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Guide: CS1003 is a PD-1 humanized recombinant IgG4 monoclonal antibody that is being developed for immunotherapy for a variety of tumors.
Suzhou- Cornerstone Pharmaceuticals (Suzhou) Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has awarded CS1003 (PD-1 Antibody) Orphan Drug (Orphan Drug DeDesignation, ODD) for the treatment of liver cell carcinoma.
the FDA's Orphan Drug Qualification, derived from the Orphan Drug Act (ODA), is the FDA's incentive to develop innovative drugs for the treatment of rare diseases.
who qualify for a new drug with orphan medicine has the opportunity to obtain a seven-year market exclusive right. In addition to
, the FDA has a series of supporting measures, such as tax breaks for orphan drugs, reductions in prescription drug user fees, research and development grants and program assistance, and fast-track approval channels.
CS1003 is a human-derived recombinant IgG4 monoclonal antibody that targets human procedural cell death protein 1 (PD-1) and is developing immunotherapy for a variety of tumors.
compared with most of the monoclonal antibodies that have been approved or are in clinical trials combining human and monkey PD-1, CS1003 is not only capable of combining human and mouse-source PD-1, but also shows a unique competitive advantage in the drug efficacy testofe of the homologous mouse tumor model. Phase I clinical trials
CS1003 are currently being conducted simultaneously in Australia, New Zealand and China.
at the same time, CS1003 Joint Levatinib first-line treatment of patients with advanced liver cancer, the global multi-center Phase III registered clinical study, is also in the group.
.