广州博济医药生物技术股份有限公司

About 广州博济医药生物技术股份有限公司

Founded in 2002 and listed on the Shenzhen Stock Exchange in 2015 (stock code 300404), Guangzhou Bio-Gene Pharmaceutical Co., Ltd. (Bio-Gene Pharma) is a novel high-tech enterprise (CRO+CDMO) providing comprehensive "one-stop" outsourcing services for the research and production of drugs, medical devices, and health supplements for domestic and international pharmaceutical companies. Headquartered in Guangzhou's Tianhe District Smart City, the company occupies nearly 3,000 square meters of modern office space and employs nearly 700 experienced, knowledgeable, and agile senior pharmaceutical research talents and regulatory experts. Bio-Gene Pharma operates nine wholly-owned subsidiaries specializing in different business areas and holds stakes in over ten other companies. Bio-Gene Pharma's "one-stop" services encompass the entire drug development lifecycle, including new drug project establishment and activity screening, pharmaceutical research (APIs, formulations), drug evaluation (pharmacology, toxicology), clinical research, dual US-China registration services, CDMO manufacturing (MAH implementation), and technology transfer. Clinical research is a core business, covering registration studies and post-marketing evaluations for drugs, medical devices, health supplements, and special medical foods, with particular expertise in innovative drugs and medical devices. Services include clinical study protocol writing, clinical monitoring, SMO (CRC services), data management and statistical analysis, BE testing, subject recruitment, and third-party audits, covering nearly all therapeutic areas. In addition to its headquarters, the company has clinical research subsidiaries in Beijing, Shanghai, and Nanjing, with nearly 40 clinical monitoring sites nationwide. The pharmaceutical research division boasts an excellent R&D team and a comprehensive CNAS quality assurance system, offering R&D services for chemical APIs and formulations, traditional Chinese medicine, and biologics. They can develop generic drugs, improved innovative drugs, and independently develop Class 1 innovative drugs. The center includes departments for chemical drugs, traditional Chinese medicine, and biological products, with established R&D platforms for formulation technologies (sustained/controlled release, injectables, inhalables, topicals), protein biologics, peptide drugs, traditional Chinese medicine compound and active component research, and a consistency evaluation center for generic drugs. They have provided over 200 new drug development and technical services, securing multiple innovative drug clinical trial approvals. The drug evaluation center is a technical service platform for assessing the efficacy and safety of innovative drugs, certified by China's GLP standards. It features nearly 6,000 square meters of animal laboratories and support facilities, with over 30 million in advanced equipment, capable of conducting over 10 new drug evaluations concurrently. The center comprises eight departments and two committees, including pharmacology, toxicology, quality assurance, experimental animals, and an ethics committee, all operating under a robust quality assurance system and a strong research team. They possess extensive experience in efficacy screening and evaluation, non-clinical safety evaluation (including preliminary tests), and pharmacokinetic studies for chemical drugs, biologics, traditional Chinese medicine, and medical devices. CDMO manufacturing is handled by Guangzhou Bio-Gene Pharmaceutical Science and Technology Park Co., Ltd. The park has a registered capital of 130 million yuan and covers 33,000 square meters. Phase I includes over 20,000 square meters of incubator space and GMP manufacturing facilities, encompassing quality control, an office building, solid dosage workshops (tablets, hard capsules, granules, powders), traditional Chinese medicine extraction workshops, chemical API workshops, and supporting infrastructure for fire safety, environmental protection, and utilities. Services include MAH implementation, process scale-up research, clinical trial material production, placebo production, project registration, and new drug project investment and financing. Since its inception, Bio-Gene Pharma has adhered to its business philosophy of "Honesty, Trustworthiness, Professionalism, Authority." The company has provided over 600 clinical research services and over 300 preclinical research and registration services, including more than 40 high-difficulty innovative drugs. Through its R&D services, it has helped clients obtain over 60 new drug certificates, more than 80 drug registration approvals, 13 traditional Chinese medicine protection certificates, and numerous clinical trial approvals. Through years of development, Bio-Gene has become one of the few CROs capable of providing comprehensive one-stop services. By leveraging the synergy across its business segments, the company can complete the entire process of new drug development, from pharmaceutical studies, pharmacology, toxicology, and clinical trials to registration and contract manufacturing. This approach saves clients R&D costs, communication expenses, and time. Bio-Gene Pharma holds a leading position in China's domestic CRO industry in terms of technical strength, service quality, service scope, and team building, establishing itself as a flagship enterprise among Chinese CRO companies.