Recently, many domestic pharmaceutical companies have ushered in new progress in new drug research and development!

【Pharmaceutical Network Enterprise News】Under the background of accelerating the approval and review of new drugs and the rapid development of the domestic innovative drug industry, the clinical trials and new drug listing speed of local pharmaceutical companies are accelerating significantly
.
Only recently, there have been new progress in
the research and development and listing of many new drugs such as Pyrrotinib maleate tablets of Hengrui Pharmaceutical, WuXi Junochi Orensai Injection, and Zaiding Pharmaceutical Efgartigimod injection.
Hengrui Pharmaceutical Pirrolitinib Maleate Tablets Indications New Indications Approved On October 10, Hengrui Pharmaceutical announced that it received the "Notice of Acceptance" issued by the State Drug Administration, and the application for marketing authorization of Pirotinib maleate tablets submitted by the company was accepted
by the State Food and Drug Administration.
The indications for listing are: pyrrotinib in combination with trastuzumab and docetaxel, suitable for the treatment of epidermal growth factor receptor 2 (HER2) positive, advanced stage did not receive anti-HER2 therapy recurrent or metastatic breast cancer patients
.
Pirrrotinib is a small molecule, irreversible and pan-ErbB receptor tyrosine kinase inhibitor independently developed by Hengrui Pharmaceutical, and is also the first HER1/HER2/HER4 targeted drug
independently developed in China 。 WuXi Junociraki Orence Injection New Indications Approved On October 9, WuXi Juno announced that China's State Drug Administration has approved its CD19-targeting autologous chimeric resistance T cell immunotherapy product Ricky Olga Lunsai Injection (Benoda ® ) for the treatment of adult refractory refractory or recurrent follicular lymphoma (r/r FL)
after two or more systematic treatments 。 This is Benota's ® second approved indication after being approved for marketing in September last year, making it the first cellular immunotherapy product approved in China for the treatment of patients with r/r FL
.
Zaiding Pharma Efgartigimod Injection Approved Clinical On October 9, according to the CDE website, Zaiding Pharma FcRn antagonist Efgartigimod Injection was approved clinically to carry out research on
the treatment of bullous pemphigoid pemphigus.
It is understood that Eefgartigimod is the first approved FcRn antagonist, the drug is approved in the United States for the treatment of acetylcholine receptor antibody positive adult systemic myasthenia gravis patients, in Japan the drug is approved for the treatment of steroid or non-steroid immunosuppressive therapy does not adequately respond to the systemic myasthenia gravis adult patients
.
In China, on July 13, Zaiding Pharma announced that the NMPA has officially accepted a new drug marketing application for the FcRn antagonist Egamod α injection (efgartigimod) for the treatment of patients with
systemic myasthenia gravis.
In addition, the drug has also successfully landed in Hainan Boao Lecheng International Medical Tourism Pilot Zone
.
Changchun Baike anti-rabies virus drug clinical approval On October 9, Changchun Baike announced that the company recently received the "Drug Clinical Trial Approval Notice" issued by the State Drug Administration for natural hologenic anti-rabies virus monoclonal antibody CBB1 injection, and the natural whole human antirano virus monoclonal antibody CBB1 injection was approved clinically, and it is planned to carry out the study of passive immunity of
patients bitten and scratched by rabies or other rabies-carrying animals 。 Changchun Gaoxin said that if the antibody variety successfully completes clinical trials and is approved for listing, it will help Baike Bio optimize the product structure and industrial layout, promote the overall development of the main business, and further improve the company's long-term profitability
.
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