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TSL2402 (also known as CMI2402) is an oral fixed-dose combination tablet containing silybin and carvedilol, developed by Tasly Pharmaceutical Group in collaboration with China Pharmaceutical University. It is designed as a Class 2.3 Modified New Combination Pharmaceutical for the treatment of primary biliary cholangitis (PBC) in patients with Scheuer stage S2 or higher liver fibrosis who can tolerate ursodeoxycholic acid (UDCA) baseline treatment. Silybin, a natural hepatoprotective compound, and carvedilol, a non-selective beta-blocker, act synergistically to inhibit hepatic stellate cell (HSC) activation and reduce excessive collagen deposition. Mechanistically, the combination targets the Wnt/β-catenin signaling pathway, specifically down-regulating the Wnt ligand Wnt4, to alleviate liver fibrosis. TSL2402 received clinical trial approval from China's National Medical Products Administration (NMPA) in August 2026.
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