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Flourishing WuXi Biologics in talks to make vaccines for scandal-hit China: report

January 24, 2019 By fiercepharma

WuXi Biologics has been surfing a surge of growth in biologic drugs, but the contract manufacturer isn't just interested in novel medications. It's also eyeing an older type of therapy: vaccines, which have come under special scrutiny in China lately.

The biologics CDMO is in talks with three vaccine developers to make their products in China, and the shots could start to bring in significant sales beginning in about 2021, the South China Morning Post reported based on an interview with CEO Chris Chen.

“The fundamental issues in the industry are quality-control related,” he said, as quoted by the SCMP. “As the only company in China that can produce biologics biopharmaceutical products for the global market, we already have a globally accepted quality assurance system. … [W]e can play a leading role in elevating vaccine standards.”

WuXi Biologics is forming a joint venture with veterinary vaccine maker Shanghai Hile Bio-Technology to “primarily engage in human vaccine (e.g., cancer vaccine) CDMO business,” the company said in a disclosure (PDF) to the Hong Kong Stock Exchange last July. The new firm is expected to have registered capital of 500 million Chinese yuan ($74 million), with 70% coming from WuXi.

Chen’s comments come as China is still reeling from a vaccine manufacturing scandal that emerged in July 2018. Changchun Changsheng Life Sciences, one of the country’s largest vaccine suppliers, was found to have falsified data for its rabies vaccine; before that, it had also sold substandard DPT vaccines meant for children. Further investigation found systematic problems in the way Changsheng made its products, including the use of expired materials.

Although a sweeping inspection initiated later by Chinese drug authorities cleared all 45 of the still-functioning vaccine makers in the country, and China’s top leaders promised tougher oversight, the public’s confidence in the domestic industry has been shaken.

Most Chinese-made vaccines have been used within the country. Because the products are not offered to the Western world, local vaccine makers’ manufacturing facilities have not been examined by U.S. or European watchdogs.  

Last March, WuXi Biologics became the first Chinese company to receive approval from the U.S. FDA for biological products after its plant near Shanghai cleared a pre-license inspection to make Taiwan-based TaiMed Biologics’ newly approved HIV therapy Trogarzo.

On an expansion spree, WuXi Biologics is busy building new facilities around the world. It unveiled plans last April to invest €325 million ($369 million) in a production site in Ireland, and then announced a $240 million investment in a 48,000-liter center in Shijiazhuang, China. About $80 million will help erect a Singapore facility, and another $60 million will go toward a new site in Worcester, Massachusetts. Construction has just commenced on a 1.5 million-square-feet Biologics Innovation Center in Shanghai that will house more than 3,000 scientists.

 

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