Jiangsu Hengrui Pharmaceuticals(01276): SHR-A1811 included in revolutionary therapeutic drug list

Jiangsu Hengrui Pharmaceuticals (01276) announced that its subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has had its injection of camptothecin mucin monoclonal antibody (SHR-A1811) included in the list of breakthrough therapies by the National Medical Products Administration Drug Evaluation Center. This is the 11th indication of camptothecin mucin monoclonal antibody to receive breakthrough therapy certification. The company's injection of camptothecin mucin monoclonal antibody has already been approved for two indications in China: for the treatment of unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) adults with HER2 (ERBB2) activating mutations who have previously received at least one systemic therapy, and for the treatment of locally advanced or metastatic HER2-positive adult breast cancer patients who have previously received one or more anti-HER2 drugs. According to data from the International Agency for Research on Cancer (IARC) of the World Health Organization in 2022, breast cancer is the second most common malignant tumor globally and the most common malignancy in women. Global statistics show approximately 2.297 million new cases of female breast cancer annually in 2022. The incidence and mortality rates of breast cancer vary by region worldwide. In China, the 2022 cancer statistics show that breast cancer accounts for 15.6% of all malignant tumor incidences (approximately 357,000 cases) and about 75,000 deaths. Currently, the incidence of breast cancer in China is rapidly increasing, ranking second in the spectrum of female tumors. The injection of camptothecin mucin monoclonal antibody can bind to HER2-expressing tumor cells and induce cell cycle arrest and apoptosis by delivering toxins into the tumor cell lysosomes through proteinase cleavage. The released toxins have high membrane permeability, which can enhance bystander killing effects and improve the efficacy of anti-tumor therapy. In addition to the company's injection of camptothecin mucin monoclonal antibody, other similar products available on the market in China for intravenous infusion include Ado-trastuzumab emtansine developed by Roche, Fam-trastuzumab deruxtecan developed by AstraZeneca in collaboration with Daiichi Sankyo, vidisitumab monoclonal antibody developed by REMEGEN, and bodu monoclonal antibody developed by KOLONBIO Tech. According to the EvaluatePharma database, the total global sales of similar products in 2025 are approximately 8.157 billion US dollars. As of now, the accumulated research and development investment in the injection of camptothecin mucin monoclonal antibody-related projects is approximately 1.971 billion yuan (unaudited).