This indication expansion marks Zebeike® as the first and currently only[1] precision combination therapy in China for treating BRCA2 gene-mutated metastatic hormone-sensitive prostate cancer. Compared to the current standard of care, this therapy reduces the risk of disease progression by 54%[2]
BeijingJune 22, 2026 /PRNewswire/ — Johnson & Johnson announced today that its innovative therapeutic drug Zebeike® (Niraparib Abiraterone Acetate Tablets) has been officially approved by the National Medical Products Administration, for use in combination with prednisone or prednisolone for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) carrying germline and/or somaticBRCA2 gene mutations[2]. Previously, Zebeike® was approved for treating adult patients with metastatic castration-resistant prostate cancer (mCRPC) carrying germline and/or somaticBRCA gene mutations[2]. BRCA-mutated prostate cancer is typically more aggressive, leading to poor patient outcomes[3]. As the first and currently only[1] precision combination therapy in China targetingBRCA-mutated prostate cancer, this new indication expansion addresses the urgent unmet clinical treatment needs of these patients[4].
Cherry Huang, President of Johnson & Johnson Innovative Medicine China, stated: “The approval of this new indication for Zebeike® not only validates our commitment to continuously delivering transformative innovative therapies across the full course of prostate cancer but also fills the urgent treatment gap for mHSPC patients with BRCA2 mutations, once again highlighting the importance of genetic testing in prostate cancer diagnosis and treatment. Johnson & Johnson will continue to focus on the real-world needs of prostate cancer patients at different stages, support comprehensive disease management, and translate cutting-edge scientific breakthroughs into tangible patient benefits.”
This approval is based on positive results from the Phase III AMPLITUDE study. Compared to the current standard of care, Zebeike® combined 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)[2]. Additionally, this therapy significantly delayed the time to symptom progression (TSP), reducing the risk of symptom progression by 59% (HR=0.41; 95% CI: 0.29–0.65)[2]. In terms of safety, the safety profile of Zebeike® in mHSPC patients was consistent with previous observations in mCRPC patients, with no new safety signals identified[5].
In recent years, the incidence and mortality rates of prostate cancer in China have shown a continuous upward trend[6], with over 50% of prostate cancer patients presenting with metastasis at initial diagnosis[7]. As a critical treatment window for delaying disease progression, optimizing treatment strategies for mHSPC directly impacts long-term patient survival[8]. If not effectively treated during the mHSPC phase, patients will rapidly progress to mCRPC, with the annual all-cause mortality rate surging from 16% to 56%[9]. Therefore, in the 2026 updates of authoritative guidelines such as NCCN, EAU, and CSCO, based on evidence from the AMPLITUDE study, the combination of niraparib and abiraterone has been newly recommended for patients with BRCA-mutated metastatic hormone-sensitive prostate cancer[10],[11],[12], marking a shift of precision treatment to earlier stages of the disease.
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[1] Johnson & Johnson submitted an application based on Category 2 (2.4) modified new drug new compound formulation under the “Chemical Drug Registration Classification and Application Data Requirements” and received approval. Category 2: Modified new drugs not yet marketed domestically or internationally. Refers to drugs optimized in structure, dosage form, formulation process, route of administration, or indications based on known active ingredients, with clear clinical advantages. 2.4: Drugs with new indications containing known active ingredients. |
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[2] AKEEGA® CHINA PRESCRIBING INFORMATION, JUNE 2026. |
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[3] FETTKE H, ET AL. EBIOMEDICINE, 2023;95. |
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[11] CSCO Clinical Guidelines for the Diagnosis and Treatment of Prostate Cancer 2026 |
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AMPLITUDE is a global, multicenter, randomized, double-blind, placebo-controlled Phase III study that enrolled 696 patients with HRR gene-mutated metastatic castration-sensitive prostate cancer (mHSPC). Patients were randomized 1:1 to receive niraparib + abiraterone + prednisone (n=348) or placebo + abiraterone + prednisone (n=348) combined with ADT, aiming to evaluate the efficacy and safety of the combination regimen compared to standard treatment. |