Peptide News Digest

#Madrigal-Pharmaceuticals

3 stories

Regulatory · View digest

Hengrui Pharma Disclosed Saturday August 22, 2026 That China's Center for Drug Evaluation (CDE) Granted Implied License for HRS-4729 in Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD) and Hepatitis, Extending Hengrui's Cardiometabolic Pipeline Beyond Its Existing Ribupatide (GLP-1/GIP Dual Agonist Licensed Ex-China to Kailera Therapeutics, in Global Phase 3) Into the Growing MASH Commercial Category That Is Anchored Commercially by Madrigal Pharmaceuticals' Rezdiffra (Resmetirom, First MASH Drug Approved March 2024) and Novo Nordisk's Wegovy (Semaglutide 2.4 mg, First GLP-1 Receptor Agonist Approved for MASH in August 2025); The Hengrui CDE Implied License Provides Approval to Initiate Human Clinical Trials in China Under a Simplified Regulatory Pathway

Hengrui Pharma disclosed Saturday August 22, 2026 that China's Center for Drug Evaluation (CDE) granted implied license for HRS-4729 in metabolic dysfunction-associated fatty liver disease (MAFLD) and hepatitis. The CDE implied license is a Chinese regulatory instrument that provides approval to initiate human clinical trials in China under a simplified pathway (similar in function to a US Investigational New Drug application, though procedurally different). Kailera, which licensed the drug outside Greater China as KAI-4729, described it in its August 12, 2026 results as a once-weekly injectable GLP-1/GIP/glucagon receptor tri-agonist. The disclosure extends Hengrui's cardiometabolic pipeline beyond its existing ribupatide (once-weekly injectable GLP-1/GIP dual agonist licensed ex-China to Kailera Therapeutics and in the global Phase 3 KaiNETIC program) into the growing MASH commercial category. MASH commercial market context: the category is anchored by Madrigal Pharmaceuticals' Rezdiffra (resmetirom, a thyroid hormone receptor beta agonist and the first FDA-approved MASH drug, approved March 2024) and Novo Nordisk's Wegovy (semaglutide 2.4 mg received FDA accelerated approval for non-cirrhotic MASH with moderate-to-advanced fibrosis in August 2025). The Hengrui advance into MAFLD/hepatitis positions the company for a potential fourth cardiometabolic franchise beyond obesity, type 2 diabetes, and cardiovascular disease.

Clinical Trials · View digest

Madrigal Rezdiffra EASL 2026 Day 1 Eight-Poster Data Drop (May 27): Cardiovascular Lp(a)/LDL-C/ApoB Reductions + ANTICIPATE-NASH Portal Hypertension Risk Score Improvement in Compensated F4c MASH Cirrhosis

Madrigal Pharmaceuticals delivered eight Rezdiffra (resmetirom) poster presentations at EASL 2026 today. Key data: secondary analysis of MAESTRO-NASH and MAESTRO-NAFLD-1 documented Rezdiffra-driven improvements in cardiovascular lipid risk markers (Lp(a), LDL-C, ApoB); a two-year analysis in patients with compensated MASH cirrhosis (F4c) showed meaningful improvement in ANTICIPATE-NASH risk scores, a validated marker for clinically significant portal hypertension. Real-world effectiveness analyses and noninvasive biomarker plus machine-learning models for predicting MASH and fibrosis improvement rounded out the presentation slate. Rezdiffra (resmetirom) — a thyroid hormone receptor β agonist small molecule, not a peptide — was approved March 2024 as the first FDA-approved MASH therapy for noncirrhotic MASH with F2-F3 fibrosis. The compensated MASH cirrhosis (F4c) data extend the case toward an indication where the GLP-1/glucagon peptide programs (pemvidutide IMPACT, survodutide SYNCHRONIZE-1, retatrutide MASLD Phase 3) are also competing.

Industry · View digest

Madrigal Rezdiffra EASL 2026 (May 20 Announcement): Cardiovascular and Portal Hypertension Risk Marker Data from MAESTRO-NASH + MAESTRO-NAFLD-1 Secondary Analyses

Madrigal Pharmaceuticals announced May 20 that multiple abstracts from its Rezdiffra (resmetirom) development and real-world evidence programs will be presented at EASL 2026 in Barcelona. Headline analyses include cardiovascular risk markers — secondary analysis of Phase 3 MAESTRO-NASH and MAESTRO-NAFLD-1 examining improvements in Lp(a), LDL-C, and ApoB — and portal hypertension risk improvement in compensated MASH cirrhosis (F4c) measured by ANTICIPATE-NASH risk scores. Real-world evidence and noninvasive biomarker analyses round out the slate. Rezdiffra (a thyroid hormone receptor β agonist, not a peptide) was approved March 2024 as the first FDA-approved MASH therapy for noncirrhotic MASH with F2-F3 fibrosis. The EASL data extend the case toward compensated MASH cirrhosis and cardiovascular outcomes — a competitive context for the GLP-1/glucagon peptide programs (semaglutide ESSENCE, pemvidutide IMPACT, survodutide SYNCHRONIZE-1, retatrutide MASLD Phase 3) running on parallel tracks.