On February 14th, RemeGen Co., Ltd. (688331.SH/09995.HK) declared that: An open-label, single-center, phase Ib/II clinical study on the safety, efficacy and pharmacokinetic characteristics of Disitamab Vedotin for injection in combination with pyrotinib maleate tablets in the treatment of patients with locally advanced or metastatic non-small cell lung cancer with HER2 gene mutations was officially approved by the Center for Drug Evaluation of the National Medical Products Administration (NMPA).

The purpose of this study is to evaluate the safety and tolerability of Disitamab Vedotin in combination with pyrotinib maleate in patients with locally advanced or metastatic non-small cell lung cancer with HER2 gene mutations, and to determine the dose-limiting toxicity, maximum tolerated dose/recommended combined dose of Disitamab Vedotin in combination with pyrotinib.

Non-small cell lung cancer is a type of lung malignant tumor originating from the bronchial mucosa, bronchial glands and alveolar epithelium, and it is one of the most common malignant tumors in the world. It has become the first cause of death from malignant tumors in the urban population in China. Non-small cell lung cancer accounts for about 80% of all lung cancers, and about 75% of patients are in the middle and advanced stages at the time of discovery, with a poor 5-year survival rate. HER2 mutations can promote the proliferation, survival, invasion and metastasis of tumor cells. Non-small cell lung cancer patients with HER2 activating mutations have poor prognosis and a large unmet clinical need.

Disitamab Vedotin (trade name: Aidixi®) is the first original antibody-drug conjugate (ADC) drug in China independently developed by RemeGen. Targeting HER2 protein on the surface of tumor cells, it can accurately identify and kill tumor cells, and has achieved excellent clinical data in clinical trials for the treatment of urothelial carcinoma and other tumors. It is the first ADC drug in China that has been dually granted by both the US FDA and China NMPA for breakthrough therapy. In 2021, the indications for gastric cancer and urothelial cancer of Disitamab Vedotin were successively approved by the NMPA for marketing, and both have been approved into the national medical insurance drug catalog. Global multicenter pivotal phase II trials for the treatment of urothelial carcinoma are progressing rapidly.