{"id":42074,"date":"2025-09-23T14:56:42","date_gmt":"2025-09-23T06:56:42","guid":{"rendered":"https:\/\/flcube.com\/?p=42074"},"modified":"2025-09-23T14:56:43","modified_gmt":"2025-09-23T06:56:43","slug":"sichuan-kelun%e2%80%91biotechs-a400-receives-nda-acceptance-in-china","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=42074","title":{"rendered":"Sichuan Kelun\u2011Biotech\u2019s A400 Receives NDA Acceptance in China"},"content":{"rendered":"\n<p><strong>Sichuan Kelun\u2011Biotech Biopharmaceutical Co., Ltd.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/6990:HKG\">HKG: 6990<\/a>) announced today that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for <strong>A400<\/strong> (also known as <strong>EP0031<\/strong>). The application targets adult patients with RET\u2011fusion positive locally advanced or metastatic non\u2011small\u2011cell lung cancer (NSCLC).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-what-is-a400-ep0031\">What Is A400\/EP0031?<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Next\u2011Generation RET Inhibitor<\/strong> \u2013 A highly selective oral agent that blocks oncogenic RET signaling in NSCLC, medullary thyroid cancer (MTC), and other solid tumors harboring RET alterations.<\/li>\n\n\n\n<li><strong>Clinical Profile<\/strong> \u2013 In March\u202f2021, Kelun\u2011Biotech granted <strong>Ellipses\u202fPharma Limited<\/strong> an exclusive license to develop, manufacture, and commercialize EP0031 outside Greater China and select Asian markets.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-regulatory-milestone\">Regulatory Milestone<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>NDA Acceptance<\/strong> \u2013 The CDE\u2019s endorsement follows positive data from the two pivotal Phase\u202f2 cohorts (KL400\u2011I\/II\u201101) of the study.<\/li>\n\n\n\n<li><strong>Cohort Outcomes<\/strong> \u2013 Cohort\u202f1 (first\u2011line) and Cohort\u202f2 (second\u2011line+) evaluated 90\u202fmg QD dosing in treatment\u2011na\u00efve and pre\u2011treated RET\u2011fusion positive NSCLC patients, respectively.<\/li>\n\n\n\n<li><strong>Efficacy &amp; Safety<\/strong> \u2013 Both cohorts met primary endpoints, demonstrating robust activity even in patients with prior immunotherapy or brain metastases, while maintaining an encouraging and manageable safety profile.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-implications\">Market Implications<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Competitive Positioning<\/strong> \u2013 A400\/EP0031 offers a differentiated, highly selective therapeutic option in the rapidly expanding RET\u2011targeted oncology segment.<\/li>\n\n\n\n<li><strong>Global Reach<\/strong> \u2013 With Ellipses holding rights outside China, the drug is poised for accelerated international commercialization, potentially capturing a significant share of the $10\u2011$15\u202fbillion RET\u2011inhibitor market.<\/li>\n\n\n\n<li><strong>Strategic Value for Kelun\u2011Biotech<\/strong> \u2013 The NDA acceptance strengthens the company\u2019s portfolio and signals growth potential for future solid\u2011tumor indications.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-key-takeaways\">Key Takeaways<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>NMPA endorsement<\/strong> of A400\/EP0031 validates strong Phase\u202f2 data and positions the drug for first\u2011in\u2011class approval in China.<\/li>\n\n\n\n<li><strong>International partnership<\/strong> with Ellipses expands the commercial footprint beyond Greater China.<\/li>\n\n\n\n<li><strong>Positive safety profile<\/strong> in heavily pre\u2011treated populations enhances the drug\u2019s appeal to clinicians and payers alike.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Sichuan Kelun\u2011Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) announced today that the Center for Drug Evaluation&#8230;<\/p>\n","protected":false},"author":1,"featured_media":42079,"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":[16,971,1832,38],"class_list":["post-42074","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-cancer","tag-hkg-6990","tag-kelun-biotech-biopharmaceutical","tag-market-approval-filings"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Sichuan Kelun\u2011Biotech\u2019s A400 Receives NDA Acceptance in China - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Sichuan Kelun\u2011Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) announced today that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for A400 (also known as EP0031). The application targets adult patients with RET\u2011fusion positive locally advanced or metastatic non\u2011small\u2011cell lung cancer (NSCLC).\" \/>\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=42074\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Sichuan Kelun\u2011Biotech\u2019s A400 Receives NDA Acceptance in China\" \/>\n<meta property=\"og:description\" content=\"Sichuan Kelun\u2011Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) announced today that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for A400 (also known as EP0031). 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