Seventeen Class 1 Innovative Drugs Receive IND Approval in China for the First Time

According to the official website of the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) and publicly available information, this week (August 4th to August 9th), there were 17 Class 1 innovative drugs...First IND Approval in China.These products coverSmall molecule drugs, antibodies, antibody-drug conjugates (ADC), mRNA vaccines, cell and gene therapiesAnd other types.

Abogen: ABO2102 Injection

Mechanism of Action: Covers MultipleKRASMutant Novel mRNA Tumor Vaccine

Indications: TreatmentKRASLocally Advanced or Metastatic Solid Tumors with Mutations

Abogen's Novel Class 1 Drug ABO2102 Approved for Clinical Trials, Intended for Monotherapy or Combination with SintilimabKRASLocally advanced or metastatic solid tumors with mutations. Public information shows that ABO2102 is developed by Abogen.Can cover multiple types simultaneouslyKRASNovel mRNA tumor vaccine with mutations, suitable for carriersKRASPatients with solid tumors harboring any of the five common mutationsABO2102 Therapeutic Cancer Vaccine Demonstrates Promising Antitumor Activity in Preclinical Studies and Achieves Broad Coverage of HLA (Human Leukocyte Antigen) Subtypes. Preclinical Data Shows That the T Cells Activated by This Vaccine Can Precisely RecognizeKRASNew antigens on the surface of mutated cells effectively kill tumor cells.This endogenous immune response not only avoids the common off-target toxicity of targeted drugs but also continuously suppresses tumor recurrence through immune memory mechanisms.。

Minghui Pharmaceutical: Injectable MHB042C

Mechanism of Action: Anti-c-Met ADC

Indications: Advanced Solid Tumors

Minghui Pharmaceutical Ltd.'s Class 1 new drug, MHB042C for injection, has been approved for clinical trials, intended for the development of treatment for advanced solid tumors. According to the abstract published at the 2025 AAC conference,MHB042C is a next-generation anti-c-Met ADC that utilizes a humanized VHH fragment targeting c-Met, fused with the human IgG1 Fc segment to deliver cytotoxic payloads. Compared to traditional monoclonal antibodies, this smaller VHH-Fc fusion protein has a higher potential for tumor tissue penetration.This unique structure simplifies the conjugation process, with a drug-to-antibody ratio (DAR) of 4. The Fc function has been silenced to reduce non-specific ADC uptake. The payload, SuperTopoiTM, is a novel DNA topoisomerase I inhibitor, which is 3 to 5 times more potent than DXd. The product demonstrates potent anti-tumor activity and favorable safety profiles both in vitro and in vivo, supporting advancement into clinical development.

Neowise Biotechnology: NW-101C Injection

Mechanism of Action: Autologous TCR-T Cell Therapy Targeting PRAME

Indications: Specific advanced malignant solid tumors

Neowise Biotechnology's申报的1类新药NW-101C注射液 has been approved for clinical trials. It is intended to be developed for advanced malignant solid tumors (including ovarian cancer, malignant melanoma, esophageal squamous cell carcinoma, squamous cell carcinoma of the lung, soft tissue sarcoma, and triple-negative breast cancer) that are HLA-A*02:01 positive and PRAME positive, and cannot be surgically removed as they are recurrent or metastatic. According to Neowise Biotechnology's press release, this is...A PRAME-targeting autologous TCR-T cell therapy candidateRAME is a tumor antigen target that is highly expressed in a variety of solid tumors but hardly expressed in normal tissues. In preclinical studies, NW-101C injection demonstrated favorable anti-tumor activity and good safety.

Sanofi (Sanofi）SAR402663 Injection

Mechanism of Action:Novel Anti-VEGF Chimeric Molecule Gene Therapy

Indications: Neovascular Age-Related Macular Degeneration (nAMD)

Sanofi's Novel Drug SAR402663 Injection Approved for Clinical Trials, Intended for Development in TreatmentnAMD. According to publicly available information from Sanofi, this is aA novel anti-VEGF chimeric molecule gene therapy: Preclinical studies have shown that intravitreal gene delivery of sFLT01 mediated by adeno-associated virus type 2 (AAV2) can effectively inhibit angiogenesis in a mouse model of oxygen-induced retinopathy.sFLT01 is a high-affinity VEGF binder.。

Huayu Pharmaceutical:Human Umbilical Cord Mesenchymal Stem Cell Injection

Mechanism of Action:"Spot Type"Human Umbilical Cord Mesenchymal Stem Cells

Indications: Intended for the treatment ofPatients with idiopathic pulmonary fibrosis

Huayu Pharmaceutical's“"Spot Type"Human Umbilical Cord Mesenchymal Stem Cell Injection, a Class 1 New Drug, Approved for Clinical Trials, Intended for Development in TreatmentIdiopathic Pulmonary Fibrosis (IPF）。Human umbilical cord mesenchymal stem cells are considered a promising new strategy for treating IPF due to their potent immunomodulatory, antifibrotic, and tissue repair potential.

Qinhe Force Pharmaceutical:IMD303 for Injection

Mechanism of Action:Anti-CTLA-4 Antibody

Indications: Advanced malignant solid tumors

Affinity Pharmaceuticals' Application for a Class 1 New DrugIMD303 for Injection Approved for Clinical Trials, Intended for Treatment DevelopmentAdvanced malignant solid tumors. Public information shows,Qinheforce focuses on the development of Tumor Microenvironment-Activated (TMEA) drugs, delivering and releasing drugs by sensing the state of the tumor microenvironment, reducing drug toxicity, and enhancing efficacy.IMD303 is aTMEANovel chemically conjugated anti-CTLA-4 antibody.In preclinical studies,The ProductIn the primary resistance model of anti-PD-1, it exhibits strong anti-tumor activity when used alone and shows significant synergistic effects when combined with IMD101 (a TMEA cytokine that releases IL-2).

Haisco:HSK47388 Tablets

Mechanism of Action: New Chemical Drug

Indications: Psoriasis

Haisco's Class 1 new chemical drug HSK47388 tablets has been approved for clinical trials, intended for the development of treatment for psoriasis. According to Haisco's announcement,It is developed byOrally administered, potent, and highly selective drug candidate intended for the treatment of autoimmune diseases.Preclinical study results showed that HSK47388 could inhibit inflammatory responses in rats in a dose-dependent manner, while also demonstrating good tolerability and a wide safety margin.

Frontline Pharmaceutical: TJ101 for Injection

Mechanism of Action: Bispecific ADC Targeting EGFR and B7-H3

Indications: Advanced Solid Tumors

Tuoji Pharmaceutical's wholly-owned subsidiary, Yixian Pharmaceutical, has received clinical approval for its Class 1 new drug, TJ101 for injection, which is being developed to treat advanced solid tumors. According to publicly available information from Tuoji Pharmaceutical, TJ101It is a bispecific antibody-drug conjugate (ADC) targeting EGFR and B7-H3 for the treatment of advanced solid tumors.Compared with traditional monoclonal ADCs, TJ101 utilizes bispecific ADC technology to enhance tumor killing, selectivity, and minimize off-target toxicity. TJ101 is linked to a proprietary topoisomerase I inhibitor via a cleavable linker, with a DAR of 8. After internalization by tumor cells, the linker is enzymatically cleaved in lysosomes, releasing the payload to directly kill the tumor cells and strongly eradicate neighboring tumor cells.

LM Pharma: LM-24C5 for Injection

Mechanism of Action: CEACAM5 x 4-1BB Bispecific Antibody

Indications: CEACAM5-positive advanced solid tumors

LM-24C5, a novel Class 1 drug developed by Lixun Pharmaceuticals, has been approved for clinical trials. It is intended for the treatment of advanced solid tumors (such as non-small cell lung cancer and colorectal cancer) that are CEACAM5 positive. Public information indicates that this is a CEACAM5 x 4-1BB bispecific antibody.A novel CEACAM5-dependent 4-1BB bispecific agonist antibody that redirects and activates T cells to CEACAM5-positive tumor cells by binding to the 4-1BB antigen, achieving localized T-cell activation while reducing systemic toxicity., which is expected to become a potential new therapy for colorectal cancer and other CEACAM5-positive tumors.

In addition to the aforementioned new drugs, the Class 1 new drugs that received implied clinical trial approval in China for the first time this week also include:

• HW241045 Tablets, a new chemical drug developed by Renfu Innovative Drug Research and Development Center, are intended for the treatment of idiopathic pulmonary fibrosis.

• The new biological product EXG202 injection, submitted by Jiayin Bio, is intended for the treatment of patients with wet age-related macular degeneration (wAMD);

• Roche's newly declared chemical drug RO7840734 targets the treatment of locally advanced or metastatic breast cancer that is estrogen receptor-positive (ER+) and human epidermal growth factor receptor 2-negative (HER2-).

• SZ Pharmaceutical's newly declared chemical drug SZ2001 tablet is under development for the treatment of anemia caused by chronic kidney disease (CKD), including both dialysis and non-dialysis patients;

• Hengrui Medicine's newly declared biologic SHR-7782 Injection, intended for cancer treatment development; and the new chemical drug HRS-6093 Tablets, intended for treating carriers.KRASG12DMutated solid tumors;

• DC411151 Capsule, a novel chemical drug jointly filed by Minsheng Pharmaceutical and the Shanghai Institute of Materia Medica, Chinese Academy of Sciences, is under development for the treatment of moderate to severe active ulcerative colitis.

• The new biologic drug SIBP-A10 injection, developed by Shanghai Institute of Biological Products, is intended for the treatment of malignant tumors such as non-small cell lung cancer, head and neck cancer, renal cancer, and glioblastoma.

We look forward to the smooth progress of the subsequent clinical development process for these investigational new drugs, which will bring new treatment options to patients as soon as possible.

References:

[1] Official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China.Retrieved Aug 9, From https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c