Janssen's Dual-Mechanism Therapy Niraparib-Abiraterone Receives New Indication Application Acceptance in China for Hormone-Sensitive Prostate Cancer with HRR Mutations
Johnson & Johnson
Medical Device R&D and Manufacturer
Recently(August 22), Center for Drug Evaluation, National Medical Products Administration of China（CDE）Official Website Announcement:Johnson & JohnsonInnovative Compound Formulations under the CompanyNiraparib Abiraterone TabletsThe new indication application has been officially accepted.
Screenshot source: CDE official website
According to data from Mox Entropy Pharmaceuticals,Niraparib Abiraterone TabletsYesJohnson & JohnsonThe innovative compound preparation launched by the company combines a PARP inhibitor.NiraparibAndrogen Synthesis InhibitorsAbirateroneThe dual mechanism of action.
Source of Screenshot: Mosentropy Global Drug R&D Database
Indication Expansion: From mCRPC to Hormone-Dependent Prostate Cancer
According to the CDE public information and Johnson & Johnson's global registration and application updates, the new indication applied for this time isHormone-dependent prostate cancer, specifically targeting homologous recombination repair（HRR）Gene Mutation(Including BRCA1/2)Metastatic Castration-Sensitive Prostate Cancer（mCSPC）Patient.
Previously,Niraparib Abiraterone TabletsApproved in the EU and the US in 2023, for use in combinationPrednisoneTreatment of BRCA1/2 Mutation in Metastatic Castration-Resistant Prostate Cancer（mCRPC）First-line treatment; In October 2024, the drug was approved for the first time in China, becoming the first and only dual-action combination formulation approved in the country, filling the market gap in the mCRPC field for combination therapy.
Screenshot source: Mosentropy Global Drug R&D Database
The submission for this expanded indication, together withJohnson & JohnsonJuly 2025 to the European Medicines Agency（EMA）The submitted extension applications are consistent, all based on the breakthrough data support from the Phase III clinical trial AMPLITUDE.
AMPLITUDE Study: Data Supporting Efficacy and Safety
AMPLITUDE Study is a global, multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial designed to evaluateNiraparib AbirateroneUnitedPrednisoneAndrogen Deprivation Therapy（ADT）Efficacy and safety in mCSPC patients carrying HRR gene mutations. The study enrolled 696 patients, of whom 55.6% had BRCA1/2 gene variations, and were randomly assigned to the experimental group in a 1:1 ratio.(Niraparib Abiraterone + Prednisone)or control group(Placebo + Prednisone). Core efficacy data are as follows:
Primary Endpoint:Median Radiological Progression-Free Survival in the Experimental Group（rPFS）Not yet reached, significantly better than the control group's 29.5 months, with a 37% reduction in the risk of disease progression or death.（HR=0.63，p=0.0001）。
BRCA Subgroup:Among 191 patients with BRCA mutations, the median rPFS in the experimental group was also not reached, compared to 26 months in the control group, with a 48% reduction in risk.（HR=0.52，p<0.0001）。
Secondary endpoint:Time to Symptom Progression in the Experimental Group（TSP）Significantly extended, with a 50% reduction in the risk of symptom progression; in the BRCA subgroup, the risk was reduced by 56%. Additionally, the first interim analysis showed an improvement in overall survival in the experimental group.（OS）Showing an improving trend.
Safety Features:Grade 3/4 Adverse Events in the Experimental Group（AE）The incidence rate was 75.2%, higher than the control group's 58.9%, with the most common AE being anemia.（38.5% vs 12.1%）and Hypertension（22.7% vs 15.2%）, but the discontinuation rate due to AE was low.（11.0% vs 6.9%）, with overall safety being controllable.
Clinical Significance: Filling the Treatment Gap for mCSPC in China
Prostate cancer is one of the most common malignant tumors in Chinese men, among which metastatic castration-sensitive prostate cancer（mCSPC）Patients account for about 30%. Traditional treatment involves androgen deprivation therapy.（ADT）Primarily, but the median survival period is only 3-5 years, and it easily progresses to castration-resistant prostate cancer.（CRPC）. The AMPLITUDE study was the first to confirm that, for HRR mutations(Especially BRCA1/2)mCSPC patients,Niraparib AbirateroneCombination therapy can significantly delay disease progression, providing a precise intervention strategy for populations with genetic mutations.
Niraparib Abiraterone TabletsAs Johnson & Johnson's core product in the prostate cancer field, its global sales have exceeded $2 billion. This new indication submission in China not only reflects Johnson & Johnson's patient-centered R&D strategy but also injects new momentum into its continued growth in the Chinese market.
At the same time, pharmaceutical companies in China are accelerating their布局 in the prostate cancer field.Hengrui Medicine、BeiGeneSeveral companies have also launched clinical trials for combination therapy with PARP inhibitors, butJohnson & JohnsonWith the first-mover advantage and global data support, it remains difficult to surpass in the short term.
Source of screenshot: Mosan Medical Global Drug Research and Development Database
Johnson & JohnsonNiraparib Abiraterone TabletsThe acceptance of the new indication's marketing application marks a significant advancement in China’s prostate cancer treatment field. With its unique dual mechanism of action and remarkable clinical efficacy, this drug is expected to bring new hope to patients in China. In the future, as research deepens and registration progresses,Niraparib Abiraterone TabletsMay play an increasingly important role in the treatment of prostate cancer.
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