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

According to public 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 website HER2 is an important biomarker that is commonly expressed in many different tissues and whose 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 "qualified approved drugs".
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 preliminary Phase 2 clinical findings for the treatment of second-line urethroid cancer with Vidicido monotherapy.
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 trials.
Rongchang Bio plans to submit to China's State Drug Administration in the first half of 2021 vidicido 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).
: The Drug Review Center (CDE) of the State Drug Administration of China. Retrieved Dec 17, 2020, from the post-hearing data collection of Rongchang Creatures. Retrieved Nov 8, 2020, from Source: Medical Mission Hills