Eligible approval Rongchang BioHER2 antibody association drug to be included in the priority review.

Today, China's State Drug Administration Drug Review Center (CDE) recently announced that Rongchang bio's injectable vircido monoantigen was included in the list of varieties to be reviewed as a priority, on the grounds that "qualified drugs are eligible for approval."
in Rongchang bio's product pipeline, did not query the name of the Wei Dixito single resistance.
based on the company's disclosure of the progress of the product under development, it is speculated that the antibody co-drug RC48 (disitamab vedotin), which targets HER2, may be its core candidate.
Screenshot Source: CDE Website Rongchang Bio is dedicated to the discovery, development and commercialization of first-in-class and best-in-class biopharmaceuticals for the treatment of unsupereneated autoimmune, oncology and ophthalmological diseases with a wide range of medical needs in China and around the world.
, the company filed an IPO application with the Hong Kong Stock Exchange.
Disitamab vedotin is an anti-HER2 antibody drug coupled (ADC) developed by the company, and Rongchang Bio is developing a candidate drug to treat common HER2 expression adaptations that currently lack treatment, including HER2 expression (IHC 1 plus or more) cancer adaptations other than breast cancer, and HER2 low expression cancers (IHC 2 plus/FISH-or IHC 1 plus).
in China, Rongchang Bio is conducting a number of clinical studies on disitamab vedotin involving adaptations including breast cancer, urethra skin cancer, bile tube cancer, non-small cell lung cancer, and stomach cancer.
of these clinical trials are registered clinical trials targeting symptoms including stomach cancer, urethra cancer, and her2 low expression breast cancer.
Rongchang Bio said in its prospectus for the IPO filed with the Hong Kong Stock Exchange in June that it planned to submit a new drug listing application (NDA) for the treatment of stomach and urethra cancer to the State Drug Administration of China (NMPA) in the third quarter of 2020 and the first half of 2021, respectively.
this time into the proposed priority review means that the drug is expected to accelerate its approval in China.
According to Rongchang Bio's prospectuse, disitamab vedotin has shown excellent anti-tumor activity and good tolerance in clinical studies of stomach cancer and urethra skin cancer: as of June 22, 2020, 127 patients who had underwent second-line chemotherapy were over-expressed in Phase 2 registered clinical trials for stomach cancer (IHER2) In patients with HC 2 plus or IHC 3 plus) gastric or GEJ cancer, the objective remission rate (ORR) of disitamab vedotin was 24.4% (confirmed by the Independent Review Board (IRC) assessment), with a median non-progression lifetime (PFS) of 4.1 months and a median total survival (OS) of 7.6 months.
in a preliminary Phase 2 clinical study of 43 patients with HER2 over-expression (IHC 2 plus or IHC 3 plus) second-line urethra cancer, disitamab vedotin had a best ORR of 60.5%, or 51.2% of confirmed ORR and a medium PFS of 6.9 months.
in the United States, disitamab vedotin has been approved by the FDA for the orphan drug for stomach cancer (for the treatment of rare diseases) and has been approved by the FDA to conduct phase 2 clinical studies of urethra skin cancer in the United States.
Rongchang Bio plans to launch a clinical study in the United States in 2021 on the treatment of urethra and stomach cancer patients.
References: The Drug Review Center (CDE) of the State Drug Administration of China. Retrieved Aug 26, 2020, from s2. Retrieved June 29, 2020, from the drug clinical trial registration and information disclosure platform. From.