Corning Jerry/ Simcere's PD-L1 combined with lenvatinib was approved for the treatment of endometrial cancer
September 15, 2021
On September 15, 2021, Corning Jereh and Simcere announced that the clinical trial application of Envolimab Injection (R&D code: KN035) combined with Lenvatinib mesylate was approved by the National Medical Products Administration. It is used to treat locally advanced, metastatic or recurrent non-microsatellite highly unstable (non-MSI-H)/non-DNA mismatch repair defects (non-MSI-H) and non-microsatellite highly unstable (non-MSI-H)/non-DNA mismatch repair defects (non-MSI-H) that are not suitable for radical treatment and are not suitable for radical treatment. dMMR) endometrial cancer. Endometrial cancer is a common gynecological malignant tumor. Some patients are already at an advanced stage at the time of diagnosis, or have recurrence or metastasis after treatment. There is currently no standard back-line treatment plan for advanced and recurrent endometrial cancer, and it is urgent to explore new treatment strategies and models. Envolimab is a PD-L1 single domain antibody Fc fusion protein independently developed by Corning Jereh. As the world's first subcutaneous injection of PD-L1 single domain antibody, it has submitted a marketing application to the National Medical Products Administration (NMPA) and received priority review. The relevant indications include microsatellite instability (MSI-H) that has failed the previous standard treatment / Mismatch repair defect (dMMR) advanced colorectal cancer, gastric cancer and other advanced solid tumors. Lenvatinib mesylate is a small molecule vascular targeted chemotherapy generic drug approved by Simcere Pharmaceuticals in July this year. It is indicated for patients with unresectable hepatocellular carcinoma who have not received systemic treatment in the past. As an oral multi-target kinase inhibitor, lenvatinib can selectively inhibit the kinase activity of vascular endothelial growth factor (VEGF) receptors, as well as other receptor tyrosine kinases related to pro-angiogenesis and carcinogenic pathways ( RTK) activity, including fibroblast growth factor (FGF) receptor, platelet-derived growth factor (PDGF) receptor, transfection rearrangement (RET), etc. A number of international clinical studies have proved that the combination of immunotherapy and anti-angiogenesis targeted drugs can significantly improve patient benefits. Earlier, the original lenvatinib product was also approved in the United States for treatment with PD-1 inhibitors. Specific patients with advanced endometrial cancer. The advantage of the combination regimen of envolimab and lenvatinib is that envolimab is administered by subcutaneous injection and lenvatinib is an oral tablet. Both are convenient to administer and help improve patient compliance. Reduce the occupation of medical resources and realize the chronic disease management of tumors.
About Envolimab Injection (KN035)
Envolimab injection (development code: KN035) is a PD-L1 single domain antibody Fc fusion protein independently developed by Corning Jereh. Based on its unique design, it has advantages in safety, convenience, and compliance, and patients do not need to Intravenous drip, while having lower medical costs. On March 30, 2020, Corning Jereh, Siddi Pharmaceuticals, and Simcere Pharmaceuticals reached a strategic cooperation. As the original researcher, Corning Jereh was responsible for production and quality, Siddica was responsible for clinical development in the oncology field, and Simcere Pharmaceuticals was responsible for Exclusive commercial promotion of products in Mainland China. At present, Envolimab injection (KN035) has been simultaneously carried out clinical trials for multiple tumor indications in China, the United States and Japan, and multiple indications have entered registration/phase III clinical trials. Envolizumab injection (KN035) has been granted the orphan drug designation for advanced biliary tract cancer and soft tissue sarcoma by the US FDA. Its application for marketing in China has been formally accepted by the National Medical Products Administration (NMPA) and included in the priority review.
