On March 23, Rongchang Bio (688331.SH/09995.HK) announced that its independently developed original antibody-drug conjugate (ADC), vidicetuzumab (RC48, Aidixi®), has been officially approved for marketing by the National Medical Products Administration for a new indication. It is used to treat adult breast cancer patients with unresectable or metastatic HER2-low expression (IHC 1+ or IHC 2+/ISH-) and liver metastases who have previously received at least one systemic therapy at the metastatic stage, or who have relapsed during or within 12 months after completing adjuvant chemotherapy.

This is the fourth indication for which vedictetumab has been approved for marketing in China, following gastric cancer, urothelial carcinoma, and HER2-positive advanced breast cancer with liver metastasis.

The clinical research evidence supporting this approval for marketing of a new indication is based on a randomized, open-label, parallel-controlled, multicenter phase III clinical trial (RC48-C012) conducted in China. This study demonstrated that vedicetumab has good efficacy and safety in treating adult breast cancer patients with unresectable or metastatic HER2-low expression (IHC 1+ or IHC 2+/ISH-) and liver metastases who have previously received at least one systemic therapy during the metastatic stage, or who have relapsed during or within 12 months after completing adjuvant chemotherapy. The trial was conducted at 60 clinical research centers across China, with Academician Xu Binghe of the Cancer Hospital of the Chinese Academy of Medical Sciences as the principal investigator.
Dr. Jianmin Fang, CEO of Rongchang Biotechnology, stated that breast cancer poses a serious threat to patients' lives and health, and the need for clinical treatment is urgent. Previously, vediclatus was approved in China for the treatment of HER2-positive advanced breast cancer with liver metastases, making it the world's first and only ADC drug precisely targeting this indication. This new indication approval further benefits patients with low HER2 expression and liver metastases, achieving full coverage of HER2 expression levels for breast cancer treatment with liver metastases, demonstrating significant clinical value. He expressed his sincere gratitude to all the researchers and patients who have driven the clinical research.
Breast cancer is the most common malignant tumor among women worldwide. According to GLOBOCAN 2022 data, there are 2.3 million new cases of breast cancer and 670,000 deaths worldwide each year [1] . In China, there are 357,000 new cases of breast cancer and 75,000 deaths annually [2] . Among the new cases of breast cancer each year, about 3% to 10% of patients have distant metastases at the time of diagnosis. Liver metastasis is a more serious and highly lethal type of metastasis in breast cancer. About 17.8% to 35% of patients with metastatic breast cancer will develop liver metastases, and the 5-year survival rate is about 20%. Traditional treatments for advanced breast cancer that cannot be treated surgically include chemotherapy and radiotherapy, which patients often cannot tolerate and eventually the disease progresses.
HER2 is an important driver gene and prognostic indicator for breast cancer. In breast cancer patients, about 45% to 55% of cases are in a state of low HER2 expression [3] . The 3-year survival rate of breast cancer patients with low HER2 expression is about 20%, and about one-third of patients will experience recurrence and metastasis. The prognosis of visceral metastasis is far worse than that of non-visceral metastasis. For a long time, these patients have had limited treatment options after progressing with standard endocrine therapy or chemotherapy.
Vidicetumab is China's first original ADC drug independently developed by Rongchang Biotechnology. Since 2021, it has been approved for four indications: HER2-overexpressing locally advanced or metastatic gastric cancer, HER2-overexpressing locally advanced or metastatic urothelial carcinoma, HER2-positive advanced breast cancer with liver metastases, and HER2-low expression breast cancer with liver metastases. This approval of a new indication not only provides solid evidence for clinical decision-making but also offers patients better treatment options. While continuously expanding its monotherapy indications, Rongchang Biotechnology is actively exploring the combination of vidicetumab with other drugs, which will benefit a wider range of patients in the future.

https://bydrug.pharmcube.com/news/detail/6e790157801a1030f2654ca4eecd9477