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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

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.

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.

More from Asia

Japan Price Cuts For Epkinly and Lunsumio Following CEA

 
• By Lisa Takagi

Japan is cutting more drug reimbursement prices following cost effectiveness analysis and is applying the methodology to a new group of products including Wegovy and Leqembi.

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.

Japan Reimburses 11 New Drugs But Slashes Price Of Others By Up To 20%

 
• By Lisa Takagi

Japan's NHI program continues to give and take as 11 new drugs are granted reimbursement, while the prices of others - including three ophthalmic therapies - are cut by up to 20% under a Market Expansion Repricing scheme.