12 Anticancer Blockbuster Drugs Expected to Gain Approval in China in the Second Half of 2025

Daiichi-Sankyo/AstraZeneca: Datopotamab
TROP2 ADC

In March 2024, the TROP2 ADC jointly developed by Daiichi Sankyo and AstraZenecaDedabotumabFiled for marketing approval in China for the treatment of patients who have previously received systemic therapy.Adult patients with HR-positive, HER2-negative unresectable or metastatic breast cancer, expected to be approved in Q3 this year.

Results from the pivotal Phase III clinical trial TROPION-Breast 01 showed that, in patients with HR+/HER2- breast cancer who had previously received endocrine therapy and at least one systemic treatment, and who have inoperable or metastatic disease,The mPFS of the Dabotumab treatment group reached 6.9 months.(vs chemotherapy group 4.9 months)`, which can reduce the risk of disease progression or death in patients by 37%.`。

Screenshot source: Insight Database

Ascentage PharmaPharma：Lisheng Clindamycin
First China-Produced BCL-2 Inhibitor

Ascentage PharmaLisheng Clinda（APG-2575 ）InNovember 24th, Application for ListingIncluded in the priority review for the treatment ofRefractory or Relapsed Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma（CLL/SLL）Patient。Insight database shows,Lisheng ClaranYesThe First Domestically Produced Product to Report for Market LaunchBCL-2 Inhibitor,Expected to be approved in Q3 this year。

Screenshot source: Insight database

Efficacy and Safety Results of Lisocabtagene Maraleucel in Heavily Pretreated CLL Patients Presented at the 2023 ASH Annual Meeting:

• CLL PatientsORR was 73.3%（33/45），CR/CRi Rate: 24.4%（11/45), and the CR/CRi rate showed an increasing trend with the dose escalation.

• In patients undergoing peripheral blood MRD testing,38.9%（7/18`) Achieve MRD-negative status`. In patients detected with bone marrow MRD,66.7%（4/6`) MRD-negative`。

• The median time to first remission was 2.07 months., with a median PFS of 18.53 months and a 30-month OS rate of 86.3%,This suggests that Rezvilutamide has the potential to bring long-term survival benefits for CLL patients.

• In addition, APG-2575 has demonstrated good safety and tolerability in R/R CLL patients.

Currently, Lisencrab is simultaneously advancing two Phase III registrational clinical trials for the treatment of CLL/SLL globally: one is the GLORA study, with the indication beingLisheng Cladribine Combined with BTK InhibitorTreatmentBTK Inhibitor-Treated CLL/SLLPatient; another is the GLORIA-2 study, with the indication beingLisheng Cladribine Combined with AcalabrutinibComparison of Immunochemotherapy for Treatment-Naive CLL/SLL Patients.

In China's BCL-2 sector, currently only AbbVie'sVenetoclaxApprovedFor treatmentTherapy AML. In terms of domestically produced drugs, apart from Ascentage Pharma'sLisheng Clora, BeiGene'sSotoclaxAlso submitted the marketing application for CLL/SLL and MCL this year.

Simcere: Suvizumab

Next-Generation VEGF Monoclonal Antibody

March 2024, SimcereSuvizumabReported for Market Launch in China, Indications areCombined chemotherapy is used to treat cases where platinum-based chemotherapy has failed.Recurrent ovarian cancer, fallopian tube cancer, or primary peritoneal cancer,Expected to be approved in Q3 this year.

Suvizumab is a product introduced by Simcere.A Novel Recombinant Humanized Anti-VEGF Rabbit Monoclonal Antibody。Its Phase III SCORES Study for the Treatment of Platinum-Resistant Ovarian Cancer（NCT04908787）Has reached the primary clinical endpoint. 2025 ASCOData released at the conference showed:

• InBIRC-Assessed mIn terms of PFS,Suvictamab + ChemotherapyFor5.49 months, Control Group（Placebo + Chemotherapy）For 2.73 months; Investigator-assessedSuveximab mPFS was 5.39 months, compared to 2.46 months in the control group;
• Suvizitamab + Chemotherapy GroupMedian OS was 15.31 months, Control group is14.03 months;The 24-month OS rate was 33% in the survestmab plus chemotherapy group and 22.3% in the control group.
• In addition, in the OR evaluated by researchers and BIRCIn terms of R and DCR indicators, the SurveCTA monoclonal antibody + chemotherapy group also demonstrated a consistent trend of benefit.

BeBetter Med: Disulfiram

The World's First PI3K×HDAC Dual-Target Inhibitor to Report Production

In October 2023, BeBetter Med's Dualiristat was submitted for marketing authorization in China. The application has been included.Priority Review, used forRelapsed or Refractory Diffuse Large B-Cell Lymphoma（r/r DLBCL）Third-line and above treatment for adult patients, expected to be approved in Q3.

The marketing application of this drug is based on a pivotal Phase IIb clinical trial, which enrolled 93 patients with r/r DLBCL. The data showed that, in terms of the primary endpoints — ORR assessed by IRC and investigators — Duality met the conditional marketing requirements communicated with the CDE, while significantly extending patients' overall survival. It also demonstrated good safety and tolerability.

Previously,DoubleRisita has beenPositive results achieved in Phase IIa clinical trial: at the recommended dose for Phase II（22.5 mg/m²）Below, Dualisib is used for third-line and above treatment of r/r DLBCL.ORR was 50%, DCR was 66.7%。

Insight database shows,This is the world's first and currently only PI3K×HDAC dual-target inhibitor approved for marketing.。For third-line and above treatment of r/r DLBCL in China, currently only Antengene's XPO1 inhibitor Selinexor, a small molecule chemotherapy drug, has been approved. If Duvorasib is approved, it will provide patients with more treatment options.

Shanghai Hengrun Dasheng Biotechnology Co., Ltd.: Run Dakin Allogeneic CAR-T

The 4th CD19 CAR-T in China

In December 2023, Shanghai Hengrun Dasheng Biotechnology Co., Ltd. submitted Run Dakin Olun for market approval in China.For the treatment of relapsed/refractory B-cell non-Hodgkin lymphoma（B-NHL）It is expected to be approved in Q3 this year. This is the fourth CD19 CAR-T product submitted for marketing in China.

Runda Gene Therapy（HR001）It is a CAR-T product targeting CD19. According to Shanghai Hengrun Dasheng Biotechnology Co., Ltd., its self-developed stable cell line viral vector production system has achieved scaled-up virus production, effectively reducing the cost of single-dose CAR-T cell therapy products, including Runta Kyrieucel.

Runda Gene TherapyCompleted the pivotal Phase II clinical trial for the treatment of relapsed/refractory B-NHL. Phase II clinical trial data shows(As of May 16, 2023)：

• The ORR at 3 months was 48% (49/103), and among the 90 patients in the ITT set with ECOG scores of 0-1, 46 achieved objective response at 3 months, resulting in a 3-month ORR of 51%, demonstrating efficacy superior to salvage therapy.

• In terms of safety, among 103 subjects, 46 experienced SAEs, the incidence rate of CRS was 95.1%, with the incidence rate of Grade 3 or higher CRS being 5.8%; the incidence rate of neurotoxicity events was 23.3%, and the incidence rate of Grade 3 or higher neurotoxicity events was 1%.

Johnson & Johnson: Lanzetinib
Third-Generation EGFR-TKI

January 2024, Johnson & JohnsonLanreotideReport listing in China，The speculated indication is in combination with Amivantamab.(Intravenous Injection)Used forEGFR-sensitive mutations in locally advanced or metastatic NSCLC First-line Treatment，Expected to be approved in Q3 this year。

Lanreotide isJohnson & Johnson fromIntroduced by Yuhan Corporation, South KoreaAn orally administrable, brain-penetrant third-generation EGFR-TKI that targets the T790M mutation and activating EGFR mutations while sparing wild-type EGFR.

Currently,Lanreotide has been approved overseas in combination with Johnson & Johnson'sAmivantamab（EGFR×c-MET Bispecific Antibody）Used forFirst-line treatment for EGFR-sensitive mutation NSCLC.

Source of screenshot: Insight Database

Novartis: Lutetium [177Lu] Texiveptide

PSMA-Targeted Radioligand Therapy

2024In November, Novartis' Heavyweight NuclearMedicinePluvicto's（Lutetium [177Lu] TexiveptideThe listing application has been accepted and included in the priority review, applicable toProstate-Specific Membrane Antigen（PSMA）Positive Metastatic Castration-Resistant Prostate Cancer（mCRPC) Third-line treatment,It is expected thatQ4 Approval. This April,Pluvicto has been filed in China.The Second Indication。

Results from the pivotal Phase III clinical trial VISION show：Pluvicto+SoC GroupProgression-Free Survival in Imaging（rPFS）8.7Months, andStandard Treatment（SoC）Group Only3.4 months,Overall Survival（OS）For 15.3Months`, also higher than`Standard Treatment Group11.3 months. MoreoverCompared with SoC, Pluvicto+SoC can reduce the risk of death in patients, as well as the risk of radiological disease progression or death.

Screenshot source: Insight database

GSK: Mabalant Monoclonal Antibody
The World’s First BCMA ADC

In December 2024, GSK's injectableMaribotamabThe listing application has been accepted. This application has been included in the priority review, with the indication forMaribotumabIn combination with bortezomib and dexamethasonePreviously received at least one treatmentMultiple Myeloma（MM）Adult Patients，Expected to be approved in Q4。

Maribantumab isThe World's First BCMA ADC Submitted for Marketing Approval。Phase III Trial DREAMM-7 EvaluatedMaribotumab+Bortezomib+DexamethasoneEfficacy and safety in treating relapsed/refractory MM patients, control group isDaratumumab +Bortezomib + Dexamethasone.The primary endpoint of the study is PFS.

Data presented at the 2025 ASCO Annual Meeting showed that, in the intent-to-treat population (ITT) En:

• In terms of median PFS,MaBlinatumomabThe group has not yet reached, the daratumumab group was 12.6 months,MaBeBetter MedAnti-GroupReduced the risk of disease progression or death by 61% in patients.（HR=0.39）；MaBlinatumomabGroup'sThe 18-month PFS rate was 69%., significantly higher than the 41% in the daratumumab group。

• MaBlinatumomabGroupORR was 86%(vs Control Group 74%), CR was 34%(vs Control Group 15%), 18-month OS rate was 85%(vs control group 73%)。

Boehringer Ingelheim: Zongletinib

• ORR was 71%, wherein 7% of the patients achieved complete remission（CR），DCR up to 96%；In patients with brain metastases who have been treated（n=27）Showing intracranial activity inResponse Rate Reached 41%, Disease Control Rate Reached 81%。
• Median Duration of Response（DoR）Reached 14.1 months, median progression-free survival（PFS）Up to 12.4 months。
• Meanwhile, Zongge Tinib continues to demonstrate a manageable safety profile.

  
  

In September 2024, Hengrui Pharma's Class 1 new drug Relafusp-alpha Injection was submitted for marketing approval in China. It is used in combination with fluorouracil and platinum-based drugs for locally advanced unresectable, recurrent, or metastatic conditions.First-line Treatment for Gastric and Gastroesophageal Junction AdenocarcinomaInsight database shows that this isThe World's First PD-L1/TGF-β Dual-Target Novel Drug to Report for Production, expected to be approved in Q4 this year.

Screenshot source: Insight database

Relafusp-α（SHR-1701）Is aAnti-PD-L1/TGF-βRII Bifunctional Fusion ProteinPublished at ESMO 2024Phase III Trial SHR-1701-III-307Data show that, compared with the placebo + chemotherapy group, the SHR-1701 + chemotherapy group significantly extended the overall survival of patients with gastric cancer or gastroesophageal junction adenocarcinoma:

• In the PD-L1 CPS≥5 population,The median OS in the SHR-1701 group was 16.8 months, and the median OS in the placebo group was 10.4 months., HR=0.53, p<0.0001, reaching statistical significance.

• In the ITT population,The median OS in the SHR-1701 group was 15.8 months, and the median OS in the placebo group was 11.2 months., HR=0.66, p<0.0001, reaching statistical significance.

In terms of secondary endpoints:

• In the PD-L1 CPS≥5 population, SHR-1701 group and placebo group mPFS were 7.6 months and 5.5 months, respectively.HR=0.5; Confirmed in the SHR-1701 group and placebo groupORR was 56.5% and 32.7%, respectively, and DoR was 10.2 months and 5.1 months, respectively.

• In the ITT population，The mPFS for the SHR-1701 group and placebo group were 7.0 months and 5.5 months, respectively, HR=0.57; The confirmed ORR for the SHR-1701 group and placebo group were 53.4% and 32.8%, respectively, and the DoR were 8.5 months and 5.3 months, respectively.

In May 2024, Betta Pharmaceuticals' Class 1 new drugTirzepatideFiled for marketing authorization in China, with the indication ofCombined with FulvestrantFor patients who have progressed after prior endocrine therapyHR+/HER2- Locally Advanced or Recurrent Metastatic Breast Cancer, expected to be approved in Q4 this year.

Trilaciclib is a cyclin-dependent kinase CDK4/6 inhibitor with a novel structure. The Phase III BTP-66732 study evaluated trilaciclib + fulvestrant vs.Placebo + FulvestrantEfficacy in treating HR+/HER2- locally advanced, recurrent, or metastatic breast cancer.

24th San Antonio Breast Cancer Symposium（SABCS）The updated data published shows a median follow-up time of 12.9 months.The median PFS in the Terisil group was 16.5 months.(Investigator Assessment), while the placebo group was only 5.6 months; compared with the placebo group, the Tairexili group showed a significant improvement in PFS,Reduced the risk of disease progression or death by 63%（HR 0.37; P＜0.0001）The PFS assessed by the IRC is consistent with the results evaluated by the investigators.TirilizumabOverall safety is good and controllable.

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