The first domestic ADC declaration for listing is to be reviewed as a matter of priority.

On August 26th, Rongchang Bio submitted an application for the listing of the injection-based Wedixito monoanti-anti-listing in accordance with the scope of priority review (v) drugs that meet the conditions for approval "to be included in the priority review and approval procedures."
disitamab vedotin, RC48, Adichie) is an anti-HER2 antibody drug concedes (ADC), Rongchang Bio submitted its application for market on August 20, but CDE has not yet disclosed its acceptance number.
, according to Rongchang Bioport Exchange prospectuse, the indications submitted this time should be stomach cancer.
RC48 (Edhi), Source: Rongchang Bio-Official WeChat RC48 Treatment of HER2 Over-Expression of Local Late stage or Metastatic Gastric Cancer Phase II Clinical Research Latest Advances presented at the ASCO2020 Conference, led by Professor Shen Lin of Peking University Cancer Hospital In the group of 127 patients who had previously received chemotherapy in systems of 2 or above, HER2 over-expression (including ICH3 plus, IHC2 plus/FISH plus, and IHC2 plus/FISH-patients) had advanced stomach cancer (including gastroesophageal adenocarcinoma).
results showed that the objective mitigation rate (ORR), the main efficacy indicator assessed by the Independent Efficacy Evaluation Committee (IRC), was 23.6%, the medium non-progression lifetime (PFS) was 4.1 months, and the medium total survival (OS) was 7.5 months.
in terms of safety, RC48 common adverse events for white blood cell count reduction, hair loss, neutral granulocyte count reduction, etc., to light and moderate mainly, clinically basically controllable.
wall newspaper show details, source: Rongchang Biological Official WeChat Rongchang Bio said that the above-mentioned research in the past received 2 lines and above chemotherapy in patients with local advanced or metastatic gastric cancer has a prominent effect, filling her2 over the expression of local late stage or metastatic gastric cancer (including gastroesophageal adenocarcinoma) there is a huge and urgent medical need for third- and post-line treatment, and the study also includes HER2 low expression (IHC2 plus/FISH-) tumor patients, broadening the range of traditional HER2-positive patients and expanding the target patient population.
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