Successful FDA EUA of first indigenous combo mAb therapy may boost China’s credibility, says GlobalData

The National Medical Products Administration (NMPA) of China has recently approved Brii Biosciences’ amubarvimab/romlusevimab combination as the first COVID-19 neutralizing antibody combination therapy in the country. The company is currently pursuing emergency use authorization (EUA) from the FDA. If approved, it becomes the first combo antibody therapy from a Chinese company to gain entry into the global market, says GlobalData, a leading data and analytics company.

According to the GlobalData Pharma Intelligence Center, besides amubarvimab/romlusevimab, AstraZeneca’s tixagevimab + cilgavimab (Evusheld) is the only other combo antibody therapy in Phase III that is likely to be submitted for NMPA’s approval in China.

Sasmitha Sahu, Pharma Analyst at GlobalData, comments: “Monoclonal antibody (mAb) therapies are slow and expensive to produce and as such supplies can be limited. AstraZeneca could prioritise other key markets over China, even if its combo therapy will be approved by the NMPA. Hence, the approval of a domestic product has ensured COVID-19 at-risk Chinese patients access to antibody therapies.”

According to NMPA, the total number of confirmed COVID-19 cases on the mainland had reached 100,076 as of 16 December 2021, including 1,556 patients still receiving treatment. It detected its first Omicron case only on 14 December.

Sahu continues: “Although Chinese vaccines dominate their domestic market and are supplied to many other smaller markets, they had a very little penetration into the major markets. With reportedly lower COVID-19 cases in China, more and more Chinese companies are expanding their horizons by conducting global trials for drugs, including COVID-19 therapies, aiming for drug approvals at global levels.”

Moreover, Brii Bio reported that the amubarvimab/romlusevimab combination retains neutralizing activity against the Omicron variant based on recent new in vitro pseudovirus neutralization data. AstraZeneca is the only other company with a combo therapy to assert the same for its Evusheld. The recent preliminary data on the Omicron variant has highlighted that combination mAb therapies could be relatively effective over individual mAb therapies.

Sahu concludes: “Although vaccination rates are rising and reportedly new cases have started coming down at the global level, the COVID-19 scare resumed in the form of Omicron variant. Nevertheless, a positive EUA for its combo mAb therapy from the FDA will boost Brii’s credibility and outreach in the global market until additional combo mAb therapies enter the pipeline landscape.”

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