▎Edited by the WuXi AppTec content team

The official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration announced that more than ten Class 1 new drugs received implied permission for clinical trials in China for the first time this week. These new drugs come fromHansoh Pharma,Tasly Biopharm、Sino Cells、Baiji Bio、Lanlai TechnologyCompanies such as, involvingTCR-T Therapy、Human Umbilical Cord Mesenchymal Stem Cells、AAV Gene Therapy、Trispecific Antibodyand other new molecular types, which are intended to be developed for the treatment ofTumor、Heart Failure、Gaucher's Disease、Schizophrenia, etc. This article will introduce some of these new drugs for readers' reference only (the order is not significant).

Screenshot source: CDE official website

Lingyi Biotech: LY-M001 Injection

Mechanism of Action: AAV Gene Therapy Drugs

Indications: Gaucher's disease

According to the press release from Lingyi Biotech, LY-M001 is a self-developed product by the company.Adeno-Associated Virus (AAV) Gene Therapy Drugs，The product has been approved for clinical use in China this time and is proposed to be developed for the treatment of Type I or Type III Gaucher's disease.It is also the first innovative drug of the company to receive clinical trial implied permission.LY-M001Using recombinant adeno-associated virus (rAAV) as a vector, a single intravenous infusion is administered.Expresses the glucocerebrosidase required by patients, and can stably express in the body for a long term while degrading harmful glycolipid metabolites.TherebyAchieve the Goal of Long-term Treatment for Gaucher's Disease. PreliminaryInvestigator-Initiated TrialsBed Test (IIT)Data show that the product has performed well in terms of efficacy and safety, with no adverse events reported. The U.S. IND application for LY-M001 was accepted in December 2023.

Baiji Bio: BRL03 Injection

Mechanism of Action: Gene-Modified TCR-T Cell Products

Indications: Solid Tumors

According to the news release from Biotheus, BRL03 is a self-developed product of the company.Gene-Modified TCR-T Cell Products, which belongs to adoptive immune cell therapy technology. The basic principle is to collect immune cells from the patient's blood, genetically engineer them in vitro to enhance the T cells' specific recognition and killing efficacy against tumor cells, and then infuse them back into the patient's body to achieveDirect KillTumorOr stimulate the body's immune function to indirectly kill tumorsThe purpose. IIT studies show that this product has good safety and preliminary efficacy in the treatment of solid tumors. In September 2023, the U.S. FDA approved the Phase 1/2 clinical trial application for BRL03 for the treatment of various advanced solid tumors (including lung cancer, gastric cancer, etc.). This product has now been approved for clinical trials in China and is intended to be developed for the treatment of EBV-positive advanced solid tumor patients, including nasopharyngeal carcinoma, pulmonary lymphoepithelioma-like carcinoma, and gastric adenocarcinoma.

Shanghai Tasly Pharmaceutical Co., Ltd.: Human Umbilical Cord Mesenchymal Stem Cell Injection (B2278 Injection)

Mechanism of Action: Human Umbilical Cord Mesenchymal Stem Cells

Indications: Chronic Heart Failure

Image Source: 123RF

According to the announcement by Hansoh Pharma, HS-10509 is a Class 1 new drug independently developed by the company. It has recently been approved for clinical trials in China and is intended for the treatment of schizophrenia. Schizophrenia is a chronic mental illness that affects how a person thinks, feels, and behaves. The condition includes positive symptoms (hallucinations, delusions), negative symptoms (difficulty experiencing pleasure, social withdrawal), and cognitive impairments.As a chronic, recurrent disease with low patient treatment adherence, the high relapse rate and fluctuating condition have long been the main challenges in the treatment of schizophrenia, indicating unmet clinical needs.

SCTC21C Injection by Sinocelltech

Mechanism of Action: Monoclonal Antibody against CD38

Indications: Hematological Tumors

SCTC21C is a monoclonal antibody injection independently developed by Sinocelltech that targets CD38. CD38 is a transmembrane glycoprotein expressed on the surface of hematopoietic cells and is widely present on various hematopoietic cells. Its expression level in malignant hematopoietic cells is significantly higher than in corresponding normal cells, making it an important target for treating CD38+ hematologic tumors.SCTC21C enhances the killing effect on CD38+ tumor cells through modifications to the Fc segment.Preclinical studies have shown that SCTC21C has good preclinical pharmacokinetics and safety results. The product has been approved for clinical trials in China and is intended to be developed for the treatment of CD38+ hematological tumors.

Bioray Biopharmaceuticals, Entropy Bio: BR115 Injection

Mechanism of Action: HER2 ECD2, HER2 ECD4, CD3 Targeting Trispecific Antibody

Indications: Solid Tumors

BR115 (CMG6A19) is a trispecific antibody jointly developed by Bright Biology and Entropy Biology.Can specifically bind to HER2 ECD2 and/or HER2 ECD4 on the surface of tumor cells, and simultaneously bind to the CD3 molecule on the surface of T cells, thereby recruiting T cells to the vicinity of target cells and redirecting the cytotoxic activity of T cells., inducing T cell activation and lysing target cells; additionally, BR115It is also possible.Dual blockade of HER2 downstream signaling inhibits tumor cell growthCompared with traditional bispecific antibody drugs, BR115 can selectively kill HER2 high-expression tumor cells, while its effect on tissues with normal HER2 expression is significantly reduced, demonstrating better tumor specificity and safety. This product has been approved for clinical trials in China and is intended to be developed for advanced malignant solid tumors.