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The latest announcement from the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China shows that the marketing application of Naxitumumab injection declared by SciClone Pharmaceuticals has been included in the proposed priority review, and it is planned to be developed for the treatment of relapse Or patients with refractory high-risk neuroblastoma
.
Public information shows that nalcistumumab is a humanized monoclonal antibody targeting ganglioside (GD2) and has been granted priority review qualification, breakthrough therapy designation and orphan drug designation by the US FDA
Screenshot source: CDE official website
Naxitamab-gqgk (Danyelza) is an antibody targeting GD2 developed by Y-mAbs Therapeutics (hereinafter referred to as "Y-mAbs")
.
GD2 antigen is expressed on the surface of tumors generated by neuroectoderm, including neuroblastoma, melanoma and osteosarcoma
In December 2020, Saisheng Pharmaceutical reached an exclusive indefinite license agreement with Y-mAbs, and obtained the latter's two products, nalxitumumab and omburtamab, in the Greater China region (including mainland China, Hong Kong, Macau and Macau).
Taiwan) exclusive cooperative development and commercialization rights
.
Another product, omburtamab, is intended to be developed for the treatment of neuroblastoma in children with central nervous system/pial metastasis
In July of this year, Saisheng Pharmaceutical and Y-mAbs jointly submitted an application for the marketing authorization of Naxitumumab to the National Medical Products Administration (NMPA) of China
.
According to the public information of priority review, the indications for this application of nalcistumumab are: combined administration with granulocyte-macrophage colony stimulating factor (GM-CSF) for the treatment of bone or bone marrow lesions.
It is worth mentioning that in November 2020, the FDA has expedited the approval of naxituzumab for the treatment of such patients
.
According to Y-mAbs's official website, the approval of nalxitumumab in the United States is based on two key clinical research data
A study named 201 (including 22 patients) showed that among the patients with relapsed or refractory high-risk neuroblastoma treated with nalcistumumab combined with GM-CSF: 45% (10/22) of the patients Complete or partial response to treatment (overall response rate, ORR); 36% (8/22) of the patients found no physical evidence of the disease in imaging or tissue examination; 9% (2/22) of the patients The tumor has shrunk by more than 50%
Another study named 12-230 (including 38 patients) showed that: 34% (13/38) of the patients who received naxituzumab combined with GM-CSF had a complete or partial response to the treatment; 26% (10 /38) of the patients did not find physical evidence of the disease in the imaging examination or tissue examination; 8% (3/38) of the patients had their tumors shrunk by more than 50%
Reference materials:
[1] Center for Drug Evaluation (CDE) of China National Medical Products Administration.
[3] FDA Approves Y-mAbs' DANYELZA® (naxitamab-gqgk) for the Treatment of Neuroblastoma.
[4] Danyelza official website.
