Merck's PD-1 Inhibitor Keytruda® Approved in China for Hepatocellular Carcinoma Treatment

Used forPatients with hepatocellular carcinoma (HCC) who have previously received sorafenib or oxaliplatin-based chemotherapy (HCC) Patient

ShanghaiOctober 10, 2022PR Newswire -- MSD (the corporate name of Merck & Co., Inc., located in Rahway, New Jersey, U.S.) announced that its PD-1 inhibitor Pembrolizumab (trade name: Keytruda^®️) has been approved by the National Medical Products Administration (NMPA) of China as a monotherapy for the treatment of patients with hepatocellular carcinoma (HCC) who have previously received sorafenib or oxaliplatin-based chemotherapy. The approval of this new indication is based on data from the Phase III clinical trial, KEYNOTE-394.

"China is a country with a high incidence of cancer, particularly liver cancer, which sees a large number of new cases and deaths each year in China, causing great heartache."Anna Tian, Senior Vice President of MSD Global and President of MSD China"For a long time, MSD has remained firmly committed to the field of liver diseases and possesses a rich pipeline ranging from prevention to treatment. With the approval of the 9th indication for pembrolizumab in China, more patients with hepatocellular carcinoma will have access to cutting-edge treatment options, highlighting our determination and commitment to ushering in an era where cancer is treatable and potentially curable."

According to data from the World Health Organization, in 2020, there were approximately 410,000 new cases of liver cancer in China, accounting for about 45% of the global total; in the same year, approximately 391,000 people died from liver cancer in China, second only to lung cancer, making it the second leading cause of cancer-related deaths in the country.^[1]-[2]From 2012 to 2015, the five-year survival rate for liver cancer patients in China was only 12.1%.^[3], 70%-80% of patients are already at the middle or advanced stage at the time of diagnosis.^[4]; Difficult to treat, short survival period, poor quality of life, urgently needing to find more treatment options.^[5]。

"The data from the KEYNOTE-394 study was released at a global academic conference earlier this year, and now pembrolizumab has been approved in China for second-line treatment of advanced hepatocellular carcinoma. As researchers, we are greatly encouraged."KEYNOTE-394Principal Investigator,Professor Shukui Qin, Professor at Nanjing University of Chinese Medicine and Director of the Oncology Center at Nanjing Jinling Hospital"Noted that 'Currently, the survival benefit for patients with advanced hepatocellular carcinoma after treatment remains low, and there is still a significant unmet medical need. The approval of this new indication for pembrolizumab provides a new 'weapon' in the fight against hepatocellular carcinoma, a difficult-to-treat cancer, and offers clinicians and patients a new treatment option.'"

"MSD is always actively exploring ways and possibilities to change cancer treatment, pushing the boundaries of science forward."Dr. Zhengqing Li, Senior Vice President of MSD and President of MSD China Research Center"In the field of liver cancer treatment, there are currently multiple clinical trials in MSD's global R&D program in which China is participating, exploring different treatment stages and regimens. We will continue to work closely with Chinese researchers to promote the development of innovative oncology treatment research in China, benefiting more patients in China."

About MSD

For 130 years, MSD has remained committed to our mission of saving lives and improving quality of life, dedicated to enhancing the brilliance of life by providing medicines and vaccines to tackle some of the world's most challenging diseases. MSD is the trade name of Merck & Co., Inc., headquartered in Rahway, New Jersey, USA. Through far-reaching policies, programs, and partnerships, we are fulfilling our commitment to improving access to healthcare for patients and the public. Today, MSD continues to lead at the forefront of research and development, addressing diseases that threaten the health of people and animals worldwide.--Including cancers, infectious diseases such as HIV and Ebola, and emerging animal diseases-- To advance its prevention and treatment, committed to becoming a global leading research-intensive biopharmaceutical company. For more information, please visit the official website of MSD headquarters.www.msd.com, or follow MSD's social media accounts on Twitter, Facebook, Instagram, YouTube, and LinkedIn.

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 a manufacturing plant in Hangzhou, integrating R&D, manufacturing, and commercial operations. We are fully committed to providing the people of China with high-quality innovative medicines, vaccines, and services for the benefit of 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] IARC. China Fact Sheet (2020).

[2] IARC, World Fact Sheet (2020)

[3] Zeng, Hongmei et al. "Changing cancer survival in China during 2003-15: a pooled analysis of 17 population-based cancer registries." The Lancet. Global health vol. 6,5 (2018): e555-e567. doi:10.1016/S2214-109X(18)30127-X

[4] Expert Group of the National Multicenter Prospective Early-Stage Liver Cancer Warning and Screening Project, Expert Consensus on Early Liver Cancer Screening Strategies in China, Chinese Journal of Hepatology, June 2021, Vol. 29, No. 6

[5] Shuke Qin, et al., Advances in Immunotherapy for Hepatocellular Carcinoma, "Progress in Chinese Clinical Oncology 2020"