HEC Pharm USA, Inc.
Company overview. HEC Pharm USA, Inc. is the U.S. subsidiary of HEC Pharm Co., Ltd., the pharmaceutical arm of China's HEC Group (Guangdong HEC Technology Holding Co., Ltd., listed on the Shanghai Stock Exchange, 600673.SH). It is a private, wholly owned U.S. affiliate, incorporated in New Jersey around 2010–2011, with its principal U.S. place of business in Princeton/Plainsboro, New Jersey per court filings and state drug-licensing records. Public directory data on the U.S. entity is thin and inconsistent — D&B lists roughly 2 employees and about $233K in revenue, which appears to capture only a small registered presence; the Chinese parent group states it employs more than 20,000 people across its businesses, and the HEC Pharm group is estimated at 2,000–5,000 employees with revenues in the $500M–$1B range.
Products / operations. HEC Pharm USA functions as the U.S. regulatory, distribution, and commercialization arm for its parent, which researches, develops, and manufactures active pharmaceutical ingredients (notably macrolide antibiotics and antivirals via bio-fermentation) and finished generic dosage forms in China. Per Novartis's complaint, HEC Pharm USA "develops, manufactures, and/or distributes generic drug products" for the U.S. market in concert with HEC Pharm Co., Ltd.; it holds state manufacturer and drug-distributor licenses. Its key U.S. product effort has been ANDA No. 207939 for generic fingolimod 0.5 mg capsules, a copy of Novartis's multiple-sclerosis drug Gilenya®.
Patent-litigation posture. HEC Pharm USA is an operating company — a generic-drug defendant, not a non-practicing entity. Its sole tracked case is as a defendant: Novartis Pharmaceuticals Corporation v. HEC Pharm Co., Ltd. et al. (D. Del., filed 2020-01-28), part of a longer Hatch-Waxman (ANDA) dispute. The District of Delaware venue is standard for such brand-vs.-generic litigation.
Notable context. The 2020 suit concerns a Novartis method-of-treatment patent (U.S. 10,543,179) involving VZV screening and vaccination before fingolimod dosing, and follows earlier Gilenya litigation (e.g., C.A. No. 18-1043, where a 2020 Delaware bench trial found HEC liable and permanently enjoined its generic until the '405 patent expires in December 2027). FDA granted HEC's ANDA final approval in December 2019 (later converted to tentative approval), and HEC reportedly launched its generic in late 2022 while the patent disputes continued.