{"id":28610,"date":"2022-07-01T21:34:00","date_gmt":"2022-07-01T13:34:00","guid":{"rendered":"https:\/\/flcube.com\/?p=28610"},"modified":"2025-03-03T21:56:15","modified_gmt":"2025-03-03T13:56:15","slug":"kelun-pharmas-skb264-adc-receives-breakthrough-therapy-designation-for-tnbc","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=28610","title":{"rendered":"Kelun Pharma’s SKB264 ADC Receives Breakthrough Therapy Designation for TNBC"},"content":{"rendered":"\n

The Center for Drug Evaluation (CDE) website indicates that Sichuan Kelun Pharmaceutical Co., Ltd\u2019s (SHE: 002422<\/a>) SKB264, an antibody – drug conjugate (ADC) targeting trophoblast cell-surface antigen 2 (TROP2), has been awarded a breakthrough therapy designation (BTD) for the treatment of locally advanced or metastatic triple – negative breast cancer (TNBC).<\/p>\n\n\n\n

Drug Profile<\/strong>
SKB264 directly targets tumor cells by connecting novel toxin molecules through the TROP2 monoclonal antibody, effectively reducing off – target toxicity while maintaining efficacy and safety. The drug has obtained three clinical trial approvals in China: as a monotherapy for advanced solid tumors, in combination with Kelun’s anti – PD – L1 drug KL – A167 for advanced or metastatic non – small cell lung cancer and TNBC, and as a monotherapy in the second – line setting for advanced or metastatic TNBC (Phase III study).<\/p>\n\n\n\n

Licensing Agreement<\/strong>
On May 16, 2022, Kelun Pharma entered into a USD 1.36 billion licensing agreement with Merck Sharp & Dohme Corp., (MSD) granting the US company development and commercial rights to an undisclosed biologic drug candidate from Kelun’s pipeline. Local media speculated that the TROP2 – targeted SKB264 was the subject of the deal. Kelun Pharma announced earlier this week that it had received USD 30 million from MSD, indicating the full initiation of the partnership.<\/p>\n\n\n\n

Competitive Landscape<\/strong>
Other companies such as DAC Biotech \/ Junshi Bio, Fudan – Zhangjiang, Escugen Bio \/ Tot Bio, and others are also developing TROP2 – ADC products, though these are currently at the Phase I or II stage.-Fineline Info & Tech<\/a><\/p>\n\n\n\n

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

The Center for Drug Evaluation (CDE) website indicates that Sichuan Kelun Pharmaceutical Co., Ltd\u2019s (SHE:…<\/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":[35,34,16,2859,464,296,371,2675,176,1185,2571],"class_list":["post-28610","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-adc-xdc","tag-breakthrough-therapy","tag-cancer","tag-dac-biotechnology","tag-escugen","tag-junshi-biosciences","tag-kelun-pharmaceutical","tag-merck-sharp-dohme","tag-msd","tag-she-002422","tag-tot-biopharm"],"yoast_head":"\nKelun Pharma's SKB264 ADC Receives Breakthrough Therapy Designation for TNBC - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"The Center for Drug Evaluation (CDE) website indicates that Sichuan Kelun Pharmaceutical Co., Ltd\u2019s (SHE: 002422) SKB264, an antibody - drug conjugate (ADC) targeting trophoblast cell-surface antigen 2 (TROP2), has been awarded a breakthrough therapy designation (BTD) for the treatment of locally advanced or metastatic triple - negative breast cancer (TNBC).\" \/>\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=28610\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Kelun Pharma's SKB264 ADC Receives Breakthrough Therapy Designation for TNBC\" \/>\n<meta property=\"og:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. 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