According to the information obtained from the Zhongtong Finance APP on October 6th, in the just-concluded month of September, several Class 1 new drugs in China obtained implied clinical trial approvals for the first time. Among them, more than 20 Class 1 new drugs are targeted at tumor indications. These new drugs come from companies such as Hengrui Medicine (600276.SH), Kangfang Biotech (09926), BeiGene (06160), and Xinda Biotech (01801). In terms of mechanism of action, these anti-tumor new drugs cover bispecific antibodies, antibody-drug conjugates (ADC), oncolytic bacteria drugs, CAR-T cell therapy, personalized tumor vaccines, and so on.
Specifically, Hengrui Medicine has obtained clinical approval for three Class 1 anti-tumor new drugs, all of which are Class 1 biological products. According to the announcement from Hengrui Medicine, these three products are: 1) SHR-2005 injection, which can activate and promote the response of anti-tumor T cells to inhibit tumor growth, and is intended to be developed for the treatment of bladder cancer; 2) Injection SHR-5495, which can selectively activate immune cells in tumors by utilizing the difference in PD-1 expression on tumor and peripheral T cells, thus avoiding excessive activation of peripheral T cells, and is intended to be developed for the treatment of malignant solid tumors; 3) Injection SHR-1826, which can specifically bind to target antigens on the surface of tumor cells and kill tumor cells after being internalized into them, and is intended to be developed for the treatment of advanced malignant solid tumors.
KT032 cell injection from Kaiti Medical is a new multi-chain CAR-T based on the company's self-developed DAP-CAR platform technology. This technology platform provides natural immune receptor signals to T cells. The design of this receptor separates the recognition functional domain from the activation functional domain, allowing T cells to naturally switch between coupled activation and decoupled resting states, maintaining the CAR expression level of T cells in the solid tumor microenvironment, avoiding CAR-T cell exhaustion and dysfunction, and thus enabling CAR-T to exert better anti-solid tumor efficacy.
Kangfang Biotech has obtained clinical approval for two Class 1 anti-tumor new drugs, both of which are bispecific antibodies. Among them, AK131 is a bispecific antibody targeting PD-1 and CD73 independently developed by Kangfang Biotech. AK131 has demonstrated good anti-tumor activity in preclinical studies and is intended to be developed for the treatment of advanced solid tumors. Another product, AK132 injection, is an asymmetric monovalent bispecific antibody targeting Claudin18.2/CD47. It is also Kangfang Biotech's sixth innovative bispecific antibody drug to enter the clinical research stage. The indication for this drug's clinical approval is advanced malignant tumors.
DeShengji Pharmaceuticals's D3L-001 has been approved for clinical use and is intended to be developed for the treatment of HER2-positive advanced solid tumors. This is a bispecific antibody targeting both HER2 and CD47, which has previously been approved for clinical use in the United States. It can preferentially bind to tumor cells with high affinity to HER2, reducing its binding to normal tissues, thereby reducing the potential blood toxicity of the CD47 target, and maximizing the synergistic effects of antibody-dependent cell cytotoxicity (ADCC) and antibody-dependent cell phagocytosis (ADCP).
Innovent Biologics's Class 1 new drug IBI334 has been approved for clinical use and is intended for the treatment of patients with unresectable, locally advanced, or metastatic solid tumors. According to public information from Innovent Biologics, IBI334 is a dual antibody targeting EGFR/B7-H3 and is currently undergoing Phase 1 clinical trials overseas. The mechanism of action of the EGFR/B7-H3 dual antibody therapy mainly involves simultaneously inhibiting tumor growth and enhancing the immune system's killing ability to achieve a dual attack on tumors.
BeiGene is conducting Phase 1 clinical trials overseas for its investigational DGKζ inhibitor, BGB-30813. The DGKζ inhibitor blocks the activity of DGKζ, thereby preventing the proliferation and survival of tumor cells. In addition, DGKζ can also affect tumor progression by influencing the cell cycle and apoptosis mechanisms.
Tongyong Kang Pharmaceuticals's TYK-00540 is a new generation of oral, highly efficient small molecule CDK2/4/6 inhibitor developed by the company. It can be used to treat malignant solid tumors, including advanced breast cancer after resistance to CDK4/6 inhibitors. This drug has been approved for clinical use and is intended for the treatment of locally advanced/metastatic solid tumors.
Bohui Biotech's BB3008 is a selective small molecule inhibitor of hematopoietic progenitor kinase 1 (HPK1) developed by the company. Experiments have shown that BB3008 can significantly activate T cell activity and can effectively inhibit tumor growth when used alone or in combination with PD-1 inhibitors. It has excellent pharmacokinetics and controllable safety. This drug has been approved for clinical use and is intended for the treatment of advanced solid tumors.
Huajin Pharmaceuticals's Sangmeiweike (SGN1 injection) is an oncolytic bacterium, which is a genetically engineered biological product that can precisely target and rapidly dissolve tumors. It kills tumors and prevents tumor spread by carrying a specific methionine hydrolyzing enzyme on a attenuated Salmonella carrier, depriving tumors of essential amino acids for growth. It is an efficient oncolytic product targeting a broad spectrum of solid tumors. After this product is approved for clinical use, it will officially conduct two clinical trials in mainland China: intravenous administration and intratumoral administration, targeting advanced solid tumors.
Kangdesai Medical's Class 1 new drug CUD002 injection has been approved for clinical use and is intended for the treatment of refractory/resistant recurrent ovarian cancer. It is a tumor vaccine based on patient tumor neoantigens and mRNA-edited dendritic cells (DC).
This product is custom-designed and manufactured based on the unique mutation information of patients. It can stimulate the patient's own immune system to accurately kill tumor cells by targeting the expression of ovarian cancer-related antigens and neoantigens, thereby reducing the risk of recurrence.
NCB003, developed by New Code Biotech, is a next-generation targeted long-acting interleukin-2 drug intended for the treatment of advanced malignant solid tumors. According to publicly available information from New Code Biotech, interleukin-2 has the disadvantages of a short half-life and significant side effects in clinical practice, which NCB003 aims to address. Preclinical studies have shown that NCB003 has a significant inhibitory effect on various transplanted tumors in vivo. The product is relatively stable in the bloodstream, with a prolonged half-life compared to interleukin-2, and it is safe and tolerable at effective doses, providing a certain safety margin.

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On October 6th, according to the official website of the Drug Evaluation Center of the China National Medical Products Administration, several Class 1 new drugs have obtained clinical trial implied consent for the first time in China in the just-concluded month of September. Among them, more than 20 Class 1 new drugs are targeted at oncology indications.

More than 20 new anti-tumor drugs of Class 1 have been approved for clinical trials, involving companies such as Kangfang Biotech.