Janssen's Innovative Therapy Zebeiqo® Gains New Indication in China, Targeting a RMB 37.6 Billion Prostate Cancer Market

　　【Pharmaceutical Network Product News】In recent years, the incidence of prostate cancer in China has shown an upward trend, making it one of the most common high-incidence tumors. According to relevant data projections, by 2030, the number of new prostate cancer cases in China may exceed 165,000, and the market size for prostate cancer drugs in China is expected to reach approximately RMB 37.6 billion during the same period. Regarding advanced treatment options for prostate cancer, in addition to traditional methods such as radical surgery, radical radiotherapy, endocrine therapy, and chemotherapy, many new therapeutic approaches have emerged in recent years with the continuous advancement of medical research, and innovative drugs are gradually becoming available.
 

Johnson & Johnson recently announced that its innovative therapeutic drug Zebec (niraparib and abiraterone acetate tablets) has officially received approval from the National Medical Products Administration (NMPA) for use in combination with prednisone or prednisolone in adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) harboring germline and/or somatic BRCA2 mutations. Previously, Zebec had been approved for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) carrying germline and/or somatic BRCA mutations. Prostate cancer with BRCA mutations is typically more aggressive and associated with a poorer prognosis. As a precision combination therapy targeting BRCA-mutated prostate cancer, this expansion to a new indication will provide patients with new treatment options.
 

The approval of Zebeike is based on the positive results from the Phase III AMPLITUDE study. Compared with current standard-of-care regimens, Zebeike in combination 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 time to symptomatic progression (TSP), reducing the risk of symptomatic progression by 59% (HR=0.41; 95% CI: 0.29–0.65). Regarding safety, the safety profile of Zebeike in patients with metastatic hormone-sensitive prostate cancer (mHSPC) was consistent with that previously observed in patients with metastatic castration-resistant prostate cancer (mCRPC), with no new safety signals identified.
 

In addition to the approval of new indications for the aforementioned innovative drugs, several domestic pharmaceutical companies have recently announced new progress in their innovative prostate cancer therapies. For instance, Henlius recently announced that the National Medical Products Administration (NMPA) has approved its Investigational New Drug (IND) application for a Phase I clinical trial of HLX3902 injection (a STEAP1xCD3xCD28 trispecific antibody) (HLX3902) for the treatment of metastatic castration-resistant prostate cancer (mCRPC) and other advanced solid tumors.
 

The announcement indicates that HLX3902 is a tri-specific antibody drug independently developed by the company, intended for the treatment of metastatic castration-resistant prostate cancer (mCRPC) and other advanced solid tumors. HLX3902 is a tri-specific T-cell engager that simultaneously targets STEAP1, CD3, and CD28. By concurrently activating CD3 and CD28, HLX3902 enhances the ability of T cells to lyse STEAP1-expressing tumor cells. Furthermore, through the optimization of the primary (CD3) and secondary (CD28) signals for T-cell activation, it augments T-cell activation, proliferation, and survival, thereby achieving therapeutic efficacy in mCRPC and other advanced solid tumors. Preclinical studies have demonstrated that HLX3902 exhibits favorable anti-tumor efficacy and safety profiles, holding promise for clinical benefit.
 

Recently, Hengrui Medicine announced that the European Medicines Agency (EMA) has accepted its Marketing Authorization Application (MAA) for rezvilutamide tablets (brand name: Aieruien), an innovative drug independently developed by the company, for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) with high tumor burden. This marks a critical step toward the drug’s entry into the European market.
 

According to available data, rezvilutamide is a Class 1 new drug independently developed by Hengrui Medicine and represents China’s first novel androgen receptor inhibitor. It was approved in China in 2022 for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) with high tumor burden. The drug has been recommended by domestic and international guidelines, including the Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Prostate Cancer. The current marketing application is based on the CHART study, an international multicenter Phase III clinical trial.
 

Furthermore, in the field of prostate cancer, in December 2025, Grand Pharma’s innovative radiopharmaceutical drug conjugate (RDC) TLX591-CDx (Illuccix®, gallium Ga68 PSMA-11) for the diagnosis of prostate cancer achieved positive top-line results in its Phase III clinical trial conducted in China, successfully meeting the primary clinical endpoint. According to the announcement, TLX591-CDx is a globally innovative diagnostic radiopharmaceutical based on radionuclide-small molecule conjugation technology, targeting prostate-specific membrane antigen (PSMA), and is indicated for the diagnosis of newly diagnosed and recurrent prostate cancer.
 

Looking ahead, the introduction of more innovative drugs and the dynamic adjustment of the national reimbursement drug list will facilitate the broader adoption of cutting-edge therapies with proven efficacy and safety in primary care settings, thereby benefiting a larger population of patients with advanced-stage, high-risk gene-mutated prostate cancer. The synergistic innovation efforts of pharmaceutical companies both domestically and internationally will continue to drive advancements in the diagnosis and treatment of prostate cancer.
 

Disclaimer: Under no circumstances shall the information contained herein or the opinions expressed constitute investment advice for any person.