{"id":24354,"date":"2022-11-15T13:04:00","date_gmt":"2022-11-15T05:04:00","guid":{"rendered":"https:\/\/flcube.com\/?p=24354"},"modified":"2025-01-31T13:15:43","modified_gmt":"2025-01-31T05:15:43","slug":"peru-approves-bmss-reblozyl-and-beigenes-brukinsa","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=24354","title":{"rendered":"Peru Approves BMS&#8217;s Reblozyl and BeiGene&#8217;s Brukinsa"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">Peru&#8217;s General Directorate of Medicines, Supplies and Drugs (DIGEMID) has approved Bristol-Myers Squibb&#8217;s (BMS; <a href=\"https:\/\/www.google.com\/finance\/quote\/BMY:NYSE\">NYSE: BMY<\/a>) erythropoietic aid Reblozyl (luspatercept) and BeiGene&#8217;s (NASDAQ: BGNE; <a href=\"https:\/\/www.google.com\/finance\/quote\/6160:HKG\">HKG: 6160<\/a>; <a href=\"https:\/\/www.google.com\/finance\/quote\/688235:SHA\">SHA: 688235<\/a>) Bruton&#8217;s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib), according to <a href=\"https:\/\/flcube.com\/\">Fineline Info &amp; Tech<\/a> analysis. The approvals mark significant milestones for both drugs in the Latin American market.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Drug Profiles and Indications<\/strong><br>Reblozyl is indicated for the treatment of anemia associated with beta thalassemia, myelodysplastic syndromes with ring sideroblasts (MDS-RS), and myelodysplastic\/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS\/MPN-RS-T). The drug is a recombinant fusion protein that acts as an erythroid maturation agent by binding to several members of the transforming growth factor-\u03b2 (TGF-\u03b2) superfamily of ligands, which is upstream of the Smad2\/3 pathway that displays elevated signaling in beta thalassemia and MDS.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Brukinsa, developed by BeiGene, is a BTK inhibitor that inhibits the proliferation and survival of malignant B lymphocytes by covalently binding to the active site of BTK, an enzyme crucial for B lymphocyte proliferation, trafficking, chemotaxis, and adhesion. Last month, BeiGene announced several Latin American approvals for Brukinsa in mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), and Waldenstr\u00f6m&#8217;s macroglobulinemia (WM).<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Market and Competitive Landscape<\/strong><br><a href=\"https:\/\/flcube.com\/\">Fineline Info &amp; Tech<\/a> analysis indicates that this is the third regulatory approval for BMS&#8217;s Reblozyl in Latin America, following approvals in Brazil and Uruguay. Meanwhile, BeiGene&#8217;s Brukinsa will enter Peru&#8217;s competitive BTK inhibitor market, where it will compete with Johnson &amp; Johnson&#8217;s (J&amp;J; <a href=\"https:\/\/www.google.com\/finance\/quote\/JNJ:NYSE\">NYSE: JNJ<\/a>) Imbruvica (ibrutinib), AstraZeneca&#8217;s (AZ, <a href=\"https:\/\/www.google.com\/finance\/quote\/AZN:NASDAQ\">NASDAQ: AZN<\/a>) Calquence (acalabrutinib), and several ibrutinib generics. Brukinsa is already available in Argentina, Mexico, Brazil, Chile, Ecuador, El Salvador, Paraguay, and Uruguay.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Peru&#8217;s General Directorate of Medicines, Supplies and Drugs (DIGEMID) has approved Bristol-Myers Squibb&#8217;s (BMS; NYSE:&#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_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_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},"jetpack_post_was_ever_published":false},"categories":[7,11],"tags":[130,770,185,2092,429,428,847,150,149,871,849,858,848],"class_list":["post-24354","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-astrazeneca","tag-az","tag-beigene","tag-beone-medicines","tag-bms","tag-bristol-myers-squibb","tag-hkg-6160","tag-jj","tag-johnson-johnson","tag-nasdaq-azn","tag-nyse-bmy","tag-nyse-jnj","tag-sha-688235"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.5 (Yoast SEO v27.9) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Peru Approves BMS&#039;s Reblozyl and BeiGene&#039;s Brukinsa - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Peru&#039;s General Directorate of Medicines, Supplies and Drugs (DIGEMID) has approved Bristol-Myers Squibb&#039;s (BMS; NYSE: BMY) erythropoietic aid Reblozyl (luspatercept) and BeiGene&#039;s (NASDAQ: BGNE; HKG: 6160; SHA: 688235) Bruton&#039;s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib), according to Fineline Info &amp; Tech analysis. 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