{"id":39772,"date":"2025-08-20T14:17:25","date_gmt":"2025-08-20T06:17:25","guid":{"rendered":"https:\/\/flcube.com\/?p=39772"},"modified":"2025-08-20T14:17:26","modified_gmt":"2025-08-20T06:17:26","slug":"haihe-biopharma-seeks-japan-approval-for-risovalisib-in-pik3ca-mutated-ovarian-cancer","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=39772","title":{"rendered":"Haihe Biopharma Seeks Japan Approval for Risovalisib in PIK3CA-Mutated Ovarian Cancer"},"content":{"rendered":"\n<p>Haihe Biopharma Co., Ltd. has filed a market application with Japan\u2019s Ministry of Health, Labour and Welfare (MHLW) for risovalisib (CYH33), a PI3K\u03b1 inhibitor targeting ovarian clear cell carcinoma (OCCC) patients with PIK3CA gene mutations whose disease has progressed or recurred after prior chemotherapy.<\/p>\n\n\n\n<p><strong>Drug Mechanism and Background<\/strong><br>Risovalisib is a highly selective phosphatidylinositol 3-kinase \u03b1 (PI3K\u03b1) inhibitor independently developed by Haihe Biopharma. It received orphan drug designation from Japan\u2019s MHLW in June 2025 and holds global intellectual property rights.<\/p>\n\n\n\n<p><strong>Clinical Trial Results<\/strong><br>The multinational, multicenter, open-label, single-arm Phase 2 trial (CYH33-G201) evaluated risovalisib\u2019s efficacy and safety in patients with OCCC and PIK3CA mutations. Results demonstrated significant antitumor activity, supporting the drug\u2019s potential as a new precision treatment option for OCCC.<\/p>\n\n\n\n<p><strong>Future Outlook<\/strong><br>With its promising trial data and orphan drug status, risovalisib represents a significant advancement in the treatment of OCCC and highlights Haihe Biopharma\u2019s commitment to innovative oncology solutions.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Haihe Biopharma Co., Ltd. has filed a market application with Japan\u2019s Ministry of Health, Labour&#8230;<\/p>\n","protected":false},"author":1,"featured_media":39773,"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":[16,1910,38,109],"class_list":["post-39772","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-cancer","tag-haihe-biopharma","tag-market-approval-filings","tag-precision-medicine"],"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 Biopharma Seeks Japan Approval for Risovalisib in PIK3CA-Mutated Ovarian Cancer - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Haihe Biopharma Co., Ltd. has filed a market application with Japan\u2019s Ministry of Health, Labour and Welfare (MHLW) for risovalisib (CYH33), a PI3K\u03b1 inhibitor targeting ovarian clear cell carcinoma (OCCC) patients with PIK3CA gene mutations whose disease has progressed or recurred after prior chemotherapy.\" \/>\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=39772\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Haihe Biopharma Seeks Japan Approval for Risovalisib in PIK3CA-Mutated Ovarian Cancer\" \/>\n<meta property=\"og:description\" content=\"Haihe Biopharma Co., Ltd. has filed a market application with Japan\u2019s Ministry of Health, Labour and Welfare (MHLW) for risovalisib (CYH33), a PI3K\u03b1 inhibitor targeting ovarian clear cell carcinoma (OCCC) patients with PIK3CA gene mutations whose disease has progressed or recurred after prior chemotherapy.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=39772\" \/>\n<meta property=\"og:site_name\" content=\"Insight, China&#039;s Pharmaceutical Industry\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/profile.php?id=61566606313834\" \/>\n<meta property=\"article:published_time\" content=\"2025-08-20T06:17:25+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-08-20T06:17:26+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/08\/2012.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"1080\" \/>\n\t<meta property=\"og:image:height\" content=\"608\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Fineline Cube\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. 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