Congratulations to Fochon Pharmaceuticals (Fosun Pharma subsidiary) for their selective BCL-2 inhibitor FCN-338 and tablet (CXHL2000200, CXHL2000201, CXHL2000202) have been accepted by the CDE (Center for Drug Evaluation), NMPA for clinical trials. It has received US FDA approval in May this year for clinical trials. The potential indications of FCN-338 are mainly for the treatment of hematological malignancies.
Sundia assists Fochon Pharmaceuticals to complete part of the pharmaceutical CMC research of FCN-338 tablets, including formulation development, release testing, stability research, and GMP batch production support, which accelerated the development of Fochon ‘s new drug.
B-cell lymphoma-2 (Bcl-2) family proteins are key regulators of apoptosis, which is vital for proper tissue development and cellular homeostasis. Bcl-2 family proteins are functionally classified as either anti-apoptotic, such as Bcl-2, Bcl-xL and Mcl-1, or pro-apoptotic, including Bid, Bim, Bad, Bak and Bax. Anti-apoptotic Bcl-2 family members are often found to be up-regulated in many types of human cancers. Therefore, targeting BCL – 2 has emerged as a promising therapeutic approach in cancer.
Sundia once again demonstrates our one-stop service platform is been able to shorten the timeline and reduce the cost for the development of customers’ preclinical new drug programs. Sundia strive to provide a fully integrated CRO services and quality project management service for more and more partners, reducing cost and increase efficiency for the drug research and development. We are looking forward to the success of Fochon on bringing more innovative and quality drug to global patients.
About Fosun Pharma
Founded in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (“Fosun Pharma”; stock code: 600196.SH, 02196.HK) is a leading healthcare group in China. Fosun Pharma has built a strong root in China and developed a global operation strategy, with pharmaceutical manufacturing and R&D being the largest and core business segment, together with strong presences in medical devices and diagnostics, healthcare services, pharmaceutical distribution and retail.
With R&D innovation as core driving factor, Fosun Pharma continues to optimize its pharmaceutical operations across both innovative and generic drugs. The company has established international R&D centers for excellence in areas such as innovative small molecule drugs, high-value generic drugs, biologics, and cell-therapy.
As a leading, fully-integrated ‘one-stop-shop’ service provider, Sundia provides a variety of CRO services in drug discovery and development which includes Library Design, Parallel Synthesis, Custom Synthesis, Medicinal Chemistry, in vitro & in vivo Biology, DMPK, Process Development, Analytical Chemistry, Formulation Development, and Preclinical testing to meet clients’ specific project needs. Leveraging our rich project management and IND submission expertise, Sundia can efficiently integrate all the studies that are required for NMPA/FDA IND submissions and are compliant with global GMP standards.