PARTNERING WITH CASI PHARMACEUTICALS
CASI has built a fully integrated, world class biopharmaceutical company dedicated to the successful development and commercialization of innovative medicines. We are a U.S. Nasdaq-listed company with China and U.S. operations and dedicated management teams with deep knowledge of global drug development, tech transfer & commercialization in both China & the U.S. With over 100 employees in China and the U.S., CASI personnel are trained in global operations and have extensive expertise in U.S./China clinical, regulatory and commercial requirements and standards.
- 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®
- CMC Team - expertise in all areas of CMC (biologics/cellular, parenterals, oral solids) and GMP regulations
- State-of-the-art cGMP manufacturing plant in Wuxi, China – over 100,000 sq meters of building area
CASI is committed to building a product portfolio of innovative therapeutics, initially focusing on hematology-oncology diseases. Working collaboratively with our partners, CASI is a trusted U.S. partner for companies who want to bring their innovative therapies into the China market. Leveraging our U.S. and China hematology-oncology expertise and resources, our goal is to work closely with partners to develop and commercialize products rapidly and effectively. Our extensive relationships with key hematologists and oncologists and the premier cancer hospitals in China ensures high-quality clinical data is generated under ICH GCP standards to support global registrations.
CASI welcomes partnership opportunities with companies and academic/research institutions that are developing innovative therapeutics for hematologic malignancies and solid tumors.
Acquired exclusive China rights for three U.S. FDA-approved marketed products:
EVOMELA® (melphalan for injection), ZEVALIN® (ibritumomab tiuxetan), MARQIBO® (vincristine sulfate LIPOSOME injection)
Black Belt Therapeutics
License agreement for exclusive worldwide rights to a novel anti-CD38 monoclonal antibody (CID-103)
Juventas Cell Therapy, LtD.
License agreement for exclusive worldwide license and commercialization rights to an autologous anti-CD19 T-cell therapy product (CNCT19)
Acquired a portfolio of 25 U.S. FDA-approved abbreviated new drug applications (ANDAs), and four pipeline ANDAs
Laurus Labs Limited
Acquired U.S. FDA-approved ANDA for tenofovir disoproxil fumarate (TDF), indicated for the treatment of hepatitis B virus
Wuxi Huishan Economic Development Zone
Agreements to build a state-of-the-art cGMP manufacturing site strategically located in the in Jiangsu Province, China
For more information about partnering with CASI Pharmaceuticals and our Business Development group, please contact us via email to: email@example.com.
Please also refer to our Business Development Partnering presentation below.