Darolutamide Receives Third Approval in China for Metastatic Hormone-Sensitive Prostate Cancer
核心洞察
The Chinese National Medical Products Administration (搜索) approved darolutamide (Nubeqa) in combination with androgen deprivation therapy for metastatic hormone-sensitive prostate cancer (搜索) patients.
The Phase III ARANOTE trial demonstrated that darolutamide plus ADT reduced the risk of radiological progression or death by 46% compared to placebo plus ADT.
This approval provides Chinese physicians with greater treatment flexibility, allowing darolutamide use with or without chemotherapy for mHSPC patients.
The Chinese National Medical Products Administration (搜索) (NMPA) has approved darolutamide (Nubeqa) in combination with androgen deprivation therapy (ADT) for patients with metastatic hormone-sensitive prostate cancer (搜索) (mHSPC), marking the third approval for this indication in China. The approval, announced on February 3, 2026, is based on compelling results from the pivotal Phase III ARANOTE trial.
Clinical Trial Results Drive Approval
The ARANOTE trial demonstrated significant clinical benefits for patients treated with darolutamide plus ADT. The study showed that this combination reduced the risk of radiological progression or death by 46% compared to placebo plus ADT (HR 0.54; 95% CI 0.41–0.71; P<0.0001). The randomized, double-blind, placebo-controlled Phase III study enrolled 669 patients who were randomized 2:1 to receive 600 mg of darolutamide twice daily or matching placebo in addition to ADT.
Consistent benefits in radiological progression-free survival were observed across prespecified subgroups, including patients with high-volume (HR 0.60, 95% CI: 0.44-0.80) and low-volume (HR 0.30, 95% CI: 0.15-0.60) mHSPC. The treatment was generally well tolerated, with darolutamide plus ADT showing lower discontinuation rates due to adverse events compared to placebo plus ADT.
Addressing Growing Disease Burden in China
Prostate cancer (搜索) represents a significant and growing health challenge in China. The disease burden has increased substantially in recent years, with projections indicating continued growth. By 2030, an estimated 315,310 new cases and 81,540 deaths are expected in China. Globally, prostate cancer is the second most common cancer in men and the fifth most common cause of cancer death in men worldwide, with approximately 1.5 million men diagnosed and about 397,000 deaths in 2022.
"The rising incidence of prostate cancer (搜索) in China poses a serious threat to men's health, and highlights that patients need personalized support," said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer.
Treatment Landscape Evolution
Professor Xing Nianzeng from Cancer Hospital Chinese Academy of Medical Sciences emphasized the importance of this treatment window: "mHSPC is a crucial treatment window to delay progression to poor prognosis mCRPC. Over the past decade, the treatment for mHSPC has evolved from ADT alone to combination regimens. Darolutamide, new-generation androgen receptor (搜索) inhibitor, is increasingly becoming standard therapy for mHSPC."
The approval provides physicians with enhanced treatment flexibility. Professor Xing noted that "ARANOTE shows an effective darolutamide-based option without docetaxel for patients who cannot or will not receive chemotherapy."
Regulatory Context and Global Reach
This approval was processed through Project Orbis, a program for promising cancer treatments coordinated by the FDA that provides a framework for concurrent submission and review of cancer medicines by international partner authorities. The program aims to give patients faster access to innovative cancer treatments and includes regulatory authorities from Australia, Brazil, Canada, Israel, Singapore, Switzerland, and the United Kingdom.
With this latest approval, darolutamide plus ADT is now indicated in China for the treatment of adult patients with mHSPC, either with or without docetaxel. Darolutamide is already approved in mHSPC in combination with ADT and docetaxel in over 85 markets worldwide, including China.
Drug Profile and Mechanism
Darolutamide is an oral androgen receptor (搜索) inhibitor with a unique chemical structure that binds with high affinity to the androgen receptor. It exhibits a strong antagonistic effect against the androgen receptor, inhibiting receptor function and growth of prostate cancer (搜索) cells. Preclinical models and neuroimaging data in healthy humans support darolutamide's low potential for blood-brain barrier penetration.
The recommended dose is 600 mg (two 300 mg film-coated tablets) twice daily, totaling 1,200 mg per day. The tablets should be taken with meals, and patients should continue hormone-reducing therapy during treatment with darolutamide.
Safety Profile
The ARANOTE study demonstrated that the incidence of all adverse events, including serious and grade 3 and grade 4 adverse events, in the darolutamide plus ADT treatment group was comparable to placebo plus ADT. This tolerability profile, combined with a limited risk of potentially critical interactions with other medications, positions darolutamide as a favorable treatment option for physicians and patients.
Darolutamide is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company. The robust clinical development program continues to investigate darolutamide across various stages of prostate cancer (搜索), including ongoing Phase III trials evaluating its efficacy in different patient populations and treatment combinations.