SHANGHAI, China, June 18, 2026 — Hengrui Pharma (“Hengrui”) (600276.SH; 01276.HK) today announced that the European Medicines Agency (EMA) has validated the Marketing Authorisation Application (MAA) for Renruirez^® (rezvilutamide) in combination with androgen deprivation therapy (ADT) for the treatment of adult men with high‑volume metastatic hormone‑sensitive prostate cancer (mHSPC).

About CHART Study

The application is based on data from the SHR‑3680‑III‑HSPC study (CHART, NCT03520478), an international, multicenter, randomized, controlled Phase 3 trial. The study aimed to assess the efficacy and safety of rezvilutamide in combination with ADT versus bicalutamide in combination with ADT in patients with high‑volume metastatic hormone‑sensitive prostate cancer (mHSPC). Professor Dingwei Ye of Fudan University Shanghai Cancer Center served as the global lead principal investigator. The trial was conducted jointly at 72 sites in China and Europe.

A total of 654 patients with high‑volume mHSPC were enrolled and randomly assigned in a 1:1 ratio to the experimental arm (rezvilutamide plus ADT) or the control arm (bicalutamide plus ADT). The primary endpoints were Independent Review Committee (IRC)‑assessed radiographic progression‑free survival (rPFS) and overall survival (OS). Secondary endpoints included investigator‑assessed rPFS, time to PSA progression, time to next skeletal-related event, time to initiation of next anti‑prostate cancer therapy, and objective response rate (ORR).

The results of the study showed that first‑line treatment with rezvilutamide in combination with ADT conferred significant survival benefits and a manageable safety profile in patients with high‑volume mHSPC. As of the cutoff date of February 28, 2022, patients in the rezvilutamide arm experienced a 54% reduction in the risk of radiographic progression or death compared with the control arm (median rPFS: not reached vs. 23.5 months; HR = 0.46, 95% CI 0.36–0.60). With regard to overall survival, rezvilutamide plus ADT significantly extended OS, corresponding to a 42% reduction in the risk of death (median OS: not reached vs. not reached; HR = 0.58, 95% CI 0.44–0.77; P = 0.0001). These findings were published in The Lancet Oncology in 2022^[1].

As of the cutoff date of June 6, 2025, with a median follow-up of 72.8 months, the final OS analysis demonstrated a sustained OS benefit for the rezvilutamide arm over the control arm, corresponding to a 41% reduction in the risk of death (median OS: 78.8 months vs. 44.8 months; HR = 0.59, 95% CI 0.47–0.73). These updated findings were presented as a poster at the 2026 Annual Meeting of the American Society of Clinical Oncology (ASCO) ^[2].

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. The disease ranks first in incidence across 118 regions, representing a major threat to public health ^[3]. In Europe, prostate cancer is the most common cancer in men and the third leading cause of cancer death ^[4].

Prostate cancer cell growth is androgen dependent. Owing to sustained activation of the androgen receptor (AR) signaling pathway, patients with metastatic hormone-sensitive prostate cancer (mHSPC) will inevitably progress to metastatic castration-resistant prostate cancer (mCRPC) and experience disease progression, even after receiving castration therapy (with or without first-generation antiandrogen therapy). The five-year survival rate for mCRPC is below 30% ^[5]. The use of second-generation AR inhibitors in combination with castration therapy has been shown to effectively delay the time to progression to mCRPC and significantly extend overall survival ^[6-8].

About Rezvilutamide

Rezvilutamide represents a Class 1 innovative drug independently developed by Hengrui Pharma with full proprietary intellectual property rights. It was approved in China in 2022 as the first domestically developed novel androgen receptor (AR) inhibitor for the treatment of patients with high‑volume metastatic hormone‑sensitive prostate cancer (mHSPC).

Rezvilutamide has provided a novel therapeutic option for patients with prostate cancer since its launch in 2022. It has been incorporated as a Grade I recommendation (Category 1A evidence) in the CSCO Prostate Cancer Diagnosis and Treatment Guidelines (2025 Edition), a Class I recommendation in the CACA Guidelines for the Integrated Diagnosis and Treatment of Prostate Cancer (2025 Edition), and a strong recommendation in the EAU Prostate Cancer Guidelines (2026 Edition) ^[5-7].

About Hengrui Pharma: Innovation to Benefit Patients Worldwide

Hengrui Pharma is an innovative, 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.

Hengrui Pharma Cautionary Statement Regarding Forward-Looking Statements

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.

Hengrui Pharma

Media Inquiries: Yizhen Yang: yizhen.yang.yy390@hengrui.com

Investors: Lina Zhang: lina.zhang.lz511@hengrui.com

References:

[1]. Gu W, et al. Rezvilutamide versus bicalutamide in combination with androgen-deprivation therapy in patients with high-volume, metastatic, hormone-sensitive prostate cancer (CHART): a randomised, open-label, phase 3 trial. The Lancet Oncology. 2022 Oct;23(10):1249–60.

[2]. Dingwei Ye, et al. Rezvilutamide (Rez) versus bicalutamide (Bic) plus androgen-deprivation therapy (ADT) in high-volume, metastatic, hormone-sensitive prostate cancer (mHSPC): 5-year outcomes of the phase 3 CHART trial. J Clin Oncol 44, 5090-5090(2026).

[3]. 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.

[4]. Union, E. Prostate cancer burden in EU-27. 2021.

[5]. Chinese Anticancer Association Genitourinary Oncology Committee. [Chinese experts consensus on the treatment of metastatic prostate cancer 2018 edition]. Zhonghua Wai Ke Za Zhi. 2018;56(9):646.

[6]. Guidelines of Chinese society of clinical oncology (CSCO): prostate cancer. 2025.

[7] China Anti-Cancer Association (CACA) Guidelines for the Integrated Diagnosis and Treatment of Prostate Cancer.2025

[8]. EAU - EANM - ESTRO ESUR - ISUP - SIOG Guidelines on Prostate Cancer. 2026.