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How Paxlovid Approval May Influence China's Pandemic Policies

New Focus on Treatments Not Vaccines?

 
• By Brian Yang

In a surprise move, China has conditionally approved Pfizer’s oral COVID-19 antiviral Paxlovid, a development that may have far-reaching consequences for the country's pandemic policies and domestic drug developers. 

Paxlovid EUA dispensing information
CHINA APPROVES PFIZER'S PAXLOVID BUT 'COVID ZERO' POLICY SHIFT NOT IN SIGHT • Source: Nielsen Hobbs; the Pink Sheet | Paxlovid EUA dispensing information

China's approval of Pfizer Inc.'s oral antiviral Paxlovid (nirmatrelvir/ritonavir), announced on 11 February, marked the first approval in the country of a COVID-19 drug from a foreign firm, and the move is expected to pave the way to potential easing of some of the most restrictive pandemic control measures in the world.

The approval of the 3CL protease inhibitor was for mild-to-moderate disease in adults with an elevated risk of developing severe symptoms - the potential recipient groups include seniors and those with

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More from China

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.

Elevar/Hengrui’s Second US CRL A Bad Omen For Multiregional Trials In Asia-Dominant Cancers?

 
• By Dexter Jie Yan

While CMC glitches linger over a US NDA for Elevar/Hengrui’s novel liver cancer combination following a second complete response letter, the separate issue of underrepresentation of US patients in multiregional trials is looming large after new FDA draft guidance last year.

More from Asia

Japan Looks To Build Domestic Capacity In New Modalities

 
• By Lisa Takagi

Japan's trade ministry is providing new support to build domestic capacity for new modalities including cell and gene therapies, as part of wider efforts to support the national bioventure ecosystem.

Pipeline To Product – What Is Driving Cell And Gene Therapy Progress In India?

 
• By Vibha Ravi

US-based Colossal Labs has claimed to bring back the dire wolf from extinction. While the science is not as dramatic in India yet, cell and gene therapies are making progress as treatments for cancer and other diseases. Pink Sheet takes a look at what is driving CGT success and growth.

Japan Identifies Drugs ‘In Urgent Need’ Of Development

 
• By Lisa Takagi

Artesunate for malaria, TB drug pretomanid and omadacycline for pneumonia and skin infections are among the drugs identified by Japanese regulatory authorities in urgent need of domestic development.