{"id":4646,"date":"2024-04-17T23:36:12","date_gmt":"2024-04-17T15:36:12","guid":{"rendered":"https:\/\/flcube.com\/?p=4646"},"modified":"2024-10-13T19:54:55","modified_gmt":"2024-10-13T11:54:55","slug":"innovent-biologics-ibi133-receives-tacit-approval-for-clinical-trial-from-chinas-cde","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=4646","title":{"rendered":"Innovent Biologics’ IBI133 Receives Tacit Approval for Clinical Trial from China’s CDE"},"content":{"rendered":"\n

The Center for Drug Evaluation (CDE) in China has granted tacit clinical trial approval to Innovent Biologics, Inc. (HKG: 1801<\/a>) for its antibody drug conjugate (ADC) IBI133. The molecule is slated for assessment as a treatment for irresectable locally advanced or metastatic solid tumors. Previously, in December 2023, IBI133 had entered a Phase I\/II clinical study in Australia for the treatment of solid tumors.<\/p>\n\n\n\n

It is projected that after EGFR TKI treatment, a significant percentage of primary non-small cell lung cancer (NSCLC) and advanced EGFR mutated tumors will express HER3, which is a member of the receptor tyrosine kinase EGFR family. Although no HER3-targeted product is currently available globally, Daiichi Sankyo’s ADC, patritumab deruxtecan, was involved in a USD 22 billion deal with Merck, Sharp & Dohme (MSD; NYSE: MRK). Patritumab deruxtecan received breakthrough therapy designation (BTD) in the US in December 2021 and demonstrated promising results in the pivotal Phase II HERTHENA-Lung01 study for non-small cell lung cancer with EGFR mutations, achieving an objective response rate (ORR) of 29.8% and a median duration of remission of 6.4 months.<\/p>\n\n\n\n

In a separate development, Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506<\/a>) has recently initiated a Phase III trial in China for another ADC targeting EGFR and HER3 in recurrent or metastatic esophageal squamous cell carcinoma. Last month, Bristol-Myers Squibb (BMS; NYSE: BMY<\/a>) entered into an USD 8.4 billion agreement with Biokin for the joint development and commercialization of this drug in the United States. – Flcube.com<\/a><\/p>\n\n\n\n

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The Center for Drug Evaluation (CDE) in China has granted tacit clinical trial approval to…<\/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":[35,151,429,428,16,62,910,198,849,857],"class_list":["post-4646","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-adc-xdc","tag-biokin-pharmaceutical","tag-bms","tag-bristol-myers-squibb","tag-cancer","tag-clinical-trial-approval-initiation","tag-hkg-1801","tag-innovent-biologics","tag-nyse-bmy","tag-sha-688506"],"yoast_head":"\nInnovent Biologics' IBI133 Receives Tacit Approval for Clinical Trial from China's CDE - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"The Center for Drug Evaluation (CDE) in China has granted tacit clinical trial approval to Innovent Biologics, Inc. 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