By 2025, it is expected that 30 new cancer drugs will be approved in China! From companies such as Hengrui, BEIGENE, Astrazeneca PLC Sponsored ADR, Novartis AG Sponsored ADR, etc.

Astrazeneca PLC Sponsored ADRPD-L1 Clinical treatment advances and new drug development in the field of cancer have always been highly anticipated, and cancer accounts for the highest proportion of newly approved drugs in China every year. This article will combine information from the official website of China's National Medical Products Administration Drug Evaluation Center (CDE) and various company public materials to list 30 new cancer drugs expected to be approved for market in China by 2025. These drugs are expected to bring new treatment options for a range of cancer types including lung cancer, breast cancer, ovarian cancer, prostate cancer, nasopharyngeal cancer, gastric cancer, colorectal cancer, lymphoma, leukemia, and more. (The data collected in this article covers new drugs submitted to CDE for approval between January 2024 and December 2024; new drugs included in this list are only those classified as Category 1, 3.1, or 5.1; only potential first-time approved drugs are included, excluding new indications). GlaxoSmithKline plc Sponsored ADR(GSK.US): Belantamab Mafodotin for injection Mechanism of action: ADC targeting BCMA Indication: Multiple myeloma Belantamab mafodotin is an ADC targeting BCMA developed by GSK, consisting of a humanized anti-BCMA monoclonal antibody and the cytotoxic drug auristatin F linked by an uncutable connector. In December 2024, the product's market approval application was accepted by the CDE and given priority review for the indication of use in combination with bortezomib and dexamethasone to treat adult patients with relapsed or refractory multiple myeloma who have received at least one prior therapy. Yiduoshenzhou: IM19 Mechanism of action: Autologous CAR-T cell targeting CD19 Indication: Diffuse large B-cell lymphoma IM19 is a candidate product developed by Yiduoshenzhou targeting CD19 with autologous CAR-T cells, utilizing innovative CAR molecular design and production processes to provide more specific therapeutic effects. In November 2024, the product's market approval application was accepted by the CDE for the treatment of relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL). Additionally, in August 2024, Yiduoshenzhou reached a commercial authorization agreement with Huadong Medicine for the mainland China region. Yasheng Pharmaceuticals (06855): Lisaftoclax tablets Mechanism of action: Bcl-2 selective inhibitor Indication: CLL/SLL Lisaftoclax (APG-2575) is a novel oral Bcl-2 selective inhibitor developed by Yasheng Pharmaceuticals to selectively inhibit the Bcl-2 protein, restoring the normal apoptosis process of cancer cells and achieving the goal of tumor treatment. In November 2024, the product's market approval application was accepted by the CDE and given priority review, intended for the treatment of refractory or relapsed chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). Novartis AG Sponsored ADR (NVS.US): Pluvicto Lutetium-177 PSMA injection Mechanism of action: PSMA-targeted radioligand therapy Indication: Prostate cancer Pluvicto Lutetium-177 PSMA injection is a PSMA-targeted radioligand therapy developed by Novartis AG Sponsored ADR. In November 2024, the product's market approval application was accepted by the CDE and given priority review for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in adult patients who are positive for prostate-specific membrane antigen (PSMA), and who have received androgen receptor pathway inhibition and taxane chemotherapy. Additionally, the application for the market approval of Gallium-68 Ga-DOTA-TATE injection preparation kit, also submitted by Novartis AG Sponsored ADR, was simultaneously accepted. This product, after being radiolabeled with 68Ga, can be used as a radiopharmaceutical diagnostic agent for identifying PSMA-positive lesions in adult prostate cancer patients through positron emission tomography (PET). AbbVie (ABBV.US): Epcoritamab Mechanism of action: CD3/CD20 bispecific antibody Indication: Diffuse large B-cell lymphoma or follicular lymphoma Epcoritamab is a subcutaneous CD3/CD20 bispecific antibody that has previously been approved by the FDA in the United States for the treatment of diffuse large B-cell lymphoma and follicular lymphoma. This innovative therapy was also ranked by industry media Evalute as one of the top ten potential blockbuster therapies in 2023. In November 2024, the product's market approval application in China was accepted by the CDE. Shouyao Holdings (688197.SH): Cotyatinib Mechanism of action: ALK inhibitor Indication: ALK-positive non-small cell lung cancer In October 2024, the market approval application for Cotyatinib granules, a Category 1 new drug jointly applied by Shouyao Holdings and Beijing Sl Pharmaceutical, was accepted. According to the announcement by Shouyao Holdings, this is an ALK inhibitor developed independently by the company, with the indication for monotherapy in ALK-positive locally advanced or metastatic non-small cell lung cancer patients. AstraZeneca PLC Sponsored ADR (AZN.US): Tremelimumab Mechanism of action: Anti-CTLA-4 monoclonal antibody Indication: Non-small cell lung cancer/liver cancer In October 2024, AstraZeneca PLC Sponsored ADR's market approval applications for the anti-CTLA-4 monoclonal antibody tremelimumab and the PD-L1 inhibitor durvalumab were accepted under the biological product Category 3.1, with specific indications yet to be disclosed. Public information shows that this combination therapy has previously been approved for the treatment of advanced or unresectable hepatocellular carcinoma in adult patients in countries and regions including the United States, the European Union, and Japan. Durvalumab is a PD-L1 inhibitor launched by AstraZeneca PLC Sponsored ADR.The combination of the immune checkpoint inhibitor tremelimumab and chemotherapy has been approved for the treatment of metastatic non-small cell lung cancer.600276.SHSHR2554 Mechanism of action: EZH2 inhibitor Indications: Peripheral T-cell lymphoma SHR2554 is an EZH2 inhibitor developed by Jiangsu Hengrui Pharmaceuticals. In October 2024, the product's marketing application was accepted by the CDE and included in priority review, intended for patients with relapsed or refractory peripheral T-cell lymphoma who have received at least one previous systemic therapy. In 2023, Jiangsu Hengrui Pharmaceuticals reached a cooperation agreement with Treeline Corporation worth over 700 million US dollars, granting the latter exclusive rights to develop, manufacture, and commercialize SHR2554 worldwide except in Greater China. Lupe Biopharma (02157): Injection of Vebicotutuzumab Mechanism of action: ADC targeting EGFR Indications: Nasopharyngeal cancer Vebicotutuzumab is an ADC targeting EGFR developed by Lupe Biopharma, consisting of an EGFR-targeting monoclonal antibody and the potent microtubule inhibitor MMAE linked by a vc linker. In September 2024, the product's marketing application was accepted by the CDE and included in priority review, for use in patients with recurrent/metastatic nasopharyngeal cancer who have failed at least second-line systemic chemotherapy and treatment with PD-1/PD-L1 inhibitors. Jiangsu Hengrui Pharmaceuticals: Rirafup- Injection Mechanism of action: Dual-function fusion protein targeting PD-L1/TGF-RII Indications: First-line treatment of gastric and gastroesophageal junction adenocarcinoma In September 2024, the Class 1 new drug Rirafup- injection (SHR-1701) of Jiangsu Hengrui Pharmaceuticals received marketing application acceptance from the CDE, indicated for the first-line treatment of locally advanced unresectable, recurrent, or metastatic gastric and gastroesophageal junction adenocarcinoma in combination with fluoropyrimidine and platinum-based drugs. Rirafup- injection is a dual-function fusion protein targeting PD-L1/TGF-RII developed by Jiangsu Hengrui Pharmaceuticals. Jiangsu Hengrui Pharmaceuticals: Ricotuzumab Duocarmycin Mechanism of action: ADC targeting HER2 Indications: Non-small cell lung cancer Ricotuzumab Duocarmycin is an ADC targeting HER2 developed by Jiangsu Hengrui Pharmaceuticals, composed of the anti-HER2 antibody Duocarmycin, a cleavable linker, and the topoisomerase I inhibitor effective payload SHR169265. In September 2024, the product's marketing application was accepted by the CDE and included in priority review, for the treatment of locally advanced or metastatic HER2-mutated non-small cell lung cancer patients who have received at least one previous systemic therapy. Pierre Fabre: Encorafenib Capsules Mechanism of action: Small molecule BRAF inhibitor Indications: BRAF V600E-mutant colorectal cancer In September 2024, Pierre Fabre's Class 5.1 new drug Encorafenib capsules received marketing application acceptance from the CDE, with specific indications not yet disclosed. Encorafenib is an oral small molecule BRAF kinase inhibitor. The product has been approved in the United States and the European Union for the treatment of melanoma, colorectal cancer, non-small cell lung cancer, and other cancer indications. Based on the clinical research progress in China, the indication for this marketing application may be BRAF V600E-mutant colorectal cancer. Bangshun Pharmaceutical: Bontinib Mechanism of action: JAK2 inhibitor Indications: Myelofibrosis In August 2024, Class 1 new drug Bontinib (OB756 tablets) of Bangshun Pharmaceutical received marketing application acceptance from the CDE, intended for the treatment of high-risk myelofibrosis (MF) patients. Bontinib is a selective JAK2 inhibitor with a novel chemical structure, mainly used in the clinical treatment of myelofibrosis, polycythemia vera, and essential thrombocythemia, among other diseases. Precision Bio: Pucilundsai Injection Mechanism of action: CAR-T cell therapy drug Indications: B-cell acute lymphoblastic leukemia In August 2024, the new drug marketing application for Pucilundsai injection was accepted by the CDE and included in priority review, for the treatment of CD19-positive relapsed or refractory B-cell acute lymphoblastic leukemia patients aged 3 to 21. Pucilundsai (pCAR-19B cell autologous infusion preparation) is independently developed by Precision Bio, specifically designed for CAR-T cell immunotherapy targeting CD19-positive B-cell hematologic malignancies. Sinochem Pharma: Culmerciclib Mechanism of action: CDK2/4/6 inhibitor Indications: HR-positive, HER2-negative breast cancer In July 2024, the Class 1 innovative drug Culmerciclib capsules (TQB3616) applied by Sinochem Pharma for marketing received acceptance from the CDE, indicated for use in combination with fulvestrant injection for the treatment of HR-positive, HER2-negative locally advanced or metastatic breast cancer previously treated with endocrine therapy. Culmerciclib is a novel CDK2/4/6 inhibitor, with enhanced CDK2 and CDK4 inhibition activity, potentially overcoming resistance issues observed with current CDK4/6 inhibitors in clinical settings. Sinochem Pharma: Rovadicitinib Mechanism of action: JAK/ROCK inhibitor Indications: Myelofibrosis In July 2024, the Class 1 new drug Rovadicitinib tablets (TQ05105) of Sinochem Pharma received marketing application acceptance from the CDE for the treatment of high-risk myelofibrosis (MF). Rovadicitinib is a JAK/ROCK inhibitor with a new chemical structure primarily used to treat myelofibrosis.In the past, Tesimide was developed independently by Zhengda Tianqing with a completely new chemical structure as a JAK/ROCK inhibitor, which can inhibit the transmission of the JAK/STAT signaling pathway and thus exert anti-tumor activity.HUTCHMED, Ipsen: Tazemetostat Mechanism of action: EZH2 methyltransferase inhibitor Indication: Follicular lymphoma Tazemetostat is an EZH2 methyltransferase inhibitor developed by Epizyme, a subsidiary of Ipsen. HUTCHMED is responsible for the research, development, production, and commercialization of tazemetostat in mainland China, Hong Kong, Macau, and Taiwan. In June 2024, the product's marketing application was accepted by the CDE and included in priority review, with the proposed indication being for adult patients with EZH2 mutation-positive relapsed or refractory follicular lymphoma (FL) who have received at least two prior systemic therapies. Novartis AG Sponsored ADR: Asciminib Mechanism of action: STAMP inhibitor Indication: Chronic myeloid leukemia (CML) In June 2024, the marketing application for the tablet of Asciminib hydrochloride submitted by Novartis AG Sponsored ADR was accepted by the CDE, with the specific indication yet to be disclosed. According to public information from Novartis AG Sponsored ADR, Asciminib is a CML treatment drug that is a specific STAMP inhibitor targeted against ABL in the United States. The product has been granted accelerated approval for the treatment of newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+CML-CP) adult patients and for the treatment of previously treated Ph+CML-CP adult patients. Studies on the use of this product as monotherapy and in combination regimens for the treatment of Ph+CML-CP are ongoing. INNOCARE, Incyte Corporation: Tantexuzumab Mechanism of action: CD19-targeted monoclonal antibody Indication: Diffuse large B-cell lymphoma Tantexuzumab is a CD19-targeted, Fc-optimized, humanized monoclonal antibody. INNOCARE and Incyte Corporation have partnered to obtain the development and exclusive commercialization rights for tantexuzumab in the Greater China region for hematologic malignancies and solid tumors. In June 2024, the marketing application for tantexuzumab was accepted by the CDE and included in priority review, targeting the indication of use in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not suitable for autologous stem cell transplantation (ASCT). BEIGENE (06160): Zanidatamab for injection Mechanism of action: HER2 bispecific antibody Indication: Biliary tract cancer Zanidatamab (ZW25) is a HER2-targeted bispecific antibody that simultaneously binds to two non-overlapping HER2 epitopes. BEIGENE reached a licensing agreement with Zymeworks in 2018 for approximately $430 million, granting exclusive rights to this product in Asia (excluding Japan), Australia, and New Zealand. In June 2024, the marketing application for this product was accepted by the CDE for the treatment of locally advanced unresectable or metastatic biliary tract cancer in patients with high HER2 expression who have received prior systemic therapy. Roche (RHHBY.US): Inavolisib tablets Mechanism of action: PI3K inhibitor Indication: Breast cancer Inavolisib (GDC-0077) is an oral therapy with dual mechanism of action, highly potent and selective for PI3K inhibition in vitro, and capable of triggering the specific degradation of PI3K protein mutants. In June 2024, the marketing application for this product was accepted by the CDE, with plans to use it in combination with CDK4/6 inhibitors and endocrine therapy for the treatment of adult patients with locally advanced or metastatic breast cancer who have PIK3CA mutations, HR-positive/HER2-negative. Shanghai Fosun Pharmaceutical (02196): Fumaitinib Mechanism of action: MEK1/2 selective inhibitor Indication: Adult dendritic cell and tissue cell tumors, Plexiform neurofibromatosis (PN) associated with type 1 neurofibromatosis (NF1) in children Fumaitinib (FCN-159) is a novel small molecule chemical drug independently developed by Shanghai Fosun Pharmaceutical, a MEK1/2 selective inhibitor. In April and May 2024, the marketing applications for the two indications of this product were successively accepted by the CDE and included in priority review, for the treatment of adult dendritic cell and tissue cell tumors and for the treatment of plexiform neurofibromatosis (PN) associated with type 1 neurofibromatosis (NF1) in children aged 2 and above. Gechis (01167): Gleceradib tablets Mechanism of action: KRAS G12C inhibitor Indication: Non-small cell lung cancer Gleceradib is a KRAS G12C inhibitor developed by Gechis. In May 2024, the marketing application for this product was accepted by the CDE and included in priority review for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with KRAS G12C mutations who have received at least one prior systemic therapy. Huadong Medicine (000963.SZ): Maihuatinib Mechanism of action: EGFR/HER2 potent small molecule inhibitor Indication: EGFR-mutated non-small cell lung cancer In May 2024, the Class 1 new drug Maihuatinib tablets from Huadong Medicine were accepted for marketing, intended for first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 21 L858R substitution mutation. Maihuatinib (mifanertinib) is an irreversible EGFR/HER2 potent small molecule inhibitor that suppresses tumor growth by irreversibly inhibiting tyrosine kinase phosphorylation and downregulating ErbB signaling.S(300558.SZ): TerexiliMechanism of action: CDK4/6 inhibitor Indication: HR-positive, HER2-negative breast cancer In May 2024, Betta Pharmaceuticals' class 1 new drug tibremciclib (formerly known as taibeziclib) was accepted for marketing application, indicated for HR-positive, HER2-negative locally advanced or metastatic breast cancer that has progressed after prior endocrine therapy. Tibremciclib is a CDK4/6 inhibitor with a novel structure developed independently by Betta Pharmaceuticals, showing good CDK4/6 target selectivity within the CDK family at the kinase level. Xuanzhu Biotech: Daxitinib Mechanism of action: ALK inhibitor Indication: ALK-positive non-small cell lung cancer In April 2024, Xuanzhu Biotech under Sihuan Pharma submitted an application for marketing approval of the first-class innovative oncology drug daxitinib tablets (product code: XZP-3621), intended for the treatment of locally advanced or metastatic non-small cell lung cancer patients who are ALK-positive. Daxitinib is a new generation ALK inhibitor developed by Xuanzhu Biotech, with a unique structural design that enhances the inhibitory activity at resistant sites, and can penetrate the blood-brain barrier to effectively treat brain metastases in cancer. Simcere Pharma (02096): Suvisita monoclonal antibody Mechanism of action: Anti-VEGF monoclonal antibody Indication: Ovarian cancer Suvisita monoclonal antibody (suvemcitug) is a new generation recombinant humanized anti-vascular endothelial growth factor (VEGF) rabbit monoclonal antibody. In March 2024, the new drug application for this product was accepted by the CDE for use in combination with platinum-based chemotherapy to treat refractory ovarian, fallopian tube, or primary peritoneal cancer patients. Daiichi Sankyo, Astrazeneca PLC Sponsored ADR: Detapotamab deruxtecan Mechanism of action: TROP2-targeted ADC Indication: HR-positive, HER2-negative breast cancer In March 2024, the first-class new drug injectable detapotamab deruxtecan (Dato-DXd) developed by Daiichi Sankyo was accepted for marketing approval by the CDE, intended for the treatment of unresectable or metastatic HR-positive, HER2-negative breast cancer in adult patients who have received systemic therapy in the advanced or metastatic stage. This is a TROP2-targeted antibody-drug conjugate (ADC) developed jointly by AstraZeneca and Daiichi Sankyo for global commercialization, listed as one of the top ten potential blockbuster R&D projects in 2024 by industry media Evaluate. Pfizer Inc. (PFE.US): Elranatamab injection Mechanism of action: BCMACD3 bispecific Indication: Multiple myeloma Elranatamab is a subcutaneous injection BCMACD3 bispecific antibody developed by Pfizer Inc., which binds to BCMA on multiple myeloma cells and CD3 receptors on T cells to activate T cells to kill myeloma cells. In January 2024, the application for elranatamab injection was accepted by the CDE for priority review, for the treatment of relapsed or refractory multiple myeloma (MM) adult patients who have received at least three prior treatments. Johnson & Johnson (JNJ.US): Lazertinib Mechanism of action: EGFR-TKI Indication: EGFR-mutant non-small cell lung cancer In January 2024, Johnson & Johnson's application for lazertinib tablets was accepted for marketing approval by the CDE. Lazertinib mesylate is a third-generation oral EGFR-TKI. Speculated indications for this marketing application include first-line treatment with EGFR/MET bispecific antibody therapy avatinabab for locally advanced or metastatic non-small cell lung cancer (NSCLC) adult patients with EGFR exon 19 deletion or exon 21 L858R substitution mutations. In China, avatinabab was first approved by the NMPA in February 2025 for first-line treatment of locally advanced or metastatic NSCLC adult patients with EGFR 20 insertion mutations. This article is reprinted from the "Medical Observation" public account, GMTEight editor: Jiang Yuanhua.