
2001-11-30
Medium-sized
0 Inquired
0 Favorited
ConnectService Type:
T - Technology and Patent Services
Industry:
Pharmaceuticals and Chemical Intermediates
Country / Region:
China
Company Type:
Publicly listed company
Registered Capital:
RMB 60.96 million
Shandong Luoxin Pharmaceutical Group Co., Ltd. (Stock Code: 002793.SZ) is an integrated chemical pharmaceutical enterprise engaged in drug research and development, manufacturing, and marketing, focusing on major disease areas including gastrointestinal disorders, oncology, anti-infectives, respiratory diseases, and cardiovascular conditions. The Company’s core businesses encompass chemical active pharmaceutical ingredients (APIs), chemical finished dosage forms, biosimilars, and traditional Chinese medicine (TCM) preparations. Its key products include Lansoprazole for Injection (the first domestically approved product to pass consistency evaluation), Tegoprazan Tablets (China’s first approved potassium-competitive acid blocker), Ambroxol Hydrochloride Oral Solution (ranked No. 1 in retail pharmacy sales nationwide), Ceftriaxone Sodium for Injection, and Budesonide Suspension for Inhalation (LX-03), among others. Leveraging two national high-tech enterprises, one national enterprise technology center, one postdoctoral research workstation, and multiple provincial engineering technology research centers, the Company has undertaken ten national “Major New Drug Creation” Science and Technology Major Projects and received one Second Prize of the National Science and Technology Progress Award. As of the end of 2024, it holds 236 valid invention patents and has filed 32 PCT international patent applications; it has over 100 ongoing R&D projects, including LY01011, an innovative drug that has entered Phase II clinical trials. The Company operates integrated API and formulation manufacturing bases compliant with China’s Good Manufacturing Practice (GMP), U.S. FDA current GMP (cGMP), and European Directorate for the Quality of Medicines & HealthCare (EDQM) standards. Its three major production bases—Linyi, Hengxin, and Xiamen—have all obtained certification from China’s National Medical Products Administration (NMPA); certain workshops have also passed on-site inspections by the U.S. FDA. All production units are incorporated into China’s national drug traceability system, and the Company has achieved certification under ISO 9001, ISO 14001, and ISO 45001 management systems. Its products are distributed across all 31 provinces, autonomous regions, and municipalities directly under the Central Government of China, as well as Hong Kong and Macao, achieving over 85% coverage in primary healthcare institutions and over 70% coverage in Grade III hospitals. More than 20 products have obtained EDQM Certificates of a Suitability of Active Substance, FDA Drug Master File (DMF) registrations, or approvals from Korea’s Ministry of Food and Drug Safety (MFDS). In 2023, export revenue to Southeast Asia, the Middle East, Latin America, and other regions increased by 22.6% year-on-year. The Company offers diversified collaboration opportunities to domestic and international pharmaceutical enterprises, including technical cooperation, joint overseas regulatory registration support, customized development of APIs and formulations, generic drug consistency evaluation support, and collaborative clinical development of innovative drugs.
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