3 new anti-tumor drugs approved by Xinda Bio have been approved for clinical targets involving CTLA-4, GITR and PD-1.

Screenshot source: CDE official website 1, drug name: IBI310 action mechanism / target: anti-CTLA-4 monoclonal antibody IBI310 is a recombinant all-human source anti-cytotoxic T lymphocyte-related antigen-4 (CTLA-4) monoclonal antibody developed by Cynda Bio.
The product targets CTLA-4 to increase the anti-tumor immune response mediated by human effect T cells and the immunosuppressive activity mediated by weakened regulatory T cells (Tregs cells), thereby suppressing the immune escape of cancer cells and improving the body's immune response.
the product has been approved in two clinical trials in CDE, with advanced cervical cancer and advanced hepatocellular carcinoma.
Based on the Drug Clinical Trial Registration and Information Disclosure Platform, IBI310 has registered five clinical trials in China, including advanced hepatocellular carcinoma, melanoma, high microsatellite instability (MSI-H) or mismatch repair defect (dMMR) advanced colorectal cancer.
, the first patient recruitment was completed in a Phase 3 registered study in China to assist in the treatment of melanoma.
According to an early study published by Cinda Bio at this year's ASCO Annual Meeting, the study was divided into phases 1a and 1b, of which phase 1a was IBI310 monodring therapy for advanced solid tumors that failed standard treatment, and phase 1b was IBI310 combined with Cindilli monotherapy for advanced melanoma.
data show that the clinical results of IBI310's joint Cyndili monoanti-anti-anti-preclinical results show a certain degree of safety and anti-tumor activity, showing that combination therapy can play a synergistic role.
2, drug name: IBI102 action mechanism / target: anti-GITR monoclonal antibody According to a previous press release issued by Xinda Bio, IBI102 is an anti-GITR monoclonal antibody, a new class 1 biological drug.
, Xinda Bio submitted its first clinical trial application for IBI102 in China and was accepted.
the product has been tacitly approved for CDE clinical trials and is intended to be developed for use in advanced malignant tumors.
GITR refers to the glucocorticoid-induced tumor necrosis factorreptor protein, which is a new member of the TNFR super family.
studies have shown that GITR, like other costulent molecules, plays a key role in the activation of T cells, and that its activity can enhance the efficacy of other anticancer therapies, especially immunosuppressants, through synergy.
, GITR has become a potential new target for cancer immunotherapy.
Based on an earlier paper published in the journal ImmunoSciencelogy, the researchers found in mouse models that anti-GCR antibodies, in combination with anti-PD-1 antibodies, can work together to fight tumor growth, and that combination therapy can also promote the proliferation of CD8-T cells in tumors.
3. Drug Name: Xindili monoantigen injection mechanism/target: PD-1 inhibitor Xindili monoantigen is an innovative PD-1 monoclonal antibody jointly developed by Xinda Bio and Eli Lilly and Company, which was approved in China at the end of 2018 for the treatment of recurring/refractic classic Hodgkin's lymphoma.
November, the drug was added to a new version of China's national health-care list, becoming the first PD-1 inhibitor to enter the new version of China's national health-care catalog.
outside China, Syndicant also obtained three orphan drug qualifications for external T-cell lymphoma, T-cell lymphoma and esophageal cancer.
has obtained the implied permission of clinical trials to develop an adaptation for advanced hepatocellular carcinoma.
CDE website shows that the product has been approved in China for a number of clinical trials, indications involving non-squamous non-small cell lung cancer (NSCLC), advanced/metastatic hepatocellular carcinoma, stomach cancer, advanced malignancies and other cancers.
Xindia Bio-Public Information, more than 20 clinical studies (more than 10 of which are registered clinical trials) are currently under way to assess its anti-tumor effects on a wide range of solid and blood tumors.
It is worth mentioning that two new adaptive applications for the non-scaly NSCLC first-line treatment, and the combined treatment of first-line scaly NSCLC patients by Cindili monoantigen and Gissitalbin have also been accepted by the NMPA.
In addition, the product reached the main research endpoint in the in-period analysis of ORIENT-2 in the treatment of advanced/metastatic esophageal squamous cancer in single-drug second-line treatment, and in the in-phase analysis of phase 3 ORIENT-32 in the first-line treatment of advanced liver cancer.
: The Drug Review Center of the State Drug Administration of China. Retrieved Oct 12, 2020, from s.2. Thyda Bio Press Releases and Public Information s.3. Wang B. Zhang W. Jankovic V, et al. Group cancer immunotherapy targeting PD-1 and GITR can rescue CD8 plus Tcell dysfunction and maintain memory phenotype. Sci Immunol. 2018 Nov 2;3 (29). pii: eaat7061. Source: Medical Mission Hills.