Merck's PD-1 Inhibitor Keytruda® Approved in China for First-Line Treatment of Unresectable or Metastatic Melanoma

       Shanghai, China, September 14, 2024 — MSD (the corporate name of Merck & Co., Inc., Kenilworth, NJ, USA) announced that its PD-1 inhibitor, pembrolizumab (trade name: Keytruda),^®) has been approved by the National Medical Products Administration (NMPA) of China for first-line treatment of unresectable or metastatic melanoma. This approval changes the indication for melanoma in the product’s prescribing information from “Pembrolizumab is indicated for the treatment of unresectable or metastatic melanoma that has failed first-line treatment” to “Pembrolizumab is indicated for the treatment of unresectable or metastatic melanoma.”

       "With this approval, pembrolizumab will once again offer a new treatment option for more patients with melanoma."Anna Tian, Senior Vice President of MSD Global and President of MSD China"It demonstrates our persistent efforts and commitment to exploring more groundbreaking innovative treatment solutions for patients, from the approval of the first indication in China in 2018 as a second-line treatment for advanced melanoma, to now expanding its use to first-line treatment, paving the way for an era where cancer can be treated and potentially cured."

       Malignant melanoma arises from the malignant proliferation of melanocytes. In China, the age-standardized incidence rate of malignant melanoma is approximately 0.37 per 100,000.^[1], which is a rare malignant tumor. In 2022, there were approximately 8,800 new cases of cutaneous melanoma in China, with about 5,400 deaths.^[1]。

       "Malignant melanoma is one of the more difficult cancers to treat effectively. In China, most cases of malignant melanoma are diagnosed at an advanced stage. With the approval of several PD-1 inhibitors in China in 2018, immunotherapy has become one of the recommended second-line or higher salvage treatments for advanced malignant melanoma in China."^[2]。”Professor Guo Jun from Peking University Cancer Hospital"We are very pleased to see that pembrolizumab will potentially bring new options and hope to more patients with advanced melanoma."

       "Whether globally or within China, the first indication for Pembrolizumab was in the field of melanoma treatment, offering cancer patients a new option for treatment."Dr. Zhengqing Li, Senior Vice President of MSD Global and President of MSD China R&D Center"On the occasion of the 10th anniversary of pembrolizumab's global approval, we are very pleased to see its new indication for first-line treatment of advanced melanoma approved in China, further demonstrating our leadership in the field of cancer treatment. We will continue to explore and innovate treatment options to benefit more cancer patients."

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About MSD China

       China is a crucial part of MSD's global growth strategy. MSD’s China headquarters is located in Shanghai, with a research and development center in Beijing and manufacturing facilities in Hangzhou, Ningbo, and Tianjin, integrating R&D, manufacturing, and commercial operations. We are fully committed to providing high-quality innovative medicines, vaccines, and services to the people of China, benefiting Chinese society. For more information, please visit the MSD China official website.www.msdchina.com.cn, or subscribe to MSD China's official WeChat account msd_china.

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[1] Zheng Rongshou, Chen Ru, Han Bingfeng, et al. Analysis of the prevalence of malignant tumors in China in 2022 [J]. Chinese Journal of Oncology, 2024, 46(3): 221-231.

[2] Chinese Society of Clinical Oncology (CSCO) Melanoma Expert Committee. CSCO Guidelines for the Diagnosis and Treatment of Melanoma 2023.