Bristol Myers Squibb Accelerates Access to Innovative Immuno-Oncology Therapy Yervoy® in Greater Bay Area

SHENZHEN, Sept. 3, 2021 /PRNewswire/ -- Bristol-Myers Squibb announced today that, leveraging the "Greater Bay Area Medical Devices and Drugs Policy" implemented in the Guangdong-Hong Kong-Macao Greater Bay Area, its innovative immuno-oncology drug Opdivo^®（Ipilimumab Injection）has officially been introduced into clinical use at The University of Hong Kong-Shenzhen Hospital, with the first cohort of patients beginning to benefit. Bristol-Myers Squibb stated that it will partner with clinical experts in the Greater Bay Area to provide innovative treatment options for more patients.

Last November, eight departments, including the State Administration for Market Regulation, the National Medical Products Administration, and the National Development and Reform Commission, issued the *Work Plan for the Innovative Development of Regulatory Systems for Drugs and Medical Devices in the Guangdong-Hong Kong-Macao Greater Bay Area*. The plan proposes to allow drugs that are in urgent clinical need and already marketed in Hong Kong and Macao, as well as medical devices that are urgently needed clinically, already procured and used by public hospitals in Hong Kong and Macao, and demonstrate advanced clinical applications, to be used in eligible medical institutions in the mainland part of the Guangdong-Hong Kong-Macao Greater Bay Area upon approval by the Guangdong Provincial People's Government. In accordance with the principle of "phased implementation and pilot programs first," The University of Hong Kong-Shenzhen Hospital is the sole designated inaugural pilot hospital.

In the Hong Kong Special Administrative Region, Yervoy^®The approved indication is unresectable or metastatic melanoma. Meanwhile, Opdivo^®(Nivolumab Injection) in Combination with YERVOY^®The approved indications for the dual immunotherapy combination regimen in the Hong Kong Special Administrative Region include: unresectable or metastatic melanoma, metastatic non-small cell lung cancer, advanced renal cell carcinoma, and metastatic colorectal cancer with microsatellite instability-high (MSI-H)/mismatch repair deficiency (dMMR).

In June this year, the Guangdong Provincial Medical Products Administration approved The University of Hong Kong-Shenzhen Hospital's application regarding the importation of Opdivo^®application. This initiative enables Bristol-Myers Squibb’s immuno-oncology treatment regimens to fully leverage their innovative advantages, meeting the clinical treatment needs of the Guangdong-Hong Kong-Macao Greater Bay Area through accelerated market availability. The first batch of Opdivo^®Delivered to The University of Hong Kong-Shenzhen Hospital on August 17.

Professor Kong Fengming, Director of the Thoracic Oncology Center at The University of Hong Kong-Shenzhen Hospital, stated: “Today’s progress is of great significance. The Greater Bay Area policies enable us to access innovative drugs earlier, allowing for timely and effective improvement in patients’ survival and quality of life, while further addressing unmet clinical needs. We also look forward to continuously accumulating real-world data through clinical practice, facilitating the earlier availability of more innovative drugs to benefit a broader patient population in the future.”

Chen Siyuan, President of Bristol-Myers Squibb Mainland China and Hong Kong, stated: “Benefiting from the innovative policies in the Greater Bay Area, we look forward to accelerating the introduction of more innovative products, enabling doctors and patients in Mainland China to gain timely access to professional support and innovative treatment options. As a long-term partner in China, Bristol-Myers Squibb is committed to working closely with the Chinese government to foster an environment conducive to pharmaceutical innovation, enabling Chinese patients to benefit from our innovative medicines at an earlier stage. We also fully recognize that China has already emerged as one of the world’s most dynamic innovation ecosystems. We have made a long-term commitment to China and are dedicated to becoming an innovation leader that is deeply rooted in and originates from China.”

In accordance with relevant regulations, designated medical institutions in the nine mainland cities of the Guangdong-Hong Kong-Macao Greater Bay Area are permitted to use drugs and medical devices approved in Hong Kong and Macao. Bristol-Myers Squibb stated that it will continue to closely monitor policy developments and leverage broader collaborations to ensure that more innovative drugs are promptly introduced into approved medical institutions under relevant policies, thereby serving patients in the Greater Bay Area.