City prepares to boost antigen test manufacturing

Shanghai will establish a production base for COVID-19 antigen test kits with a daily capacity of 5 to 10 million to better accommodate the testing needs of the 25 million permanent residents in the city.

With the support of the city and Pudong district government, a new production base of Shanghai Outdo Biotech, the first enterprise approved to produce COVID-19 antigen test kits in the city in early April, will be established within the Zhangjiang Hi-tech Park, covering an area of 10,000 square meters.

The production base will utilize advanced automated facilities and is expected to pass good manufacturing practice certification by the end of this year, said executives from the enterprise.

"We hope that the current COVID-19 wave will come to an end soon so that the new production base can kick off construction. We'll strive to complete the construction by the end of this year and start production as soon as possible," said Gao Hengjun, general manager of the enterprise.

Outdo Biotech, which currently has a daily production capacity of 3 million antigen test kits, has provided its products to millions of households for testing over the past weeks.

However, the majority of the capacity so far comes from commissioned production at an enterprise in Wuhan, Hubei province, as the factory in Shanghai is lacking raw material and labor amid the current outbreak.

The enterprise's current daily production in Shanghai is 200,000, Gao said, adding that the company's production site abides by closed-loop management throughout the process to ensure production safety.

There are so far at least 27 enterprises approved to produce COVID-19 antigen test kits in the country, and three are from Shanghai.

The Shanghai Science and Technology Commission announced on Saturday that an experimental COVID-19 vaccine based on mRNA technology domestically developed by Shanghai-based high-tech biotechnology company, Stemirna Therapeutics, was approved by the National Medical Products Administration for clinical trials.

The new vaccine is capable of targeting the D614G mutation contained in multiple variants of the novel coronavirus, including the currently dominant Omicron strain, said the enterprise.

The company has set up factories in Shanghai's Pudong and Fengxian districts to guarantee mass production of the vaccine. The yearly output of the vaccine from the two factories is expected to hit 400 million doses, said Li Hangwen, founder and chairman of the company.

He said its team has mastered core technologies of mRNA vaccines and is ready with the core patents of key technologies and equipment for mass production of mRNA vaccines with all the key materials having achieved domestic substitution.

"The Phase II clinical trials of the mRNA vaccine in Laos have enrolled enough participants. The trial data so far could preliminarily verify that the product has good safety performance," said Li.

"We're also establishing a sales team to contact well-known enterprises at home and abroad to communicate on relevant future collaborations," he said.

As a key scientific innovation company in the city, Stemirna Therapeutics, founded in 2016, has pioneered in the research and development of mRNA medicine and the clinical trial of mRNA cancer individualized vaccines.