Domestic 1 class of new drugs outbreak! In two weeks 25 varieties were approved clinically

"Pharmaceutical network industry dynamics" domestic category 1 new drugs are ushering in an outbreak period! Over a two-week period (September 12-September 25), a total of 60 new drugs (involving 92 acceptance numbers) were approved for clinical trials, of which 31 varieties (38 acceptance numbers) were domestic new drugs, accounting for more than 50%.
Of the 31 approved clinically approved domestic new drugs, 25 are domestic category 1 new drugs, involving dozens of production enterprises such as Tianjin Hemei Pharmaceuticals, Dongsian Pharmaceuticals, Kangfang Biologicals, Zhengda Tianqing, Tengrui Pharmaceuticals, Hualan Biologicals, Hengrui Pharmaceuticals, Xinda Bio, Xinlitai, Sansheng Guojian, etc.
September 12 - September 25, Hengrui a total of two new class 1 drugs were approved clinically, respectively, injection with Karelli pearl monoanti, SHR-1701 injection, of which carelli pearl monoantigen is a humanized anti-PD-1 monoclonal antibody, has been approved Hodgkin lymphoma, advanced hepatocellular cancer, advanced esophageal squamous and non-small cell lung cancer four adaptation.
SHR-1701 can promote the active effect of T cells, but also can effectively improve the tumor micro-environment immune regulation, effectively promote the immune system for tumor cells.
Also has two new drugs approved clinically, heC122505 MSOH tablets, recombinant anti-VEGF humanized monoclonal antibody injection.
, the new class 1 drug HEC122505MsOH tablet is an efficient, highly selective MAO-B reversible inhibitor, clinically intended to be used in the treatment of Parkinson's disease with lyso-doba.
class 2 new drug recombinant anti-VEGF humanized monoclonal antibody injection is an antibody drug targeting endodermal growth factor (VEGF).
Phase 3 clinical study (ORIENT-32) of Cindili monoantigen injection approved for clinical use in first-line treatment of advanced liver cancer was analyzed in the medium term to reach the main research endpoints of progress-free survival (PFS) and total lifetime (OS).
this is the first phase of a three-phase study in the world to publish a combined treatment of programmed cell death protein 1 (PD-1) inhibitors for the first-line treatment of advanced liver cancer.
Xinlitai's recombinant human neuromodulating protein 1-anti-HER3 antibody fusion protein injection (SAL007) is a wholly-owned Sun Company of the United States Salubis independently developed, with global intellectual property rights NRG-1 (neuromodulating protein-1) fusion antibody drugs, intended to develop adaptation for chronic heart failure.
it is understood that the product is also the first Sino-US double report of innovative biological drugs, in February 2020 by the United States FDA clinical trial approval, is currently conducting human clinical trials in the United States.
recombinant anti-IL-4R alpha humanized monoclonal antibody injection is a humanized anti-IL-4R alpha monoclonal antibody independently developed by Sansheng Guojian, with a brand-new amino acid sequence.
the current global market for IL-4R alpha target monoantigen is Sanofi's Dupixent, which was approved in China in June 2020.
2019, Dupixent's global sales were EUR 2,074 million, up 163.2% year-on-year.
AK117 (CD47 monoclonal antibody) injections from Kangfang Bio were approved for clinical use in advanced solid tumors or lymphomas.
it is understood that targeted CD47 drug single drug and combined therapy in both blood tumors and solid tumors have shown good anti-tumor efficacy, is the next generation of tumor immunotherapy hot target.
In addition, Zhengda Qing's class 1 new drug TQB2618 injection was approved for clinical adaptation to advanced solid tumors;