{"id":43576,"date":"2025-10-16T16:03:17","date_gmt":"2025-10-16T08:03:17","guid":{"rendered":"https:\/\/flcube.com\/?p=43576"},"modified":"2025-10-16T16:03:18","modified_gmt":"2025-10-16T08:03:18","slug":"haihe-biopharma-grants-taiho-pharmaceutical-exclusive-license-for-risovalisib-in-japan","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=43576","title":{"rendered":"Haihe\u202fBiopharma Grants Taiho\u202fPharmaceutical Exclusive License for Risovalisib in Japan"},"content":{"rendered":"\n<p><strong>China\u2011based Haihe Biopharma Co., Ltd.<\/strong> (the \u201cLicensor\u201d) announced today that it has entered into an exclusive license agreement with <strong>Taiho Pharmaceutical Co., Ltd.<\/strong> (the \u201cLicensee\u201d) for the development, manufacture, and commercialization of the phosphatidylinositol\u202f3\u2011kinase alpha (PI3K\u03b1) inhibitor <strong>risovalisib<\/strong> (development code: CYH33) in the Japanese market.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-key-deal-highlights\">Key Deal Highlights<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Exclusive Rights<\/strong> \u2013 Taiho Pharmaceutical obtains sole rights to develop, manufacture, and sell risovalisib tablets in Japan.<\/li>\n\n\n\n<li><strong>Financial Terms<\/strong> \u2013 Haihe will receive an upfront payment, milestone\u2011based development and sales payments, and ongoing royalties on net sales within the licensed territory.<\/li>\n\n\n\n<li><strong>Strategic Continuity<\/strong> \u2013 This is the second collaboration between Haihe and Taiho, following their joint venture on glumetinib.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-about-risovalisib\">About Risovalisib<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Feature<\/th><th>Detail<\/th><\/tr><\/thead><tbody><tr><td><strong>Class<\/strong><\/td><td>Novel, highly potent, PI3K\u03b1\u2011selective inhibitor<\/td><\/tr><tr><td><strong>Intellectual Property<\/strong><\/td><td>Global independent IP owned by Haihe Biopharma<\/td><\/tr><tr><td><strong>Clinical Focus<\/strong><\/td><td>PIK3CA\u2011gene\u2011mutation\u2011positive ovarian clear cell carcinoma (OCCC) that has progressed or recurred after chemotherapy<\/td><\/tr><tr><td><strong>Regulatory Status<\/strong><\/td><td>NDA submitted to Japan (August\u202f2025); Orphan Drug designation by MHLW (June\u202f2025)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-implications-for-the-japanese-oncology-market\">Implications for the Japanese Oncology Market<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Unmet Need<\/strong> \u2013 OCCC is a rare, aggressive subtype of ovarian cancer with limited treatment options.<\/li>\n\n\n\n<li><strong>Orphan Designation<\/strong> \u2013 The MHLW orphan status may accelerate review, provide market exclusivity, and enable price\u2011support mechanisms.<\/li>\n\n\n\n<li><strong>Strategic Value<\/strong> \u2013 Taiho\u2019s established oncology portfolio and distribution network will fast\u2011track risovalisib\u2019s clinical development and market entry.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-forward-looking-statements\">Forward\u2011Looking Statements<\/h3>\n\n\n\n<p>This release contains forward\u2011looking statements that involve risks and uncertainties. Actual results may differ materially.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>China\u2011based Haihe Biopharma Co., Ltd. (the \u201cLicensor\u201d) announced today that it has entered into an&#8230;<\/p>\n","protected":false},"author":1,"featured_media":43577,"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":[7,10],"tags":[16,1910,1447],"class_list":["post-43576","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-deals","tag-cancer","tag-haihe-biopharma","tag-taiho-pharmaceutical"],"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>Haihe\u202fBiopharma Grants Taiho\u202fPharmaceutical Exclusive License for Risovalisib in Japan - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China\u2011based Haihe Biopharma Co., Ltd. (the \u201cLicensor\u201d) announced today that it has entered into an exclusive license agreement with Taiho Pharmaceutical Co., Ltd. (the \u201cLicensee\u201d) for the development, manufacture, and commercialization of the phosphatidylinositol\u202f3\u2011kinase alpha (PI3K\u03b1) inhibitor risovalisib (development code: CYH33) in the Japanese market.\" \/>\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=43576\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Haihe\u202fBiopharma Grants Taiho\u202fPharmaceutical Exclusive License for Risovalisib in Japan\" \/>\n<meta property=\"og:description\" content=\"China\u2011based Haihe Biopharma Co., Ltd. (the \u201cLicensor\u201d) announced today that it has entered into an exclusive license agreement with Taiho Pharmaceutical Co., Ltd. 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