{"id":30655,"date":"2022-06-16T22:16:00","date_gmt":"2022-06-16T14:16:00","guid":{"rendered":"https:\/\/flcube.com\/?p=30655"},"modified":"2025-03-26T22:18:14","modified_gmt":"2025-03-26T14:18:14","slug":"sichuan-keluns-kl340399-wins-nmpa-approval-for-solid-tumor-trials","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=30655","title":{"rendered":"Sichuan Kelun’s KL340399 Wins NMPA Approval for Solid Tumor Trials"},"content":{"rendered":"\n

China-based Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422<\/a>) announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its next-generation small-molecule STING agonist, KL340399. The approval allows the company to proceed with trials for locally advanced, recurrent, or metastatic solid tumors suitable for intratumoral injection.<\/p>\n\n\n\n

Drug Mechanism and Innovation<\/strong>
KL340399 is a new-generation small-molecule STING agonist of the acyclic dinucleotide (CDN) type, developed independently by Kelun Pharm. It has a stable molecular structure and can be administered systemically. Preclinical studies demonstrated that KL340399 effectively binds to the human interferon gene-stimulating (STING) protein, activating the STING signaling pathway. This activation induces the expression of type I interferon and anti-tumor cytokines, resulting in significant dose-dependent inhibition of tumor growth in animal models. The drug also shows potential for synergistic combination with PD-(L)1 antibodies and has been well-tolerated in safety assessments during animal modeling.<\/p>\n\n\n\n

Market Context<\/strong>
Currently, no STING agonist is available on the market globally. Novartis\u2019s ADU-S100 and Merck\u2019s MK-1454 are in Phase II clinical trials, while domestic firms like Genor Bio, Adlai Nortye, and HaiHe Bio are also developing their own STING agonists.-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

China-based Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) announced receiving clinical trial approval from the…<\/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":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[16,62,371,25,1185],"class_list":["post-30655","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-cancer","tag-clinical-trial-approval-initiation","tag-kelun-pharmaceutical","tag-potential-first-in-class","tag-she-002422"],"yoast_head":"\nSichuan Kelun's KL340399 Wins NMPA Approval for Solid Tumor Trials - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its next-generation small-molecule STING agonist, KL340399. 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