Janssen Announces China Approval of ZEJULA® (Niraparib Abiraterone Acetate Tablets) as First and Only Precision Combination Therapy for BRCA2-Mutated Metastatic Hormone-Sensitive Prostate Cancer

The expansion of this indication marks Zebeike^®It has become the first and currently only precision combination therapy in China for the treatment of BRCA2-mutated, metastatic, hormone-sensitive prostate cancer. Compared with existing standard treatment regimens, this therapy reduces the risk of disease progression by 54%.

Johnson & Johnson announced today that its innovative therapeutic drug, Zepzelca^®(Niraparib and Abiraterone Tablets) have been officially approved by the National Medical Products Administration for use in combination with prednisone or prednisolone in patients carrying germline and/or somaticBRCA2Adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) harboring gene mutations. Previously, Zebeike^®Approved for the treatment of patients with germline and/or somaticBRCAAdult patients with metastatic castration-resistant prostate cancer (mCRPC) harboring gene mutations.BRCAMutant prostate cancer is typically more aggressive, leading to a poor prognosis for patients. As a precision combination therapy targeting BRCA-mutant prostate cancer, this new indication expansion addresses the urgent unmet clinical treatment needs of these patients.

Cherry Huang, President of Johnson & Johnson Innovative Medicine China, stated: “This time, Zeptec”^®The approval of the new indication not only reaffirms our commitment to continuously launching transformative innovative therapies throughout the entire disease course of prostate cancer, but also fillsBRCA2“The urgent unmet treatment needs of patients with metastatic hormone-sensitive prostate cancer (mHSPC) harboring mutations further underscore the critical importance of genetic testing in the diagnosis and management of prostate cancer. Johnson & Johnson remains committed to addressing the practical needs of patients at all stages of prostate cancer, supporting comprehensive disease management throughout the care continuum, and translating cutting-edge scientific breakthroughs into tangible patient benefits.”

This approval is based on the positive results of the Phase III AMPLITUDE study. Compared with the current standard of care, Zebeike^®Combination therapy with prednisone and androgen deprivation therapy (ADT) significantly prolonged radiographic progression-free survival (rPFS), reducing the risk of disease progression or death by 54% (HR=0.46; 95% CI: 0.32–0.66). Meanwhile, this regimen also significantly delayed the time to symptomatic progression (TSP), lowering the risk of symptomatic progression by 59% (HR=0.41; 95% CI: 0.29–0.65). In terms of safety, Zebec^®The safety profile in patients with mHSPC was consistent with that previously observed in patients with mCRPC, and no new safety signals were identified.

In recent years, the incidence and mortality rates of prostate cancer in China have shown a continuous upward trend, with more than 50% of patients presenting with metastasis at initial diagnosis. As a critical therapeutic window for delaying disease progression, the optimization of treatment strategies for metastatic hormone-sensitive prostate cancer (mHSPC) is directly linked to long-term patient survival. If mHSPC is not effectively treated, patients will rapidly progress to metastatic castration-resistant prostate cancer (mCRPC), causing the annual all-cause mortality rate to surge from 16% to 56%. Therefore, in the 2026 updates of authoritative domestic and international guidelines, including those from the NCCN, EAU, and CSCO, the regimen of niraparib combined with abiraterone has been newly recommended based on evidence from the AMPLITUDE study, for use inBRCAMutant Metastatic Castration-Sensitive Prostate Cancer Patients: This Move Marks the Shift of Precision Therapy Toward Earlier Stages of the Disease.

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