Gelonghui, March 11 | China Biopharmaceutical (01177.HK) announced that the two innovative drugs “anlotinib hydrochloride capsules” and “TQB2916 (CD40 agonist)” developed by the group's subsidiary, Zhengda Tianqing Pharmaceutical Group Co., Ltd. (“Zhengda Tianqing”), will present five research results at the 2024 American Cancer Association Annual Meeting (“AACR”).
Anlotinib is an oral novel small-molecule multi-target receptor tyrosine kinase inhibitor (TKI) independently developed by Zhengda Tianqing. It can effectively inhibit kinases such as VEGFR1-3, PDGFRα/beta, FGFR1-4, and c-KIT. By regulating tumor microenvironment reprogramming, it can inhibit tumor angiogenesis, inhibit tumor growth, and regulate the immune microenvironment.
In May 2018, anlotinib hydrochloride capsules were approved for marketing by China's National Drug Administration (“NMPA”). It is the first drug approved for third-line treatment of advanced non-small cell lung cancer in China. Anlotinib hydrochloride capsules have been approved in China for five indications: third-line non-small cell lung cancer, third-line small cell lung cancer, soft tissue sarcoma, medullary thyroid cancer, and differentiated thyroid cancer. In January 2023, the marketing application for the sixth indication of anlotinib hydrochloride capsules was officially accepted by the China National Drug Administration Drug Evaluation Center (“CDE”) for first-line treatment of small cell lung cancer in combination with bemosubizumab “TQB2450 (PD-L1 inhibitor)” and chemotherapy. In February 2024, the marketing application for the seventh indication of anlotinib hydrochloride capsules was officially accepted by the CDE for the treatment of recurrent or metastatic endometrial cancer in combination with bemosubizumab.
CD40 agonists mainly exert tumor suppression effects by activating antigen-presenting cells (APC) to promote the activation of immune cells. tqb2916 is an excitatory all-human IgG2 monoclonal antibody targeting CD40. In vitro pharmacodynamics results show that TQB2916 can activate B cells and dendritic cells, which in turn activates T cells to secrete IFN-gamma. Preclinical in vivo pharmacodynamic results showed that TQB2916 can significantly inhibit tumor growth in animal models. Currently, no CD40 agonists have been approved for marketing in the world. Similar products have shown promising development prospects in the fields of pancreatic cancer, soft tissue sarcoma, melanoma, and esophageal cancer.