Local injection

China approves its first homegrown HPV vaccines


Researchers at Oxford University are currently developing a therapy that could clear up persistent human papillomavirus (HPV) infections – which are known to be responsible for almost all cervical cancers. While existing vaccines work as a preventative measure, the new drug is designed to help the human immune system detect HPV viruses hidden inside cells. With it, even patients that contracted the high-risk strains of the virus would not have to worry about a relapse of the infection.

Trials for the new drug will begin in the UK and Belgium in March. However, before such a cure is available, the best bet against the cancer-causing disease is the three vaccines produced by GlaxoSmithKline (GSK) and Merck, which are proven to inoculate against two, four, or nine HPV strains respectively (over 150 varieties have thus far be found).

The problem? Scarce supply, especially when more and more countries around the world are rolling out HPV vaccination programmes for pre-teens. In China alone, at least one billion of such injectables are believed to be lacking. We reported in May last year that the shortage has created a thriving black market for profiteers selling illegally imported, or counterfeit, vaccines on the mainland and even in Hong Kong (see WiC452).

It is against this backdrop that China’s National Medical Products Administration approved the country’s first domestic HPV vaccine on January 3. Named ‘Cecolin’, the remedy targets HPV types 16 and 18 (which are responsible for up to 70% of cervical cancers), and is intended for females between the ages of 9 and 45.

At Cecolin’s third-stage clinical trial, which involved 7,372 females across five provincial-level regions, 97.8% of the recipients were successfully shielded from persistent HPV infection, while none developed HPV-linked precancerous lesions, according to Xiamen Innovax Biotech, which co-developed the vaccine with Xiamen University.

What sets Cecolin apart from its rivals is a formula that can significantly drive down the costs of manufacturing HPV vaccines (which are not covered by Chinese health insurance), Zhang Jun, vice-dean of Xiamen University’s School of Public Health, told local media Jiemian.

Cecolin will be offered at Rmb329 ($47) per shot, making its full course 50% less expensive than GSK’s 2-valent Cervarix in China, and not even a quarter of the price of Merck’s 9-valent Gardasil, noted the China Securities Journal.

The implication is that Cecolin might see its production scale up more quickly, while its average cost for end users will prove much lower, especially for those having their injections at a younger age (9-14), where only two doses, as opposed to three, are required for the immunisation programme to be completed.

Robust demand is expected to support sales. Chongqing Zhifei, the sole distributor of Merck’s 4-valent and 9-valent HPV vaccines in China has already logged a 119% year-on-year growth in revenue to Rmb7.67 billion ($1.1 billion) for the first three quarters in 2019 and made Rmb1.76 billion of profit.

Innovax is planning to launch Cecolin in May, and to produce around eight million shots for the China market this year.

That’s big: it represents nearly 79% of the tally of all HPV vaccines administered last year, according to a research report by Southwest Securities.

And to cater for the demand for vaccines that could provide a defence against a wider range of HPV viruses (Cecolin is 2-valent), it is also developing its proprietary 9-valent version, which is undergoing phase two clinical trials, while working too on a next-generation vaccine with GSK. That collaborative effort targets worldwide commercialisation, including Europe and the US, according to the agreement between the two pharmaceutical companies signed last September.

Almost doubling its net profits between 2016 and 2018 to Rmb293 million, Innovax’s parent company Beijing Wantai Biological Pharmacy Enterprise is reportedly looking to raise Rmb380 million in a domestic IPO this year. Should the stock flotation pan out, 40% of the proceeds will be set aside for HPV vaccine projects, reports Guancha, a local news portal.

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