Astrazeneca plc has reached an agreement with Shenzhen-based Kangtai Biological Products Co. Ltd. to produce its COVID-19 vaccine AZD-1222 in China. The Chinese firm is required to produce at least 100 million doses by the end of the year, and at least 200 million doses by the end of 2021.

To achieve the goal, Astrazeneca will transfer the technical know-how and support to enable Kangtai to develop, produce and commercialize the vaccine candidate in China. Both companies may continue their partnership in other markets.

Leon Wang, global executive vice president, international and China president at Astrazeneca, said the company hopes to leverage Kangtai’s technology and manufacturing capability to enable the supply of AZD-1222 in China.

According to Kangtai’s announcement, the Chinese vaccine developer will have the exclusive rights to carry out clinical trials in China and will need to ensure its manufacturing capability can meet the agreed target. Financial terms were undisclosed.

Best known for its hepatitis B vaccine, Kangtai was established in 1992 and has five vaccines on the market in China. With manufacturing facilities in Shenzhen and Beijing, the Chinese vaccine developer has produced more than 1 billion doses of vaccines with a 100% approval rate to date, according to its interim report this year.

Astrazeneca’s vaccine candidate has entered phase III trials and yielded positive results in phase I/II studies. It was well-tolerated and generated robust immune responses against the SARS-CoV-2 virus in all 1,077 healthy volunteers ages 18 to 55. A single dose resulted in a fourfold increase in antibodies to the SARS-CoV-2 virus spike protein in 95% of participants one month after injection.

Despite the encouraging data, China’s regulations have made it unclear whether AZD-1222 will be able to receive rapid regulatory clearance.

“To bring the vaccine to China, you must conduct a phase III trial [there]. But there’re no patients in China, so it’s unlikely to conduct phase III trials there to apply for registration. We can only conduct phase I/II studies there,” Wang said at a webinar hosted by the Hong Kong Stock Exchange and China Pharmaceutical Innovation and Research Development Association on July 6.

“There is still no clear direction whether Chinese regulators will accept overseas phase III data for an NDA application,” he added.

Kangtai has not responded to BioWorld’s inquiry about the clinical development plan for AZD-1222.

The deal with Kangtai is part of Astrazeneca’s ambition to produce 2 billion doses of AZD-1222 worldwide through partnerships. It has also inked pacts with the Coalition for Epidemic Preparedness Innovations (CEPI), the Gavi vaccines alliance and the Serum Institute of India to produce a total of 1.3 billion doses.

On July 21, the British pharma giant entered a deal with South Korea’s SK Bioscience Co. Ltd. to produce AZD-1222 in the Asian country with plans for exports as well. South Korea’s Ministry of Health and Welfare has vowed to support both companies to accelerate vaccine production and export. But details of the production system remain undisclosed.

AZD-1222 is not the only foreign-made vaccine candidate to be brought into China. German firm Biontech SE’s mRNA-based BNT-162b1 is now in a phase I study in China in collaboration with Shanghai Fosun Pharmaceutical (Group) Co. Ltd. following a $135 million deal. Last week, both companies said 72 participants have been dosed with BNT-162b1 in the study, which aims to enroll 144 healthy volunteers. Once BNT-162b1 is cleared in China, Fosun will gain the exclusive rights to commercialize the vaccine in China, Hong Kong, Macau and Taiwan.

Meanwhile, three Chinese domestic vaccine makers, namely China National Biotec Group (CNBG), Sinovac Biotech Ltd. and Cansino Biologics Inc., have advanced their vaccine candidates to phase III trials in Brazil, Abu Dhabi and Saudi Arabia, respectively. They are striving to enhance their manufacturing capabilities at the same time.

The state-backed CNBG is preparing to ensure an annual capacity of 220 million doses of vaccine from its production units in Beijing and Wuhan. CNBG’s chairman, Liu Jingzhen, told Chinese state media last month that its vaccine could go to market this year.

Cansino CEO Yu Xuefeng said in a July 6 webinar that the company is planning for mass production, while Sinovac is also building new facilities in Beijing to step up production of its Coronavac vaccine to 100 million doses a year. 

China's NMPA reiterated in a meeting last month that it will strive to accelerate the approval of COVID-19 vaccines. China’s Ministry of Industry and Information Technology has also called on local authorities to support preparation for vaccine production.

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