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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 of the CheckMate-078 study, in which 90% of participants were...

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More from China

BIOSECURE Act Returning, Privacy, Gain-of-Function Bills Coming, Senate Sponsor Says

 
• By Laura Helbling

Legislation prohibiting work with certain Chinese biopharma firms will be reintroduced soon, Democratic Sen. Gary Peters said. And it will not be the only bill tied to international biotech competition and security concerns that will be considered.

US FDA’s Expanded Surprise Foreign Inspections: Impact And Enforcement Hoops

 
• By Anju Ghangurde

As the US FDA expands unannounced foreign inspections building on pilots in India and China, experts expect higher scrutiny of overseas sites and perhaps even an industry shakeout in the longer term, though staffing and enforcement challenges could slow things down.

China Plans Clinical Data Protection By Product Category For First Time

 
• By Xu Hu

After almost seven years, China’s NMPA has once again published draft measures for clinical trial data protection, opening these up to public comments. While specific protection periods by drug category are proposed, some clarifications are still needed.

China Approvals Rise But Conditional-To-Full Conversion Slips

 
• By Xu Hu

A new annual report from China's CDE shows a rise in overall product approvals but a fall in the transition rate for conditional to full approvals, possibly signalling more stringent requirements.

More from Asia

US FDA’s Expanded Surprise Foreign Inspections: Impact And Enforcement Hoops

 
• By Anju Ghangurde

As the US FDA expands unannounced foreign inspections building on pilots in India and China, experts expect higher scrutiny of overseas sites and perhaps even an industry shakeout in the longer term, though staffing and enforcement challenges could slow things down.

DIA Korea: Medical Turmoil, Global Factors Blunt Korea’s Trial Edge

 
• By Jung Won Shin

DIA Korea hears how multiple domestic and global factors are affecting the environment for clinical trials in South Korea, and what actions may be taken to address this.

India Signals ‘Systemic Changes’ In CGT Regulatory Approach

 
• By Anju Ghangurde

India is pressing ahead with “big shifts” in its regulatory approach for cell and gene therapies. Reduced “layers of review”, tighter internal timelines, upcoming guidelines to facilitate CGT development and reforms in the constitution of expert committees are some of the key changes.