Zhengda Tianqing Adamu monoantine submitted listing application Anrotini submitted 3 clinical applications!

According to the information published by the Drug Review Center (CDE) of the State Drug Administration of China, Zheng Da Qing today submitted the application for listing of Adamu singofa injections, and three clinical trial applications for Theroitinib, a TKI inhibitor.
According to public information, Zhengda Qing has been approved for the market in recent years, including the first generic drug injection of benzodiazepine hydrochloride and the treatment of rheumatoid arthritis drug tofatibin tablets.
at the same time, the company's innovative products are also worth paying attention to, especially its investment in anti-tumor.
today, we will take stock of the first class of new drugs in the research products.
Adamu monotophosm: TNF-alpha antibody Adamu monoantigen research products for Xiu Merlot, is the world's first approved listing of all-human anti-tumor necrosis factor monoclonal antibodies, which has been approved in China six indications.
the inflammation of a variety of immune-mediated diseases in humans is associated with tumor necrosis factor alpha (TNF-alpha), Adamu monotophobic selectively binds to TNF-alpha molecules, preventing them from attaching to healthy cells, thereby reducing the damage caused by excessive TNF-alpha.
based on this principle, Adamu monotomacants can be used to treat a wide range of immunomediated diseases.
according to CDE's official website, Zhengda Tianqing is the sixth Chinese company to submit an application for a single anti-Trump listing, of which Baiotai and Haizheng Pharmaceuticals have been approved for listing.
Anrotinib: TKI inhibitor Anrotinib is a new type of small molecule multi-target tyrosine kinase (TKI) inhibitor developed after more than 10 years, which can effectively inhibit veGFR, PDGFR, FGFR, c-Kit and other kinases, with anti-tumor angiogenesis and inhibit tumor growth.
May 2018, Anrotini was approved for the first time in China through a priority review process, and has been approved for three adaptations: three-line treatment of advanced non-small cell lung cancer, the treatment of soft tissue sarcoma, and the third-line treatment of small cell lung cancer.
January this year, the fourth new indication application for Anrotini was included in the list of priority review varieties.
it is worth mentioning that the drug has been approved after "fast steps" into China's national health insurance directory.
is currently studying the effectiveness of anarotine and combination drugs in a number of clinical trials.
TQB2450: PD-L1 antibody TQB2450 injection is an innovative anti-PD-L1 all-humanized monoclonal antibody developed by Zhengda Qing, to develop indications including melanoma, lung cancer, primary large B cell lymphoma and advanced soft tissue sarcoma.
last December, Zhengda Tianqing Registration launched a multi-center phase 3 clinical trial of TQB2450 or placebo joint Arodini-EC program compared to the EC program to treat first-line widespread small cell lung cancer.
note, The TQB2450 is also the main partner of Thearotini.
Zhengda Tianqing has launched the recruitment of patients with phase 1b clinical studies of these two drugs in the country in January this year to jointly treat patients with recurrent/difficult-to-treat ovarian cancer.
Paanpri monotophoid (Anico, AK105) :PD-1 antibody Paanpri saabisre is a recombinant humanized anti-PD-1 monoclonal antibody developed by Kangfang Bio.
last June, Kangfang Bio and Zhengda Tianqing spent 689 million yuan to set up a joint venture company to jointly develop the AK105 project and promote the registration and commercialization of the drug.
it is worth mentioning that the Application for New Drug Listing (NDA) of Pinepri monotoma has been accepted by CDE for the treatment of patients with recurrent or refractive classic Hodgkin's lymphoma (cHL) who have undergone at least second-line system chemotherapy.
, Paiamply is also conducting four registration trials in China for other indications and is expected to submit NDA within the next 1-2 years.
TQ-B3101: Small molecule target inhibitor TQ-B3101 capsule is a small molecule target inhibitor developed and declared by Zhengda Tianqing, registered as a class 1.1 of primary drugs.
query According to the Chinese drug clinical trial registration and information publicity platform, a 2-phase single-arm, multi-center clinical study evaluating the efficacy and safety of TQ-B3101 capsules for the treatment of ROS1-positive non-small cell lung cancer subjects is recruiting patients.
last October, the product was again approved for clinical use in interstitulated lymphoma kinase (ALK)-positive locally advanced and metastatic non-small cell lung cancer (NSCLC), stomach cancer, lymphoma, etc.
TQA3563: New DRUG NASH Last June, Zhengda Qing TQA3563 tablets were approved by the NMPA Drug Review Center for clinical trials for non-alcoholic fatty hepatitis (NASH) treatment.
under the drug clinical trial registration and information disclosure platform, the drug is currently conducting a Phase 1a clinical trial of tolerance and pharmacokinetics in healthy subjects, with a plan to enroll 70 subjects.
in addition to the above five products, Zhengda Qing and a number of new class 1 drugs have been approved by CDE clinical trials.
involves indications including asthma, as well as a variety of solid and hematomas.
it is worth mentioning that in May last year, Zhengda Tianqing has reached a strategic cooperation agreement with Platinum Pharmaceuticals to develop and commercialize innovative antibody drugs in the field of oncology immunity and immune diseases.
we look forward to continuing to bring innovative products to patients that will benefit more patients.
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