Thirteen Class 1 New Drugs Granted Clinical Trial Approval in China

According to the official website of the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) and publicly available information, last week (April 13th to April 18th), there were 131Class Innovative DrugFirst obtained clinical trial implied permission (IND) in China.These products cover antibodies, antibody-drug conjugates (ADC),Cell therapy, gene therapy, etc.。

3SBIOINC: SSS67 Injection

Mechanism of Action: Targeting ActRTetravalent bispecific antibody targeting IIA and ActRIIB

Indications: Long-term weight management in adult patients

3SBIOINC's SSS67 Injection Approved for Clinical Trial, Intended for Long-Term Weight Management in Adult Patients. According to public information, SSS67 is developed by 3SBIOINC.A tetravalent bispecific antibody drug capable of simultaneously binding to ActRIIA and ActRIIB receptors, achieving dual effects of fat reduction and muscle mass increase by regulating pathways related to fat metabolism and muscle synthesis.。This product is expected to achieve the ideal weight management goals of fat reduction and muscle mass increase through differentiated inhibition of dual targets, combined with existing drugs.

Qilu Pharmaceutical: Injectable QLS5212

Mechanism of Action: ADC Drug (Specific Target Not Disclosed)

Indications: Proposed for advanced solid tumors

Qilu Pharmaceutical's Application for Injectable QLS5212 Approved for Clinical Trials, Intended for Advanced Solid Tumors. According to Qilu Pharmaceutical's press release, injectable QLS5212 is an ADC drug developed by the company. Its design concept fully utilizes the synergistic effect of antibody targeting and the highly efficient cytotoxicity of small-molecule toxins, aiming to address common clinical challenges in the treatment of advanced solid tumors such as drug resistance, recurrence, and non-specific toxic side effects. Preclinical research data of the drug has demonstrated favorable anti-tumor activity and manageable safety characteristics.

CSPC: SYS6051

Mechanism of Action: ADC Targeting TF

Indications: Advanced Solid Tumors

CSPC's SYS6051 Approved for Clinical Trials, Aiming to Treat Advanced Solid Tumors. Public information shows that this is an antibody-drug conjugate (ADC) targeting tissue factor (TF), intended for the treatment of malignant tumors with positive TF expression.This product employs a humanized TF-targeting IgG1 antibody, conjugating the topoisomerase I inhibitor Exatecan to the antibody via a protease-cleavable linker, with a drug-to-antibody ratio (DAR) of 6.Compared with traditional cysteine thiol-maleimide conjugated ADCs, SYS6051 exhibits enhanced resistance to retro-Michael elimination reactions, resulting in higher stability.

Gan&Lee Pharmaceuticals: GLR1062 Injection

Mechanism of Action: AAV-Delivered Gene Therapy (Expressing VEGF Antagonist)

Indications: nAMD

Gan&Lee Pharmaceuticals' GLR1062 Injection Approved for Clinical Trials, Aiming to Develop Treatment for Adult Neovascular (Wet) Age-Related Macular Degeneration (nAMD). Public information shows that GLR1062 InjectionIt is a Class 1 innovative biologic drug that utilizes gene therapy technology and employs recombinant adeno-associated virus (AAV) as the delivery vector. This product achieves long-term expression of vascular endothelial growth factor (VEGF) antagonists in the body through a single intravitreal injection.`, which is expected to control the condition in the long term and significantly improve patient compliance and treatment outcomes.`

Tophar BioPharm: Human Umbilical Cord Mesenchymal Stem Cell Injection

Mechanism of Action: Human Umbilical Cord Mesenchymal Stem Cells

Indications: Diabetic Nephropathy

Tuohua Pharmaceutical's申报的人脐带间充质干细胞注射液 has been approved for clinical trials, aiming to develop a treatment for diabetic kidney disease. Public data indicates that these stem cells can exert therapeutic effects through multiple pathways and targets, inhibiting renal inflammation, regulating the immune microenvironment, and reducing glomerular and tubular damage. They can also slow the progression of renal fibrosis, decrease extracellular matrix deposition, and protect renal function. Additionally, they can improve insulin resistance, promote microvascular repair, and delay the progression of kidney disease from both metabolic regulation and tissue repair dimensions, reducing urine protein levels and stabilizing the glomerular filtration rate.

Benda Biologics: BTL-101 Injection

Mechanism of Action: Tri-specific T-cell Engager Targeting BCMA×GPRC5D×CD3ε

Indications: Relapsed/Refractory Multiple Myeloma

BTL-101 Injection, developed by Bendaobi, has been approved for clinical trials and is intended to treat relapsed/refractory multiple myeloma. Public information indicates that BTL-101 is a next-generation trispecific T-cell engager targeting BCMA×GPRC5D×CD3ε. The product optimizes CD3 affinity, enabling "rapid binding and rapid dissociation," effectively killing tumor cells while reducing the risk of T-cell exhaustion and cytokine release syndrome (CRS). This product not only holds promise as a potential new therapy in the field of multiple myeloma but also has the potential to expand into autoimmune diseases (such as systemic lupus erythematosus and immune nephropathy) by deeply eliminating pathogenic plasma cells through short-term treatment, achieving "immune resetting" and long-term drug-free remission.

In addition to the above new drugs, the Class 1 new drugs that received clinical trial implied permission in China this week also include:

Zhongshen Innovation Pharmaceuticals and Thermo Pharma's BCR-0003 tablets have been approved for clinical trials, intended for development to treat peripheral neuropathic pain.

HRS-3005 Tablets, submitted by Hengrui Medicine, have been approved for clinical trials and are intended for the treatment of B-cell malignancies.

Biotai Pharmaceuticals' injectable HY016 has been approved for clinical trials, intended for development to treat advanced solid tumors.

HX011 Injection, developed by Houxian Bio, has been approved for clinical trials. It is intended to be developed for advanced solid tumors that have no effective treatment options after existing standard treatments, including but not limited to melanoma, colon cancer, triple-negative breast cancer, and lung cancer.

Newray Biotech's NEWR0919 eye drops approved for clinical trial, intended for dry eye development.

Huikang Biotech's human lysozyme eye drops approved for clinical trials, intended for dry eye development.

HX102 Tablets, developed by Huaxia Shengsheng, have been approved for clinical trials and are intended for the treatment of early- and mid-stage Parkinson's disease.

We look forward to the smooth progress of the subsequent clinical development process of these new drugs under research.Bring to patients as soon as possibleNew treatment options have arrived.

References:

[1] Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China.From https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c