News from the Beijing News On July 25, Hengrui Medicine issued an announcement that the State Food and Drug Administration approved the issuance of the “Approval Notice for Drug Clinical Trials”, agreeing to carry out SHR-A1811 for injection combined with pyrotinib or azithromycin Phase Ib/II clinical study of the safety, tolerability, pharmacokinetics and efficacy of debelimumab in subjects with HER2-abnormal advanced non-small cell lung cancer.
Pyrrotinib maleate tablets (trade name: Ai Ruini) were conditionally approved by the State Food and Drug Administration in August 2018 and released in July 2020 Fully approved, the approved indication is combined with capecitabine for the treatment of epidermal growth factor receptor 2 (HER2)-positive patients with recurrent or metastatic breast cancer who have received trastuzumab; June 2022, Ma The indications of pyrotinib lecithin combined with trastuzumab and docetaxel for the neoadjuvant treatment of patients with HER2-positive early or locally advanced breast cancer are conditionally approved for marketing.
Pyrotinib is a small molecule, irreversible, pan-ErbB receptor tyrosine kinase inhibitor. The HER2 small molecule inhibitors that have been marketed at home and abroad for breast cancer treatment include Lapatinib (trade name: Tykerb), Neratinib (trade name: Nerlynx) and Tucatinib (trade name: Tukysa). After querying the EvaluatePharma database, the total global sales of Tykerb, Nerlynx and Tukysa in 2021 will be approximately US$687 million. Up to now, about 1,124.12 million yuan has been invested in research and development of projects related to pyrotinib maleate tablets.
SHR-A1811 for injection can induce cell cycle arrest by binding to HER2-expressing tumor cells and endocytosis, releasing toxins through proteolytic cleavage in tumor cell lysosomes thereby inducing tumor cell apoptosis. Upon inquiry, similar products that have been listed abroad include Ado-trastuzumab emtansine (trade name: Kadcyla) and Fam-trastuzumab deruxtecan (trade name: Enhertu). Kadcyla was developed by Roche and was imported and listed in China in 2019. Enhertu was developed by AstraZeneca and Daiichi Sankyo. There are other ARX788, DP303c, A166, RC48, SYD985, BAT8001 and other products in clinical trials at home and abroad. After querying the EvaluatePharma database, the combined global sales of Kadcyla and Enhertu in 2021 will be approximately US$2.752 billion. Up to now, about 142.53 million yuan has been invested in research and development of SHR-A1811 related projects for injection.
Adebelimumab is a humanized anti-PD-L1 monoclonal antibody independently developed by Hengrui Medicine, which can specifically bind to PD-L1 molecules to block The PD-1/PD-L1 pathway, which leads to tumor immune tolerance, reactivates the anti-tumor activity of the immune system, thereby achieving the goal of treating tumors. Similar foreign products, Atezolizumab (trade name: Tecentriq), Avelumab (trade name: Bavencio) and Durvalumab (trade name: Imfinzi), have been approved for sale in the United States, among which Atezolizumab and Durvalumab have been approved for sale in China. There are similar products in China: Envolimab (trade name: Envida) from Corning Jereh/Sidi Pharmaceuticals and Sugelimab (trade name: Zejiemei) from CStone Pharmaceuticals have been approved by the State Food and Drug Administration. . Upon inquiry, the combined global sales of Atezolizumab, Avelumab and Durvalumab in 2021 will be approximately US$6.7 billion. Up to now, about 342.85 million yuan has been invested in research and development projects related to adebelimumab injection.
Proofreading Liu Baoqing