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.

Photo: Getty
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The new French revolution: how En Marche! disrupted politics

The rise of Emmanuel Macron's party has shattered the accepted wisdom.

Alexandre Holroyd bears many similarities to his new boss, Emmanuel Macron. Like the French president, a former banker, Holroyd started his career in the private sector, at the management consultancy firm FTI. At 39, Macron is the youngest ever French president; Holroyd is nine years younger. Both are strongly pro-European and confident in their common mission.

“The Assemblée Nationale is going to profoundly change,” Holroyd told me, sipping fizzy water in a café near St Paul’s Cathedral in London on 16 June. Two days later, in the second round of the French legislative election, he was elected France’s MP for northern Europe – one of the 11 constituencies for French expats around the world – representing Macron’s party, En Marche! (“Forward!”), which swept to a resounding victory.

“People said, ‘These newbies from En Marche! won’t know what to do,’” he told me. “But they will reflect French society: diverse, equal, with multidisciplinary experiences.”

Macron’s election in May capped a remarkable 12 months for the former economy minister, who left the Parti Socialiste (PS) government to run as an independent candidate. But the real power – of the kind that will allow him to implement the liberal reforms he has promised France – arrived only with the legislative election victory.

En Marche! won 350 of the 577 parliamentary seats, a majority that should enable the president to pass laws in the house easily. And the party did so by selecting younger, more socially diverse candidates than is usual in French politics. As with Holroyd, most of the candidates for En Marche! were running for office for the first time. When the National Assembly reopens, three-quarters of the faces will be new.

The renewal of the political class was one of Macron’s main campaign pledges. “There was this will to stop the two main parties’ [the PS’s and the Républicains’] sectarian obstructionism,” Holroyd said. “The French people are fed up with it.”

Much like a Silicon Valley start-up disrupting a sector of the economy – Uber with taxis, for instance – En Marche! sought to disrupt French politics. Macron launched it in April 2016 as a “political club” while still serving in François Hollande’s government. Three months later, more than 3,000 people attended its first event in Paris. The movement welcomed people of all political parties, allowing them to sign up for free online.

Today En Marche! has more than 240,000 supporters. The party’s main source of funding was individual donations and during the presidential campaign, it raised €6.5m. (Macron also took out an €8m personal loan.)

The rise of Macron and En Marche! has shattered the accepted wisdom of French politics: 39 is too young for a president; one cannot be “neither left nor right”; a career in the private sector does not lead to politics; no one can run for the presidency without the support of a pre-existing party.

Yann L’Hénoret, the director of the documentary Emmanuel Macron: Behind the Rise (available on Netflix), described En Marche! as a “very young” team in which “everyone could give their own view” before Macron had the final say. “Young people are said not to be politically engaged. I saw the inverse, every day, all the time,” L’Hénoret told me.

En Marche! members set up more than 4,000 local committees across France and beyond. Anyone interested in Macron’s project could create one and invite family members, friends and neighbours to take part. “Engage in a march, a conversation, a dinner,” the movement’s website suggested.

The groups then started “the Great March”, a canvassing initiative. “It was like an audit of the society,” said Holroyd. A dual citizen of France and Britain who grew up in west London, he became one of the early marcheurs in July 2016, when he quit his consulting job to set up the London committee. He had never been a member of any party before but Brexit acted as a trigger. “I saw my father’s country tearing itself off from Europe and realised I would regret it if I didn’t contribute to Macron’s project, whose European values I profoundly share.”

A graduate of London’s Lycée Français and Kings College, Holroyd could easily engage with his French expat peers – something that helped him win 70 per cent of the vote in the second round. “The only other party to go and talk to the people was the Front National,” Holroyd said. “The particularity of En Marche! is that many members came from the private sector. It’s exceptional in politics that people in the party have professional experiences. It spoke to many people.”

As En Marche! crowdsourced its candidates, it also ensured that its policies resonated with their locals. During the London “march”, 95 per cent of the participants told the committee that they were expats in the UK because of the economic opportunities here. Macron wants France to be able to entice professionals, too. Financially and socially, his goal can be summed up as: “Make France attractive again.”

Achieving a parliamentary majority has boosted Macron’s hopes of implementing major changes. Reforms may start as soon as this summer, with a liberal reorganisation of France’s rigid labour laws, which currently offer strong protection for workers. “France must invest in the industries of the future,” Holroyd said, quoting his president by the word. “Renewable energy, denuclearisation, ecological transition . . . We must become champions in these fields.”

Despite the scale of the victory, Macron’s team will have noted that the turnout was at a historic low on 18 June – at 42 per cent – suggesting widespread voter apathy. And despite its much-praised social diversity, En Marche! has only one working-class MP for every five middle-class ones. “We are conscious that we’ll be in a difficult situation if, by the end of the mandate, things have not changed for the people who have been left behind for years,” Holroyd said. “Those in outer suburbs, in post-industrial and rural lands.”

If they are to succeed, Macron and his MPs will have to find a way to win them over.

This article first appeared in the 22 June 2017 issue of the New Statesman, The zombie PM

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