Among them, the website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration announced that the BGC515 capsule declared by Suzhou Qiaoji Biotechnology has been approved for clinical use and is intended to be developed for the treatment of advanced solid tumors. According to the data, BGC515 is an oral covalent TEAD inhibitor developed internally by BridGene Biosciences.

 

 

 

DAT-2645, a class 1 new drug declared by Qingyao Pharmaceutical, was approved for clinical use last week, and is intended to be used for patients with advanced or metastatic solid tumors carrying the function deletion mutation of breast cancer susceptibility gene 1/2 (BRCA1/2) and/or other defects in the deoxyribonucleic acid damage repair (DDR) pathway. According to the data, this is a PARG inhibitor developed by Danqing Pharmaceutical, which specifically kills tumor cells carrying specific DNA damage repair defects through a synthetic lethal mechanism. It is reported that the indications of DAT-2645 include many common cancers such as breast cancer, ovarian cancer, pancreatic cancer, prostate cancer, uterine cancer, gastric cancer, colorectal cancer, etc. It is expected to expand the indications of PARP inhibitor ineffectiveness and solve the pain points of PARP inhibitor resistance, which has a potential clinical application prospect of "broad-spectrum therapeutics".

 

 

 

The anti-tumor candidate drug, DNA polymerase θ (Pol θ) small molecule inhibitor SIM0508, independently developed by Xiansheng Pharmaceutical, also received a drug clinical trial approval notice from the National Medical Products Administration (NMPA) of China last week. It is planned to conduct clinical trials of SIM0508 for advanced solid tumors.

 

 

 

The BC011 antibody injection developed by Baochuan Biotechnology was approved for clinical trials last week, and the indication for clinical approval this time is advanced solid tumors. Data shows that BC011 is a novel TNFR2 non blocking therapeutic antibody that can promote CD8+T cell proliferation and increase the proportion of effector T cells in the tumor microenvironment. Research has shown that BC011 monotherapy and in combination with anti-PD-1/L1 antibodies exhibit good anti-tumor activity in mouse tumor models.

 

 

 

Last week, Puzhong discovered that the injection grade AMT-676 was also approved for clinical use, intended for the treatment of advanced solid tumors. According to the data, this is an anti-CDH17 antibody conjugated drug (ADC) and also an investigational drug for pan gastrointestinal tumors. Studies have shown that it plays an important role in the invasion and metastasis of various tumors, especially in digestive system tumors.

 

 

 

Last week, Shenzhou Cell received the "Drug Clinical Trial Approval Notice" issued by the National Medical Products Administration, approving the clinical trial of the company's independently developed product SCTB41 injection for monotherapy of advanced malignant solid tumor patients. SCTB41 products are various solid tumor immunotherapy three specific antibody injections independently developed by Shenzhou Cell with the goal of differentiation and competitive advantage.

 

 

 

In addition, the new generation Bcl-2 inhibitor HZ-L105, jointly developed by Hezheng Pharmaceutical and Hongye Pharmaceutical, was approved for clinical trials last week and is intended to be developed for the treatment of mature B-cell malignancies. According to preclinical research results presented at the 2023 American Association for Cancer Research (AACR) Annual Meeting, this product has high activity, high selectivity, and the ability to overcome Bcl-2 mutation resistance that may occur after long-term use of vinclar.

 

 

 

Last week, Zhigen Pharmaceutical, a subsidiary of Warner Bros. Pharmaceutical, received the "Drug Clinical Trial Approval Notice" for ZG-002 tablets approved and issued by the National Medical Products Administration. According to the data, ZG-002 is a new class 1 new drug developed independently by Zhigen Medicine for the treatment of autoimmune diseases, currently intended for the treatment of moderate to severe plaque psoriasis.

 

 

 

The bexotegrass tablets applied for by Pliant Therapeutics were also approved for clinical use in China last week, with plans to develop a treatment for idiopathic pulmonary fibrosis. The data shows that this is a dual inhibitor of oral small molecule α v β 6 and α v β 1 integrin, which reduces the expression of various pro fibrotic genes by inhibiting the TGF - β signaling pathway.

 

 

 

Last week, Shouyao Holdings also received the "Drug Clinical Trial Approval Notice" approved by the National Medical Products Administration. The company's SY-7166 single drug application for the treatment of multiple myeloma has been approved. Data shows that SY-7166 is a highly active and selective immunoproteasome inhibitor with good preclinical anti-tumor activity and safety.