{"id":1010,"date":"2024-09-14T15:39:14","date_gmt":"2024-09-14T07:39:14","guid":{"rendered":"https:\/\/flcube.com\/?p=1010"},"modified":"2024-12-03T20:50:30","modified_gmt":"2024-12-03T12:50:30","slug":"jiangsu-hengruis-her2-targeted-adc-shr-a1811-receives-priority-review-from-chinas-nmpa","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=1010","title":{"rendered":"Jiangsu Hengrui’s HER2-Targeted ADC SHR-A1811 Receives Priority Review from China’s NMPA"},"content":{"rendered":"\n

Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276<\/a>), a leading pharmaceutical company in China, has announced that the National Medical Products Administration (NMPA) has accepted its market filing for trastuzumab rezetecan (SHR-A1811), an antibody-drug conjugate (ADC) targeting HER2, with priority review status. The drug is intended for the treatment of adult patients with locally advanced or metastatic HER2 mutant non-small cell lung cancer (NSCLC) who have previously received at least one systemic therapy.<\/p>\n\n\n\n

The market for HER2-targeted ADCs in China has seen the approval of similar products from global pharmaceutical giants Roche (Kadcyla) in 2019 and AstraZeneca\/Daiichi Sankyo (Enhertu) in 2023. Additionally, RemeGen, a local Chinese firm, received conditional approval for its disitamab vedotin in June 2021.<\/p>\n\n\n\n

The filing for SHR-A1811 is supported by the positive results of the Phase II SHR-A1811-I-103 study, which met its primary endpoint. The data demonstrated that SHR-A1811 monotherapy achieved significant improvements over preset historical data in treating HER2 mutant NSCLC patients, notably increasing the objective response rate (ORR) among the subjects. -Fineline Info & Tech<\/a><\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced…<\/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":[35,2586,83,38,852],"class_list":["post-1010","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-adc-xdc","tag-hengrui-pharmaceuticals","tag-her2","tag-market-approval-filings","tag-sha-600276"],"yoast_head":"\nJiangsu Hengrui's HER2-Targeted ADC SHR-A1811 Receives Priority Review from China's NMPA - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that the National Medical Products Administration (NMPA) has accepted its market filing for trastuzumab rezetecan (SHR-A1811), an antibody-drug conjugate (ADC) targeting HER2, with priority review status. 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