**Merck’s PD-1 Inhibitor Keytruda® (Pembrolizumab Injection) Approved in China for Platinum-Resistant Ovarian Cancer Indication**

China’s first and currently only approved^[1]PD-1 inhibitor for a platinum-resistant ovarian cancer immunotherapy combination regimen

ShanghaiJune 25, 2026 /PRNewswire/ — Merck Sharp & Dohme (MSD), a trade name of Merck & Co., Inc., headquartered in Rahway, New Jersey, USA, announced that its PD-1 inhibitor pembrolizumab (brand name: Keytruda®) has been approved by China’s National Medical Products Administration (NMPA) for use in combination with paclitaxel (with or without bevacizumab) for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one or two prior lines of systemic therapy and whose tumors express PD-L1 (Combined Positive Score [CPS] ≥ 1) as assessed by a fully validated test. This new indication approval is based on data from the Phase III clinical trial KEYNOTE-B96 (ENGOT-ov65).

“We are very pleased that Keytruda® (pembrolizumab) has become the first PD-1 inhibitor approved in China for a platinum-resistant ovarian cancer immunotherapy combination regimen, bringing a new treatment option for these patients,” said Kaiyu Tang, Senior Vice President, MSD, and President, MSD China. “Ovarian, endometrial, and cervical cancers are the three most common malignant tumors of the female reproductive system^[2]. This approval marks the comprehensive coverage of all three major tumor types by pembrolizumab, filling a crucial gap in gynecologic oncology immunotherapy. Leveraging our rich product portfolio and long-term commitment to women’s health, we will continue to collaborate with multiple stakeholders to help improve standardized diagnosis and treatment levels, illuminate the path forward for more female patients, and safeguard women’s health through sustained innovation.”

Ovarian cancer is one of the common malignant tumors among women in China. According to the latest data from the National Cancer Center, approximately 61,900 new cases of ovarian cancer and 32,500 deaths were reported in China in 2024, ranking it third in incidence and second in mortality among female reproductive system malignancies^[3]. Due to a lack of effective screening methods and atypical early symptoms, about 70% of patients are diagnosed at an advanced stage^[4]. Despite standard treatment^[5], approximately 70% of patients will experience recurrence, often facing the challenge of platinum resistance^[6], which poses significant treatment difficulties and underscores the urgent need for new therapeutic strategies in clinical practice.

“Platinum resistance has long been regarded as a major challenge in ovarian cancer treatment^[4]. Once patients develop platinum-resistant ovarian cancer, they often face limited treatment options, poor efficacy, and unfavorable prognoses^[7],” said Professor Xiaohua Wu, Lead Principal Investigator of the KEYNOTE-B96 study in China, Chief Expert of the Gynecologic Oncology Multidisciplinary Treatment Team at Fudan University Shanghai Cancer Center, and Chair of the Ovarian Cancer Committee of the Chinese Anti-Cancer Association. “This newly approved indication represents a potentially milestone advancement in the treatment of platinum-resistant ovarian cancer in China, offering a new therapeutic option for patients. We look forward to this innovative regimen bringing hope to more patients.”

“We are delighted to see the approval of Keytruda® (pembrolizumab) for platinum-resistant ovarian cancer in China. Although immune checkpoint inhibitors have achieved breakthrough progress in various solid tumors, their clinical benefit in ovarian cancer has remained relatively limited^[8], especially for patients with platinum-resistant disease, where treatment exploration has always been a challenging focus for the industry,” said Dr. Zhengqing Li, Senior Vice President, MSD, and President, MSD China R&D Center. “This approval is a significant outcome of our sustained efforts in this field and another example of MSD China’s close collaboration with global R&D teams to bring cutting-edge innovation to benefit patients in China. Moving forward, we will continue to be patient-centric, driving innovative research and contributing to the construction of a ‘Healthy China’.”

This content is supported by MSD China.

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