Nine new Class 1 drugs were approved clinically from Roche, GSK, Hengrui Pharmaceuticals...

China's State Drug Administration Drug Review Center (CDE) recently announced that a number of new Class 1 drugs have been approved for clinical trials, not only BTK inhibitors, IL-5 antagonists, TLR7 astrists, SHP2 inhibitors Pan-FGFR inhibitors, as well as antonymic oligonucleotide drugs, anti-TIGIT antibodies, anti-CD20 monoantigens, etc., covering multiple sclerosis, chronic hepatitis B, asthma, AIDS, non-alcoholic fatty hepatitis and other diseases.
of this article, 9 new drugs are introduced (ranked in no order).
1, Roche: BTK inhibitor fenebrutinib adaptation: Multiple sclerosis (MS) adult patient Fenebrutinib is an oral, reversible non-co-priced Bruton tyrosine kinase (BTK) inhibitor developed by Roche that can cross the blood-brain barrier.
BTK is important for the development and function of a variety of immune cells, including B lymphocytes and macrophages.
researchers believe that by inhibiting BTK, adaptive and congenital immune cells associated with neuroinvestation in the brain and spinal cord can be regulated.
According to Roche's public data, fenebrutinib not only inhibits the activation of B cells, but also inhibits the activation of myelin cells in the blood, including macrophages and small glial cells, potentially reducing both acute and chronic inflammation in MS patients.
, Roche has initiated a number of Phase 3 clinical trials to assess the effectiveness of fenebrutinib in patients with resuscute MS and primary progressive MS.
2, GlaxoSmithKline (GSK): Antisysmtic oligonucleotide drug GSK3228836 injection; IL-5 antagonist GSK3511294 Injection Adaptation: Chronic B Hepatitis; Asthma GSK has two new Class 1 drugs approved clinically, one is GSK3228836 injection, which is an antisant oligonucleotide drug developed jointly by GSK and Ionis Pharmaceuticals.
antonym oligonucleotide is a small, synthetic single-stranded nucleic acid polymer with different chemical properties, which can regulate gene expression through a variety of mechanisms.
In livers infected with HBV, GSK3228836 specifically identifies the mRNA that HBV is used to form viral antigens (the protein that causes disease) and digests the virus mRNA by collecting enzymes from the liver itself, reducing the level of the viral protein HBsAg.
based on data presented by GSK at the European Society for Liver Research (EASL) Liver Conference at the end of August 2020, GSK3228836 has achieved positive results in Phase 2a clinical trials for patients with chronic hepatitis B.
test results showed that in patients treated at GSK3228836 at doses of 300 mg, levels of surface antigens in hepatitis B were reduced in patient groups that had previously received nucleotide analogs (NA) and had not been treated with NA.
another drug is GSK3511294 injection.
according to publicly available information, GSK3511294 is a lecytocyte interlethion-5 (IL-5) antagonist to be developed for the treatment of asthma and is in the phase 1 clinical study phase worldwide.
IL-5 targets can be developed to treat asthma on the basis that studies have found that in some patients with severe asthma, eosinophils overgrowth, compared with standard therapy, reducing the increase of eosinophils in the tragastic acidophils can be more effective in improving asthma symptoms and reducing the number of acute exacerbation attacks.
and the overgrowth of eosinophils depends on IL-5.
findings make IL-5 an ideal target for researchers to develop innovative asthma treatments.
3, Hengrui Pharma: TLR7 selective astration SHR2150 capsule adaptation: the treatment of HIV-1 infected patients SHR2150 is a TLR7 selective astration developed by Hengrui Pharmaceuticals TLR7 is one of the members of Tol-like subjects (TLR), responsible for the identification of pathogen single-stranded RNA, mainly distributed in plasma cell-like synth cells (pDC), B cells in the cell, in the human body to identify and remove pathogenic microorganisms play an important role.
TLR7-like agonists act as immune enhancement by stimulating plasma cell-like deutergenic cells (secreting interferon-α (IFN-α) and acting on other immune cells (NK cells, macrophages).
, SHR2150 has been approved to conduct clinical studies in advanced/metastasis malignancies, according to CDE publicity.
the drug obtained four clinically implied licenses, and the adaptive disorders to be developed are used for the treatment of HIV-1 infected patients.
4, Regenerant Biology: Anti-TIGIT Antibody JS006 Injection Adaptation: Advanced solid tumor JS006 is a recombinant humanized anti-TIGIT (T-cell immunoglobulin and TIM domain) monoclonal antibody injection developed by Regeneration Bio.
TIGIT is an inhibitory subject expressed mainly on the surface of T cells and NK cells, which binds to highly expressed PPR subjects on tumor cells and mediates the inhibitory signals of immune response, thus directly inhibiting the killing effect of NK cells and T cells on tumor cells, similar to the inhibitory effect of PD-1 on T cells.
preclinical results show that JS006 can specific block TIGIT-PVR inhibition path, stimulate the activity of lethal immune cells, secrete tumor killer factors.
In addition, a number of preclinical trial results show that anti-TIGIT antibodies and anti-PD-1/PD-L1 antibodies can play a synergistic anti-tumor effect, the combination of the two is expected to increase the response of cancer patients to immunotherapy, expand the range of potential beneficiaries.
5, Xuanzhu Bio: XZP-5610 Tablet Adaptation: Non-Alcoholic Fatty Hepatitis (NASH) According to Xuanzhu Bio-Website, XZP-5610 is designed to be developed for the treatment of non-alcoholic fatty liver disease (NAFLD).
the drug this approved clinical study adaptation is NASH.
NASH is a severe type of non-alcoholic fatty liver disease caused by excessive accumulation of fat in the liver.
NASH is associated with chronic liver inflammation and liver cell damage, which can lead to fibrosis, cirrhosis, and ultimately liver failure and even liver cancer.
currently, no drugs have been approved worldwide for the treatment of NASH.
model studies have shown that XZP-5610 can significantly improve fat change, inflammation and fibrosis in animal livers, and the properties and safety of the drug substitutes are excellent, according to the website of Xuanzhu Biologicals.
XZP-5610 can be used alone or in association with other targeted drugs to treat NAFLD-related diseases.
6, Sanhe Pharmaceuticals: SHP2 inhibitor SH3809 tablet adaptation: Advanced solid tumor SH3809 is a small molecule inhibitor targeted at SHP2 developed by Sanhe Pharmaceuticals, intended for the treatment of solid tumors.
SHP2 not only participates in cancer-causing signals by mediating the active RAS-MAPK signal, but also participates in regulating the PD-1/PD-L1 signaling path, promoting immune escape.
expression or activation of SHP2 has been shown to be closely related to the development of multiple cancers.
studies have shown that inhibiting SHP2 activity blocks the conduction of RAS signaling pathlines and activates the body's immunity, so SHP2 inhibitors have potential anti-tumor effects.
SH3809 tablets, which were submitted for clinical trials in category 1 of the chemicals, received two implied permits to develop an adaptive tumor with advanced solid tumors.
According to an earlier press release issued by the company, SH3809 was licensed for FDA clinical trials in December 2020, the third variety licensed for FDA clinical trials by San He Pharmaceuticals and the first to self-declared and independently complete the publication of eCTD, an internationally recognized documentation format.
7, Lunsheng Medicine: Pan FGFR inhibitor ARQ087 capsule adaptation: advanced urethra skin cancer ARQ087 (derazantinib) with FGFR gene mutation is an oral pan FGFR (fibroblast growth factor inhibitor) inhibitor.
the FGFR family mainly drives cell proliferation, differentiation and migration.
inhibitors developed for FGFR are used to block FGFR-mediated signaling paths by targeting the target area, which is expected to inhibit tumor growth.
According to an earlier press release issued by Lunsheng Pharmaceuticals, ARQ087 has achieved an objective remission rate of 21% in clinical phase 1/2 studies of patients with intrapatulpheric bile tube cancer (iCCA) with FGFR2 gene fusion, nearly three times higher than standard chemotherapy.
this time, ARQ087 capsules have been granted implied permission in clinical trials at CDE to develop advanced urethra skin cancer that carries mutations in the FGFR gene.
previous clinical trials of the product for the treatment of non-surgical excision or late iCCA subjects who are positive for FGFR2 gene fusion and have failed in at least first-line system therapy have been approved by CDE.
According to the drug clinical trial registration and information disclosure platform, Lunsheng Pharma is currently conducting a study on the safety effectiveness of ARQ087 in subjects with advanced solid tumor and FGFR2 fusion, non-resection of first-line treatment failure, recurrence/metastasis of endo-hepatic bile duce cancer.
8, Shanghai Pharma: Recombinant anti-CD20 humanized monoclonal antibody off-cortical injection adaptation: CD20 positive B-cell non-Hodgkin's lymphoma Shanghai Pharmaceutical wholly-owned subsidiary Shanghai Cross-Link Pharmaceutical Research and Development Co., Ltd. developed "reorganization" Anti-CD20 humanized monoclonal antibody off-skin injection "for the treatment of biological products 1 new drugs, this approved clinical trial of the adaptation is - to develop for CD20-positive B-cell non-Hodgkin lymphoma."
study found that CD20-targeted monoclonal antibodies can kill B cell-sourced lymphocytes or B-cells in the immune system through a variety of mechanisms, including antibody-dependent cell-mediated cytotoxic action (ADCC), complement-dependent cytotoxic action (CDC), direct apoptosis, antibody-mediated phagocytosis (ADCP) and so on.
, CD20 single anti-target therapy is an important treatment for B-cell malignant tumors.
on the approval of these new class 1 drugs for clinical studies and look forward to their follow-up trials and the early benefit of the vast number of patients.
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