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Approval For Access? Decoding The Significance Of China’s Opdivo Opening

 
• By Brian Yang

First comes the approval, then market access. A rapid regulatory clearance for BMS’s Opdivo in China not only pioneers a new and potentially huge market for immuno-oncology treatments, but may potentially set an example in how to expand market access for many new therapies waiting to get into the country, amid multiple recent regulatory and policy changes.

Trump & China
CHINA OPDIVO APPROVAL TO OPEN MORE DOORS?

China will herald a new era of cancer treatment after recently approving the first immuno-oncology therapy in the country, Bristol-Myers Squibb Co.’s Opdivo (nivolumab), giving the drug access to the world’s second-largest pharma market.

The regulatory clearance, for the potentially huge non-small cell lung cancer indication, came just months after the company announced results...

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More from China

Beijing City Releases AI Action Plan Including Drug Regulation

 
• By Xu Hu

Amid the wait for an action plan to apply AI tools to drug regulation at the national level in China, capital city Beijing has released its own vision of scenarios for the technology in the healthcare sector.

China Unveils Multiple Policies To Support Innovative Drugs Throughout Life Cycle

 
• By Xu Hu

China has announced a raft of new measures to encourage innovative drug development across the product life cycle, including using insurance data to differentiate new therapies and applying commercial insurance to selected novel products.

To Compete With China, US FDA Must Deregulate Early Gene Therapy Studies, CAR-T Inventor Says

 
• By Sarah Karlin-Smith

FDA regulation was painted as an obstacle to US dominance in the cell and gene therapy space even as panelists at an agency event praised the Office of Therapeutic Products' track record under Nicole Verdun.

China NMPA Lays Out Regulatory Priorities At DIA

 
• By Xu Hu

At this year’s DIA China meeting, the national regulator updated its policy focus areas for this year, including clinical trial data protection and pilot projects to shorten IND approval times.

More from Asia

Korea Pre-Review Consultations Help Accelerate R&D

 
• By Jung Won Shin

A system of pre-regulatory review consultations for innovative drugs and devices in South Korea has contributed to the accelerated development of such products.

What Pharma Needs To Know About Vietnam’s Drug Registration Reforms

 
• By Neena Brizmohun

Newly introduced rules for streamlining drug registration in Vietnam are said to present both opportunities and challenges for stakeholders.

Profit-Sharing AI Model Proposed To Boost Korean Drug R&D

 
• By Jung Won Shin

A differentiated profit-sharing model to accelerate the use of AI in drug development using clinical and patient data is being proposed in South Korea, but the idea faces multiple practical challenges