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Article source: Medical Cube Info
Author: Pickup
On April 7, the CDE official website showed that the clinical application of PEN-866 sodium for injection by Saisheng Pharmaceutical was accepted by the State Food and Drug Administration
PEN-866 is a small molecule drug conjugate (SMDC) developed by Saison Pharmaceuticals and is currently conducting a Phase II basket trial for solid tumors in the United States
Antibody drug conjugates (ADCs) are undoubtedly the most concerned representatives of drug conjugates nowadays, and the therapeutic breakthroughs and transactions of listed and clinical drugs have also attracted much attention; however, the defects of ADC drugs are also obvious, such as the inability to target intracellular proteins, Complex production processes and regulatory challenges,
Different from ADC, SMDC achieves targeted localization through small molecules and precise drug release, which is also a potential branch in the drug conjugate track
PEN-866 structure
Importantly, SMDC has similar advantages to ADC in clinical manifestations, especially the control of adverse reactions
Clinical data showed that no DLT (dose limiting toxicity) was observed with PEN-866 at the recommended dose (175 mg/m2), and only 1 patient experienced uncomplicated grade G3 transient neutropenia , compared with irinotecan up to 53.
PEN-866 was originally developed by Tarveda.
It is reported that the companies currently deploying small molecule conjugated drugs in China include Tongyi Medicine (CBP-1008, CBP-1018), Institute of Basic Medicine, Chinese Academy of Medical Sciences (DTX-P7), Saisheng Pharmaceutical (PEN-866, T- 2143), Taiwan Haoding Biotechnology (OBI-3424)
Note: The original text has been deleted