30 Oncology Innovations Set for 2025 Approval in China: Pipeline Highlights from Hengrui, BeiGene (06160.HK), AstraZeneca (SZN.US), Novartis, and More

Advances in clinical treatment and new drug development in the field of cancer have always attracted significant attention, and cancer represents the disease type with the highest proportion of new drugs approved for marketing in China each year. This article will integrate information from the official website of the Center for Drug Evaluation (CDE) under the China National Medical Products Administration and publicly available data from various companies.Review of 30 New Cancer Drugs Expected to Be Approved for Marketing in China by 2025They are expected to bring new treatment options for a series of cancer types, including lung cancer, breast cancer, ovarian cancer, prostate cancer, nasopharyngeal cancer, stomach cancer, colorectal cancer, lymphoma, and leukemia. (The statistical scope of this article covers new drugs that submitted marketing applications to the CDE from January 2024 to December 2024; only new drugs registered under categories 1, 3.1, and 5.1 are included; only new drugs with the potential for first-time approval are counted, excluding new indications.)

GSK (GSK.US): Mabalant Monoclonal Antibody for Injection

Mechanism of Action: BCMA-Targeted ADC

Indications: Multiple Myeloma

Belantamab mafodotin, developed by GSK, is an ADC targeting BCMA. It consists of a humanized anti-BCMA monoclonal antibody conjugated with the cytotoxic agent auristatin F via a non-cleavable linker. In December 2024, the product's marketing application was accepted by the CDE and granted priority review for its intended indication.In combination with bortezomib and dexamethasone, used for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

Yimiao Shenzhou: IM19

Mechanism of Action: Autologous CAR-T Cells Targeting CD19

Indications: Diffuse Large B-Cell Lymphoma

IM19 is a product developed by Beijing Yimiaoshenzhou Medical Technology Co., Ltd.Autologous CAR-T Cell Candidate Targeting CD19, which adopts an innovative CAR molecular design and production process, can provide more specific therapeutic effects. In November 2024, the marketing application of this product was accepted by the CDE for the treatment ofRelapsed or Refractory Diffuse Large B-Cell Lymphoma (r/r DLBCL)In addition, in August 2024, Beijing Yimiaoshenzhou Medical Techology Co., Ltd. also reached a commercial authorization cooperation with Huadong Medicine for IM19 in mainland China.

Ascentage Pharma (06855): Lisenclestat Tablets

Mechanism of Action: Bcl-2 Selective Inhibitor

Indications: CLL/SLL

Lisaftoclax (APG-2575) is a novel oral Bcl-2 selective inhibitor independently developed by Jiangsu Ascentage Pharma Development Co., Ltd. By selectively inhibiting the Bcl-2 protein, it restores the normal apoptosis process in cancer cells, thereby achieving the purpose of treating tumors. In November 2024, the marketing application for this product was accepted by the CDE and included in the priority review, intended for use in...Treatment of refractory or relapsed chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).

Novartis (NVS.US): Lutetium [Lu] Texiveptide Injection

Mechanism of Action: PSMA-Targeted Radioligand Therapy

Indications: Prostate Cancer

Lutetium [7Lu] Tixeviptide Injection is Pluvicto, a PSMA-targeted radioligand therapy developed by Novartis. In November 2024, the product's marketing application was accepted by the CDE and included in the priority review, applicable for the treatment ofProstate-Specific Membrane Antigen (PSMA)-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC) in adult patients who have received androgen receptor pathway inhibitors and taxane-based chemotherapy.At the same time, the marketing application of Novartis' radiopharmaceutical Gallium [68Ga] Gozetotide Injection for preparation has also been accepted. After being radiolabeled with 68Ga, this product...Can be used as a radioactive diagnostic reagent, suitable for identifying PSMA-positive lesions in adult patients with prostate cancer through Positron Emission Tomography (PET).

AbbVie (ABBV.US): Epcoritamab

Mechanism of Action: CD3/CD20 Bispecific Antibody

Indications: Diffuse Large B-Cell Lymphoma or Follicular Lymphoma

Epcoritamab is a subcutaneously administeredCD3/CD20 bispecific antibody, which has previously been approved by the U.S. FDA for the treatment of diffuse large B-cell lymphoma and follicular lymphoma.This innovative therapy was also listed by the industry media Evaluate as one of the top ten potential blockbuster therapies in 2023. In November 2024, the product's marketing application in China was accepted by the CDE.

Shouyao Holdings (688197.SH): Conteltinib

Mechanism of Action: ALK Inhibitor

Indications: ALK-positive non-small cell lung cancer

In October 2024, the marketing application for Kangtaitini Granules, a Class 1 new drug jointly submitted by Shouyao Holdings and Double-Crane Pharmaceuticals, was accepted. According to the announcement by Shouyao Holdings, this is an ALK inhibitor independently developed by the company, and the indication for this marketing application isMonotherapy for patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer.

AstraZeneca (AZN.US): tremelimumab

Mechanism of Action: Anti-CTLA-4 Monoclonal Antibody

Indications: Non-Small Cell Lung Cancer / Liver Cancer

In October 2024, AstraZeneca filed a Category 3.1 biologics application forAnti-CTLA-4 monoclonal antibody tremelimumab and PD-L1 inhibitor durvalumabThe listing application has been accepted, but the specific indications have not been disclosed. Public information shows that the combination therapy consisting of these two products has already been approved in the United States, the European Union, Japan, and other countries and regions for treatment.Advanced or unresectable hepatocellular carcinomaAdult PatientsDurvalumab has also been approved.In combination with a short course of tremelimumab and chemotherapy for the treatment of metastatic non-small cell lung cancer。

Hengrui Medicine (600276.SH): SHR2554 Tablet

Mechanism of Action: EZH2 Inhibitor

Indications: Peripheral T-cell Lymphoma

SHR2554 is an EZH2 histone methyltransferase inhibitor developed by Hengrui Medicine. In October 2024, the marketing application for this product was accepted by the CDE and included in the priority review.Intended for relapsed or refractory peripheral T-cell lymphoma patients who have previously received at least one line of systemic treatment.In 2023, Hengrui Medicine entered into a collaboration agreement worth over $700 million with Treeline, granting the latter exclusive rights to develop, manufacture, and commercialize SHR2554 outside of Greater China.

LePu Biologics (02157.SZ): Injection of Vericiguat Monoclonal Antibody

Mechanism of Action: ADC Targeting EGFR

Indications: Nasopharyngeal Cancer

Vibegron is an ADC targeting EGFR developed by Lepu Biopharma, consisting of an EGFR-targeting monoclonal antibody conjugated with the potent microtubule inhibitor MMAE molecule via a vc linker. In September 2024, the marketing application for this product was accepted by the CDE and included in the priority review, applicable to...Patients with recurrent/metastatic nasopharyngeal carcinoma who have failed at least two prior lines of systemic chemotherapy and PD-1/PD-L1 inhibitor treatment.

Hengrui Medicine: Relafusp-α Injection

Mechanism of Action: Anti-PD-L1/TGF-βRII Bifunctional Fusion Protein

Indications: First-line treatment for gastric and gastroesophageal junction adenocarcinoma

In September 2024, Hengrui Medicine's Class 1 new drug Relafusp-alpha Injection (SHR-1701) marketing application was accepted by the CDE, indicated for use in combination with fluorouracil and platinum-based drugs for locally advanced unresectable, recurrent, or metastatic conditions.Adenocarcinoma of the Stomach and Gastroesophageal JunctionFirst-line treatment. Relafusp-alpha Injection is independently developed by Hengrui MedicineAnti-PD-L1/TGF-βRII bifunctional fusion protein.

Hengrui Medicine: Ruikang Trastuzumab

Mechanism of Action: Antibody-Drug Conjugate (ADC) Targeting HER2

Indications: Non-Small Cell Lung Cancer

Rui Kang Trastuzumab is independently developed by Hengrui Medicine.HER2-targeted ADC, composed of the anti-HER2 antibody trastuzumab, a cleavable linker, and the topoisomerase I inhibitor payload SHR169265. In September 2024, the marketing application for this product was accepted by the CDE and granted priority review for patients who have previously received at least one systemic therapy.Treatment of adult patients with locally advanced or metastatic HER2-mutant non-small cell lung cancer.

Pierre Fabre: Encorafenib Capsules

Mechanism of Action: Small Molecule BRAF Inhibitor

Indications: BRAF V600E mutation-positive colorectal cancer

In September 2024, Pierre Fabre's申报的5.1类新药Encorafenib CapsulesThe listing application has been accepted by the CDE, but the specific indications have not been disclosed yet. Encorafenib is aOral small molecule BRAF kinase inhibitor. The product has been approved in the United States and the European Union for the treatment of cancer indications such as melanoma, colorectal cancer, and non-small cell lung cancer. Based on the progress of clinical research in China, the indication for this marketing application is likely to beBRAF V600E Mutation Colorectal Cancer。

Bangsun Pharmaceutical: Bangruitinib

Mechanism of Action: JAK2 Inhibitor

Indications: Myelofibrosis

In August 2024, the marketing application for Bangshun Pharmaceutical's Class 1 new drug, Bangruitinib (OB756 tablets), was accepted by the CDE for the proposed treatment ofIntermediate- and high-risk myelofibrosis (MF) patients.Bumetinib is a selective JAK2 inhibitor with a novel chemical structure, mainly used for the clinical treatment of diseases such as myelofibrosis, polycythemia vera, and essential thrombocythemia.

Precision Biologics: Pucilencer Injection

Mechanism of Action: CAR-T Cell Therapy Drugs

Indications: B-cell Acute Lymphoblastic Leukemia

August 2024,Puciluzumab InjectionThe new drug marketing application was accepted by the CDE and included in the priority review for the treatment ofPatients aged 3 to 21 years with CD19-positive relapsed or refractory B-cell acute lymphoblastic leukemia.Pucilencer (pCAR-19B Autologous Cell Infusion Preparation) was independently developed by Precision Biologics.A CAR-T cell immunotherapy product developed for CD19-positive B-cell-derived malignant hematological diseases.

Zhengda Tianqing: Cumoxil

Mechanism of Action: CDK2/4/6 Inhibitor

Indications: HR-positive, HER2-negative breast cancer

In July 2024, the marketing application for Zhengda Tianqing's Class 1 innovative drug Culmerciclib (TQB3616) capsules was accepted by the CDE, with the indication being...In combination with fulvestrant injection for HR-positive, HER2-negative locally advanced or metastatic breast cancer previously treated with endocrine therapy.Cumorxil is a novel cyclin-dependent kinase 2, 4, and 6 (CDK2/4/6) inhibitor,Its enhanced CDK2 and CDK4 inhibitory activity may help overcome the current clinical resistance to CDK4/6 inhibitors.

Zhengda Tianqing: Rofacitinib

Mechanism of Action: JAK/ROCK Inhibitor

Indications: Myelofibrosis

In July 2024, the marketing application for Zhengda Tianqing's Class 1 new drug Rovadicitinib Tablets (TQ05105) was accepted by the CDE for the treatment of intermediate- and high-risk myelofibrosis (MF). Rovadicitinib Tablets are independently developed by Zhengda Tianqing.A JAK/ROCK inhibitor with a novel chemical structure that can inhibit the JAK/STAT signaling pathway, thereby exerting antitumor activity.

Hutchmed, Ipsen: Tazemetostat

Mechanism of Action: EZH2 Methyltransferase Inhibitor

Indications: Follicular Lymphoma

Tazemetostat was developed by Epizyme, a subsidiary of Ipsen.EZH2 Methyltransferase InhibitorHutchmed is responsible for the research, development, production, and commercialization of taletrectinib in mainland China, Hong Kong, Macao, and Taiwan. In June 2024, the product's marketing application was accepted by the CDE and included in the priority review, with the proposed indication beingAdult patients with EZH2 mutation-positive, relapsed or refractory follicular lymphoma (FL) who have previously received at least two systemic treatments.

Novartis: Asciminib

Mechanism of Action: STAMP Inhibitor

Indications: Chronic Myeloid Leukemia (CML)

In June 2024, Novartis' marketing application for Arseni Hydrochloride Tablets was accepted by the CDE, with the specific indication yet to be disclosed. According to publicly available information from Novartis,Asciminib is a CML treatment drug that specifically targets the ABL myristoyl pocket (STAMP inhibitor).In the United States, the product has been granted accelerated approval for the treatment of newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+CML-CP) in adult patients and is also approved for the treatment of previously treated Ph+CML-CP adult patients. The product is currently under investigation as a monotherapy and in combination regimens for the multi-line treatment of Ph+CML-CP.

Noochina, Incyte Corporation: Tafasitamab

Mechanism of Action: Anti-CD19 Monoclonal Antibody

Indications: Diffuse Large B-Cell Lymphoma

Tafasitamab is a humanized monoclonal antibody targeting CD19 with an optimized Fc domain. NovoCure and Incyte Corporation have reached a collaboration, granting NovoCure exclusive rights to develop and commercialize tafasitamab for hematological malignancies and solid tumors in Greater China. In June 2024, the marketing application for tafasitamab was accepted by the CDE and included in the priority review process for its indications.In combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplantation (ASCT).

BeOne Medicines (06160): Zenidatamab Injection

Mechanism of Action: HER2 Bispecific Antibody

Indications: Biliary Tract Cancer

Zanidatamab (zanidatamab, ZW25) isA HER2-targeted bispecific antibody that can simultaneously bind to two non-overlapping HER2 epitopesBeOne Medicines entered into a licensing collaboration worth up to approximately $430 million with Zymeworks in 2018, obtaining exclusive rights to this product in Asia (excluding Japan), Australia, and New Zealand. In June 2024, the product's marketing application was accepted by the CDE for use in...HER2-high, unresectable locally advanced or metastatic biliary tract cancer previously treated with systemic therapyPatient.

Roche (RHHBY.US): Enalapril Tablets

Mechanism of Action: PI3Kα Inhibitor

Indications: Breast Cancer

Inavolisib (GDC-0077) is an oral therapy with a dual mechanism of action, demonstrating high in vitro potency and selectivity as a PI3Kα inhibitor, and is capable of specifically triggering the degradation of mutant PI3Kα proteins. In June 2024, the marketing application for this product was accepted by the CDE, intended for use in combination with the CDK4/6 inhibitor palbociclib and endocrine therapy.For the treatment of adult patients with PIK3CA-mutated, HR-positive/HER2-negative locally advanced or metastatic breast cancer.

Fosun Pharma (02196): Fumatinib

Mechanism of Action: MEK1/2 Selective Inhibitor

Indications: Adult dendritic cell and histiocytic neoplasms, pediatric type 1 neurofibromatosis (NF1)-associated plexiform neurofibromas (PN)

Fumaitinib (FCN-159) is a novel small-molecule chemical drug independently developed by Fosun Pharma, and a selective MEK1/2 inhibitor. In April and May 2024, the marketing applications for two indications of this product were successively accepted by the CDE and included in the priority review, respectively for the treatment ofAdult Dendritic Cell and Histiocytic Tumors, andTreatment of plexiform neurofibromas (PN) associated with neurofibromatosis type 1 (NF1) in children aged 2 years and older.

Jacobio (01167): Golarestat Tablets

Mechanism of Action: KRAS G12C Inhibitor

Indications: Non-Small Cell Lung Cancer

Glecirasib is a KRAS G12C inhibitor independently developed by JAB Biotherapeutics. In May 2024, the marketing application for this product was accepted by the CDE and included in the priority review, applicable to...Adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring KRAS G12C mutations who have previously received at least one line of systemic treatment.Treatment.

Huadong Medicine (000963.SZ): Maihua Tyrosine Kinase Inhibitor

Mechanism of Action: Potent Small Molecule Inhibitor of EGFR/HER2

Indications: EGFR-mutated non-small cell lung cancer

In May 2024, the marketing application for Huadong Medicine's Class 1 new drug, Maohuatinib Tablets, was accepted, intended for use inEGFR First-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring exon 21 L858R substitution mutation.Mifanertinib is aIrreversible EGFR/HER2 Potent Small Molecule Inhibitor, by irreversibly inhibiting tyrosine kinase autophosphorylation, leads to the downregulation of ErbB signaling, thereby suppressing tumor growth.

Betta Pharmaceuticals (300558.SZ): Teriseli

Mechanism of Action: CDK4/6 Inhibitor

Indications: HR-positive, HER2-negative breast cancer

In May 2024, the marketing application for Beta Pharma's Class 1 new drug Tibremciclib (formerly known as Taibeixilie) was accepted, applicable toHR-positive, HER2-negative locally advanced or late-stage recurrent metastatic breast cancer that has progressed after prior endocrine therapy.Terisili is a CDK4/6 inhibitor with a novel structure independently developed by Beta Pharma. At the kinase level, this product has demonstrated good CDK4/6 target selectivity within the CDK family.

Xuanzhu Biotech: Daxitinib

Mechanism of Action: ALK Inhibitor

Indications: ALK-positive non-small cell lung cancer

In April 2024, Xuanzhu Bio, a subsidiary of Siho Pharma, submitted its innovative Class 1 anti-tumor drug Daxitinib Tablets (Product Code: XZP-3621) for marketing authorization, intended for the treatment ofFirst-line Treatment of ALK-positive Locally Advanced or Metastatic Non-Small Cell Lung CancerPatient. Dasatinib is a new generation ALK inhibitor developed by Xuanzhu Biotech, with a unique structural design that enhances the molecule's inhibitory activity against drug-resistant sites. Additionally, itAble to cross the blood-brain barrier and effective against brain metastases of tumors.。

Simcere Pharmaceutical (02096): Suvizumab

Mechanism of Action: Anti-VEGF Monoclonal Antibody

Indications: Ovarian Cancer

Suvemcitug (suvemcitug) is a new generation of 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.Combination chemotherapy is used for the treatment of recurrent ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that has failed platinum-based chemotherapy.

Daiichi Sankyo, AstraZeneca: Datopotamab

Mechanism of Action: TROP2-Targeted ADC

Indications: HR-positive, HER2-negative breast cancer

In March 2024, the marketing application for datopotamab deruxtecan (Dato-DXd), a novel class 1 drug for injection developed by Daiichi Sankyo, was accepted by the CDE for the treatment ofAdult patients with HR-positive, HER2-negative unresectable or metastatic breast cancer who have previously received systemic treatment at the stage of unresectable or metastatic disease.This is a TROP2-targeted antibody-drug conjugate (ADC) jointly developed by AstraZeneca and Daiichi Sankyo, and commercialized globally through their collaboration. This ADC has been listed by the industry media Evaluate as one of the top ten potential blockbuster R&D projects in 2024.

Pfizer (PFE.US): Elranatamab Injection

Mechanism of Action: BCMA×CD3 Bispecific Antibody

Indications: Multiple Myeloma

Elranatamab was developed by Pfizer.A Subcutaneous Injection BCMA×CD3 Bispecific AntibodyOne end binds to BCMA on myeloma cells, and the other end binds to the CD3 receptor on the surface of T cells, bringing them together and activating the T cells to kill the myeloma cells. In January 2024, the marketing application for elranatamab injection was accepted by the CDE and included in the priority review.For the treatment of adult patients with relapsed or refractory multiple myeloma (MM) who have received at least three prior therapies.

Johnson & Johnson (JNJ.US): Lanzetinib

Mechanism of Action: EGFR-TKI

Indications: EGFR-mutated non-small cell lung cancer

In January 2024, the marketing application for Lazertinib Mesylate Tablets submitted by Johnson & Johnson was accepted by the CDE. Lazertinib Mesylate Tablets (lazertinib) is aThe Third Generation of EGFR-TKI Oral Drugs. According to publicly available information, the indication for this marketing application is:Combination of EGFR/MET bispecific antibody therapy Amivantamab as first-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 19 deletion or L858R substitution mutation in exon 21.In China, Amivantamab was approved by the NMPA for the first time in February 2025, for the first-line treatment of adult patients with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations.

This article is reprinted from the "MedView" WeChat Official Account, edited by Jiang Tongcheng: Jiang Yuanhua.