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
Show Hide image

Donald Trump's threats give North Korea every reason it needs to keep nuclear weapons

The US president's warning that he may “totally destroy” the country is a gift to Kim Jong-un's regime. 

Even by Donald Trump's undiplomatic standards, his speech at the UN general assembly was remarkably reckless. To gasps from his audience, Trump vowed to "totally destroy" North Korea if it persisted with its threats and branded Kim Jong-un "rocket man". In an apparent resurrection of George W Bush's "axis of evil", the US president also declared: “If the righteous many do not confront the wicked few, then evil will triumph". 

For North Korea, Trump's words merely provide further justification for its nuclear weapons programme. Though the regime is typically depicted as crazed (and in some respects it is), its nuclear project rests on rational foundations. For Kim, the lesson from the fall of Saddam Hussein and Muammar Gaddafi was that tyrants pay a price for relinquishing their arms. The persistent threats from the US strengthen the regime's domestic position and reinforce a siege mentality. Though North Korea must be deterred from a pre-emptive strike, it must also be offered incentives to pursue a different path. 

As Trump's Secretary of State Rex Tillerson remarked last month: "We do not seek a regime change, we do not seek a collapse of the regime, we do not seek an accelerated reunification of the peninsula, we do not seek an excuse to send our military north of the 38th Parallel. We are not your enemy... but you are presenting an unacceptable threat to us, and we have to respond. And we hope that at some point they will begin to understand that and we would like to sit and have a dialogue with them."

The present nadir reflects the failures of the past. In 1994, the Clinton administration persuaded North Korea to freeze its nuclear programme in return for economic and diplomatic concessions. A communique declared that neither state had "hostile intent" towards the other. But this progress was undone by the Bush administration, which branded North Korea a member of the "axis of evil" and refused to renew the communique.

The subsequent six-party talks (also including China, Russia South Korea and Japan) were similarly undermined by the US. As Korea expert Mike Chinoy records in the Washington Post in 2005, the Bush administration provocatively "designated Macau's Banco Delta Asia, where North Korea maintained dozens of accounts, as a 'suspected money-laundering concern.'" When a new agreement was reached in 2007, "Washington hard-liners demanded that Pyongyang accept inspections of its nuclear facilities so intrusive one American official described them a 'national proctologic exam'".

For North Korea, the benefits of nuclear weapons (a "treasured sword of justice" in Kim's words) continue to outweigh the costs. Even the toughened UN sanctions (which will ban one third of the country's $3bn exports) will not deter Pyongyang from this course. As Tillerson recognised, diplomacy may succeed where punishment has failed. But Trump's apocalyptic rhetoric will merely inflate North Korea's self-righteousness. 

George Eaton is political editor of the New Statesman.