Thursday, July 2, 2020

How a Chinese Firm Jumped to the Front of the Virus Vaccine Race - Bloomberg

How a Chinese Firm Jumped to the Front of the Virus Vaccine Race - Bloomberg





How a Chinese Firm Jumped to the Front of the Virus Vaccine
Race
Bloomberg News
July 1, 2020, 10:24 PM GMT+1 Updated on July 2, 2020, 9:02
AM GMT+1

When a group of Chinese
scientists
gathered over barbecue and beer in a Toronto backyard a decade ago, talk drifted to their homeland’s
vaccines, which had long lagged the developed world on quality and safety. Four
of them decided to act.

They left top positions at global pharmaceutical
companies in Canada to set up a biotechnology firm half a world away in
Tianjin, China
, hoping to produce vaccines on par with Western countries.
Now, that company, CanSino Biologics Inc., is vaulting into the global
spotlight as connections on both sides of the Pacific make it one of the
front-runners in the race for a coronavirus vaccine.

CanSino’s Chinese-born chief executive officer, Yu Xuefeng,
formerly a senior executive at drugmaker Sanofi’s Canadian vaccine operations,
has maintained relationships in Canada and China even as geopolitical
disagreements polarize both countries. Yu has boosted his firm’s scientific prowess
by tying up with the Canadian
government’s largest research organization
. At home, he’s worked with a
prominent Chinese military scientist,
first on an Ebola vaccine and now on CanSino’s experimental coronavirus shot.

In May, CanSino became the first globally to publish a full
scientific study
on its early human trials, an important step because it
allows researchers worldwide to assess a vaccine’s potential.

The company -- which is yet to generate revenue and logged a
$22 million loss last year -- has so far kept up with, and occasionally even
outpaced, Western pharmaceutical giants with the speed of its initial
coronavirus vaccine trials. The research is still too nascent to know if the
shot from CanSino, or indeed any company, will provide the magic bullet
countries are seeking to open up while the pandemic rages. But CanSino’s
inroads show China’s young biotechnology industry is becoming a global
contender, and a powerful tool for President Xi Jinping.

CanSino “deserves credit for the speed with which they
pushed the vaccine through pre-clinical studies and human testing,” said Wang
Ruizhe, a pharmaceutical industry analyst at Capital Securities Corp. in
Shanghai. “It tells you something about their ability to mobilize and leverage
the resources that it takes to get all these done. The resources required here
are substantial.”

A spokesperson for the Chinese company, citing media reports
in May, said Canadian Prime Minister Justin Trudeau is supportive of the
Canadian researchers working on clinical trials for a coronavirus vaccine with
CanSino.

China’s pharmaceutical industry has been dogged by safety
incidents and quality scandals. But in recent years, parts of it have grown
more advanced as hundreds of Chinese scientists trained in the West have come
home.

Called hai gui, or “sea turtles,” these returnees have
capitalized on relationships and expertise gained in countries like the U.S.
and Canada, and created new companies. CanSino’s CEO Yu -- 57, who has a
doctorate from Canada’s McGill University in microbiology and was the head of
vaccine development and production at Sanofi Pasteur in Canada -- belongs to
this new breed of executives.

In the prospectus for CanSino’s 2019 public offering in Hong
Kong, Yu described the difficult choices he and his colleagues made in forging
their new path back home in China.

“Most of our families
stayed in Canada,
and we could only see them a few times a year,” he wrote.
“When you think about your young kids and teenagers growing up without dads,
when you know your wife had to shovel out of 10 inches of deep snow early
morning in -20°C wind chill all by herself – those were the tough moments.”

Both Sides
The name CanSino represents the Chinese characters for
health, hope and promises, while in English it’s a combination of Canada and
China. Besides Yu, other top officials at the firm have Canadian connections.
Chief Scientific Officer Zhu Tao was also a senior scientist at Sanofi Pasteur
in Canada. The company’s success has relied on threading the needle between
both nations.

In February 2014,
about five years after returning to China, Yu licensed a technology from the
National Research Council of Canada called HEK 293 cell lines, which is
required to produce large quantities of a vaccine reliably.
That science
went on to partly underpin CanSino’s viral vector technology.

An advanced way to make a vaccine, a viral vector is a
genetically modified virus that is no longer harmful to humans, but can serve
as a vehicle to carry the genes of another germ to prepare the immune system
for attack. Few Chinese companies had that technology in 2014, when a Chinese
army researcher called Chen Wei began looking for viral vector expertise to
produce a vaccine amid Africa’s Ebola outbreak.

Ebola Vaccine
A major general in China’s People’s Liberation Army, Chen
headed the Institute of Biotechnology at the country’s Academy of Military
Medical Sciences. She went on to work with CanSino to develop an Ebola vaccine
that in 2017 was approved in China for emergency use and national stockpiling.

Chen has star status in China. In a nationalistic movie
called Wolf Warrior II, the character of a scientist who develops a vaccine
against a deadly African virus is believed to be modeled on her. She developed
a therapy used by Chinese health workers during the SARS outbreak of 2003.

Chen is also known for a singular dedication to her work. In
a 2004 interview with state-run CCTV, she said she presented her findings on
the SARS therapy to Beijing’s municipal authorities after dosing her
four-year-old son with it for two months because she was so sure about her
research.

CanSino’s long-running relationship with Chen paid off again
this year. CanSino and her team raced through pre-clinical studies on the
coronavirus vaccine -- called Ad5-nCoV. They secured Beijing’s help on
everything from isolating virus strains to animal testing. Chen and the
institute couldn’t be reached for comment.

Mixed Results
The team started human clinical trials in Wuhan, the Chinese
city where the coronavirus first emerged, on March 16. Massachusetts-based
Moderna Inc., seen as one of the best contenders to produce an American
vaccine, started its tests in the U.S. the same day. Less than a month later,
CanSino began the second phase of wide-scale human trials. On May 22, when it published a study in the
medical journal the Lancet, the results were mixed: The shot appeared to be
safe and generated some immune response, but there were shortcomings.

Viral vector technology can have limitations when some
people already have pre-existing
immunity
to the vector virus used to create the vaccine. This was the case
for the adenovirus -- a genetically-altered cold-causing virus -- which CanSino used for its vaccine.
Many of those with pre-existing adenovirus immunity showed diminished response
to its coronavirus shot in the Lancet study.

‘In the Game’
For upcoming trials in Canada, CanSino has added a booster
shot for some participants to attempt to address the lackluster response from
those with pre-existing immunity to the adenovirus vector, according to a
person with knowledge of its trial design who didn’t want to be named
discussing information that’s not public.

“CanSino is in the game and it’s about where the other
so-called leaders are,” said William Haseltine, a former Harvard University HIV
researcher. “Whether anybody will cross the finish line where we ever can see
safety data that we would like to see is unknown.”

Final-stage trials could yet stymie CanSino’s outsized
ambitions. Its Ebola vaccine was approved on an emergency basis after two
stages of human testing, but the company never completed the final phase as the
epidemic petered out in Africa. CanSino doesn’t generate much revenue because
most of its products, including two late-stage meningitis vaccines, are still
in development.

The company has received some funding from Beijing for the
coronavirus vaccine, although the amount isn’t large, the person familiar with
its trials said.

Phase III
CanSino’s founders’ ties with Canada are once again proving
fortuitous as it looks to conduct Phase III tests on its vaccine. Still, there
could be challenges in conducting the sizable studies required in the final
stages if new coronavirus infections continue to taper in Canada. China has
largely stamped out its outbreak.

Researchers at Dalhousie University’s Canadian Center for
Vaccinology, who are leading the clinical trials, have said they hope to start
Phase III studies of the CanSino shot as early as this fall. Canada’s National
Research Council said if the vaccine candidate is approved by authorities
there, it has the option to produce doses of the vaccine for emergency pandemic
use in Canada. (CanSino is responsible for funding its own trials, Health
Canada, the government’s health agency, said in an email.)

Meanwhile, China’s reputation in Canada -- already damaged
by Beijing’s reaction to the arrest of Huawei Technologies Co.’s chief
financial officer in Vancouver -- has been dealt a further blow by the pandemic
and perceptions China hid the virus initially. That could fuel more scrutiny of
CanSino and its vaccine in Canada.

Other companies are also racing ahead. Moderna is set to
test its vaccine among 30,000 people in the U.S. in July, while an early-stage
trial of a Pfizer Inc. and BioNtech SE shot showed it’s safe and prompted
patients to produce antibodies against the coronavirus. A vaccine co-developed
by the University of Oxford and AstraZeneca Plc also started the final stage of
human testing in Brazil in June.

At home, state-run vaccine developer China National Biotec
Group Co. has secured approval from health authorities in the U.A.E. to conduct
Phase III testing for the two shots it developed against the coronavirus.
Beijing-based Sinovac Biotech Ltd. has inked a deal to do final tests in
Brazil, too. The outcome for all of these companies -- and CanSino -- will only
be known once this ultimate stage of scientific studies is complete.

The viral vector CanSino is using is a relatively safe
approach compared to other techniques but it’s hard to make a call on efficacy
for now,”
said Wang, the Shanghai-based analyst. “There’s no shortage of
histories where promising efforts made it to the last stage of testing only to
see things fall apart.”

— With assistance by Natalie Obiko Pearson, Dong Lyu, and
Yunong Wu


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