{"id":10513,"date":"2023-12-21T00:04:00","date_gmt":"2023-12-20T16:04:00","guid":{"rendered":"https:\/\/flcube.com\/?p=10513"},"modified":"2024-12-03T21:48:59","modified_gmt":"2024-12-03T13:48:59","slug":"jiangsu-hengrui-medicine-wins-nmpa-approvals-for-sle-and-lymphoma-drug-candidates","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=10513","title":{"rendered":"Jiangsu Hengrui Pharmaceuticals Wins NMPA Approvals for SLE and Lymphoma Drug Candidates"},"content":{"rendered":"\n<p>Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading Chinese pharmaceutical company, has announced that it has received separate clinical trial approvals from China&#8217;s National Medical Products Administration (NMPA) for two of its drug candidates, SHR0302 and SHR2554. SHR0302 is anticipated to treat systemic lupus erythematosus (SLE), while SHR2554 is intended for the treatment of mature lymphocytic tumors in combination with CHOP\/CHOEP or CD20 monoclonal antibodies.<\/p>\n\n\n\n<p>SHR0302, a highly selective Janus kinase 1 (JAK1) inhibitor, is currently the subject of multiple clinical studies for conditions including vitiligo, ulcerative colitis, Crohn&#8217;s disease, ankylosing spondylitis, psoriatic arthritis, and alopecia areata. In 2018, Hengrui entered into a licensing agreement with Arcutis (<a href=\"https:\/\/www.google.com\/finance\/quote\/ARQT:NASDAQ\">NASDAQ: ARQT<\/a>), granting the US company exclusive rights to the drug in the US, European Union, and Japan. Currently, there are no domestic JAK1 inhibitors on the market in China, with products such as Pfizer\u2019s abrocitinib, Novartis\u2019s (<a href=\"https:\/\/www.google.com\/finance\/quote\/NVS:NYSE\">NYSE: NVS<\/a>) Jakavi (ruxolitinib), Eli Lilly\u2019s (<a href=\"https:\/\/www.google.com\/finance\/quote\/LLY:NYSE\">NYSE: LLY<\/a>) Olumiant (baricitinib), and AbbVie\u2019s (<a href=\"https:\/\/www.google.com\/finance\/quote\/ABBV:NYSE\">NYSE: ABBV<\/a>) upadacitinib being examples of commercially available JAK1 inhibitors globally.<\/p>\n\n\n\n<p>SHR2554, an enhancer of zeste homolog 2 (EZH2) inhibitor discovered by Hengrui, was first approved for a Phase I clinical trial in China in May 2018 for the treatment of recurrent\/refractory mature lymphocytic tumors. In January 2023, the molecule was awarded breakthrough therapy designation (BTD) status in China for use in recurrent or refractory peripheral T-cell lymphoma. Other EZH2 inhibitors in the market include Epizyme\u2019s Tazverik (tazemetostat), which received marketing approval for the treatment of metastatic or locally advanced epithelioid sarcoma (ES) in adults and adolescents aged 16 and above in 2020, and for adult recurrent\/refractory follicular lymphoma (r\/r FL) in June of the same year. Other similar products in the space are Pfizer\u2019s PF-06821497, Daiichi Sankyo\u2019s (<a href=\"https:\/\/www.google.com\/finance\/quote\/4568:TYO\">TYO: 4568<\/a>) valemetostat, and Constellation\u2019s CPI-0209, which was acquired by Morphosys.<a href=\"https:\/\/flcube.com\">-Fineline Info &amp; Tech<\/a><\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading Chinese pharmaceutical company, has announced that&#8230;<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[234,125,65,16,62,194,199,2586,1253,140,853,911,865,852,978],"class_list":["post-10513","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-abbvie","tag-arcutis-biotherapeutics","tag-auto-immune","tag-cancer","tag-clinical-trial-approval-initiation","tag-daiichi-sankyo","tag-eli-lilly","tag-hengrui-pharmaceuticals","tag-nasdaq-arqt","tag-novartis","tag-nyse-abbv","tag-nyse-lly","tag-nyse-nvs","tag-sha-600276","tag-tyo-4568"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Jiangsu Hengrui Pharmaceuticals Wins NMPA Approvals for SLE and Lymphoma Drug Candidates - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading Chinese pharmaceutical company, has announced that it has received separate clinical trial approvals from China&#039;s National Medical Products Administration (NMPA) for two of its drug candidates, SHR0302 and SHR2554. SHR0302 is anticipated to treat systemic lupus erythematosus (SLE), while SHR2554 is intended for the treatment of mature lymphocytic tumors in combination with CHOP\/CHOEP or CD20 monoclonal antibodies.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/flcube.com\/?p=10513\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Jiangsu Hengrui Pharmaceuticals Wins NMPA Approvals for SLE and Lymphoma Drug Candidates\" \/>\n<meta property=\"og:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. FLCUBE delivers reliable data, news, and intelligence to broaden your horizons and sharpen your decision-making. 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