SHANGHAI, China, October 8, 2026 - Hengrui Pharma ("Hengrui") (600276.SH; 01276.HK) today announced that the European Medicines Agency (EMA) has validated the Marketing Authorisation Application (MAA) for Wevdury® (fuzuloparib) in combination with abiraterone acetate and prednisone or prednisolone for the proposed indication of treating metastatic castration-resistant prostate cancer (mCRPC) in adult patients.
About the FUZUPRO Study
This application is based on data from the SHR3162-III-305 study (FUZUPRO, NCT04691804), an international, multicenter, randomized, double-blind, placebo-controlled phase 3 trial. The study aimed to assess the efficacy and safety of fuzuloparib in combination with abiraterone and prednisone (AA-P) versus placebo in combination with AA-P as first-line treatment in patients with metastatic castration-resistant prostate cancer (mCRPC). Professor Dingwei Ye of Fudan University Shanghai Cancer Center served as the global lead principal investigator. The trial was conducted jointly at 132 sites worldwide.
A total of 496 patients with mCRPC were enrolled in the study (including 236 patients enrolled outside the Chinese mainland and randomly assigned at a 1:1 ratio to the experimental arm (fuzuloparib plus AA-P) or the control arm (placebo plus AA-P). The primary endpoint was radiographic progression-free survival (rPFS) assessed by blinded independent central review (BICR).
The study results showed that, as first-line treatment for mCRPC, the experimental arm significantly extended rPFS compared with the control arm, with a manageable safety profile. As of the data cutoff on March 23, 2025, the median rPFS was 24.8 months in the experimental arm versus 19.9 months in the control arm (hazard ratio [HR] = 0.71; 95% CI 0.55-0.91). These findings were orally presented at the 2026 Annual Meeting of the American Society of Clinical Oncology (ASCO) [1].
About Prostate Cancer
Prostate cancer is the second most frequently diagnosed malignancy and the fifth leading cause of cancer mortality among men worldwide. In 2022, there were an estimated 1.467 million new cases and more than 397,000 deaths attributed to prostate cancer globally. It was the most frequently diagnosed cancer among men in 118 countries and regions, representing a major threat to public health [2]. In the European Union (EU), prostate cancer is the most commonly diagnosed cancer and the third leading cause of cancer death among men [3].
Metastatic castration-resistant prostate cancer (mCRPC) is a resistant state of prostate cancer that develops under the sustained pressure of continuous endocrine therapy. Standard treatment options for mCRPC include taxane-based chemotherapy and novel androgen receptor (AR)-targeted agents, novel hormonal agents (NHAs). Despite these treatment options, five-year survival remains low and the symptom burden is heavy, primarily involving bone metastasis-related pain, pathological fractures, and significantly impaired quality of life. There remains an urgent unmet clinical need for new, effective treatments [4].
About Fuzuloparib Capsules
Fuzuloparib is a Class 1 innovative drug (under China's drug registration classification) independently developed by Hengrui, and the first PARP inhibitor independently developed in China to receive approval in the country. It blocks DNA repair in tumor cells by inhibiting PARP enzyme activity. Certain indications of the product were previously included in the CDE/NMPA Priority Review and Approval procedure and listed as Breakthrough Therapy Drugs. In 2026, the invention patent for fuzuloparib capsules was honored with the 26th China Patent Gold Award.
Fuzuloparib was first approved in December 2020, and has since been approved in China for five indications: in December 2020, for the treatment of patients with platinum-sensitive recurrent ovarian, fallopian tube, or primary peritoneal cancer harboring germline BRCA mutations (gBRCAm) who had received two or more prior lines of chemotherapy; in June 2021, as maintenance therapy for adult patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who achieved a complete or partial response following platinum-based chemotherapy; in May 2024, as maintenance therapy for adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who achieved a complete or partial response following first-line platinum-based chemotherapy; and in December 2024, as monotherapy or in combination with apatinib mesylate for adult patients with germline BRCA-mutated (gBRCAm), HER2-negative metastatic breast cancer who had received chemotherapy in the neoadjuvant, adjuvant, or metastatic setting (patients with hormone receptor-positive breast cancer must have received prior endocrine therapy or be considered unsuitable for endocrine therapy).
About Hengrui Pharma
Hengrui Pharma is an innovation-driven, global pharmaceutical company dedicated to the research, development and commercialization of high-quality medicines to address unmet clinical needs. Its therapeutic areas of focus include oncology, metabolic and cardiovascular diseases, immunological and respiratory diseases, and neuroscience. Driven by a patient-focused philosophy since its founding in 1970, Hengrui Pharma remains committed to advancing human health by striving to conquer diseases, improve health, and extend lives through the power of science and technology. For more information, visit us at Hengrui.com and follow us on LinkedIn.
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This press release contains statements that reflect Hengrui Pharma's beliefs or expectations about the future or future events as of the respective dates indicated therein ("forward-looking statements"). These forward-looking statements are based on a number of assumptions about Hengrui Pharma's operations, its future development plans, market (financial and otherwise) conditions and growth prospects, and are subject to significant risks, uncertainties and other factors beyond Hengrui Pharma's control, and accordingly, actual results may differ materially from those contemplated by these forward-looking statements. No reliance should be placed on such statements, which reflect the view of the management of Hengrui Pharma as at the date of this press release. Hengrui Pharma does not undertake any obligation to update these forward-looking statements for events or circumstances that occur subsequent to such dates.
Reference
[1]. Dingwei Ye et al. Fuzuloparib combined with abiraterone acetate and prednisone (AA-P) as first-line (1L) treatment for metastatic castration-resistant prostate cancer (mCRPC): Interim results from the FUZUPRO trial. J Clin Oncol 44, 5008-5008(2026).
[2]. Bray Freddie, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries.CA Cancer J Clin. 2024 May-Jun;74(3):229-263.
[3]. Commission, E. 2024 Estimates of Cancer Cases and Deaths in the EU. 2026.
[4]. Chinese Anticancer Association Genitourinary Oncology Committee. [Chinese experts consensus on the treatment of metastatic prostate cancer 2018 edition]. Zhonghua Wai Ke Za Zhi.