What is the expected timeline for regulatory filing and potential approval in China and other markets?

Regulatory timeline

• China: The Phase‑3 data for Denifanstat were just released (Q2 2025 results). In the Chinese drug‑approval pathway, a sponsor typically files a New Drug Application (NDA) within 30‑60 days after trial data are finalized and a regulatory dossier is assembled. Given that the trial was run by Ascletis—who has an established CDE (China’s National Medical Products Administration) submission process—we can expect the NDA filing to occur in Q4 2025 (November–December). If the NDA is filed on schedule, the NMPA’s standard review period for a Phase‑3‑backed dermatology indication is approximately 12‑18 months, meaning a potential Chinese market approval by mid‑2026 to early 2027 (assuming no major regulatory setbacks.

• Other markets (U.S./EU): Ascletis and Sagimet will likely pursue parallel filings in the U.S. (FDA) and EU (EMA). In the U.S., the company will need to submit an NDA to the FDA after the China filing, typically within 30 days of the Chinese NDA to keep the global development timeline aligned. The FDA’s standard review for a new acne drug is 10‑12 months (or 6 months under a priority review, which is unlikely for an acne indication). Consequently, U.S. approval could be expected in late 2026 to early 2027. The EMA’s centralized review takes about 9‑12 months, putting EU approval roughly in the same window.

Trading implications

The imminent filing window creates a short‑to‑mid‑term catalyst. If the company confirms a Q4‑2025 NDA submission in China, the stock could see a 5‑10 % rally on the news, especially given the 70 % sentiment boost from the Phase‑3 success. Traders should watch for: (1) a formal press release announcing the exact NDA filing date (likely in a 10‑K or press release in late November); (2) any early feedback from the NMPA’s “clinical trial data” review—positive remarks can accelerate the approval timeline. A break‑out above the recent high (≈$X.XX) on strong filing news may present a buying opportunity, while a failure to file on schedule could trigger a short‑term pullback. Maintaining a stop‑loss 4‑5 % below the breakout level would protect against the risk of regulatory delays.