AstraZeneca takes COVID-19 vaccine to China with BioKangtai deal for 200M-dose capacity by 2021

We pointed out last week that China was a notable missing element in AstraZeneca’s COVID-19 vaccine strategy, despite being the drugmaker’s second-largest market. That has changed.

AstraZeneca reached a licensing deal with Chinese firm BioKangtai to help provide its adenovirus vector-based COVID-19 vaccine candidate, created by the University of Oxford, to China, AstraZeneca said (Chinese) in a social media post on Thursday. The pair will also explore the possibility of producing the vaccine for other markets.

Under the pact, AZ grants exclusive clinical development, production and commercialization rights to the vaccine in China to BioKangtai, which will in return reserve enough capacity to make at least 100 million doses of the shot by the end of 2020 and expand to 200 million doses per year by the end of 2021. Financial terms were not disclosed.

AZ’s aiming to produce 2 billion doses of the vaccine, dubbed AZD1222, worldwide by the end of 2021. Before the BioKangtai tie-up, it promised to provide the U.S. 300 million doses, the EU 300 million doses, the U.K. 100 million doses, plus up to 100 million doses in Brazil.

It signed a manufacturing and distribution agreement with R-Pharm in Russia and tapped the Serum Institute of India to provide for low-income countries. South Korea’s SK Bioscience recently joined AZ’s COVID-19 vaccine manufacturing network, and Daiichi Sankyo stated in late June that it’s in discussions to supply the shot in Japan.

AZ holds a much larger stake in China compared with its Big Pharma peers. The country is its second-largest market, behind the U.S., accounting for about a fifth of the British drugmaker’s business.

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Early clinical results showed AstraZeneca's candidate, AZD1222, triggered both antibody and T-cell immune responses. The vaccine was moved into phase 2/3 in May.

AZ’s shot is only the third foreign COVID-19 vaccine candidate to have looped in China. Fosun Pharma holds China rights to BioNTech’s mRNA program through a licensing agreement worth up to $135 million. The pair just kicked off a phase 1 trial in China with the goal to enroll 144 healthy volunteers. Outside of China, BioNTech and its partner Pfizer launched their 30,000-subject phase 3 efficacy trial last week.

In addition, Inovio previously teamed up with Beijing Advaccine Biotechnology for work on its DNA vaccine candidate, INO-4800.

China has several home-grown COVID-19 vaccines in clinical development. These include CanSino Biologics with a rival adenovirus-vectored candidate, Ad5-nCoV. While AZD1222 is based on a weakened version of an adenovirus that causes infections in chimpanzees, the CanSino version uses a common human adenovirus as its vector.

One problem with Ad5-nCoV is that many people already have pre-existing immunity against the human adenovirus. About half of the people in CanSino’s phase 2 study have high levels of neutralizing antibodies that target Ad5, and these individuals exhibited much lower antibody responses to the vaccine.

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Besides Ad5-nCoV, some advanced programs in China include two inactivated vaccine candidates by state-owned Sinopharm’s CNBG subsidiary. Clover Biopharmaceuticals has an S-Trimer subunit vaccine candidate, SCB-2019, which is being evaluated with two adjuvant systems by GlaxoSmithKline and Dynavax in phase 1 study, with results expected this month.

BioKangtai is perhaps best known in China for its self-developed acellular quadruple vaccine against Hib, diphtheria, pertussis and tetanus. It also has a recombinant hepatitis B vaccine, as well as products for pneumococcal infections and measles and rubella. Its revenues in the first half of 2020 reached CNY 870 million ($125 million), up 7.7% year over year.

Editor's Note: The story has been updated to show that BioKangtai holds exclusive commercial rights to AZD1222 in China.