Opdivo (Nivolumab Injection), China's First Immuno-Oncology Therapy, Named Among 'Top 10 Innovative Drugs of 2018'

Guided by the National Health Commission of the People's Republic of China and People's Daily, the "11th Healthy China Forum," co-hosted by People's Daily Online and Health Times, was grandly held in Beijing on January 8. At the event, the "Top 10 Innovative Drugs of 2018" list was simultaneously released, with Opdivo (nivolumab injection), the first immuno-oncology (I-O) therapeutic drug approved for marketing in China, receiving this distinguished honor.

The annual “Healthy China” Forum, themed “Grand Vision, Deep Integration,” brought together numerous stakeholders from the healthcare sector—including government officials, hospital representatives, academic societies, and enterprises—who conducted in-depth analyses and discussions on key topics such as healthcare reform under the Healthy China Strategy, pharmaceutical policies, and chronic disease prevention and control, in light of the industry’s hotspots and focal points in 2018.

2018 marked the inaugural year of cancer immunotherapy in China. On June 15, the China Food and Drug Administration (CFDA) officially approved the marketing of Opdivo (nivolumab injection), the first immuno-oncology (I-O) therapeutic agent in China, for second-line treatment of advanced non-small cell lung cancer (NSCLC). It remains the only PD-1 inhibitor approved to date for the treatment of lung cancer in China. This milestone signifies the entry of cancer treatment in China into the “immunotherapy era.” With the launch of Opdivo (nivolumab injection) in China, the traditional treatment landscape dominated by surgery, radiotherapy, and chemotherapy has been transformed, offering hope for long-term survival to a greater number of Chinese patients with advanced NSCLC.

In 2018, the Nobel Prize in Physiology or Medicine was awarded to James Allison of the United States and Tasuku Honjo of Japan in recognition of their pioneering contributions to cancer immunotherapy through CTLA-4 and PD-1 inhibitors. Bristol-Myers Squibb, holding exclusive implementation licenses for patents owned by the two Nobel laureates, leveraged their research findings and its own scientific expertise to facilitate the development of ipilimumab* and Opdivo (nivolumab injection), becoming the first biopharmaceutical company to bring immuno-oncology (I-O) therapies to China and worldwide.

In China, Bristol-Myers Squibb pioneered clinical research in immuno-oncology, focusing on locally prevalent therapeutic areas with unmet medical needs. Currently, the company has initiated or is conducting 26 immuno-oncology (I-O) clinical trials in China, most of which are Phase III studies, dedicated to exploring the application of immuno-oncology therapies across various tumor types, including lung cancer, gastric cancer, liver cancer, and esophageal cancer.

Zhao Ping, President of Bristol Myers Squibb in Mainland China and Hong Kong, stated, “I am deeply honored and proud that Opdivo has received this prestigious recognition. This marks another external endorsement of cancer immunotherapy, following the Nobel Prize awarded to Professor James Allison and Professor Tasuku Honjo for their groundbreaking contributions to the field. In China, Bristol Myers Squibb will continue to uphold its ‘patient-centric’ commitment by introducing revolutionary innovative products to meet the urgent treatment needs of Chinese patients, while delivering greater innovative value to society.”

* Not yet marketed in mainland China.

Image source: The 11th Healthy China Forum