{"id":3053,"date":"2021-11-24T15:14:00","date_gmt":"2021-11-24T15:14:00","guid":{"rendered":"https:\/\/www.prnasia.com\/story\/archive\/3587281_CN87281_0"},"modified":"2021-11-24T15:14:00","modified_gmt":"2021-11-24T15:14:00","slug":"kintor-pharma-receives-ind-clearance-by-nmpa-for-kx-826s-pivotal-study-to-treat-male-alopecia-patients","status":"publish","type":"post","link":"https:\/\/transmediavictoria.net.au\/?p=3053","title":{"rendered":"Kintor Pharma Receives IND Clearance by NMPA for KX-826’s Pivotal Study to Treat Male Alopecia Patients"},"content":{"rendered":"

SUZHOU, China<\/span>, Nov. 24, 2021<\/span> \/PRNewswire\/ — Kintor Pharmaceutical Limited (“Kintor Pharma”, HKEX: 9939), a clinical-stage biotechnology company developing innovative small molecule and biological therapeutics, today announced that the IND application for the pivotal study (phase III stage) of pyrilutamide (KX-826), a potential first-in-class drug developed by Kintor Pharma, for the treatment of male androgenetic alopecia (“AGA”) patients was cleared by the National Medical Products Administration (“NMPA”). KX-826 is the first androgen receptor (AR) antagonist which has entered the phase III clinical trial for AGA treatment in China<\/span> and global.<\/p>\n

The pivotal study is a randomized, double-blinded, placebo-controlled, multi-regional phase III clinical trial, which is designed to evaluate the efficacy and safety of KX-826 for treating male AGA patients in China<\/span>. The sample size of the phase III clinical trial is 416 and the trial duration is 24 weeks. The primary endpoint is the change from baseline in non-vellus target area hair count (TAHC) at the end of week 24.<\/p>\n

On 8 September 2021<\/span>, Kintor Pharma announced that the primary endpoint of the phase II clinical trial of KX-826 on male AGA patients in China<\/span> was well met, and KX-826 has demonstrated an outstanding efficacy and safety profile. The phase III clinical trial will be conducted in more than 20 sites (hospitals) in China<\/span>. The principal investigators (“PIs”) are Professor Zhang Jianzhong from Peking University People’s Hospital and Director Yang Qinping from Huashan Hospital of Fudan University. Kintor Pharma<\/span> expects the first patient enrollment to happen in early January 2022<\/span>.<\/p>\n

About KX-826<\/p>\n

KX-826 is an androgen receptor (AR) antagonist and a potential first-in-class topical drug for the treatment of AGA and acne vulgaris. For the AGA indication, on 8 September 2021<\/span>, Kintor Pharma announced that the primary endpoint of the phase II clinical trial of KX-826 on adult male patients was met, as results showed good efficacy and safety profile. On 11 July 2021<\/span>, Kintor Pharma announced that the Food and Drug Administration of the United States<\/span> greenlighted KX-826’s phase II clinical trial for AGA to be conducted in the United States<\/span>, and Kintor Pharma is preparing for the patients enrollment. For the acne vulgaris indication, the phase I clinical trial of KX-826 for the treatment of acne vulgaris has been completed, and Kintor Pharma is preparing for phase II clinical trial in China<\/span>.<\/p>\n

About Kintor Pharmaceutical Limited<\/p>\n

Kintor Pharmaceutical Limited is developing and commercializing a robust pipeline of innovative small molecule and biological therapeutics for androgen-receptor-related disease areas with unmet medical needs, including COVID-19, prostate, breast and liver cancer, alopecia, and acne. For more information, visit www.kintor.com.cn<\/a>.<\/p>\n

IR Team: IR@Kintor.com.cn<\/a>
<\/span>PR Team: PR@Kintor.com.cn<\/a><\/span><\/p>\n

\"Cision\" View original content:https:\/\/www.prnewswire.com\/news-releases\/kintor-pharma-receives-ind-clearance-by-nmpa-for-kx-826s-pivotal-study-to-treat-male-alopecia-patients-301431671.html<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

SUZHOU, China, Nov. 24, 2021 \/PRNewswire\/ — Kintor Pharmaceutical Limited (“Kintor Pharma”, HKEX: 9939), a clinical-stage biotechnology company developing innovative small molecule and biological therapeutics, today announced that the IND application for the pivotal study (phase III stage) of pyrilutamide (KX-826), a potential first-in-class drug developed by Kintor Pharma, for the treatment of male androgenetic […]<\/p>\n","protected":false},"author":8,"featured_media":3054,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[20],"tags":[],"class_list":["post-3053","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-business-news"],"yoast_head":"\nKintor Pharma Receives IND Clearance by NMPA for KX-826's Pivotal Study to Treat Male Alopecia Patients - My Blog<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/transmediavictoria.net.au\/?p=3053\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Kintor Pharma Receives IND Clearance by NMPA for KX-826's Pivotal Study to Treat Male Alopecia Patients - 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