmt":"2024-11-29T08:19:12","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%e5%9c%a8%e5%8d%b0%e5%ba%a6%e5%92%8c%e4%b8%ad%e5%9b%bd%e9%a6%99%e6%b8%af%e8%8e%b7%e6%89%b9%e4%b8%8a%e5%b8%82","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%e5%9c%a8%e5%8d%b0%e5%ba%a6%e5%92%8c%e4%b8%ad%e5%9b%bd%e9%a6%99%e6%b8%af%e8%8e%b7%e6%89%b9%e4%b8%8a%e5%b8%82\/","title":{"rendered":"Junshi Biosciences Announces Toripalimab Obtained Approval for Marketing in India and China\u2019s Hong Kong SAR"},"content":{"rendered":"\n<p>SHANGHAI, China, October 15, 2024 &#8212; Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, and its wholly-owned subsidiary, TopAlliance Biosciences Inc. (TopAlliance Biosciences), announce that toripalimab (Indian trade name: ZYTORVI<sup>\u00ae<\/sup>, Hong Kong trade name: LOQTORZI<sup>\u00ae<\/sup>) has been approved for marketing in India and China\u2019s Hong Kong Special Administrative Region (SAR), for treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC). The approved indications are: 1) toripalimab in combination with cisplatin and gemcitabine, for first line treatment of adults with metastatic or with recurrent, locally advanced NPC; 2) toripalimab as a single agent, for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy. Zytorvi\u00ae shall be imported and commercialized in India by Dr. Reddy\u2019s Laboratories Ltd.<\/p>\n\n\n\n<p><strong>Dr. Jianjun ZOU, General Manager and CEO of Junshi Biosciences<\/strong>, said, \u201cAs of now, toripalimab has been approved for marketing in over 30 countries and regions across three continents worldwide. With its differentiated clinical layout and outstanding clinical performance, it has brought a new treatment that can change the therapeutic landscape to local doctors and patients, which we are very excited about. Moving forward, we will continue to implement the company&#8217;s international strategy of \u2018In China, For Global\u2019 and work with partners to provide more overseas patients with high-quality innovative drugs from China.\u201d<\/p>\n\n\n\n<p>NPC is a malignant tumor that occurs in the epithelium of the nasopharynx. According to GLOBOCAN 2022 statistics, the number of newly diagnosed NPC cases in 2022 exceeded 120,000 worldwide. Due to the location of the primary tumor, surgery is rarely an option. Toripalimab is the first and only treatment for NPC approved in India and China\u2019s Hong Kong SAR.<\/p>\n\n\n\n<p>The marketing approvals are supported by results from JUPITER-02, a randomized, double-blind, placebo-controlled, multinational multi-center Phase 3 clinical study (NCT03581786) that examined toripalimab in combination with gemcitabine-cisplatin as the first-line treatment of NPC, as well as results from POLARIS-02, a multi-center, open-label, pivotal Phase 2 clinical study (NCT02915432) that evaluated toripalimab as the second-line or later treatment for recurrent or metastatic NPC.<\/p>\n\n\n\n<p>The JUPITER-02 study is the first international multi-center, double-blind, randomized Phase III clinical study in the field of immunotherapy for NPC with the largest sample size, and the world\u2019s first Phase III clinical study with preset statistical verification (Type I error control) for Overall Survival (OS) for first-line immunotherapy combined with chemotherapy for NPC compared to chemotherapy alone and demonstrated a survival benefit. The study results were presented in an oral report during the Plenary Session of the 2021 annual meeting of the American Society of Clinical Oncology (ASCO) (#LBA2) and were subsequently featured on the cover of <em>Nature Medicine<\/em>. The results were also published in full in the <em>Journal of the American Medical Association (JAMA)<\/em>. The results showed that, compared to chemotherapy alone, toripalimab in combination with chemotherapy reduced the risk of disease progression by 48% and the risk of death by 37%. The median progression-free survival (PFS) in the toripalimab plus chemotherapy group was prolonged by 13.2 months compared to chemotherapy alone, from 8.2 months to 21.4 months. In addition, patients treated with this combined therapy achieved a higher objective response rate (ORR), longer duration of response (DoR),&nbsp; and no new safety signal was identified. Long-term survival follow-up data, presented at ASCO 2024, reported a 5-year survival rate of 52.0% in the toripalimab treated arm.<\/p>\n\n\n\n<p>The POLARIS-02 results were published online in January 2021 in the <em>Journal of Clinical Oncology<\/em>. The results showed that toripalimab demonstrated durable antitumor activity in patients with recurrent or metastatic NPC who failed previous chemotherapy, with an ORR of 20.5%, a DoR of 12.8 months, and a median OS of 17.4 months while maintaining a manageable safety profile.<\/p>\n\n\n\n<p>So far, toripalimab has been approved for marketing in over 30 countries and regions, including the Chinese mainland, Hong Kong SAR, the US, European Union, and India. Several marketing applications are currently under regulatory review or submitted for review in UK, Australia, Singapore, Malaysia, South Africa, Chile, Jordan, Brazil, Columbia, Philippines, Thailand and Indonesia.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Toripalimab has been approved for marketing in India and China\u2019s Hong Kong SAR, for treatment of recurrent or metastatic NPC<\/p>\n","protected":false},"author":4,"featured_media":2926,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[22],"tags":[],"class_list":["post-2933","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 Announces Toripalimab Obtained Approval for Marketing in India and China\u2019s Hong Kong SAR - \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%e5%9c%a8%e5%8d%b0%e5%ba%a6%e5%92%8c%e4%b8%ad%e5%9b%bd%e9%a6%99%e6%b8%af%e8%8e%b7%e6%89%b9%e4%b8%8a%e5%b8%82\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Junshi Biosciences Announces Toripalimab Obtained Approval for Marketing in India and China\u2019s Hong Kong SAR - 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