Australian milk companies love China, miners adore the place, food producers are enmeshed in the dragon economy, but one of Australia’s key industries is yet to crack that market: biotechs.

But China is one of the last big frontiers for Medical Developments International (ASX:MVP), as its US application was put on hold by the US Food and Drug Administration (FDA) last year and they’re still a couple of months away from going back with more information.

Today it said the Chinese National Medical Product Administration (NMPA) had approved an investigative new drug (IND) application for its non-opioid painkiller, the Green Whistle, setting it up to move into Chinese clinical trials which should take about 12 months.

In October last year, the company unveiled a tie-up with Japan’s Daiichi Sankyo to sell Penthrox in China, Thailand and Vietnam. The company pocketed a $21m up-front payment and is in line for a further $24.7m in performance and regulatory related milestones.

And it began a registration process earlier this year for an investigational new drug application (it takes two months to translate the documents into Mandarin), the first step in the registration process.

MVP chairman, investment banker David Williams, says the NMPA asked for top-up studies on Chinese patients to add to studies in different regions around the world.

All going well Penthrox could be approved 18 months after the studies begin.

 

What MVP is doing is pretty rare, for a small cap

China has been too large a bite to swallow for Australia’s upstart biotechs, which generally specialise in the earliest stages of drug development or delivery.

The market is dominated by large foreign companies, according to consultancy Pacific Bridge Medical. Australia’s most successful health companies, CSL and Cochlear, sell into China.

The consultancy says China has a large number of small domestic generic drug makers which put little investment into research and development.

MVP’s Williams says historically companies were concerned about their IP being ripped off if they filed patents and entered China, but the company is working with Japanese major Daiichi Sankyo which already has a presence in China.

For some small foreign companies, the burden of proof for new drug registrations is heavy: China requires that new trials are conducted in-country on its own population, to ensure new drugs work the same way on Chinese people as they might on Anglo Australians, for example.

On Wednesday, Visioneering chief Dr Stephen Snowdy said this was one reason why the company was yet to start selling their contact lenses in China as myopia progression control devices: it is still working through the registration and trial processes.

In August, however, the Chinese government passed amendments to the Drug Administration Law which take effect in December and continue a trend of speeding up drug approval processes.

Baker Mackenzie partner Isabella Liu wrote in October that the changes are designed to hasten market entry for new drugs.

“The MAH [market authorisation holder — companies or institutions that have obtained drug registration certificates] mechanism separates market authorisation holding from actual manufacturing and supply activities, allowing companies and R&D institutions to more flexibly engage in suitable business models for drug development and commercialisation in China,” she said.

 

In other ASX health news today:

The outlook in Europe is sexy for Starpharma (ASX:SPL), maker of the drug-infused VivaGel condom. It’s just got the nod to sell said condoms in the EU. Fellow love-glove maker Ansell will be doing the marketing heavy lifting. The condom lube is spiked with VivaGel, a home-grown compound that fixes bacterial vaginosis — a nasty chronic condition — and can inactivate HIV, HSV and HPV.

Gastro fighter Immuron (ASX:IMC) is doing a phase three clinical trial — no mean feat for an Aussie biotech — for its gut bug buster drug Travelan in the US. The pill is already on the market in Australia as a treatment for traveller’s diarrhoea (so they’re not bothering with the is-it-safe phase one and does-it-work phase two), but registered as a dietary supplement in the US and Canada. Getting an FDA nod upgrades it to medicine — and means they can charge a bit more for it.

Marijuana dealer Zelda (ASX:ZLD) has signed up Health House to distribute its products in Australia, New Zealand, Asia and the UK. The deal includes the drugs Zelda is acquiring as part of the takeover of US company Ilera, and its insomnia treatment, provided the data from a clinical trial says what they hope it does. That data is due before March next year.

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