{"id":13318,"date":"2024-11-18T14:22:36","date_gmt":"2024-11-18T06:22:36","guid":{"rendered":"https:\/\/flcube.com\/?p=13318"},"modified":"2024-11-18T14:22:40","modified_gmt":"2024-11-18T06:22:40","slug":"sichuan-kelun-biotech-secures-nmpa-approval-for-two-antibody-drug-conjugates","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=13318","title":{"rendered":"Sichuan Kelun-Biotech Secures NMPA Approval for Two Antibody Drug Conjugates"},"content":{"rendered":"\n

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990<\/a>), a leading biopharmaceutical company based in China, has announced receiving separate Investigational New Drug (IND) approvals from the National Medical Products Administration (NMPA) for its antibody drug conjugates (ADCs), SKB535 and SKB571, which target solid tumors. This development marks a significant milestone in the advancement of novel cancer treatments in China.<\/p>\n\n\n\n

SKB535: A Milestone in Clinical Trial Approval<\/strong>
SKB535 is the first drug to be approved for clinical trials under the NMPA’s optimized novel drug clinical trial review and approval pilot program. The process, which took just 21 days to complete, highlights the efficiency of the NMPA’s review system. Out of the 9 clinical trial projects included in the pilot work, 5 have seen their IND filings accepted for review in the Center for Drug Evaluation (CDE) of NMPA, according to NMPA data.<\/p>\n\n\n\n

SKB535: Innovation in ADC Development<\/strong>
SKB535, developed based on the OptiDC platform, has demonstrated good efficacy and a safety window in pre-clinical studies for advanced solid tumors. This innovative ADC is the subject of a licensing deal between Kelun-Biotech and the US pharmaceutical giant Merck, Sharp & Dohme Inc. (MSD; NYSE: MRK), indicating its potential in the global market.<\/p>\n\n\n\n

SKB571: A Novel Bispecific ADC for Lung and Digestive System Tumors<\/strong>
SKB571, another novel bispecific ADC targeting lung cancer and digestive system tumors, also utilizes OptiDC technology. This technology enhances tumor targeting and drug antibody ratio (DAR) uniformity. Preclinical studies have shown that SKB571 has good anti-tumor effects and safety in various human tumor xenograft models and crab eating macaques. MSD exercised its exclusive option right to SKB571 during this year’s third quarter, with a payment of USD 37.5 million to Kelun-Biotech.-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), a leading biopharmaceutical company based in China, has…<\/p>\n","protected":false},"author":1,"featured_media":13319,"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":[35,62,971,1832],"class_list":["post-13318","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-adc-xdc","tag-clinical-trial-approval-initiation","tag-hkg-6990","tag-kelun-biotech-biopharmaceutical"],"yoast_head":"\nSichuan Kelun-Biotech Secures NMPA Approval for Two Antibody Drug Conjugates - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), a leading biopharmaceutical company based in China, has announced receiving separate Investigational New Drug (IND) approvals from the National Medical Products Administration (NMPA) for its antibody drug conjugates (ADCs), SKB535 and SKB571, which target solid tumors. 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