Regulatory Affairs Group - strong working relationships with the NMPA (China FDA) and US FDA – track record of successful filings/approvals
Clinical/Medical Team - extensive industry experience in oncology/hematology - strong network with the top KOLs/PIs in China
Clinical Operations and Pharmacovigilance Team - specialized in the management of clinical projects and study site data and reporting
Marketing and Sales Organization – team of experienced oncology/hematology marketing and sales professionals – successful launch of EVOMELA®
Acquired exclusive China rights for three U.S. FDA-approved marketed products:
EVOMELA® (melphalan for injection), ZEVALIN® (ibritumomab tiuxetan), MARQIBO® (vincristine sulfate LIPOSOME injection)
License agreement for exclusive China rights for first-in-class anti-FcyRIIB monoclonal antibody (BI1206)
License agreement for exclusive worldwide license and commercialization rights to an autologous anti-CD19 T-cell therapy product (CNCT19)
License agreement for exclusive worldwide rights to a novel anti-CD38 monoclonal antibody (CID-103)
License agreement for exclusive China rights for a novel formulation of Thiotepa
License agreement for exclusive Greater China Region First-in-Class VCP/P97 Inhibitor CB-5339
Distributor for importing and distributing Evomela in the Territory