Huateng Pharma Expands Support for Aficamten API Manufacture with High-Quality Intermediate Supply

Hunan Huateng Pharmaceutical Co., Ltd. (“Huateng Pharma”) is pleased to announce the offering of 1-Methyl-1H-Pyrazole-4-Carboxylic Acid (CAS No. 5952-92-1), a critical intermediate in the patented process to prepare Aficamten (CK-274). Aficamten is an investigational oral small-molecule cardiac myosin inhibitor now in Phase 3 clinical trials for both obstructive and non-obstructive hypertrophic cardiomyopathy (HCM).

Key Facts about Aficamten & Clinical Progress

l Aficamten is currently being evaluated in several Phase 3 trials, including SEQUOIA-HCM (obstructive HCM), ACACIA-HCM (non-obstructive HCM), and others exploring pediatric settings and long-term safety.

l In SEQUOIA-HCM, aficamten demonstrated significant improvements in exercise capacity, symptoms, and left ventricular outflow tract (LVOT) gradient in oHCM patients compared to placebo.

l The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for aficamten for symptomatic HCM, and the New Drug Application (NDA) is under review with a target action date of December 26, 2025. Applications are also with regulatory authorities in China and Europe.

“As Aficamten moves toward regulatory approval, Huateng Pharma is ready to provide 1-Methyl-1H-Pyrazole-4-Carboxylic Acid at high purity and in scalable quantities—from grams for R&D to multi-kilogram or commercial-scale batches,” said Brenda Xie, Sales Manager at Huateng Pharma.“We believe reliable supply of such intermediates is fundamental to accelerate drug development and ensure smooth transition into commercialization.”

About Huateng Pharma

Hunan Huateng Pharmaceutical Co., Ltd. specializes in the manufacture and supply of pharmaceutical intermediates, PEG derivatives, and custom CDMO services. With robust process development and quality systems, the company supports global innovators from early discovery, through scale-up, to commercial production.

Media Contact

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