Janssen Submits New Indication Application in China for Niraparib-Abiraterone Combination Tablet for Hormone-Sensitive Prostate Cancer

8Month22Day, ChinaCenter for Drug Evaluation, National Medical Products Administration（CDE）The official website shows,Johnson & JohnsonSubmittedNiraparib Abiraterone TabletsThe new indication's marketing application has been officially accepted. Based on Johnson & Johnson's recent global registration activities and related clinical evidence, the indication applied for in China isCombined with Prednisone or PrednisoloneUsed for treatmentHormone-dependent Prostate CancerPatient.

2024Year10Month, the drug was approved for the first time in China, becoming the first and only dual-action combination product approved in the country.

AboutNiraparib Abiraterone

Niraparib and Abiraterone is a combination drug launched by Johnson & Johnson. Niraparib and abiraterone are prescription drugs with different mechanisms of action, each used to treat specific types of cancer. Niraparib belongs toPARPInhibitors, mainly used for ovarian cancer, fallopian tube cancer, etc.BRCAPatients with gene mutations; Abiraterone is an androgen synthesis inhibitor, suitable for the treatment of castration-resistant prostate cancer.

The compound preparation was2023Year of approval in the EU and the United States for use in combination with prednisone or prednisolone in patients carryingBRCA1/2Mutant Metastatic Castration-Resistant Prostate Cancer（mCRPC）First-line treatment for adult patients.

2025Year7In the month, Johnson & Johnson announced toEMASubmitThe application for the expanded indication of Niraparib Abiraterone, seeking approval for the drug to be used in combination with prednisone or prednisolone for the treatment of hormone-dependent prostate cancer, has been supported.AMPLITUDEBased on the research data, it is speculated that the indication for this domestic application is the same.

Johnson & Johnson in2025YearASCOAt the conference, it was announced for the first time in the form of an oral report.AMPLITUDEThe results of the study. The study aimed to evaluateNiraparib AbirateroneCombined with Prednisone（AAP）, in carrying homologous recombination repair（HRR）Gene Mutation(IncludingBRCA1/2）Metastatic Castration-Sensitive Prostate Cancer（mCSPC）Efficacy and Safety in Patients. The primary endpoint of the study was radiographic progression-free survival.（rPFS）, secondary endpoints include time to symptom progression（TSP）、Overall Survival（OS）and safety, aiming to explore the clinical benefits of combination therapy for patients with hormone-dependent prostate cancer.

The results showed that the study met its primary endpoint in696ExampleHRRMutationmCSPCIn patients, the median of the experimental grouprPFSNot reached, but significantly longer than the control group（29.5Months), within the presetBRCA1/2 Similar results were observed in the subgroups. Regarding secondary endpoints, the time to symptom progression in the experimental group（TSP）Significantly improved, with the risk of symptom progression reduced.50%, and inBRCA1/2The risk of symptom progression was reduced in the subgroup.56%. In addition, in the first interim analysis, the trial group showed improvement overallOSThe trend.

In terms of safety, the combination group3/4Higher incidence of Grade adverse events（75% vs 59%）, the most common is anemia（29.1% vs 4.6%）and Hypertension（26.5% vs 18.4%）, but the discontinuation rate due to adverse events was low.（14.7% vs 10.3%）, consistent with previous studies.

Market Prospects

2025Year, the incidence rate of prostate cancer in China reached23.7/10Ten thousand, ranking second in male malignant tumors, with approximately ... new cases annually.13.4Thousands of cases, with approximately4.75Ten thousand cases. Approximately50%-60%The patient was already in the middle to late stage at the initial diagnosis.（mCRPCOrmCSPC）, of which approximately10%ThemCRPCPatient CarryingBRCAMutation,HRRA higher proportion of gene mutations.

2023The scale of China's prostate cancer drug market in the year is approximately88.14100 million yuan, including Leuprolide（31.3%）And Goserelin（27.7%）Dominant, Second GenerationARInhibitor(such as Enzalutamide)Market share is rising rapidly. As the first and only approved in ChinaPARPInhibitor andARPICompound preparation, fillingBRCAMutationmCRPCPrecision treatment gap, with a first-mover advantage.

The two marketing applications for Niraparib Abiraterone Tablets show significant differences in indications, reflecting a strategic expansion from late-stage precision treatment to early intervention. The second application not only broadened the range of gene mutations.(FromBRCAToHRR）, also targeting patients with earlier-stage prostate cancer, aims to delay disease progression through early treatment and provide patients with more comprehensive treatment options. This strategy aligns with the current trends in precision medicine and early disease intervention, with the potential to significantly improve patient outcomes.

1. CDE Official Website