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Clinical approval came in double to new drugs of Shanghai Pharma

Shanghai Pharma achieved successive research progress with two new clinically-approved drugs.

The “(5R)-5-hydroxytriptolide” (Ref. No.: CXHL1700108, CXHL1700109), co-developed by Shanghai Pharmaceutical Holding Co., Ltd. (hereafter referred to as “SPH”) and Shanghai Institute of Materia Medica (hereafter referred to as “SIMM”), Chinese Academy of Sciences, and the “Recombinant Humanized Anti-HER2 Monoclonal Antibody -MCC-DM1 Conjugate for Injection” (Ref. No.: CXSL1700072), jointly developed by SPH and its wholly-owned subsidiary Shanghai Jiaolian Drug Development Co., Ltd., have respectively received the approval document of drug clinical trial issued by China Food and Drug Administration (CFDA).

(5R)-5-hydroxytriptolide

The (5R)-5-hydroxytriptolide features the first type of new drug (FTND), and specifications of 0.5mg and 1mg tablets. It is intended to be used for AIDS chronic abnormal immune activation.

In May 2017, the application of clinical trial was formally accepted by CFDA, and the clinical trial approval document has been recently received. It still requires the evaluation and production approval from CFDA before its industrialized production.

For the time being, domestic and international similar researches are all in the clinical exploration stage, and there are no like products yet in the market.

Recombinant Humanized Anti-HER2 Monoclonal Antibody -MCC-DM1 Conjugate for Injection

Recombinant Humanized Anti-HER2 Monoclonal Antibody -MCC-DM1 Conjugate for Injection refers to conjugation product of recombination monoclonal antibody and small molecule drug, intended for HER2-positive metastatic breast cancer, injection sized 100mg (5ml) per vial

The development of the drug was launched in July 2014, and its preclinical research was completed in April 2017, followed by the submission of its clinical trial application to CFDA, which was formally accepted by CFDA in June 30, 2017. And it has recently received the approval document.

The company will soon initiate the clinical research of the drug, which will still require the evaluation and approval from CFDA, and the production approval before industrialized production and market launch.

Domestic and foreign similar drugs on the market include Kadcyla® (ado-trastuzumab emtansine,T-DM1), developed by Roche/ImmunoGen.Inc, which was approved for market launch by the U. S. Food and Drug Administration (FDA), the Japanese Ministry of Health, Labour and Welfare (MHLW) and the European Commission respectively in February 2013, September 2013, and November 2013. At present, domestic similar researches are still in the stage of clinical exploration, and there are no congeneric products in the Chinese market.

According to data of EvaluatePharma, Kadcyla’s total sales in 2017 amounted to 928 million US dollars.

 

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