Haimen Pharma Inc. is a pharmaceutical manufacturing company located in Haimen City, Jiangsu Province, China. It operates as a wholly-owned subsidiary and the primary manufacturing facility for Sinotherapeutics Inc., a specialty pharmaceutical company founded in 2012 with headquarters in Shanghai. Sinotherapeutics acquired Haimen Pharma to serve as its production base for oral solid dosage forms. The Haimen facility spans approximately 55,000 square meters and includes workshops for standard oral solids, oncology products, and nutritional products. It has passed inspections by the U.S. Food and Drug Administration (FDA) and other international regulatory bodies.
As the manufacturing arm of Sinotherapeutics, Haimen Pharma produces complex generic drugs and innovative formulation products for global markets. The company's product focus areas include oncology, infectious diseases, neurology, cardiology, and metabolism. FDA records indicate that Haimen Pharma has manufactured multiple generic drugs for the U.S. market. The facility is equipped for various stages of production, from development and validation batches to full-scale commercial manufacturing.
Haimen Pharma's patent litigation posture is that of an operating company defending its products. The company has been tracked as a defendant in one U.S. patent case and has not appeared as a plaintiff. This aligns with its business as a generic drug manufacturer, which often faces patent challenges from brand-name pharmaceutical companies under the Hatch-Waxman Act.
The single tracked case is Astellas Pharma Inc. et al. v. Haimen Pharma Inc. et al., filed in the U.S. District Court for the District of New Jersey. The lawsuit, initiated in late 2025, concerned Haimen Pharma's attempt to market a generic version of Xtandi® (enzalutamide), a blockbuster prostate cancer treatment developed by Astellas. The case was dismissed with prejudice in early 2026.