China—september 5, 2023, CDE official website announced that SHR-A1811 for injection declared by Hengrui Pharmaceuticals is to be included in the breakthrough therapeutic varieties, targeting the indication of HER2-positive advanced colorectal cancer. Public information shows that SHR-A1811 is a HER2-targeted antibody-coupled drug (ADC), which has been included in the breakthrough therapeutic varieties three times.

SHR-A1811  injection is a HER2-targeted ADC therapy ，it is independently developed by Hengrui Pharmaceuticals. It can induce apoptosis by binding to and endocytosing HER2-expressing tumor cells, releasing the toxin through protease shearing in tumor cell lysosomes, and inducing cell cycle blockade and thus apoptosis.

According to an earlier press release from Hengrui Medician, the company first disclosed data from an international, multicenter, Phase 1, first-in-human study of SHR-A1811 in patients with HER2-expressing or mutated advanced solid tumors at the 2023 American Association for Cancer Research (AACR) Annual Meeting. The study included 263 patients, most of them had received 3 or more prior lines of therapy targeting metastatic lesions. In terms of efficacy, most patients experienced tumor shrinkage after SHR-A1811 treatment. Except for patients with HER2-positive and HER2 low-expressing breast cancer, the confirmed ORR for other HER2-expressing or mutated solid tumors was 53.6%, and the 6-month PFS rate was 73.4%.

The results of preclinical studies show that SHR-A1811 has good antitumor activity, safety, tolerability and pharmacokinetic characteristics, or may further improve drug resistance and efficacy to meet the clinical needs and provide more therapeutic choices for a wide range of tumor patients.

It is reported that SHR-A1811 has been approved to carry out a number of Phase 1, 2 and 3 clinical studies, aiming to provide a potential therapeutic option for patients with tumors that have abnormalities in the HER2 gene, and to provide more clinical evidence for follow-up studies and for the drug to benefit patients.