The Monty Pharma Praquosa was approved in the micro-core biosidamine will meet the opponent.

Recently, the listing application for "Praqusha Injection" (acceptance number JXHS1800080) from Monty (China) was changed to "in-approval" in the NMPA status, which means that the drug for the treatment of recurring or incurable external T-cell lymphoma (PTCL) is about to be approved in China.
Pralatrexate,Folotyn, a folic acid-like metabolic inhibitor developed by Allos Therapeutics (acquired by Spectrum in 2012), competitively inhibits dihydrofolate reductase and also competitively inhibits polyglumine in polyglutinase folic acid, which blocks the synthesis of thymus and other monocarbon-dependent biomolecules.
September 2009, the FDA approved Pratsa for the treatment of incurable/recurring external T-cell lymphoma (PTCL) patients, known as Folotyn.
clinical trials have shown that Folotyn is significantly effective in reducing tumor volume and prolonging patient survival.
2019, Spectrum sold Folotyn to Acrotech Biopharma, a subsidiary of Therabindo, an Indian drug company, for $300 million.
external T-cell lymphoma (PTCL) is an invasive non-Hodgkin's lymphoma, quite rare, in the United States about 9,500 cases per year, and the incidence of PTCL in Asian countries is higher than in Western countries, according to the micro-core biological prospectus, China's annual new patients in 1.31-157 million people.
according to the insight database, there are currently a limited number of drugs approved worldwide for the treatment of PTCL (see table below), in addition to Thertoymetics has submitted a listing application for the treatment of PTCL.
the most commonly used first-line treatment of PTCL is CHOP chemotherapy, but the program is not good for pathological subtypes other than APK-positive ALCL, the five-year survival rate is only 30%, and the efficacy of traditional second-line chemotherapy program is not significant, New drugs for current second-line treatments include sidabamine, belista, Romidepsin, Pratsa and Vibutoxi monoantigen (for systemic ALCL and CD30 plus PTCL only).
the above-mentioned second-line treatment drugs in the Belista, Lamedesin, Praqusha are not listed in China, Vibutoxi monoantitor although approved in China, but not approved for the treatment of PTCL.
Siddamine is the only second-line drug approved for PTCL treatment in China.
Siddamine (Trade Name: Epipyriza® / Epidaza®) is a new molecule developed by Microcore Bio with global patent protection, the world's first subtype selective histone deacetylase (HDAC) oral inhibitor, national Class 1.1 new drugs were first approved by NMPA in December 2014 for the treatment of relapsed and resuscable external T-cell lymphoma, and in December 2019 for the treatment of ER-positive, HER2-negative advanced/metastatic breast cancer.
Siddamine is the first Phase II clinical trial in China to be approved for market, and the results of phase II clinical trials of the treatment PTCL show that the objective remission rate of single-drug therapy is 28%, meeting the target set by CDE, which refers to the objective mitigation rate of FDA-approved Folotyn 26.5% and Istodax (i.e., 25% Eromidesin).
2017, Siddamine was included in the National Health Insurance Program and successfully renewed for 2019.
according to a prospecto disclosed by Microcore Bio, sales of Siddamine in 2016-2018 were 0.56, 0.93 and 137 million yuan, respectively.
it is worth mentioning that in the domestic Zhengtianqing and Jiangsu Haussen has begun to lay out the Praqusha generic drug market, has been approved for clinical.
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