About PUMC

PUMC Capabilities

Since our inception, PUMC Pharmaceutical has focused on meeting the unmet medical needs of patients in China. Over the years, we have developed the broad capabilities required to bring new medicines to market.

1. Laboratory Capabilities

Although we focus on developing drugs in later clinical stages to mitigate our economic risk and optimize time to market, PUMC Pharmaceutical does maintain a fully-equipped laboratory for applied research and formulation activities. These range from reformulating NCEs in-licensed from an international partner to accommodate the unique specifications of the Chinese market, to synthesizing small-scale batches of product for our clinical trials.

2. Clinical Development

All drugs seeking marketing approval by the State Food & Drug Administration (SFDA) require clinical trials to be performed in China, involving Chinese patients. Not only does this hold true for new drugs, but also for branded and generic drugs already well-established internationally. Any existing registration dossiers and clinical data can be used as reference only.

PUMC Pharmaceutical’s Clinical Services group designs and manages clinical trials that optimize the balance between minimizing efforts that replicate existing clinical data, and meeting the SFDA’s requirements for new data.

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 a particularly arduous one by international standards, and these rigors have only intensified of late. The proper inroads are, therefore, more important today than ever before when seeking to register new products with the SFDA.

Our Regulatory Affairs group has strong, flexible expertise in negotiating the registration process. We have 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. Effective sales therefore require an extensive network of connections into the nation’s top hospitals.

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 80-90% of all Class 3 hospitals in each of China’s largest urban centers.

Our medical marketing efforts focus on conducting post-marketing clinical studies, supplemented by professional education programs employing training workshops, seminars, symposia, and paper competitions.