NEWS

The first Chinese self-developed "vidicetuzumab" was approved.

Release time:

2021-06-11 14:22

On June 9, China's State Food and Drug Administration (NMPA) announced that it had approved the listing of Rongchang Bio-injection Vidicetuzumab (trade name: Aidixi),used to treat at leastHER2-overexpressing patients with locally advanced or metastatic gastric cancer treated with 2 types of systemic chemotherapy. This approval of the drug means that,The first domestic independent research and developmentHER2 ADC officially moves from behind the scenes to the front of the stage, is expected to itsCan fully enjoy the first-mover advantage, quickly seize the advanced gastric cancer market.

Vidicetuzumab (disitamab vedotin,RC48) is an antibody drug conjugate targeting HER2 developed by Rongchang Bio. Its molecular structure includes a novel humanized HER2 antibody, its linker is cleavable in tumor cells, and its small molecule cytotoxic drug has high toxicity and side-killing effect. According to the Rongchang Bio press release, the antibody component of Vidicetuzumab is a brand new drug with differentiated biological properties. The candidate drug can target HER2 protein on the surface of the tumor, accurately identify cancer cells, penetrate the cell membrane, and then use small molecule cytotoxic drugs to kill them.

In China, the new drug marketing application for vidicetuzumab is inIt was accepted by the Center for Drug Evaluation (CDE) of the State Drug Administration of China in August 2020 and was included in the priority review for "drugs that meet the conditions for approval.

It is reported that the gastric cancer marketing application submitted by Vidicetuzumab in China is based on aPhase 2 registered clinical trial data. In this study, vidicetuzumab demonstrated excellent anti-tumor activity and was well tolerated.In addition to gastric cancer, vidicetuzumab is currently being conducted in China for urothelial cancer,HER2 low expression of breast cancer, as well as lung cancer and bile duct cancer and other clinical studies. Among them, the application of Vidicetuzumab for HER2 overexpressing locally advanced or metastatic urothelial cancer patients has been included in the breakthrough treatment variety by CDE in December 2020.

InAt the ASCO Conference in 2021, Rongchang Bio announced the latest data from a number of clinical studies of Vidicetuzumab. Preliminary results of a phase 1b/2 study showed that vidicetuzumab combined with the anti-PD-1 monoclonal antibody terreprimumab in the first-line treatment of metastatic urothelial cancer achieved an objective response rate (ORR) of 100 percent in 16 patients with varying degrees of HER2 expression. Another study on breast cancer patients also showed that vidicetuzumab also achieved good results in breast cancer patients with low HER2 expression.

Currently, Rongchang Bio is exploring the efficacy of Vidicetuzumab worldwide. In the United States,The FDA has granted fast-track status for vedicetuzumab for advanced or metastatic gastric cancer and adenocarcinoma of the gastroesophageal junction. In addition, the application of the drug to treat urothelial cancer has also received FDA's breakthrough therapy recognition and fast track qualification.

It is expected that this antibody drug conjugate will come to patients as soon as possible and bring them new treatment options.

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