{"id":20103,"date":"2023-04-03T22:04:00","date_gmt":"2023-04-03T14:04:00","guid":{"rendered":"https:\/\/flcube.com\/?p=20103"},"modified":"2024-12-28T22:11:45","modified_gmt":"2024-12-28T14:11:45","slug":"changzhou-qianhong-bio-pharma-receives-nmpa-approval-for-qhrd107-phase-ii-aml-study","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=20103","title":{"rendered":"Changzhou Qianhong Bio-pharma Receives NMPA Approval for QHRD107 Phase II AML Study"},"content":{"rendered":"\n<p>China-based Changzhou Qianhong Bio-pharma Co., Ltd (<a href=\"https:\/\/www.google.com\/finance\/quote\/002550:SHE\">SHE: 002550<\/a>) has announced obtaining approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study for its Category 1 drug QHRD107 in acute myeloid leukemia (AML). The drug is being developed for use in combination with venetoclax and\/or azacitidine, offering potential new treatment options for patients.<\/p>\n\n\n\n<p><strong>Preliminary Findings and Safety Profile of QHRD107<\/strong><br>Preliminary findings indicate that the QHRD107 capsule, an oral cyclin-dependent kinase (CDK) 9 inhibitor, is safe in AML patients with a controllable overall risk. A Phase I clinical study has successfully established a recommended dose for the Phase II stage, paving the way for further investigation into the drug&#8217;s efficacy and safety.<\/p>\n\n\n\n<p><strong>Monotherapy Potential and Antileukemia Activity<\/strong><br>As a monotherapy, QHRD107 has demonstrated certain anti-leukemia activity, suggesting that certain AML patients may benefit from the drug. The advancement to a Phase II trial marks a significant step in the development of QHRD107, which could potentially improve treatment outcomes for individuals with AML.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>China-based Changzhou Qianhong Bio-pharma Co., Ltd (SHE: 002550) has announced obtaining approval from the National&#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":[7,11],"tags":[16,62,970,969],"class_list":["post-20103","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-cancer","tag-clinical-trial-approval-initiation","tag-qianhong-bio-pharma","tag-she-002550"],"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>Changzhou Qianhong Bio-pharma Receives NMPA Approval for QHRD107 Phase II AML Study - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China-based Changzhou Qianhong Bio-pharma Co., Ltd (SHE: 002550) has announced obtaining approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study for its Category 1 drug QHRD107 in acute myeloid leukemia (AML). 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