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According to the announcement on the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), SciClone Pharmaceuticals (SciClone Pharmaceuticals) introduced the Class 1 new drug RRx-001 injection from EpicentRx, which has obtained the implied license for clinical trials and plans to develop Used for extensive stage small cell lung cancer (SCLC)
Screenshot source: CDE official website
According to a press release issued by Saisheng Pharmaceuticals earlier, RRx-001 is a next-generation small molecule immunotherapy with good safety
According to the data of a phase 2 study published in the British Journal of Cancer earlier, in 26 SCLC patients, the overall survival (OS) of the RRx-001 combined chemotherapy group reached 8.
Previously, RRx-001 had obtained the orphan drug designation for small cell lung cancer, neuroendocrine cancer and glioblastoma granted by the US FDA, and the orphan drug designation for small cell lung cancer granted by the European EMA
In China, Saisheng Pharmaceutical Co.
To this end, Saisheng Pharmaceutical will pay EpicentRx an undisclosed amount of advance payment, and if the conditions are met, it will make equity investment in the latter this year
Reference materials:
[1] Center for Drug Evaluation (CDE) of China National Medical Products Administration.
[2]EpicentRx Inc.