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 Sihuan Pharmaceutical Holdings Group Ltd has signed a tie-up with
Chinese research Academy of Military Medical Sciences (AMMS) last
week to help push the drug called JK-05 through the approval process
in China and bring it to market. The drug, developed by the academy,
is currently approved for emergency military use only.
"We believe that we can file to the Chinese Food and Drug
Administration (CFDA) before the end of the year," Sihuan's chairman
Che Fengsheng said during an investor call last week.
"They are looking at this very seriously... and we could get on the
'green light' track," he added.
Sihuan's drug is only one contender amongst a number of experimental
cures worldwide to treat Ebola, although if successful it would be a
huge boon for China's developing pharmaceutical sector and the
country's soft power in Africa, an increasingly important partner
for the world's No.2 economy.
The current outbreak, the worst on record of the disease, has killed
more than 4,000 people, mostly in West Africa.
Che said one of Sihuan's strengths was its close military ties. The
firm, which claims to be China's third largest prescription
drugmaker, was originally a military scientific unit, which was spun
off into its current form in 2001.
"We have a myriad of connections with the military medical science
units and have developed lots of products in cooperation with the
AMMS," Che said. AMMS is a research unit of the People's Liberation
Army, China's armed forces.
Che pointed out that a Chinese vaccine against a SARS outbreak a
decade ago, also developed by the military, was approved by the drug
regulator rapidly after its application, signally that JK-05 could
receive similar treatment.
"At that time the whole approval process, clinical components and
the period after was cut right down," he said.
Officials at Sihuan, which is part-owned by Morgan Stanley, were not
available for further comment on Tuesday.
TESTED ON MICE
China's Ebola cure bid still lags some way behind U.S.-developed
ZMapp and TKM-Ebola, but Sihuan management said the drug has proven
effective during animal testing on mice.
The drug, which AMMS has been studying and developing already for
five years, is similar to Japanese flu drug favipiravir, developed
by Fujifilm Holdings Corp, which has been used effectively to treat
patients with Ebola.
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ZMapp and TKM-Ebola have been tested on monkeys, which give a closer
immune response to that of humans, and have been used to treat human
patients with the disease.
JK-05 has not yet undergone clinical trials, but Sihuan management
said the firm was actively working towards clinical tests of the
drug, which could be shorter than normally required. The drug has
also shown promise against diseases such as influenza and yellow
fever.
Chinese military doctor Wang Hongquan, credited with inventing the
drug, said on the investors call that JK-05 would first be used to
treat Chinese nationals working in Africa with the disease, but
treating non-Chinese would require further international approvals.
There are millions of Chinese nationals living in Africa, with
around 10,000 in the worst affected countries - Sierra Leone, Guinea
and Liberia.
JK-05 could also be used if Ebola spreads to China.
"We can't rule out the possibility that it will spread to Asia.
Particularly in China now we have lots of connections with different
international cities and many people coming and going across our
borders," he said on the call.
Company management and analysts said an Ebola outbreak in China
would further speed up the approval process and development of the
drug.
"It is highly likely the Ebola indication could be approved very
quickly if Ebola was to spread to China," said Deutsche Bank analyst
Jack Hu in an analyst note on Sunday.
(Additional reporting by SHANGHAI newsroom; Editing by Raju
Gopalakrishnan)
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