The conference in Philadelphia last week brought together Chinese manufacturers and Peter Khoury, a programme officer at the Bill & Melinda Gates Foundation, which has partnered with the Chinese government on building vaccine R&D and manufacturing infrastructure.
Panellists agreed quality has shot up in Chinese pharma manufacturing in recent years. The Chinese government has implemented a new GMP system and pharmacopeia, and the Chinese Food and Drug Administration (CFDA) has been recognised by the WHO as a functioning regulator since 2014.
Prequalification: a key milestone
Meanwhile, the WHO has given prequalification status to two China-made vaccines, one a flu vaccine made by a subsidiary of Hualan Biological Engineering, approved earlier this month. The first Chinese vaccine to receive prequalification was a Japanese encephalitis product made by Chengdu Institute of Biological Products in 2013. Prequalification status attests to the safety and efficacy of the products and encourages NGOs such as UNICEF to buy vaccines from these vendors.
The prequalification of two vaccines “may be the start of China truly becoming a player in global health” especially for Gavi and UNICEF markets, said the Gates Foundation’s Khoury.
Steven Gao, a panellist and GM of Xiamen Innovax Biotech said his company is developing its products with a view to prequalification as a future marketing strategy.
Similarly, the CEO of Tianjin CanSino Biotechnology Inc., a Chinese vaccine-maker focusing on platform technology, told the conference Chinese companies wanting to enter the global market are thinking about GMP earlier on: “[we] have to do it right from Day One, not just at commercialisation stage.”
Chinese pharmacopeia
The new GMP rules and pharmacopeia – essentially translated versions of EMA and FDA standards, said panellists – have helped weed out low quality exports, they claimed.
“The biggest change in one word is quality,” said Shanghai Zerun Biotechnology CEO Li Shi. Since GMP rules passed, “many companies failed inspections and had to stop” manufacturing. Those which passed typically have senior staff with experience at foreign pharma multinationals, he said. Yu spent 13 years at Merck & Co., helping develop Gardasil.
Meng Li, a director at the public-sector China National Biotec Group Co., which owns the maker of the prequalified encephalitis vaccine, said the recent revamp has made the Chinese pharmacopoeia one of the most stringent in the world, with some multinationals suddenly unable to export certain products to China.
Global competition
While cost is a great advantage as China’s size lends itself to economies of scale, the panel agreed the peculiarities of Chinese regulations will be obstacles to the country’s export success.
The CFDA needs to shorten approval times for final studies and licensure: typically, IND filing in China takes one to two years, with Phases I, II, and II completed in one, two, and three years respectively.
It should also devise rules for conducting clinical studies abroad. CEO of Tianjin CanSino Biotechnology, Xuefeng Yu, his company wanted to test its Ebola vaccine candidate in Africa, but there are no regulations on how to apply for a Chinese licence after running trials overseas.
Additionally, the vaccine industry must work around rules not designed with foreign export in mind – China requires medicines to be packaged in single doses, which is not an efficient way of shipping vaccines to developing markets for local “vaccination days”.