Ascletis Completes Denifanstat (ASC40) Pre-NDA Consultation with China National Medical Products Administration
Ascletis (HKEX:1672) completed a pre-NDA consultation with China NMPA for denifanstat (ASC40) for moderate-to-severe acne vulgaris, initiated in June 2025 and completed in October 2025, and plans to submit an NDA soon.
Ascletis completed Phase II (NCT05104125) and Phase III (NCT06192264) studies; the Phase III met all primary, key secondary and secondary efficacy endpoints (ITT) and showed statistically significant improvement versus placebo. Denifanstat demonstrated a favorable safety and tolerability profile: all related TEAEs were Grade 1–2, with no related Grade 3–4 TEAEs, SAEs, permanent discontinuations, or withdrawals. Phase III results were presented at EADV Congress on Sept 17, 2025. Ascletis holds exclusive Greater China rights via license from Sagimet (Nasdaq: SGMT).
Ascletis (HKEX:1672) ha completato una consultazione pre-NDA con la NMPA cinese per denifanstat (ASC40) per l’acne vulgaris moderata-severa, avviata nel giugno 2025 e completata nell’ottobre 2025, e prevede di presentare a breve un NDA.
Ascletis ha completato gli studi di Fase II (NCT05104125) e di Fase III (NCT06192264); la Fase III ha soddisfatto tutti gli endpoints primari, secondari chiave e secondari di efficacia (ITT) e ha mostrato un miglioramento statisticamente significativo rispetto al placebo. Denifanstat ha dimostrato un profilo di sicurezza e tollerabilità favorevole: tutti i TEAE correlati erano di grado 1–2, senza TEAE correlati di grado 3–4, SAEs, interruzioni permanenti o ritiri. I risultati della Fase III sono stati presentati al Congresso EADV il 17 settembre 2025. Ascletis detiene diritti esclusivi per la Greater China tramite licenza da Sagimet (Nasdaq: SGMT).
Ascletis (HKEX:1672) completó una consulta pre-NDA con la NMPA de China para denifanstat (ASC40) para el acné vulgar moderado a severo, iniciada en junio de 2025 y completada en octubre de 2025, y planea presentar un NDA próximamente.
Ascletis completó los estudios de Fase II (NCT05104125) y Fase III (NCT06192264); la Fase III alcanzó todos los endpoints primarios, secundarios clave y secundarios de eficacia (ITT) y mostró una mejora estadísticamente significativa frente al placebo. Denifanstat demostró un perfil de seguridad y tolerabilidad favorable: todos los TEAE relacionados fueron Grado 1–2, sin TEAEs relacionados de Grado 3–4, SAEs, discontinuaciones permanentes ni retiros. Los resultados de la Fase III se presentaron en el Congreso EADV el 17 de septiembre de 2025. Ascletis posee derechos exclusivos de Gran China a través de una licencia de Sagimet (Nasdaq: SGMT).
Ascletis (HKEX:1672)은 denifanstat (ASC40)를 위한 중국 NMPA와의 NDA 사전 상담을 완료했습니다. 중등도~중증 여드름(vulgaris)으로, 2025년 6월에 시작하여 2025년 10월에 완료되었으며, 곧 NDA를 제출할 계획입니다.
Ascletis는 2상(NCT05104125)과 3상(NCT06192264) 연구를 완료했습니다; 3상은 주요 1차 및 주요 2차 및 2차 유효성 평가 지점(ITT)에서 모두 성공했고 위약 대비 통계적으로 유의한 개선을 보였습니다. Denifanstat은 안전성과 내약성 프로필이 우수함을 보였습니다: 관련 TEAE는 모두 1–2등급이었고, 관련 3–4등급 TEAE, SAEs, 영구 중단 또는 이탈은 없었습니다. 3상 결과는 2025년 9월 17일에 EADV 학회에서 발표되었습니다. Ascletis는 Sagimet(나스닥: SGMT)로부터 중국 전역의 권리를 독점적으로 보유합니다.
Ascletis (HKEX:1672) a terminé une consultation pré-NDA avec la NMPA chinoise pour denifanstat (ASC40) pour l’acné vulgaris modérée à sévère, initiée en juin 2025 et terminée en octobre 2025, et prévoit de soumettre un NDA prochainement.
Ascletis a complété les études de Phase II (NCT05104125) et de Phase III (NCT06192264); la Phase III a atteint tous les endpoints primaires, secondaires clés et secondaires d’efficacité (ITT) et a montré une amélioration statistiquement significative par rapport au placebo. Denifanstat a démontré un profil de sécurité et de tolérance favorable: tous les TEAE liés étaient de Grade 1–2, sans TEAE liés de Grade 3–4, AEs graves, arrêt définitif ou retraits. Les résultats de la Phase III ont été présentés au congrès EADV le 17 septembre 2025. Ascletis détient les droits exclusifs pour la Grande Chine par le biais d’une licence de Sagimet (Nasdaq: SGMT).
Ascletis (HKEX:1672) hat eine vor-NDA-Beratung mit der chinesischen NMPA für denifanstat (ASC40) zur Behandlung von moderatem bis schwerem Aknen Vulgaris abgeschlossen, die im Juni 2025 begann und im Oktober 2025 abgeschlossen wurde, und plant, bald einen NDA einzureichen.
Ascletis hat Phase II (NCT05104125) und Phase III (NCT06192264) Studien abgeschlossen; Phase III erreichte alle primären, wichtige sekundäre und sekundäre Wirksamkeitsendpunkte (ITT) und zeigte eine statistisch signifikante Verbesserung gegenüber Placebo. Denifanstat zeigte ein vorteilhaftes Sicherheits- und Verträglichkeitsprofil: alle damit verbundenen TEAEs waren Grade 1–2, ohne verwandte TEAEs der Grade 3–4, SAEs, dauerhafte Abbrüche oder Rückzüge. Die Ergebnisse der Phase III wurden auf dem EADV-Kongress am 17. September 2025 vorgestellt. Ascletis hält exklusive Rechte für Greater China über eine Lizenz von Sagimet (Nasdaq: SGMT).
Ascletis (HKEX:1672) أكملت استشارة قبل الـNDA مع NMPA الصينية لـ denifanstat (ASC40) لعلاج حب الشباب العقدي من المتوسط إلى الشديد، بدأت في يونيو 2025 وانتهت في أكتوبر 2025، وتخطط لتقديم NDA قريباً.
أكملت Ascletis دراسات المرحلة II (NCT05104125) والمرحلة III (NCT06192264); حققت المرحلة الثالثة جميع نقاط النهاية الأولية والثانوية الرئيسية والثانوية للفعالية (ITT) وظهر تحسن ذي دلالة إحصائية مقارنة بالدواء الوهمي. أظهر Denifanstat ملف أمان وتحمل مفضل: كانت جميع TEAEs المرتبطة من الدرجة 1–2، بدون TEAEs ذات الدرجة 3–4 المرتبطة، ولا حوادث خطيرة، ولا توقفات دائمة، ولا انسحابات. تم عرض نتائج المرحلة III في مؤتمر EADV في 17 سبتمبر 2025. تحتفظ Ascletis بحقوق حصرية للمنطقة الكبرى في الصين عبر ترخيص من Sagimet (Nasdaq: SGMT).
Ascletis (HKEX:1672) 完成了与中国药监局（NMPA）的 NDA 之前咨询，针对 denifanstat (ASC40) 用于中到重度痤疮丙型（acne vulgaris），该计划于 2025 年 6 月启动，2025 年 10 月完成，计划不久提交 NDA。
Ascletis 完成了 Phase II（NCT05104125）和 Phase III（NCT06192264）研究；Phase III 达到了 所有主要终点、关键次要终点和次要终点（ITT），相对于安慰剂显示统计学显著的改善。Denifanstat 展示了 良好的安全性和耐受性特征：所有相关 TEAEs 均为 1–2 级，未出现 3–4 级相关 TEAEs、严重不良事件（SAEs）、永久停药或退出。Phase III 的结果在 EADV 大会于 2025-09-17 披露。Ascletis 通过 Sagimet 的许可在大中华区享有独家权利（纳斯达克：SGMT）。
- Phase III met all primary and key secondary endpoints (ITT)
- Favorable safety: only Grade 1–2 related TEAEs; no related Grade 3–4 TEAEs or SAEs
- Completed pre-NDA consultation with China NMPA (June–Oct 2025); NDA planned soon
- Exclusive Greater China license from Sagimet (Nasdaq: SGMT)
- NDA not yet submitted; regulatory approval remains pending
- No numeric efficacy or complete statistical data disclosed in the announcement
Insights
Positive Phase III results and completion of pre-NDA consultation support an imminent NDA filing in China.
Ascletis completed a pre-NDA consultation with the NMPA from
The regulatory path now depends on the NDA dossier content and the NMPA review process; the consultation completion is a procedural milestone but not an approval. Important monitorable items include the formal NDA submission date, NMPA acceptance/clock start, and any reported review outcomes; expect those updates to appear after the planned filing.
- 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 Phase III randomized, double-blind, placebo-controlled, multicenter clinical trial.
Ascletis has completed the Phase II (NCT05104125) and Phase III (NCT06192264) studies of denifanstat (ASC40) for the treatment of moderate-to-severe acne vulgaris.
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.
The Phase III study results were presented as an oral presentation at the European Academy of Dermatology and Venereology (EADV) Congress 2025 in
Ascletis licensed denifanstat (ASC40) from Sagimet Biosciences Inc. (Nasdaq: SGMT) for exclusive rights in
About Ascletis Pharma Inc.
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, Ascletis has developed multiple drug candidates in-house, including 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. Ascletis is listed on the Hong Kong Stock Exchange (1672.HK).
For more information, please visit www.ascletis.com.
Contact：
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SOURCE Ascletis Pharma Inc.
FAQ
What did Ascletis announce about denifanstat (ASC40) on October 14, 2025?
Did denifanstat (ASC40) meet Phase III endpoints in Ascletis' NCT06192264 study?
What safety profile did Ascletis report for denifanstat (ASC40) in the Phase III trial?
When were Ascletis' Phase III results for ASC40 presented and where?
What regulatory step did Ascletis complete before filing an NDA for ASC40?
Who holds commercial rights for denifanstat (ASC40) in Greater China?
