{"id":24807,"date":"2022-10-28T01:12:00","date_gmt":"2022-10-27T17:12:00","guid":{"rendered":"https:\/\/flcube.com\/?p=24807"},"modified":"2025-02-02T01:14:56","modified_gmt":"2025-02-01T17:14:56","slug":"alphamab-oncology-gains-nmpa-approval-for-jskn003-clinical-trial","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=24807","title":{"rendered":"Alphamab Oncology Gains NMPA Approval for JSKN003 Clinical Trial"},"content":{"rendered":"\n

Alphamab Oncology (HKG: 9966<\/a>) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase Ia\/Ib clinical study for its JSKN003. The study will assess the safety and tolerability of JSKN003 in patients with advanced malignant solid tumors and determine the maximum tolerable dose (MTD) and recommended Phase II dose (RP2D).<\/p>\n\n\n\n

JSKN003: Drug Profile and Mechanism<\/strong>
JSKN003 is a HER2-targeted antibody drug conjugate (ADC) that utilizes the click reaction, which is considered to have improved serum stability compared to conjugates based on the maleimide-Michael reaction. The bi-epitope HER2 targeting of JSKN003 enables it to have stronger endocytosis-inducing and bystander killing effects, resulting in robust antitumor activity in HER2-expressing tumors with low drug-loaded toxicity. Last month, the drug was first dosed in a Phase I clinical study in Australia.<\/p>\n\n\n\n

Future Outlook<\/strong>
With NMPA approval, Alphamab Oncology is set to advance JSKN003 into clinical trials, marking a significant step in the development of this innovative HER2-targeted ADC. The company aims to leverage the drug’s unique mechanism of action to improve treatment outcomes for patients with advanced solid tumors.-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Alphamab Oncology (HKG: 9966) announced that it has received approval from the National Medical Products…<\/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":[35,187,16,62,83,854],"class_list":["post-24807","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-adc-xdc","tag-alphamab-oncology","tag-cancer","tag-clinical-trial-approval-initiation","tag-her2","tag-hkg-9966"],"yoast_head":"\nAlphamab Oncology Gains NMPA Approval for JSKN003 Clinical Trial - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Alphamab Oncology (HKG: 9966) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase Ia\/Ib clinical study for its JSKN003. 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