- Business
- Hainan Poly Pharm. Co., Ltd. (300630.SZ) engages in the research, development, registration, production, and sale of active pharmaceutical ingredients (APIs), excipients, and finished dosage formulations for domestic Chinese and international markets. The company manufactures a broad portfolio of products including generic injectables such as dobutamine hydrochloride, esomeprazole, ganciclovir sodium, pantoprazole sodium, sodium nitroprusside, and eptifibatide; oral solid formulations encompassing tablets, capsules, and granules like desloratadine dry suspension (Novodine), memantine hydrochloride, and oxybutynin; sterile preparations comprising pre-filled syringes, lyophilized powders, eye drops, ointments, and oral liquids; as well as APIs including acyclovir sodium, trimebutine maleate salt, and amiodarone hydrochloride, alongside contract development and manufacturing organization (CDMO) services covering raw materials, chemical and biological agents, contrast agents, and anti-tumor products with capabilities in hydrogenation, oxidation, and spray lyophilization drying. Founded in 1992 and headquartered in Haikou, Hainan Province, China, the company operates manufacturing facilities in Haikou, Hangzhou (Zhejiang), and Anqing (Anhui), with production lines compliant with cGMP standards certified by China NMPA, US FDA, EU EMA, and WHO, serving over 1,000 hospitals in China and exporting to more than 30 countries including the US, Germany, France, UK, Canada, Australia, and Southeast Asia.
In recent developments, Hainan Poly Pharm deepened its strategic CDMO partnership with US-based Imunon, Inc. in 2024 to develop and commercialize IMNN-001, a novel nanoparticle-based IL-12 immunotherapy for ovarian cancer, following successful Phase II clinical trial results showing improved overall survival by up to 15.7 months and progression-free survival by 3 months compared to standard treatments; the company provides process optimization, clinical samples, and future commercial production, with plans for Chinese market entry via Hainan Boao Lecheng International Medical Tourism Pioneer Zone. The company's injection and raw material workshops received renewed US FDA certification, while subsidiaries Zhejiang Poly Pharm's eye drop facility met Chinese, US, and EU GMP standards, and Anhui Poly Pharm launched magnesium hydroxide API with 200-ton annual capacity; additionally, azithromycin injection gained Israeli market approval. Hainan Poly Pharm participated in the 2024 DCAT Week and CPHI 2023 events to expand global CDMO/CMO collaborations, maintaining its focus on generics, antibiotics, antipyretics, analgesics, and innovative immunotherapy support amid ongoing regulatory compliance and export growth.