{"id":18220,"date":"2023-05-31T00:35:00","date_gmt":"2023-05-30T16:35:00","guid":{"rendered":"https:\/\/flcube.com\/?p=18220"},"modified":"2024-12-16T00:38:26","modified_gmt":"2024-12-15T16:38:26","slug":"chia-tai-tianqings-biosimilar-rituximab-approved-by-chinas-nmpa-for-lymphoma-treatments","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=18220","title":{"rendered":"Chia Tai Tianqing&#8217;s Biosimilar Rituximab Approved by China&#8217;s NMPA for Lymphoma Treatments"},"content":{"rendered":"\n<p>China-based Chia Tai Tianqing has announced receiving a market approval from the National Medical Products Administration (NMPA) for its biosimilar version of Roche\u2019s MabThera (rituximab), which is used for the treatment of follicular lymphoma (FL), CD20 positive diffuse large B-cell lymphoma (DLBCL), and chronic lymphocytic leukemia (CLL).<\/p>\n\n\n\n<p><strong>Phase III Study and Approval Basis<\/strong><br>The approval is based on a multi-center, randomized, double-blind, parallel-controlled Phase III study that assessed the efficacy and safety of TQB2303 combined with the CHOP regime compared with MabThera combined with CHOP in na\u00efve CD20+ DLBCL patients. The study demonstrated that Chia Tai Tianqing\u2019s biosimilar was highly similar to the originator, with less polymer impurities and low molecular impurities, and more stability after production process optimization.<\/p>\n\n\n\n<p><strong>MabThera&#8217;s Market History and Chia Tai Tianqing&#8217;s Contribution<\/strong><br>The originator, a monoclonal antibody (mAb) targeting CD20, was approved to treat B-cell non-Hodgkin&#8217;s lymphoma (NHLs) in the US in 1997 and entered the Chinese market in 2000. It was included in the National Reimbursement Drug List (NRDL) in 2017, with normal NRDL listing since 2019. HanLiKang was the first biosimilar in China, approved to treat non-Hodgkin&#8217;s lymphoma in 2019, followed by Innovent Bio\u2019s Halpryza, which received market approval in 2020. Chia Tai Tianqing\u2019s product is the third biosimilar to enter the market, offering an additional treatment option for patients with these conditions.<a href=\"https:\/\/flcube.com\">-Fineline Info &amp; Tech<\/a><\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>China-based Chia Tai Tianqing has announced receiving a market approval from the National Medical Products&#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":[43,16,661,15],"class_list":["post-18220","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-biosimilars","tag-cancer","tag-chia-tai-tianqing-pharmaceutical","tag-product-approvals"],"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>Chia Tai Tianqing&#039;s Biosimilar Rituximab Approved by China&#039;s NMPA for Lymphoma Treatments - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based Chia Tai Tianqing has announced receiving a market approval from the National Medical Products Administration (NMPA) for its biosimilar version of Roche\u2019s MabThera (rituximab), which is used for the treatment of follicular lymphoma (FL), CD20 positive diffuse large B-cell lymphoma (DLBCL), and chronic lymphocytic leukemia (CLL).\" \/>\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=18220\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Chia Tai Tianqing&#039;s Biosimilar Rituximab Approved by China&#039;s NMPA for Lymphoma Treatments\" \/>\n<meta property=\"og:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. 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