Qilu Pharma, Inc.

I'll research this company before writing the profile.

Let me verify the U.S. affiliate and ownership status.

Qilu Pharma, Inc. is the U.S. affiliate of Qilu Pharmaceutical Co., Ltd., a Chinese generic-drug and API manufacturer. The U.S. entity is a Pennsylvania corporation whose principal office is at 101 Lindenwood Drive, Suite 225, Malvern, PA, with additional registered offices in Princeton, NJ; court filings and FDA correspondence describe it as the U.S. agent for its parent's abbreviated new drug applications (ANDAs). The parent, Qilu Pharmaceutical Co., Ltd. (founded 1992), is based in Jinan, Shandong, and is a subsidiary of privately held Qilu Pharmaceutical Group Co., Ltd., whose predecessor dates to 1958. The group is not publicly listed; ownership traces to the Li family. Qilu's own site reports roughly 38,000 employees worldwide; Chinese-language sources put group revenue at about RMB 35–38 billion (≈US$5B) for 2024–2025.

Operations. Qilu is a vertically integrated maker of active pharmaceutical ingredients and finished formulations across oncology, cardiovascular/cerebrovascular, anti-infectives, psychiatric/neurological, respiratory and ophthalmology. It reports ~300 marketed products spanning generics, biosimilars (China's first approved bevacizumab biosimilar, 2019) and newer innovative drugs, with exports to more than 100 countries and FDA-approved ANDAs for the U.S. market.

Litigation posture. Qilu Pharma is an operating-company defendant, not an NPE. The case data — 1 total case, 0 as plaintiff, 1 as defendant — fits a generic manufacturer defending Hatch-Waxman ANDA suits rather than a patent assertion entity. There is no Eastern District of Texas clustering; the tracked matter sits in the District of New Jersey, a standard paragraph IV venue.

Tracked case. Helsinn Healthcare S.A. et al. v. Qilu Pharmaceutical Co., Ltd. et al., D.N.J. No. 15-cv-08132 (filed Nov. 17, 2015), reported variously as 3:15-cv-08132 and 2:15-cv-08132. Helsinn and Roche Palo Alto sued over Qilu's paragraph IV ANDA 205648 for palonosetron hydrochloride injection (generic Aloxi), asserting Orange Book patents. The FDA's 2018 approval letter states the case was dismissed and that the ANDA was tentatively approved. Public dockets also show Qilu named in other U.S. ANDA suits (D.N.J., D. Del., E.D. Pa.) that do not appear in this database.