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CStone receives IND Clearance from US FDA for CS1001-201 Study

CStone receives IND Clearance from US FDA for CS1001-201 Study

CStone Pharmaceuticals Co Ltd., a Chinese biopharma firm focused on commercializing and developing immuno-oncology and molecularly targeted drugs, has reportedly announced that it has received US FDA IND (Investigational New Drug) clearance for CS1001-201 clinical study to assess ‘Sugemalimab’ in the patients with relapsed/ refractory extranodal NK ( Natural Killer)/ T-cell T-cell lymphoma(R/R ENKTL).

The IND approval highlights that the ongoing CS1001-201 clinical trial in China will be extended to the United States.

For the record, CS1001-201 is a multicenter, single-arm pivotal Phase II clinical trial designed to assess sugemalimab monotherapy in patients R/R ENKTL. ‘Sugemalimab’ is an investigational anti-PD-L1 monoclonal antibody produced by CStone. As compared to drugs of the same class, the drug has a lesser risk of potential toxicities and immunogenicity in patients.

ENKTL is a rapidly progressing extranodal non-Hodgkin lymphoma most normally occurring in Asia than in North America and Europe. In China, the disease accounts for around 6% of total lymphoma cases. R/R ENKTL is aggressive, highly malignant, and has a poor prognosis. The patients lack effective salvage treatments if traditional, as well as standard L-asparaginase-based regimens, fail.

For these patients, doctors almost run out of treatment options as the disease progresses rapidly with tremendously short overall survival (OS). The existing approved targeted monotherapy in mainland China has a CR (Complete Response) rate of around 6%.  

Presently, there are significant unmet medical needs in patients who did not respond to first-line treatments. The drug is anticipated to offer new treatment options for these patients.

Speaking on which, Dr. Jason Yang, Chief Medical Officer of CStone said that the drug’s primary data signify the main breakthrough compared to existing treatment options and backs sugemalimab as a possible conditioning regimen for hematopoietic stem cell transplantation.

Dr. Yang added that the company works closely with US FDA (Food and Drug Administration and NMPA (National Medical Products Administration), to bring sugemalimab as a novel treatment for R/R ENKTL patients worldwide soon.

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