Where to Start

MASH is a widespread metabolic disease affecting a large patient population, yet drug treatment options are only just beginning to emerge. It is a common chronic progressive liver disease and a leading cause of cirrhosis and liver cancer. While treatment demand is urgent, the FDA has only approved two drugs for this condition, indicating a significant unmet clinical need. Since 2024, positive developments in MASH drug development have attracted numerous multinational corporations to compete for a position. It is expected that between the second half of 2026 and 2027, several major pipeline candidates will report core data, leading to rapid market expansion.

Why Just 10 ASX 200 Shares?

As the incidence of conditions like obesity, Type 2 Diabetes, and dyslipidemia rises, the number of global MASH patients approaches 400 million, with approximately 44 million in China. MASH, as a chronic progressive liver disease, is a primary cause of cirrhosis and liver cancer, creating a pressing therapeutic need. However, due to the complexity of MASH treatment, no drugs were approved for a long time. As of the first half of 2026, the FDA has only granted accelerated approval for Resmetiron (2024) and Semaglutide (2025) for treating F2-F3 MASH. No drugs for MASLD or MASH have been approved for marketing in China. The clinical demand for MASH treatment is strong, but available medications remain limited.

The Path Forward

Anti-inflammatory effects, fibrosis improvement, and lipid metabolism regulation are the core objectives of MASH drug development. The THR-β and GLP-1R targets have been validated for efficacy by directly targeting the liver and regulating systemic metabolism. Future focus should be on the differentiated advantages of GLP-1R+, FGF21, PPARs, Pan-PDE, and small nucleic acid therapies in improving efficacy and safety. 1) FGF21: Shows outstanding ability to reverse fibrosis. MNCs like Novo Nordisk, GSK, and Roche are competing to develop it, with potential to reverse F4 fibrosis, though its adverse event profile requires attention. 2) GLP-1R+: Semaglutide has successfully proven the efficacy of GLP-1RAs in treating F2-F3 MASH. Dual and triple agonists combining GIP/GCGR, including Tirzepatide, Survodutide, and Retatrutide, show even better anti-inflammatory and fibrosis-improving effects, making GLP-1R+ a potential foundational drug for combination therapy. 3) PPARs: Act on both intrahepatic and extrahepatic targets through multiple pathways to treat MASH. Adverse events like weight gain and peripheral edema should be monitored. 4) Small Nucleic Acids: Directly intervene in disease progression at the genetic level. With mature liver-targeted delivery technology, they represent an important direction for precision MASH treatment. Targets such as DGAT2, 17β-HSD13, PNPLA3, CIDEB, and MARC1 are now in clinical stages.

Key Catalyst Period

Resmetiron, the first MASH drug approved by the FDA, has seen rapid sales growth since its launch in February 2024, reaching $960 million in 2025. Several other major pipeline candidates will read out core data soon, providing a new boost to the MASH treatment market. 1) Resmetiron's Phase 3 MAESTRO-NASHOUTCOMES trial for the F4c MASH indication will report data in 2027, and if approved as the first drug for F4c MASH, its market potential could double. 2) Pegozafermin, developed by Roche/89 bio, is expected to report top-line histological data for F2-F3 MASH and F4 MASH in the first half of 2027 and 2028, respectively. 3) Efruxifermin, developed by Novo Nordisk/Akero, will report Phase 3 SYNCHRONY REAL-WORLD data in the fourth quarter of 2026 and SYNCHRONY HISTOLOGY data in 2027. 4) Lanifibranor, a pan-PPARs agonist developed by Inventiva, is expected to report top-line Phase 3 data in the fourth quarter of 2026 and submit an NDA in the first half of 2027.

Risk Factors

Risks include research and development failure, policy changes, market promotion challenges, increasing competition, and technological iteration.