{"id":27652,"date":"2022-07-22T00:31:00","date_gmt":"2022-07-21T16:31:00","guid":{"rendered":"https:\/\/flcube.com\/?p=27652"},"modified":"2025-02-24T00:34:44","modified_gmt":"2025-02-23T16:34:44","slug":"lepu-biopharmas-pucotenlimab-receives-conditional-nmpa-approval-for-msi-h-dmmr-tumors","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=27652","title":{"rendered":"Lepu Biopharma&#8217;s Pucotenlimab Receives Conditional NMPA Approval for MSI-H\/dMMR Tumors"},"content":{"rendered":"\n<p>The National Medical Products Administration (NMPA) has granted conditional market approval to Lepu Biopharma Co., Ltd&#8217;s pucotenlimab (HX008), a programmed death 1 (PD-1) targeted humanized IgG4 monoclonal antibody (mAb). The drug is indicated for microsatellite instability-high\/deficient mismatch repair (MSI-H\/dMMR) expressing tumors in two patient groups: (1) those with advanced colorectal cancer whose disease has progressed after previous chemotherapy; and (2) patients with other advanced solid tumors who have progressed after first-line treatment and lack satisfactory alternative options.<\/p>\n\n\n\n<p><strong>Drug Profile<\/strong><br>Pucotenlimab is the eighth PD-1 inhibitor developed by a domestic Chinese biopharma. The molecule employs antibody engineering technology to introduce mutations in the Fc region, enhancing FcRn binding affinity and significantly extending its half-life. Early clinical studies demonstrated the drug&#8217;s efficacy and safety across multiple solid tumor types.<\/p>\n\n\n\n<p><strong>Additional Approvals<\/strong><br>Lepu has another approval filing under review for pucotenlimab as a second-line treatment for melanoma, submitted in July 2021. The MSI-H\/dMMR indication was filed in October 2021.<\/p>\n\n\n\n<p><strong>Market Context<\/strong><br>Seven other PD-1 inhibitors developed in China include Hengrui Medicine&#8217;s camrelizumab, Innovent Bio&#8217;s Tyvyt (sintilimab), BeiGene&#8217;s tislelizumab, Junshi Bio&#8217;s Tuoyi (toripalimab), Akeso Bio&#8217;s penpulimab, Gloria Pharma&#8217;s zimberelimab, and Henlius Bio&#8217;s HaiSiZhuang (serplulimab).<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The National Medical Products Administration (NMPA) has granted conditional market approval to Lepu Biopharma Co.,&#8230;<\/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":[11],"tags":[360,185,16,1787,2586,270,198,296,3609,18,15],"class_list":["post-27652","post","type-post","status-publish","format-standard","hentry","category-drug","tag-akeso-biopharma","tag-beigene","tag-cancer","tag-gloria-pharmaceuticals","tag-hengrui-pharmaceuticals","tag-henlius-biotech","tag-innovent-biologics","tag-junshi-biosciences","tag-lepu-biopharma","tag-pd-1-l1","tag-product-approvals"],"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>Lepu Biopharma&#039;s Pucotenlimab Receives Conditional NMPA Approval for MSI-H\/dMMR Tumors - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"The National Medical Products Administration (NMPA) has granted conditional market approval to Lepu Biopharma Co., Ltd&#039;s pucotenlimab (HX008), a programmed death 1 (PD-1) targeted humanized IgG4 monoclonal antibody (mAb). The drug is indicated for microsatellite instability-high\/deficient mismatch repair (MSI-H\/dMMR) expressing tumors in two patient groups: (1) those with advanced colorectal cancer whose disease has progressed after previous chemotherapy; and (2) patients with other advanced solid tumors who have progressed after first-line treatment and lack satisfactory alternative options.\" \/>\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=27652\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Lepu Biopharma&#039;s Pucotenlimab Receives Conditional NMPA Approval for MSI-H\/dMMR Tumors\" \/>\n<meta property=\"og:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. 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