Ascletis Announces China National Medical Products Administration Acceptance of New Drug Application for Denifanstat (ASC40), a First-in-Class FASN Inhibitor for Acne Treatment

Rhea-AI Summary

Ascletis (HKEX:1672) announced on December 10, 2025 that the China National Medical Products Administration (NMPA) accepted its New Drug Application for denifanstat (ASC40), a once-daily oral FASN inhibitor for moderate-to-severe acne vulgaris.

The company said denifanstat completed Phase II (NCT05104125) and Phase III (NCT06192264) studies, and in Phase III met all primary, key secondary and secondary efficacy endpoints (ITT analysis) versus placebo with a favorable safety profile and no related Grade 3/4 adverse events or related serious adverse events. The Phase III results were presented at EADV on September 17, 2025. Ascletis holds exclusive Greater China rights under a license from Sagimet Biosciences (Nasdaq: SGMT).

Positive

• NMPA NDA acceptance on December 10, 2025
• Phase III met all primary and secondary endpoints (ITT analysis)
• Favorable safety: no related Grade 3/4 TEAEs or related SAEs
• Exclusive Greater China license from Sagimet (SGMT)

Negative

• NDA acceptance is not regulatory approval; final NMPA decision pending
• No commercialization date or regulatory timeline disclosed

Key Figures

Phase II trial Phase II Completed denifanstat acne study in China prior to Phase III

Phase III trial Phase III Randomized trial supporting China NMPA NDA acceptance for acne

EADV presentation date September 17, 2025 Phase III acne results presented at EADV Congress 2025

NDA acceptance date Dec. 10, 2025 China NMPA accepted denifanstat NDA for moderate-to-severe acne

Market Reality Check

$6.28 Last Close

Volume Volume 382,057 is about 0.7x the 20-day average 549,290, suggesting no pre-news volume spike. normal

Technical Price $6.28 sits just above the 200-day MA at $6.21, indicating a neutral-to-slightly-positive long-term trend pre-announcement.

Peers on Argus

Peers in Biotechnology showed mixed moves: SLN -9.88%, ACIU -9.61%, NMRA -6.11%, PRQR +8.92%, THRD -0.55%, pointing to stock-specific drivers for SGMT.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Nov 20	Investor conference	Neutral	-7.4%	Participation in Evercore ISI healthcare conference and fireside chat webcast.
Nov 13	Earnings update	Neutral	-12.2%	Q3 2025 financials and pipeline update including acne and MASH programs.
Nov 10	Clinical liver data	Positive	+10.8%	FASCINATE-2 Phase 2b secondary analyses showing strong fibrosis regression vs placebo.
Oct 24	Acne Phase 3 data	Positive	+24.7%	China acne Phase 3 trial met all endpoints with 480 patients over 12 weeks.
Oct 14	Investor conferences	Neutral	-1.2%	Planned participation in multiple healthcare investor conferences with webcasts.

Pattern Detected

Positive denifanstat clinical updates, especially acne Phase 3 data, have previously aligned with strong upside moves, while neutral conference and corporate updates saw modest declines.

Recent Company History

Over the last few months, SGMT has highlighted denifanstat’s progress across liver disease and acne, alongside steady investor outreach. On Oct 24, positive China acne Phase 3 data drove a +24.69% move, while earlier EADV disclosures and pre‑NDA updates in September–October prompted limited price changes. Earnings on Nov 13 and conference appearances in late 2025 were followed by pullbacks, contrasting with the strong reaction to high‑impact clinical efficacy data.

Market Pulse Summary

This announcement confirms China NMPA acceptance of the denifanstat NDA for moderate-to-severe acne, advancing the program beyond prior Phase 3 success in a 480‑patient trial. Earlier updates showed consistent efficacy and tolerability, and Ascletis holds Greater China rights under license from SGMT. Investors may watch for regulatory review progress, commercialization arrangements in China, and how this ex‑China validation supports Sagimet’s broader FASN franchise.

Key Terms

new drug application regulatory

"its New Drug Application (NDA) for denifanstat (ASC40)...has been accepted"

A new drug application is a formal request submitted to government regulators seeking approval to market a new medicine. It is like a detailed proposal that shows the drug has been tested for safety and effectiveness. For investors, receiving approval signals that the drug may soon become available for sale, potentially leading to revenue growth and impacting the company's value.

treatment-emergent adverse events medical

"All denifanstat (ASC40)-related treatment-emergent adverse events (TEAEs) were mild"

Events or symptoms that either appear for the first time or get worse after a patient starts a treatment; think of new or intensified side effects that show up once medicine or a medical device is used. Investors watch these closely because they affect whether a therapy can gain regulatory approval, be prescribed widely, or face legal and commercial setbacks—similar to how early customer complaints can sink a new product’s prospects.

serious adverse events medical

"no denifanstat (ASC40)-related serious adverse events (SAEs)"

Serious adverse events are significant problems or negative outcomes that occur during a medical treatment or clinical trial, such as severe side effects, hospitalizations, or life-threatening conditions. They matter to investors because such events can impact a company's reputation, lead to regulatory scrutiny, or delay the development of new products, ultimately affecting the company’s financial performance.

randomized, double-blind, placebo-controlled medical

"compared with placebo in a randomized, double-blind, placebo-controlled, multicenter Phase III"

A "randomized, double-blind, placebo-controlled" process is a method used to test the effectiveness of a new treatment or intervention. Participants are randomly assigned to different groups, with one receiving the real treatment and the other a fake version, called a placebo. Neither the participants nor the researchers know who is receiving which, which helps ensure unbiased results. For investors, this rigorous approach increases confidence that the findings are accurate and not influenced by guesswork or bias.

AI-generated analysis. Not financial advice.

-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.

HONG KONG, Dec. 10, 2025 /PRNewswire/ -- Ascletis 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).

"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, Ph.D., Founder, Chairman and CEO of Ascletis, "We are excited denifanstat (ASC40) is only one step away from the commercialization."

Ascletis has completed 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 Paris, France on September 17, 2025 (link).

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.

Ascletis licensed denifanstat (ASC40) from Sagimet Biosciences Inc. (Nasdaq: SGMT) for exclusive rights in Greater China.

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 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).

For more information, please visit www.ascletis.com.

Contact：

Peter Vozzo
ICR Healthcare
443-231-0505 (U.S.)
Peter.vozzo@icrhealthcare.com 

Ascletis Pharma Inc. PR and IR teams
+86-181-0650-9129 (China)
pr@ascletis.com
ir@ascletis.com 

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SOURCE Ascletis Pharma Inc.

FAQ

What did Ascletis announce about denifanstat (ASC40) on December 10, 2025?

Ascletis said the NMPA accepted the New Drug Application for denifanstat (ASC40) for moderate-to-severe acne.

What Phase III evidence supports ASC40 for acne (Ascletis, SGMT license)?

The Phase III (NCT06192264) reportedly met all primary and secondary endpoints (ITT analysis) and showed a favorable safety profile.

When were Ascletis Phase III results for denifanstat presented?

Phase III results were presented at EADV on September 17, 2025.

Does NMPA acceptance mean denifanstat (ASC40) is approved in China?

No; NMPA acceptance starts the review process but does not equal final approval.

What safety findings did Ascletis report for denifanstat in Phase III?

Ascletis reported all related TEAEs were Grade 1–2, with no related Grade 3/4 TEAEs, no related SAEs, and no related permanent discontinuations.

Which company holds rights for denifanstat in Greater China and what is the stock symbol?

Ascletis licensed denifanstat from Sagimet Biosciences, which trades as SGMT, for exclusive Greater China rights.