Janssen's Prostate Cancer Drug Zebikgo® Receives First-in-China Approval for New Indication in BRCA2-Mutated mHSPC
Johnson & Johnson
Medical Device R&D and Manufacturer
June 22,Johnson & JohnsonAnnouncementZepboca®(Niraparib Abiterone Tablets)Officially approved by the National Medical Products Administration (NMPA) for a new indication, in combination with prednisone or prednisolone for patients carryingGermline and/and/or systemic BRCA2 gene mutationMetastatic Hormone-Sensitive Prostate Cancer（mHSPC）Adult patients.
Source of screenshot: Johnson & Johnson Innovative Medicine WeCom
This approval marksChina's First and OnlyForTargeted Combination Therapy for mHSPC Patients with BRCA2 Mutations Officially Implemented.
01
Indication Expansion: From mCRPC to mHSPC
Niraparil Abiteroneis a combination formulation developed by Johnson & Johnson, combiningCharacteristics of the PARP inhibitor niraparib and the CYP17 inhibitor abiraterone acetate, achieving"Dual-Target Synergy". Approved in the European Union and the United States in March and May 2023, respectively, for first-line treatment of metastatic castration-resistant prostate cancer (mCRPC) with BRCA1/2 mutations.
Approved in China in October 2024, becoming the first and only dual-effect combination product in its class. In June 2025, its indications were expanded to include BRCA2-mutated metastatic hormone-sensitive prostate cancer.（mHSPC）. From mCRPC to mHSPC, the treatment window has shifted significantly earlier, thereby benefiting more patients with early-stage metastatic disease.
02
Robust Clinical Data: 54% Reduction in Risk of Disease Progression
The National Medical Products Administration’s approval of the market launch of this regimen is primarily based onPositive Results from the Phase III AMPLITUDE Clinical Trial. AMPLITUDE is a global, multicenter, randomized, double-blind, placebo-controlled Phase III study that enrolled a total of 696 patients with metastatic castration-sensitive prostate cancer harboring HRR gene mutations.（mHSPC）Subjects; subjects were randomized in a 1:1 ratio, with both groups receiving androgen deprivation therapy（ADT）Medication on top of baseline therapy: Experimental group（n=348）Niraparib combined with abiraterone + prednisone treatment, control group（n=348）Treatment with placebo combined with abiraterone + prednisone.
Study results indicate that, compared with existing standard treatment regimens, niraparib+ Abiraterone + Prednisone combined with ADT can significantly improve patients' imaging progression-free survival（rPFS）, which can reduce the risk of disease progression or death in patients by 54%（HR=0.46；95% CI：0.32–0.66）; meanwhile, it can significantly delay the progression of symptoms（TSP）, reducing the risk of symptom progression by 59%（HR=0.41；95% CI：0.29–0.65）。
In terms of safety, this combination regimenThe adverse event profile in the mHSPC population is consistent with that previously observed in metastatic castration-resistant prostate cancer（mCRPC）The data obtained from the population were largely consistent, and no new safety risk signals were identified.
03
Clinical Pain Point: The “Precision Gap” in the BRCA2-Mutant Population
In recent years, the incidence of prostate cancer in China has risen significantly.According to the latest release from the National Cancer Center2022The Annual Report on the Burden of Malignant Neoplasms in China shows that the incidence rate of prostate cancer in our country is per10Among 10,000 people18.61For example, it has become the most common tumor in the male genitourinary system.
Despite the progress made in the treatment of prostate cancer with the improvement of medical standards in China,mCRPCstill a fatal disease. According to statistics, approximately10-15%ofmCRPCPatient CarriedBRCA1/2Gene Mutation.
CarryBRCA1/2Prostate cancer with genetic mutations often exhibits a higher degree of malignancy, potentially demonstrating greater invasiveness and a higher proportion of metastatic disease, leading to poorer survival outcomes for patients.
This time, Zebeike® Approval of the new indication precisely targets this high-risk subgroup, providing BRCA2-mutated mHSPC patients withFirst Targeted Combination Therapy Option。
Zybego®(European and American brand name: Akeega®)It is a dual-effect tablet, a fixed-dose combination drug of niraparib and abiraterone acetate.2023Year4Month21On [date], Johnson & Johnson’s Janssen Pharmaceuticals announced that the European Union has grantedAkeegaMarketing Authorization. Currently, this drug is available in two dosage strengths: conventional strength(100mg niraparib/500mg AA)and low intensity(50mg niraparib/500mg AA)。Previously, the drug wasReceived EU marketing authorization in April 2023 for patients with mCRPC harboring BRCA1/2 mutations.
From the first global approval to the launch of new indications in China,Zebeike®The clinical value continues to be realized—combining precision targeted therapy with endocrine therapy to directly address the treatment challenges in high-risk populations with BRCA2 mutations.54% Reduction in rPFS Risk, 59% Reduction in TSP Risk, robust data supports itsCore Position in First-Line Treatment for mHSPC.
ForFor prostate cancer patients with BRCA2 mutations, a new era of treatment is dawning.
END
This article is original; please leave a message to obtain authorization for reprinting.
