About PUMC

PUMC History

PUMC Capabilities

PUMC People

PUMC Capabilities

1. Research & Development

Our R&D facilities are responsible for new product development, including development of new NCEs, reformulation, and small-scale manufacturing for pre-clinical studies.

2. Clinical Development

New drugs seeking marketing approval by the State Food & Drug Administration (SFDA) require clinical trials to be performed in China, involving Chinese patients. Existing registration dossiers and clinical data from outside China are treated as reference only.

PUMC Pharmaceutical’s Clinical Services group designs and manages clinical trials that minimize replication of existing clinical data, while still fulfilling the SFDA’s requirements.

Since 1995, PUMC Pharmaceutical’s Clinical Services group has completed over 50 clinical trials and post-marketing studies.

3. Product Registration

The process of registering new drugs in China is particularly arduous, and continues to grow in complexity and rigor.

Our Regulatory Affairs group has cultivated strong relationships with the Chinese Academy of Medical Sciences (CAMS), Peking Union Medical College (PUMC), the SFDA and leading medical authorities to ensure the most expeditious registration process possible – from application, through review, through approval, through insurance reimbursement. We also have substantial experience in intellectual property issues, and have strong relations with the Chinese Patent Office.

4. Manufacturing

PUMC Pharmaceutical's Chinese GMP-certified manufacturing facility is located in the Yanjiao Economic and Technological Development Zone in Hebei province, at the core of the Beijing-Tianjin and Bohai economic circle. The site is located approximately 30km from Beijing city center, 25km from Beijing Capital Airport, and 120km from Tianjin port. Transit from the International Trade Center to the development zone requires approximately 20 minutes.

Our 26,800 square meter facility, on 80,000 square meters of land, is equipped to manufacture, package, label and ship capsules, tablets and ointments

5. Sales & Marketing

The vast majority of ethical drugs in China are dispensed from hospital pharmacies. Our sales force, managed via regional hubs based in Beijing, Shanghai and Hangzhou, covers the key decision makers in over 450 Class 3 hospitals, defined by the Ministry of Health as general hospitals with greater than 500 beds, and with a strong research orientation. PUMC covers 70-90% of all Class 3 hospitals in each of China’s largest urban centers.

Our medical marketing efforts focus on conducting post-marketing clinical studies, paper competitions, clinical guideline commentary, and physician and patient education.