HER2-ADC drugs enter the intensive harvest period, can ARX788 support the transformation of Zhejiang medicine?

TextXu Libo, Amphetamine

The clinical application of the recombinant humanized anti-HER2 monoclonal antibody-AS269 conjugate (ARX788) for injection, which is used for the treatment of HER2-positive advanced breast cancer and gastric cancer, has been accepted by Xinma Bio, a subsidiary of Zhejiang Medicine

Judging from the listing and application data, HER2-ADC drugs have entered an intensive harvest period

Zhejiang Medicine ARX788 clinical application accepted

On January 21, the official website of CDE showed that the clinical application of the recombinant humanized anti-HER2 monoclonal antibody-AS269 conjugate (ARX788) for injection of Xinma Bio, a subsidiary of Zhejiang Medicine, was accepted

Recombinant humanized anti-HER2 monoclonal antibody-AS269 conjugate injection is a new generation of monoclonal antibody conjugated drug jointly developed by Zhejiang Medicine and Ambrx Corporation of the United States on June 14, 2013.

According to the cooperation agreement reached between Zhejiang Medicine and Ambrx, Zhejiang Medicine owns the commercial development rights of ARX788 in China.

In terms of efficacy and safety, the 2020 CSCO conference announced the phase I clinical data of ARX788 in the treatment of patients with HER2-positive breast cancer: the objective response rate (ORR) of patients in the 1.

In terms of research and development progress, in May 2021, ARX788 was included in the breakthrough therapy category by CDE, and in February 2021, it was approved to conduct Phase II/III clinical trials for the treatment of gastric cancer and gastroesophageal junction adenocarcinoma

HER2-ADC drugs enter intensive harvest period

Due to their good targeting and anticancer activity, antibody-drug conjugates (ADCs) have become a new hot spot and an important trend in drug research and development in the field of oncology, and are receiving more and more attention

According to Yaodu data, as of January 29, two HER2-ADC drugs have been approved for marketing in China, including an imported drug, Roche's trastuzumab (Kadcyla, T-DM1); In 2021, Rongchang Bio's HER2-ADC drug, Vidicitumumab (RC48), was approved for marketing, marking the birth of domestic ADC drugs; there are 4 models in clinical phase III, namely AstraZeneca and No.

Judging from the listing and application data, HER2-ADC drugs have entered an intensive harvest period

Prospects of Zhejiang Medicine and ADC Drugs

Essence Securities once stated in a research report that if 278,900 new breast cancer patients in China, 25% HER2 positive, 50% disease progression or drug resistance, ARX788 will eventually reach a 30% market share, and the drug will be priced at 100,000.

The production and commercialization of ARX788 is also progressing steadily.

The researchers of "Nuggets Innovative Drugs" believe that ADC-type antibody drugs can continue to expand the indications of other cancers and the treatment of other disease fields on the basis of bladder cancer, hematological tumors and breast cancer with the improvement of target and antibody technology.