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.

Irene Clennell Go Fund Me handout
Show Hide image

6 times the Home Office broke up British families in the name of immigration

Irene Clennell came to the UK in 1988, married a British man and had a family. In 2017, she was deported. 

Irene Clennell first arrived in London in 1988, before the Home Office’s younger staff members were even born. Soon after, she married a British man called John, and received indefinite leave to remain. They made their home in County Durham. They have two children and one grandchild. 

Now, though, Clennell is in Singapore, after being detained and forcibly deported on the orders of the British government

Her crime? She spent periods of time back in Singapore caring for her ailing parents, enough to invalidate her indefinite leave to remain. It seems the Home Office decided her parents took too long to die.

Clennell’s case matters – and not just because her husband last heard from her sobbing on a plane. Her family is the latest to be torn apart by the government’s stringent immigration rules. 

As well as an inflexible approach to the amount of time spent in the UK, the rules demand that British citizens must earn £18,600 a year to bring over a non-EU spouse – a rule that discriminates against women, who are more likely to work part-time for less pay, and those living in lower-paid regions of the country. 

With EU nationals facing an uncertain future, and the government desperate to meet immigration reduction targets, this inflexible approach matters. Here are some of the families that have felt the consequences:  

1. The father who can’t see his son

Toni Stew, from Worcester, met her husband Mohamed El Faramawi in Sharm el-Sheikh, Egypt. But this was no holiday romance – they got married six years later, and have a young son.

But because Stew works part time, in order to care for her son, she does not earn enough to sponsor her husband’s move to the UK

El Faramawi has only met his son a few times since the birth 17 months earlier.

2. A couple trying to look after their parents

Kevin Draper, from Bristol, met his wife Mae, originally from the Philippines, through friends in Hong Kong. In 1995 they settled in the UK, but then a job came up in Dubai. 

In 2011, sad news summoned Kevin home – he needed to care for his mother, who had Alzheimer’s. Meanwhile, Mae’s mother passed away, and she went to support her family in the Philippines.

She was advised to apply for a UK visitor visa, and finally received one in 2013 after two failed attempts. Having been reunited with her husband and daughter, she decided to apply for a spouse visa. But in 2014 she was told that in order to do that, she would have to return to the Philippines, and the process could take another two years.

3. A British father who was made redundant

Dominic James met his wife, an American named Katy, in 2005. After they married a year later, she managed to join him in Edinburgh for three years.

They moved out to Seattle, where they had a daughter, but the couple always intended to return to the UK. James managed to get a transfer from his employer to the Edinburgh office, but was made redundant shortly afterwards.

Despite Katy’s work experience in the UK, her visa application was denied because James, now self-employed, did not earn enough to meet the minimum income requirement rules. (The Home Office eventually granted Katy 30 months longer to stay).

4. A mother who thought the UK was home

Beverley Boothe arrived in the UK in 1979 as a teenager, to join her parents who had emigrated from Jamaica in the 1960s. 

According to Boothe, she received indefinite leave to remain in 1980. At some point in the next three decades, she lost the passport with the original stamp in it. But she assumed the Home Office had a record of her application.

It turns out they didn’t – records are only kept for 15 years from the date of the “last action”. Boothe, a criminology graduate, gave the Home Office her fingerprints and information about her family. Just before Christmas 2013, she was ordered to go to Jamaica or face deportation.

Not only did Boothe have no close family to return to, she had her own children in the UK. Although they all have British fathers, her youngest daughters were unable to obtain passports because of her status.

5. A father facing separation from his wife… and parents 

In 2012 AJ, an American, moved with his father to South Shields, Tyneside, when he went to join his new wife. There, AJ met Lian Papay, and fell in love. The couple discovered they were expecting, and married in 2013.

But Lian did not earn enough to sponsor AJ, and so her husband is forced to rely on short-term visas. Ironically, when AJ flys back to the United States, he leaves not only his wife and son, but his father and stepmother.  

6. A woman who wanted to care for her father-in-law

Gary Walsh, a Falklands war veteran, married his wife Xia Zhao, an accountant, more than 16 years ago and has two adolescent children. 

The family lived in Malaysia, but flew to the UK after hearing Gary’s elderly father was unwell. 

Xia Zhao came on a one-year visa, but after discovering how ill her father-in-law was, applied to stay and work so the family could care for him. Her application was refused, and she was advised to apply instead from China in a process that could take years. 

Julia Rampen is the editor of The Staggers, The New Statesman's online rolling politics blog. She was previously deputy editor at Mirror Money Online and has worked as a financial journalist for several trade magazines.