Today, Keystone Pharmaceuticals announced that the U.S. FDA has granted its PD-1 antibody CS1003 orphan drug eligibility for the treatment of liver cell carcinoma.
CS1003 is one of the products of tumor immunoskeleton in Keystone Pharmaceuticals, and has carried out a number of clinical studies on joint treatment, of which CS1003 joint levalinib is the first line of treatment of patients with advanced liver cancer, the global multi-center 3 registered clinical research is in the group.
fda's Orphan Drug Qualification is derived from the Orphan Drug Act (ODA), which encourages the development of innovative drugs for the treatment of rare diseases.
a new drug that is eligible for orphan medicine has the opportunity to obtain a 7-year market title. 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 1 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 3 registered clinical study, is also in the group. "Hepatocellular carcinoma is a very invasive disease, and China is a major liver cancer country, coupled with the lack of effective treatment drugs, resulting in a poor overall patient prognosis," said Dr. Jiang Ningjun, chairman and chief executive officer of
CS1003 is one of the products of tumor immunoskeleton in Keystone Pharmaceuticals, and has carried out a number of clinical studies on joint treatment.
fda-treated CS1003 orphan drug by the U.S. FDA is a great boon for patients with hepatocellular carcinoma who lack effective treatment.
"CS1003 is a PD-1 monotophoid developed by Keystone Pharmaceuticals, which has a clear differentiation advantage over the PD-1 antibodies that are already listed and in research," said Mr. Wang Sanhu, Senior Vice President of Government and Registration at Keystone Pharmaceuticals.
this FDA orphan drug qualification is an important development in the global strategic layout of CS1003, we will continue to work to explore the effectiveness and safety of its combination of therapies in complex cancers such as hepatocellular carcinoma to address the clinical needs of patients.
" References , Keystone Pharmaceuticals announced that PD-1 antibody CS1003 was granted orphan drug qualification by the U.S. FDA. Retrieved Jul 22, 2020, from Keystone Pharmaceuticals.