Sagimet Biosciences Inc. (NASDAQ: SGMT) received formal acceptance of its New Drug Application for denifanstat (ASC40) from China’s National Medical Products Administration on December 10, 2025. The acceptance clears a major regulatory hurdle and allows the company’s exclusive license partner, Ascletis, to advance commercialization plans for the acne indication in the Greater China market.
The acceptance follows a successful Phase III trial conducted in China that met all primary and secondary endpoints. The study enrolled 1,200 patients with moderate‑to‑severe acne and demonstrated a statistically significant reduction in lesion counts compared with placebo, while maintaining a favorable safety profile with no new or serious adverse events reported. The data confirm denifanstat’s first‑in‑class fatty‑acid‑synthase inhibition mechanism and support its potential to address a large unmet need in the acne market.
Under the licensing agreement, Ascletis will handle all regulatory, manufacturing, and commercial activities in China, while Sagimet retains global rights to the drug for other indications, including metabolic dysfunction‑associated steatohepatitis (MASH). The partnership leverages Ascletis’ established distribution network and regulatory experience, positioning Sagimet to capture market share quickly once final approval is obtained. The deal also preserves Sagimet’s ability to pursue denifanstat in the U.S. and other regions, where the company has already secured FDA Breakthrough Therapy designation for MASH.
Financially, Sagimet reported a net loss of $12.91 million for Q3 2025, a decline from the $9.73 million loss in Q2 2025, reflecting increased R&D spend on its acne and MASH programs. Cash, cash equivalents, and marketable securities stood at $125.5 million as of September 30, 2025, providing a runway to support ongoing clinical milestones through 2026. The company’s pipeline includes a Phase 1 study of a denifanstat‑resmetirom combination for MASH, with data expected in the first half of 2026.
CEO David Happel emphasized the company’s confidence in the FASN inhibitor platform, stating, “We remain strongly convinced of the significant therapeutic potential associated with FASN inhibition across multiple disease states.” Analysts continue to view Sagimet’s pipeline favorably, with a consensus “Strong Buy” rating and an average price target around $29.75, reflecting optimism about the company’s ability to translate clinical success into commercial revenue.
Historically, positive clinical data and regulatory milestones for denifanstat have driven investor enthusiasm. While the NMPA acceptance itself does not yet translate into revenue, it is a critical step toward market entry and is expected to strengthen Sagimet’s competitive positioning in the acne and MASH markets.
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