Regenerative Medicine Rising in the East

Asian markets at the forefront of regenerative medicine advancements.

Across the pharmaceutical industry, the Asia-Pacific has grown in importance, attracting big pharma to the region with its easy access to patient populations and low manufacturing costs.  In addition, generic drug manufacturing has massively boosted the market. However, one area in which the Asia-Pacific has really been forging its own path is in regenerative medicine. Encompassing stem cell therapy, gene therapy and tissue engineering, this innovative area of science offers the chance to repair damaged tissue and restore proper functioning to cells. It is an area of increasing interest globally, with massive potential, as demand for novel curative and reparative therapies soars as a result of the growing aged populations and rising incidence of cancers and chronic diseases. However, to date, regulatory bodies have been unwilling to approve gene therapies and stem cell therapies in the west, because of the unproven nature of the science. Instead, Asia-Pacific countries have emerged at the forefront of the commercial clinical use of these pioneering approaches.

China has led the way in gene therapy approvals to date, with Gendicine and Oncorine hitting the market in 2003 and 2005 respectively. These approvals demonstrated an important fact – that China was serious about developing regenerative medicine, sensing an opportunity to enter a young, growing market at an early stage and attract industry attention with favourable approval mechanisms. This has been replicated across other Asia-Pacific countries. In South Korea, the world’s first approved clinical stem cell treatment is Hearticellgram-AMI from FCB-Pharmicell, which uses a stem cell transplant from the patient to improve heart function. This was approved in 2011 and was followed by two other stem cell therapies in 2012. Their long-term success in the market has yet to be determined, but they represent important milestones in regenerative medicine commercialisation. Singapore, meanwhile, has made a deliberate effort to set itself up as a hub of regenerative medicine research.

It isn’t just local companies that are getting in on the action in the Asia-Pacific – US company Epieus Biotechnologies commercialised its cancer gene therapy Rexin-G in the Phillippines, and US companies such as Vical and Genzyme have entered into collaborations with Asian companies.

Some of the same advantages that make approval easier in countries such as China also damage the country’s chances of leading the industry, however. Regulations governing approval are less strict, which has led to the early approvals of therapies such as Gendicine and Oncorine. This lack of stringency in the requirements for approval has meant that without extensive further testing, the therapies cannot enter other markets such as the US and EU. In addition, there is general scepticism as to the actual benefit of therapies approved without detailed clinical trial data. In addition, despite China having a high number of patients with head and neck cancer who could benefit from the approved therapies, reimbursement and insurance coverage limitations for Chinese citizens mean that access is severely restricted. Consequently, the revenues of therapies such as Gendicine, previously predicted as having blockbuster potential, have remained stubbornly disappointing. Benda Pharmaceuticals, who own the rights to the product, was worth only $4.1m in 2010.

The unproven and unfamiliar nature of the science has led to caution from regulatory bodies and has been a frustrating deterrent to R&D by industry in the US and EU, but high patient populations, more permissive approval processes and a desire to gain a competitive advantage in a developing area with high growth potential have given the Asia-Pacific a head start in regenerative medicine. Western governments and industry are paying increasing attention to the region, attempting to ensure that they are not losing ground in the regenerative medicine market but also keen to leverage the opportunities offered in the Asia-Pacific as acceptance, demand and expertise flourish there. 

Amy Baker is a Life Science Analyst at GBI Research

Photograph: Getty Images

Amy Baker is a Life Science Analyst at GBI Research.

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Metro mayors can help Labour return to government

Labour champions in the new city regions can help their party at the national level too.

2017 will mark the inaugural elections of directly-elected metro mayors across England. In all cases, these mayor and cabinet combined authorities are situated in Labour heartlands, and as such Labour should look confidently at winning the whole slate.

Beyond the good press winning again will generate, these offices provide an avenue for Labour to showcase good governance, and imperatively, provide vocal opposition to the constraints of local government by Tory cuts.

The introduction of the Mayor of London in 2000 has provided a blueprint for how the media can provide a platform for media-friendly leadership. It has also demonstrated the ease that the office allows for attribution of successes to that individual and party – or misappropriated in context of Boris Bikes and to a lesser extent the London Olympics.

While without the same extent of the powers of the sui generis mayor of the capital, the prospect of additional metro-mayors provide an opportunity for replicating these successes while providing experience for Labour big-hitters to develop themselves in government. This opportunity hasn’t gone unnoticed, and after Sadiq Khan’s victory in London has shown that the role can grow beyond the limitations – perceived or otherwise - of the Corbyn shadow cabinet while strengthening team Labour’s credibility by actually being in power.

Shadow Health Secretary and former leadership candidate Andy Burnham’s announcement last week for Greater Manchester was the first big hitter to make his intention known. The rising star of Luciana Berger, another member of Labour’s health team, is known to be considering a run in the Liverpool City Region. Could we also see them joined by the juggernaut of Liam Byrne in the West Midlands, or next-generation Catherine McKinnell in the North East?

If we can get a pantheon of champions elected across these city regions, to what extent can this have an influence on national elections? These new metro areas represent around 11.5 million people, rising to over 20 million if you include Sadiq’s Greater London. While no doubt that is an impressive audience that our Labour pantheon are able to demonstrate leadership to, there are limitations. 80 of the 94 existing Westminster seats who are covered under the jurisdiction of the new metro-mayors are already Labour seats. While imperative to solidify our current base for any potential further electoral decline, in order to maximise the impact that this team can have on Labour’s resurgence there needs to be visibility beyond residents.

The impact of business is one example where such influence can be extended. Andy Burnham for example has outlined his case to make Greater Manchester the creative capital of the UK. According to the ONS about 150,000 people commute into Greater Manchester, which is two constituency’s worth of people that can be directly influenced by the Mayor of Greater Manchester.

Despite these calculations and similar ones that can be made in other city-regions, the real opportunity with selecting the right Labour candidates is the media impact these champion mayors can make on the national debate. This projects the influence from the relatively-safe Labour regions across the country. This is particularly important to press the blame of any tightening of belts in local fiscal policy on the national Tory government’s cuts. We need individuals who have characteristics of cabinet-level experience, inspiring leadership, high profile campaigning experience and tough talking opposition credentials to support the national party leadership put the Tory’s on the narrative back foot.

That is not to say there are not fine local council leaders and technocrats who’s experience and governance experience at vital to Labour producing local successes. But the media don’t really care who number two is, and these individuals are best serving the national agenda for the party if they support A-listers who can shine a bright spotlight on our successes and Tory mismanagement.

If Jeremy Corbyn and the party are able to topple the Conservatives come next election, then all the better that we have a diverse team playing their part both on the front bench and in the pantheon of metro-mayors. If despite our best efforts Jeremy’s leadership falls short, then we will have experienced leaders in waiting who have been able to afford some distance from the front-bench, untainted and able to take the party’s plan B forward.