CDE Weekly Update: IND Approvals for PD-1/VEGF/CTLA-4 Trispecific Antibody and KRAS-Targeting mRNA Cancer Vaccine from CStone Pharmaceuticals and Abogen Biosciences

May 21, 2025 07:20 CST Updated 07:20

CStone Pharmaceuticals

Innovative Oncology Immunotherapy and Precision Medicine Drug Developer

Abogen

Nucleic Acid Drug Developer

May 21, 2025

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According to the Center for Drug Evaluation of the National Medical Products Administration of China（CDE）According to incomplete statistics from the official website and publicly available information, last week(May 12 - May 18)，Approx. 27 itemsNovel Drug InnovationProposed for Breakthrough Therapy Designation/Proposed for Priority Review/IND Approved for Clinical Trial by Default/IND Application Accepted。(Note: This article only counts new molecular type biologics innovations such as bispecific antibodies, ADCs, and CAR-T.)

The above new developments involve mRNA therapeutic cancer vaccines targeting the undruggable KRAS, PD-1/VEGF/CTLA-4-targeted tri-specific antibodies, and disease control rate.（DCR）For 89.5% of TROP2-targeted ADCs……, from Abogen, CStone Pharmaceuticals, Kelun-Biotech, etc.

▲ May 12 - May 18 Proposed Breakthrough Therapy Designation

/Proposed for Priority Review/IND Approval by Default and IND Application

Biological Innovative Drugs Accepted by CDE

Due to limited publicly available information, Hengrui Medicine's SHR-4712 Injection, Shanghai Bio's SIBP-A16, and Anxin Huai De's AX-023 for injection(Lyophilized)Not included in the statistical table.The following will introduce some biopharmaceutical innovations with more publicly available information.

Breakthrough Therapy Drug

Xinnuowei: CLDN18.2 Targeting ADC

XNW27011 by Cinoval(CLDN18.2-targeted ADC)Proposed for inclusion in the breakthrough therapy category, with the indication: for third-line and above treatment of locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma expressing CLDN18.2.

XNW27011 adopts the tripeptide linker TMALIN and a novel isomerase inhibitor toxin YL0014, with a DAR value of 8. The Phase 1 clinical study results of XNW27011 in patients with locally advanced and/or metastatic solid tumors, presented at the 2024 ESMO Congress, demonstrated that XNW27011 has good safety and shows activity across various tumor types.(Including gastric cancer/gastroesophageal junction adenocarcinoma)and CLDN18.2 expression levels both demonstrated excellent preliminary efficacy.

Priority Review

Kelon Biotech: TROP2-Targeted ADC

Kelun-Biotech's Recombinant Anti-HER2 Monoclonal Antibody Injection(TROP2-targeted ADC)Proposed for Priority Review, the indication is for unresectable locally advanced or metastatic hormone receptor-positive disease that has previously received endocrine therapy and other systemic treatments in the advanced or metastatic stage.（HR+）And human epidermal growth factor receptor 2 negative（HER2-）Adult patients with breast cancer.

More information about Lecanemab Injection can be found in the treatment of breast cancer. Kelun Biotech's TROP2 ADC is proposed for priority review. For more information, see details.CStone Pharmaceuticals' PD-1/VEGFA/CTLA-4 Tri-specific Antibody Approved for Clinical Trials in China to Treat Solid Tumors

IND Clinical Implied Permission

Belief BioMed: AAV Gene Therapy

BBM-P002 Injection is an AAV gene therapy investigational drug independently developed by Belief BioMed, intended for the treatment of primary Parkinson's disease.More information can be found in the treatment of Parkinson's disease, Belief Biomed's AAV gene therapy approved for clinical trials

BeiGene: CLDN6/CD3 Targeting TCE

BGB-B455 for injection is BeiGene's CLDN6/CD3-targeted TCE, under development for the treatment of advanced solid tumors. According to publicly available information, BGB-B455 targets CLDN6 on tumor cells and the CD3 receptor on T cells. It may provide CLDN6-dependent anti-tumor immune responses in a more tolerable manner without causing excessive systemic toxicity.

CStone Pharmaceuticals: PD-1/VEGF/CTLA-4 Targeting Tri-specific Antibody

CS2009 for injection is a tri-specific antibody targeting PD-1/VEGF/CTLA-4 developed by CStone Pharmaceuticals, intended for the treatment of advanced solid tumors. For more information, seeCStone Pharmaceuticals' PD-1/VEGFA/CTLA-4 Tri-Specific Antibody Approved for Clinical Trials in China to Treat Solid Tumors

Junshi Biosciences:CD20/CD3 Targeted Bispecific Antibody

JS203 for injection is a bispecific antibody independently developed by Junshi Biosciences, adopting a 2:1 structure of recombinant humanized anti-CD20 and CD3. The proposed indication is its combination therapy for treating B-cell non-Hodgkin lymphoma.

JS203 Demonstrates Promising Antitumor Efficacy in Phase 1 Clinical Trial for Relapsed or Refractory B-cell Non-Hodgkin Lymphoma Patients, with Efficacy Signals Observed in Lower Dose Groups. Notably, in Diffuse Large B-cell Lymphoma Patients Treated with JS203 at 30 mg, the ORR Reached 80%, with a Complete Response Rate（CRR）Is 40%.

CSPC: GPC3/Interferon Receptor-Targeted Fusion Protein

According to publicly available data from CSPC Pharmaceutical Group, JMT106 Injection is a GPC3/interferon receptor-targeted fusion protein developed by the company for the treatment of advanced solid tumors. This fusion protein kills tumor cells through the targeting ability of the GPC3 antibody while activating immune regulation in the tumor microenvironment mediated by interferon receptors. Preclinical studies show that JMT106 has a broad range of indications and demonstrates significant anti-tumor effects in malignant tumor models such as liver cancer, lung cancer, and ovarian cancer.

IND Accepted for Review

Abogen: mRNA Vaccine

ABO2102 Injection is an mRNA therapeutic cancer vaccine developed by Abogen Biosciences targeting the undruggable KRAS. For more information, seeAbogen's mRNA Therapeutic Cancer Vaccine for "Undruggable" KRAS Target Submitted for Clinical Trial

CSPC: mRNA Vaccine

According to publicly available data from CSPC Pharmaceutical Group, SYS6026 Injection is a therapeutic mRNA vaccine developed by the company that targets the early protein antigens E6 and E7 of HPV16 and HPV18 subtypes.

SYS6026 induces a specific cellular immune response by encoding the mRNA sequences of the E6 and E7 proteins, which are early antigens of HPV16 and HPV18 subtypes. After the vaccine is injected into the body, the mRNA sequences are taken up by cells and translated into corresponding protein antigens. These antigens are then presented to the immune system, triggering a specific T-cell response. This response can break the immune tolerance state of the body towards the HPV virus, eliminate persistent viral infections, and effectively suppress the growth and spread of tumor cells.

References:

1. CDE official website and various corporate official websites

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