-Denifanstat (ASC40) met all primary, key secondary and secondary efficacy endpoints (ITT analysis) and significantly improved moderate-to-severe acne vulgaris compared with placebo in a randomized, double-blind, placebo-controlled, multicenter Phase III clinical trial.<\/i><\/p>\n
HONG KONG<\/span><\/span>, Dec. 10, 2025<\/span><\/span> \/PRNewswire\/ —\u00a0Ascletis Pharma Inc. (HKEX: 1672, “Ascletis”) announces today that its New Drug Application (NDA) for denifanstat (ASC40), a first-in-class, once-daily oral small molecule fatty acid synthase (FASN) inhibitor for the treatment of moderate-to-severe acne vulgaris, has been accepted by the China National Medical Products Administration (NMPA).<\/p>\n “Acceptance of this NDA is an important milestone in our efforts to provide a potentially groundbreaking therapeutic approach for the treatment of moderate-to-severe acne,” said Jinzi Jason Wu<\/span>, Ph.D., Founder, Chairman and CEO of Ascletis, “We are excited\u00a0denifanstat (ASC40) is only one step away from the commercialization.”<\/p>\n Ascletis has completed Phase II (NCT05104125<\/a>) and Phase III (NCT06192264<\/a><\/u>) studies of denifanstat (ASC40) for the treatment of moderate-to-severe acne vulgaris.<\/p>\n In the Phase III study, denifanstat (ASC40) met all primary, key secondary and secondary efficacy endpoints (ITT analysis) and significantly improved moderate-to-severe acne vulgaris compared with placebo. Denifanstat (ASC40) demonstrated a favorable safety and tolerability profile. All denifanstat (ASC40)-related treatment-emergent adverse events (TEAEs) were mild (Grade 1) or moderate (Grade 2). There were no denifanstat (ASC40)-related Grade 3 or 4 TEAEs and no denifanstat (ASC40)-related serious adverse events (SAEs). There were no denifanstat (ASC40)-related permanent treatment discontinuations or withdrawals observed.<\/p>\n The Phase III study results were presented as an oral presentation at the European Academy of Dermatology and Venereology (EADV) Congress 2025 in Paris, France<\/span> on September 17, 2025<\/span> (link<\/a>).<\/p>\n The Company recently completed the pre-NDA consultation with the China NMPA for denifanstat (ASC40) for the treatment of moderate-to-severe acne vulgaris and received positive feedback from NMPA.<\/span><\/p>\n Ascletis licensed denifanstat (ASC40) from Sagimet Biosciences Inc. (Nasdaq: SGMT) for exclusive rights in Greater China<\/span>.<\/p>\n About Ascletis Pharma Inc.<\/b><\/p>\n Ascletis Pharma Inc. is a fully integrated biotechnology company focused on the development and commercialization of potential best-in-class and first-in-class therapeutics to treat metabolic diseases. Utilizing its proprietary Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD) and Ultra-Long-Acting Platform (ULAP) technologies as well as Peptide Oral Transport ENhancement Technology (POTENT), Ascletis has developed multiple drug candidates in-house, including both small molecules and peptides, such as its lead program, ASC30, a small molecule GLP-1R agonist designed to be administered once daily orally and once monthly to once quarterly subcutaneously as a treatment therapy and a maintenance therapy for chronic weight management; ASC36, a once-monthly subcutaneously administered amylin receptor peptide agonist, ASC35, a once-monthly subcutaneously administered GLP-1R\/GIPR dual peptide agonist and ASC37, an oral GLP-1R\/GIPR\/GCGR triple peptide agonist for chronic weight management. Ascletis is listed on the Hong Kong Stock Exchange (1672.HK).<\/p>\n For more information, please visit www.ascletis.com<\/a>.<\/p>\n Contact\uff1a<\/p>\n Peter Vozzo<\/span> Ascletis Pharma Inc. PR and IR teams <\/p>\n -Denifanstat (ASC40) met all primary, key secondary and secondary efficacy endpoints (ITT analysis) and significantly improved moderate-to-severe acne vulgaris compared with placebo in a randomized, double-blind, placebo-controlled, multicenter Phase III clinical trial.<\/i><\/p>\n HONG KONG<\/span><\/span>, Dec. 10, 2025<\/span><\/span> \/PRNewswire\/ —\u00a0Ascletis Pharma Inc. (HKEX: 1672, “Ascletis”) announces today that its New Drug Application (NDA) for denifanstat (ASC40), a first-in-class, once-daily oral small molecule fatty acid synthase (FASN) inhibitor for the treatment of moderate-to-severe acne vulgaris, has been accepted by the China National Medical Products Administration (NMPA).<\/p>\n “Acceptance of this NDA is an important milestone in our efforts to provide a potentially groundbreaking therapeutic approach for the treatment of moderate-to-severe acne,” said Jinzi Jason Wu<\/span>, Ph.D., Founder, Chairman and CEO of Ascletis, “We are excited\u00a0denifanstat (ASC40) is only one step away from the commercialization.”<\/p>\n Ascletis has completed Phase II (NCT05104125<\/a>) and Phase III (NCT06192264<\/a><\/u>) studies of denifanstat (ASC40) for the treatment of moderate-to-severe acne vulgaris.<\/p>\n In the Phase III study, denifanstat (ASC40) met all primary, key secondary and secondary efficacy endpoints (ITT analysis) and significantly improved moderate-to-severe acne vulgaris compared with placebo. Denifanstat (ASC40) demonstrated a favorable safety and tolerability profile. All denifanstat (ASC40)-related treatment-emergent adverse events (TEAEs) were mild (Grade 1) or moderate (Grade 2). There were no denifanstat (ASC40)-related Grade 3 or 4 TEAEs and no denifanstat (ASC40)-related serious adverse events (SAEs). There were no denifanstat (ASC40)-related permanent treatment discontinuations or withdrawals observed.<\/p>\n The Phase III study results were presented as an oral presentation at the European Academy of Dermatology and Venereology (EADV) Congress 2025 in Paris, France<\/span> on September 17, 2025<\/span> (link<\/a>).<\/p>\n The Company recently completed the pre-NDA consultation with the China NMPA for denifanstat (ASC40) for the treatment of moderate-to-severe acne vulgaris and received positive feedback from NMPA.<\/span><\/p>\n Ascletis licensed denifanstat (ASC40) from Sagimet Biosciences Inc. (Nasdaq: SGMT) for exclusive rights in Greater China<\/span>.<\/p>\n About Ascletis Pharma Inc.<\/b><\/p>\n Ascletis Pharma Inc. is a fully integrated biotechnology company focused on the development and commercialization of potential best-in-class and first-in-class therapeutics to treat metabolic diseases. Utilizing its proprietary Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD) and Ultra-Long-Acting Platform (ULAP) technologies as well as Peptide Oral Transport ENhancement Technology (POTENT), Ascletis has developed multiple drug candidates in-house, including both small molecules and peptides, such as its lead program, ASC30, a small molecule GLP-1R agonist designed to be administered once daily orally and once monthly to once quarterly subcutaneously as a treatment therapy and a maintenance therapy for chronic weight management; ASC36, a once-monthly subcutaneously administered amylin receptor peptide agonist, ASC35, a once-monthly subcutaneously administered GLP-1R\/GIPR dual peptide agonist and ASC37, an oral GLP-1R\/GIPR\/GCGR triple peptide agonist for chronic weight management. Ascletis is listed on the Hong Kong Stock Exchange (1672.HK).<\/p>\n For more information, please visit www.ascletis.com<\/a>.<\/p>\n Contact\uff1a<\/p>\n Peter Vozzo<\/span> Ascletis Pharma Inc. PR and IR teams <\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"rop_custom_images_group":[],"rop_custom_messages_group":[],"rop_publish_now":"initial","rop_publish_now_accounts":[],"rop_publish_now_history":[],"rop_publish_now_status":"pending","footnotes":""},"categories":[5,7],"tags":[],"class_list":["post-41242","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cision-pr-newswire","category-cision-pr-newswire-en"],"_links":{"self":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts\/41242","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=41242"}],"version-history":[{"count":0,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts\/41242\/revisions"}],"wp:attachment":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=41242"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=41242"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=41242"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
ICR Healthcare
443-231-0505 (U.S.)
Peter.vozzo@icrhealthcare.com<\/a>\u00a0<\/p>\n
+86-181-0650-9129 (China<\/span>)
pr@ascletis.com<\/a>
ir@ascletis.com<\/a>\u00a0<\/p>","protected":false},"excerpt":{"rendered":"
ICR Healthcare
443-231-0505 (U.S.)
Peter.vozzo@icrhealthcare.com<\/a>\u00a0<\/p>\n
+86-181-0650-9129 (China<\/span>)
pr@ascletis.com<\/a>
ir@ascletis.com<\/a>\u00a0<\/p>\n