Today, Rongchang bio-anti-HER2 antibody association drugs are to be included in the breakthrough treatment varieties!

Today, China's State Drug Administration Drug Review Center (CDE) official website of the latest publicity, Rongchang biological submission of "injection recombinant humanized anti-HER2 monoanti-MMAE combination agent" is to be included in the breakthrough treatment varieties, the proposed adaptive disorders for the past after the failure of chemotherapy progress of HER2 over-expression of local late stage or metastatic urethra cancer patients.
according to publicly available information, the anti-HER2 monoantigen-MMAE coupled agent is the antibody coupled drug vidicyto monoantigen (disitamab vedotin, RC48).
September, the drug was approved by the FDA as a breakthrough therapy for second-line treatment for urethroid skin cancer.
screenshot source: CDE official website HER2 is an important biomarker that is commonly expressed in many different tissues, and its over-expression has been considered a genetic driver of multiple cancer types.
, HER2 has become one of the main targets for researchers to develop antibody-coupled drugs.
Vidicyto monoantigen, an antibody-coupled drug targeted at HER2 developed by Rongchang Bio, is being developed to treat common HER2 expression adaptations that currently lack treatment, including HER2 expressions other than breast cancer (IHC) 1 plus or more) cancer adaptations, such as stomach cancer and urethra cancer, as well as HER2 low expression cancer (IHC 2 plus/FISH-or IHC 1 plus) allergy, such as HER2 low expression breast cancer.
In China, the application for the listing of a new drug for the treatment of patients with locally advanced or metastatic stomach cancer, including gastroesophageal adenocarcinoma, has been accepted by the State Drug Administration of China (NMPA) and has been included in the priority review for "drugs that meet the conditions approved".
The application to be included in the breakthrough treatment is for patients with HER2 over-expression of local late stage or metastatic urethra skin cancer (including bladder, ureter, kidney and urethra sources) and for patients who have progressed after previous failures of chemotherapy.
HER2 over-expression is defined as IHC detection of primary or metastasis tumor tissue HER2 expression as IHC 2 plus or IHC 3 plus.
Screenshot Source: CDE Website At the 2019 Annual Meeting of the American Society of Clinical Oncology (ASCO), Rongchang Bio presented the preliminary Phase 2 clinical findings of Vidicyto single anti-treatment of second-line urethroid cancer.
clinical data showed that in this study of 43 patients with HER2 over-expression (IHC 2 plus or IHC 3 plus) second-line urethra cancer, the optimal objective remission rate (ORR) of Vidixito monoantigen (ORR) was 60.5% (26/43), with ORR confirmed at 51.2% and medium progression-free survival (PFS) at 6.9 months.
the results showed that patients with urethra skin cancer who had previously failed treatment had a clinically significant response to Vidicyto single, according to Rongchang Biolist.
also shown good safety in the trial.
Rongchang Bio plans to submit to China's State Drug Administration in the first half of 2021 Vidicyto single anti-treatment of urethra skin cancer new drug market applications.
It is worth noting that in September 2020, the FDA awarded Vidicido mono-resistant breakthrough therapy for the second-line treatment of locally advanced or metastatic urethroid cancer expressed by HER2 (IHC 2 plus or IHC 3 plus).
congratulations to Rongchang Bio Vidicido single anti-uremic skin cancer adaptation application to be included in the breakthrough treatment varieties, I hope that the drug will be approved for market at an early time, for the benefit of the vast number of patients.
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