China Adds Pfizer's Paxlovid to Diagnosis and Treatment Protocol for COVID-19 Pneumonia

by Grace Wang Mar 23, 2022

On March 15, China's National Health Commission issued the Diagnosis and Treatment Protocol for COVID-19 Pneumonia (9th Trial Version)1. The protocol includes two new COVID-19 treatments: Brii Bio's Amubarvimab/Romlusevimab Combination and Pfizer's Paxlovid.

RELATEDChina Approves Pfizer's Paxlovid, Encouraging COVID-19 Drug Development

China's official recognition of the two drugs would bring their companies more orders and may benefit relevant contract manufacturing organizations (CMO) as well as active pharmaceutical ingredient (API) makers.

Brii Bio's Amubarvimab/Romlusevimab Injection is a virus-neutralizing monoclonal antibody combination therapy, which was approved2 by China National Medical Products Administration (NMPA) on Dec. 9, 2021. The manufacturing of the drug has been entrusted3 to WuXi Biologics.

Paxlovid (Nirmatrelvir Tablets and Ritonavir Tablets) is the first oral small-molecule drug approved4 by NMPA on Feb. 11, 2022. Pfizer has authorized5 China Meheco Corporation the drug's commercialization rights in the Chinese mainland.

Though Paxlovid has been approved, it hasn't been sold on the Chinese market yet. One reason is the lack of ritonavir tablets. In China, Ascletis Pharma is the only company that has demonstrated the bioequivalence between its generic ritonavir and Abbvie's original ritonavir. Currently, Ascletis is boosting its production capacity to reach an annual output of 530 million6 ritonavir tablets this year.

With relevant supply chains built up, COVID-19 drugs will generate enormous sales. For instance, Pfizer forecasts that Paxlovid will bring approximately US$ 22 billion7 of revenue in 2022.

Grace Wang
ChemLinked Regulatory Analyst & Editor
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