2025 Oncology Drug Approvals in China: A Landmark Year of Innovation and Therapeutic Expansion

Compiled by |Medical Community News Team

Looking Back at 2025: The National Medical Products Administration (NMPA) Successively Approved Multiple New Cancer Drugs, Covering Various Fields and Providing Patients with New "Weapons." Want to Know Which New "First-Time" Drugs Are Worth Paying Attention to This Year? To Provide a Clear Overview, the Editor Has Quickly Compiled This List.List of New Cancer Drugs Approved for the First Time in China in 2025 (As of the Release Date).These breakthrough therapies, come and take a look!

Indications:Used in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (including lenalidomide and a proteasome inhibitor).

Mechanism of Action:Isatuximab is a monoclonal antibody that targets a specific epitope of the CD38 receptor on multiple myeloma cells. The product can trigger multiple different mechanisms of action, including programmed tumor cell death (apoptosis) and modulation of the body's immune response.

2025 Medical Insurance Category:B

Indications:For the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who carry susceptible FGFR3 gene mutations, have previously received at least one line of therapy containing anti-PD-1 or anti-PD-L1, and have experienced disease progression during or after such therapy, and are not candidates for surgery.

Mechanism of Action:Erdafitinib is a full fibroblast growth factor receptor (FGFR) inhibitor with significant anti-tumor activity. It primarily works by inhibiting the activity of FGFR, cutting off the growth signal transduction pathway of tumor cells, thereby achieving therapeutic effects on malignant tumors.

2025 Medical Insurance Category:Not included

Indications:For the maintenance treatment of adult patients with advanced epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have achieved complete or partial response after first-line platinum-based chemotherapy.

Mechanism of Action:Senaparib is an orally administered poly (ADP-ribose) polymerase (PARP) inhibitor. By inhibiting the activity of PARP enzymes, it blocks the repair process of DNA single-strand damage, leading to the accumulation of DNA double-strand breaks in tumor cells with homologous recombination repair deficiencies (such as BRCA mutations), thereby inducing synthetic lethality in tumor cells.

2025 Medical Insurance Category:B

Indications:Indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed on or after treatment with epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) and whose tumors have been confirmed to harbor the EGFR T790M mutation.

Mechanism of Action:Liotinib inhibits the activity of the epidermal growth factor receptor (EGFR), blocks its signaling pathway, and thereby suppresses the growth and spread of tumor cells.

2025 Medical Insurance Category:B

Indications:This product, in combination with platinum-based chemotherapy, is used for the first-line treatment of recurrent and/or metastatic squamous cell carcinoma of the head and neck.

Mechanism of Action:Finolimab Injection is a recombinant humanized anti-programmed death receptor-1 (PD-1) monoclonal antibody that inhibits tumor growth by blocking the binding of PD-1 to its ligand.

2025 Medical Insurance Category:B

Indications:Monotherapy for adult patients with relapsed or refractory multiple myeloma (R/R MM) who have previously received at least three lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.

Mechanism of Action:Talquetamab is a T-cell redirecting bispecific antibody that binds to the CD3 receptor expressed on the surface of T cells and to G protein-coupled receptor class C group 5 member D (GPRC5D) expressed on the surface of multiple myeloma cells.

2025 Medical Insurance Category:Not included

Indications:In combination with carboplatin and pemetrexed, used as a first-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) confirmed to carry epidermal growth factor receptor (EGFR) exon 20 insertion mutations.In April of the same year,Approved in combination with carboplatin and pemetrexed for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer who have EGFR exon 19 deletions or exon 21 L858R substitution mutations and whose disease has progressed during or after EGFR-TKI therapy.In August of the same year, approved in combination with Lanreotide Mesylate Tablets (Rike), for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer carrying EGFR exon 19 deletions or exon 21 L858R substitution mutations.

Mechanism of Action:Amivantamab is a bispecific drug targeting EGFR and c-MET, with multiple mechanisms of anticancer action. It not only inhibits the expression of EGFR and c-MET as well as their downstream pathways, but also blocks tumor cells in the G1 phase and induces apoptosis.

2025 Medical Insurance Category:Not included

Indications:Mainly used for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have previously received at least three lines of therapy (including 1 immunomodulatory agent, 1 anti-CD38 monoclonal antibody, and 1 proteasome inhibitor).

Mechanism of Action:A bispecific antibody targeting B-cell maturation antigen (BCMA) and CD3, which can bind to BCMA on myeloma cells and CD3 on T cells, thereby activating T cells to kill myeloma cells.

2025 Medical Insurance Category:Not included

Indications:This medication, in combination with palbociclib and fulvestrant, is indicated for adult patients with locally advanced or metastatic breast cancer that is endocrine therapy-resistant (including recurrence during or after adjuvant endocrine therapy), PIK3CA-mutated, hormone receptor (HR)-positive, and human epidermal growth factor receptor 2 (HER2)-negative.

Mechanism of Action:Mainly includes targeted degradation of mutant PI3Kα protein, blockade of the PI3K/AKT signaling pathway, induction of tumor cell apoptosis, overcoming endocrine therapy resistance, and synergistic enhancement mechanisms with other drugs.

2025 Medical Insurance Category:B

Indications:Indicated in combination with fulvestrant for adult patients with locally advanced or metastatic breast cancer that is hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, and harbors one or more PIK3CA/AKT1/PTEN alterations, whose disease has progressed after at least one endocrine therapy in the metastatic setting, or who have relapsed during adjuvant therapy or within 12 months after completing adjuvant therapy.

Mechanism of Action:Capistatin is an orally administered, highly selective AKT kinase inhibitor. By inhibiting the activity of AKT, it blocks the PI3K/AKT/mTOR signaling pathway, thereby suppressing the growth, metabolism, and survival of tumor cells.

2025 Medical Insurance Category:B

Indications:Indicated for adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer: in combination with fulvestrant for patients with disease progression after prior endocrine therapy; as monotherapy for patients with disease progression after receiving two or more endocrine therapies and one chemotherapy in the metastatic setting.

Mechanism of Action:As a novel multi-target inhibitor of CDK2/4/6/9, Pyrotinib exerts potent anti-tumor effects by blocking tumor cell proliferation pathways, inhibiting drug resistance pathways, and penetrating the blood-brain barrier. Meanwhile, it targets CDK4/6 kinase, suppressing proliferation by blocking the G1/S phase transition in tumor cells, enhancing efficacy in combination with endocrine therapy, and overcoming or delaying drug resistance.

2025 Medical Insurance Category:B

Indications:For adult patients with advanced non-small cell lung cancer (NSCLC) harboring the mouse sarcoma virus oncogene (KRAS) G12C mutation who have received at least one prior systemic therapy.

Mechanism of Action:Gorelete is an orally administered, highly selective, and irreversible KRAS G12C inhibitor. It covalently binds to the inactive state of the KRAS G12C protein, locking it in an inactive conformation, thereby inhibiting its GTP-dependent activation and downstream signaling pathways (such as MAPK), and suppressing tumor growth.

2025 Medical Insurance Category:B

Indications:Camrelizumab Injection is used in combination for patients with recurrent or metastatic cervical cancer who have failed prior platinum-based chemotherapy but have not received Bevacizumab treatment.

Mechanism of Action:Famitinib is an orally administered multi-target tyrosine kinase inhibitor (TKI), with primary targets including vascular endothelial growth factor receptor (VEGFR), platelet-derived growth factor receptor (PDGFR), c-Kit, etc., exerting its anti-tumor effects by inhibiting tumor angiogenesis and tumor cell proliferation.

2025 Medical Insurance Category:B

Indications:For adult patients with metastatic castration-resistant prostate cancer (mCRPC) who have experienced disease progression after receiving abiraterone acetate and chemotherapy, and who have not previously received novel androgen receptor inhibitors.

Mechanism of Action:Deuterated Enzalutamide is a deuterated derivative of Enzalutamide and an inhibitor of the androgen receptor (AR) signaling pathway. It inhibits the growth of prostate cancer cells by competitively inhibiting the binding of androgens to AR.

2025 Medical Insurance Category:B

Indications:This medication, in combination with fulvestrant, is indicated for adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative recurrent or metastatic breast cancer who have experienced disease progression after prior endocrine therapy.

Mechanism of Action:Fulvestrant is an oral, selective cyclin-dependent kinase 4/6 (CDK4/6) inhibitor. By inhibiting CDK4/6-CyclinD kinase activity, it blocks Rb phosphorylation, arresting the cell cycle in the G1 phase, thereby inhibiting tumor cell proliferation.

2025 Medical Insurance Category:B

Indications:Indicated for adult patients with Langerhans cell histiocytosis (LCH) and histiocytic tumors; pediatric and adolescent patients aged 2 years and above with symptomatic, inoperable plexiform neurofibromas (PN) associated with Neurofibromatosis Type 1 (NF1).

Mechanism of Action:Luvometinib is an orally administered, potent, and highly selective mitogen-activated protein kinase kinase (MEK1/2) inhibitor. It blocks the abnormal activation of the MAPK signaling pathway, thereby inhibiting tumor cell proliferation and inducing apoptosis.

2025 Medical Insurance Category:B

Indications:Indicated for adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (HR+/HER2-) locally advanced or metastatic breast cancer: in combination with an aromatase inhibitor as initial endocrine therapy; in combination with fulvestrant for patients with disease progression after prior endocrine therapy.

Mechanism of Action:Lerociclib is a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor. By inhibiting CDK4/6 kinase activity, it suppresses tumor cell proliferation.

2025 Medical Insurance Category:B

Indications:For patients with HER2 high expression (IHC3+) unresectable locally advanced or metastatic biliary tract cancer who have previously received systemic therapy.

Mechanism of Action:Zenidatamab can simultaneously bind to two non-overlapping epitopes (ECD2 and ECD4) of the HER2 protein, forming a dual signal blockade that more effectively inhibits the growth and proliferation of tumor cells.

2025 Medical Insurance Category:Not included

Indications:Indicated for the treatment of adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring HER2 (ERBB2) activating mutations who have received at least one prior systemic therapy.

Mechanism of Action:Trastuzumab Rui Kang binds to the HER2 receptor on the surface of tumor cells, blocking signal transduction pathways, inhibiting the proliferation and growth of tumor cells, inducing apoptosis of tumor cells, and simultaneously enhancing the body's immune system's ability to attack tumor cells, exerting a powerful anti-tumor effect.

2025 Medical Insurance Category:B

Indications:In combination with fulvestrant, it is indicated for adult patients with locally advanced or metastatic breast cancer that is hormone receptor (HR) positive and human epidermal growth factor receptor 2 (HER2) negative, and who have progressed after prior endocrine therapy.

Mechanism of Action:Trilaciclib is a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor. It reduces the phosphorylation of downstream key signaling molecule Rb, thereby inhibiting the proliferation of Rb-positive tumor cells.

2025 Medical Insurance Category:Not included

Indications:Suvizumab in combination with paclitaxel, liposomal doxorubicin, or topotecan for the treatment of adult recurrent ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that is platinum-resistant and has received no more than one prior systemic therapy.

Mechanism of Action:Suvucitamab blocks the binding of VEGF to receptors KDR (VEGFR2) and FLT-1 (VEGFR1) by binding to vascular endothelial growth factor A (VEGF-A), thereby inhibiting its biological activity, potently suppressing tumor angiogenesis, cutting off the nutrient supply to tumors, and ultimately achieving the goal of inhibiting tumor growth and metastasis.

2025 Medical Insurance Category:Not included

Indications:First-line treatment with amivantamab for EGFR-mutated locally advanced or metastatic NSCLC.

Mechanism of Action:Lazertinib is an oral, third-generation, brain-penetrant EGFR tyrosine kinase inhibitor (TKI) that targets both the T790M mutation and activating EGFR mutations while sparing wild-type EGFR.

2025 Medical Insurance Category:Not included

Indications:Indicated for the treatment of unresectable or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+, or IHC 2+/ISH-) breast cancer in adult patients who have previously received endocrine therapy and at least one line of chemotherapy in the advanced disease stage.

Mechanism of Action:Dedabotumab targets the TROP2 protein. It consists of an anti-TROP2 monoclonal antibody and a topoisomerase I inhibitor payload. The antibody binds to Trop2 on the surface of tumor cells, is internalized by the cell, and releases the topoisomerase I inhibitor, causing DNA damage and apoptosis.

2025 Medical Insurance Category:Not included

Indications:For the treatment of patients with ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not been treated with anaplastic lymphoma kinase (ALK) inhibitors.

Mechanism of Action:Dilorac is an anaplastic lymphoma kinase (ALK) inhibitor that binds to the ATP-binding site within the ALK kinase domain, effectively inhibiting ALK protein autophosphorylation and blocking the phosphorylation of downstream targets, thereby exerting anti-tumor effects.

2025 Medical Insurance Category:Not included

Indications:Indicated for the treatment of adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring HER2 (ERBB2) activating mutations who have received at least one prior systemic therapy.

Mechanism of Action:Zongaitinib is a selective HER2 kinase inhibitor that inhibits tumor cell proliferation and survival by blocking downstream signaling pathways (such as PI3K/AKT and MAPK) driven by HER2 activating mutations.

2025 Medical Insurance Category:Not included

Indications:For adult patients with unresectable or metastatic HER2-positive breast cancer who have previously received one or more anti-HER2 drug treatments.

Mechanism of Action:Boduo Trastuzumab uses trastuzumab as the antibody backbone, adopts the innovative K-Lock conjugation technology with a VC linker, and is combined with Duo-5, a novel MMAF analog and highly active tubulin inhibitor, with a drug-to-antibody ratio of 2.

2025 Medical Insurance Category:Not included

Indications:Indicated for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 21 (L858R) substitution mutations.

Mechanism of Action:Mefenertinib, as an irreversible EGFR/HER2 dual inhibitor, blocks signal autophosphorylation by covalently binding to the kinase domain, cutting off the self-driving mechanism of tumor cells at the source.

2025 Medical Insurance Category:Not included

Indications:For the treatment of adult patients with recurrent/metastatic nasopharyngeal carcinoma who have failed at least two prior lines of systemic chemotherapy and PD-1/PD-L1 inhibitor therapy.

Mechanism of Action:Vebecotamab, through the combination of its targeted monoclonal antibody with the potent microtubule inhibitor payload Monomethyl Auristatin E (MMAE), can specifically bind with high affinity to EGFR on the surface of tumor cells. This leads to the release of the potent payload following endocytosis and lysosomal protease cleavage, resulting in tumor cell death.

2025 Medical Insurance Category:Not included

Indications:For the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have disease progression after prior treatment with androgen receptor pathway inhibitors (ARPI) and are suitable for delayed chemotherapy, as well as for adult patients with PSMA-positive mCRPC whose disease has progressed after prior treatment with ARPI and taxane-based chemotherapy.

Mechanism of Action:Radioligand Therapy (RLT) is an innovative treatment that combines radionuclides with specific ligands targeting tumors, which can be understood as a "targeted therapy" approach that precisely locks onto cancer cells.

2025 Medical Insurance Category:Not included

Indications:In combination with FOLFOX for the first-line treatment of patients with RAS wild-type (both KRAS and NRAS wild-type) metastatic colorectal cancer (mCRC).

Mechanism of Action:Pertuzumab is a recombinant fully human IgG2 monoclonal antibody that targets the epidermal growth factor receptor (EGFR). Its mechanism of action involves specifically binding to EGFR expressed on the surface of tumor cells, inhibiting ligand-induced receptor autophosphorylation and receptor-associated kinase activation, thereby blocking downstream signal transduction, suppressing tumor cell proliferation, and inducing apoptosis.

2025 Medical Insurance Category:Not included

Indications:Indicated for adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer who have experienced disease progression after prior endocrine therapy, in combination with fulvestrant.

Mechanism of Action:Cumoxyli is a novel CDK2/4/6 inhibitor that simultaneously targets CDK2, CDK4, and CDK6 kinases, demonstrating strong selective inhibitory activity against CDK4 kinase. This helps delay resistance to CDK4/6 inhibitors in clinical settings and reduces the risk of bone marrow suppression.

2025 Medical Insurance Category:Not included

Indications:For adult and adolescent patients with solid tumors aged 12 years and above who meet the following conditions: diagnosed with neurotrophic tyrosine receptor kinase (NTRK) fusion gene by a fully validated detection method, excluding known acquired resistance mutations, suffering from locally advanced or metastatic disease, or where surgical resection may lead to severe complications, as well as patients without satisfactory alternative treatments or who have failed prior treatments.

Mechanism of Action:Zolletinib is a novel TRK inhibitor that can specifically bind to and inhibit the activity of TRK proteins. By inhibiting TRK proteins, zolletinib can block the abnormal signaling caused by NTRK fusion genes, thereby suppressing the growth and spread of tumor cells.

2025 Medical Insurance Category:Not included

The above approval status and data are sourced from the official website of the "National Medical Products Administration". If there are any omissions or other issues, please contact us.

More content related to the 2025 Year-End Review of the "Oncology Channel of the Medical Community" is in preparation. Stay tuned!