Rongchang Bio-Virdixito monoanti (RC48) treatment of urethra skin cancer was recognized by the FDA breakthrough therapy.

Recently, Rongchang Biopharmaceuticals (RemeGen) Co., Ltd. (RemeGen) announced its own research and development of antibody-drug association (ADC) drug injection with Disitamab vedotin (product name: Adichie? , study code: RC48) obtained the FDA's Breakthrough Therapy Designation, the second-line treatment of patients with her2 expression (IHC 2 plus or IHC 3 plus) with local late stage or metastatic urethra cancer.
months ago, the new drug was approved by the FDA as fast-track.
breakthrough therapy stems from the Food and Drug Administration's Safety and Innovation Act (FDASIA), which aims to accelerate the development and review of new drugs for serious or life-threatening diseases.
As another FDA drug review channel following fast-track, accelerated approval, and priority review, breakthrough therapy-certified drug development can be further guided by closer guidance, including senior FDA officials, to ensure that new treatment options are available to patients in the shortest possible time.
the FDA's breakthrough therapy determination means that the clinical data of the new drug show significant efficacy compared to existing treatments, which will accelerate the process of clinical development and meet the needs of patients at an early time.
According to the results of the study, presented at the 2019 annual meeting of the American Society of Clinical Oncology,ASCO, led by Professor Guo Jun, Vice Dean of The Oncology Hospital of Peking University, the confirmed objective remission rate (cORR) was as high as 90.7% among the 43 subjects of second-line and multi-line urethra skin cancer treated with RC48-ADC.
, there are no drugs at home and abroad to treat HER2-positive urethra skin cancer has been approved on the market.
the above-mentioned results of RC48 achieved a major breakthrough, not only high efficiency, but also greatly extended the survival of patients after the failure of first-line treatment, to fill the huge medical needs.
On August 27, 2020, the application for the listing of a new drug used to treat patients with locally advanced or metastatic gastric cancer (including gastroesophageal adenocarcinoma) was formally accepted by the State Drug Administration of China and included in the priority review and approval process, the first independently developed ADC drug in China to submit an application for the listing of a new drug.
the drug was also certified as an FDA gastric cancer orphan drug in September 2018 and is scheduled to be tested in phase II clinical trials for stomach cancer in the United States in 2021.
also carried out HER2 low-expression breast cancer Phase III clinical research in China, next year will be launched in the United States Phase III clinical research.
2021, Wedixito monoantigen will conduct multiple phase II/III clinical studies of adaptive disorders in China.
ADC drug market will reach $9.93 billion in 2025, with a compound annual growth rate of 25.9 percent, according to ATA forecasts.
because of the complexity of ADC structure, its process development and traditional production of monoclonal antibodies involve higher technical difficulties and complexity.
Rongchang Bio has a fully integrated ADC development and production platform covering the entire process of ADC development and production, with production facilities that meet global GMP requirements.
Using a unique and powerful ADC platform, Rongchang Bio has developed a series of ADC drugs, in addition to RC48 has applied for a new drug market in China, RC88 is in Phase I clinical trials, RC108 has been declared clinical and accepted by the National Drug Administration Drug Review Center (CDE), and in the next few years every year will enter the clinical research stage of ADC candidate drugs, the prospects are unlimited.
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