China’s Ebola Cure eyes Fast-track Mass Market Approval

SHANGHAI, Oct 16 (TSR) – China‘s third biggest pharmaceutical company in prescription drug market is optimistic that they would get fast-track approval before the end of the year from the government for an anti-Ebola cure currently used by the Chinese military to be made available for the public.

Beijing Sihuan Pharmaceutical Holdings Group Ltd has signed a collaboration agreement with the Institute of Microbiology and Epidemiology, Academy of Military Medical Sciences (AMMS) last week to help push the drug called JK-05 through the approval process and bring it to mass market. AMMS is a research unit of the People’s Liberation Army, China’s armed forces.

The drug, developed by the Chinese research 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.

Meanwhile, as China joins the race to help treat a deadly outbreak of a disease that has spread from Africa to the United States and Europe, President Xi Jinping has pledged further efforts with the international community to fight against the Ebola epidemic that has run rampant in three West African nations, according to a press release on Thursday.

“The Ebola epidemic is now rampant in West Africa, threatening people’s life and health there,” Xi said Wednesday afternoon as he received credentials of new ambassadors to China according to China Daily.

“(The epidemic) has become a common challenge for the international community in a non-traditional security field,” said the Chinese president.

On Sept 18, Xi announced an aid package of 200 million yuan (about $32.54 million) for West African countries to combat Ebola, including Liberia, Sierra Leone and Guinea. The Chinese government has also sent medical supplies and medical experts to the countries.

“We will continue to work together with the international community to fight against the Ebola epidemic,” Xi said.

Beijing Sihuan’s strengths is its close myriad of connections with the military medical science units and have developed lots of products in cooperation with the AMMS. The firm was originally a military scientific unit, which was spun off into its current form in 2001, now partly owned by Morgan Stanley.

Pursuant to the terms of the Collaboration Agreement, Beijing Sihuan will pay a technology transfer and drug development fee of RMB 10 Million (USD$1.6M) to AMMS for the ownership and franchise of the drug.

JK-05 drug is only one contender and the only existing drug with results among 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 new world’s No 1 economy.

The current outbreak, the worst on record of the disease, has killed more than 4,000 people, mostly in West Africa.

Beijing Sihuan group do not doubt that JK-05 will be approved.

Che pointed out that a Chinese vaccine against a SARS outbreak a decade ago, also developed by the Chinese 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.

Will it work?

Ebola virus was first recognized in 1976 in Zaire (now the Democratic Republic of Congo) in an outbreak that affected 318 people and resulted in 280 deaths. The virus and its five subtypes belong to a family of viruses called Filoviridae; only four of the five subtypes have caused disease in humans. The virus affects humans and non-human primates, but the natural reservoir of Ebola remains unknown. This means the exact origin and natural habitat of the virus are a mystery, with significant implications for treatment and prevention.

Scientists believe Ebola spreads through zoonotic transmission- that is, coming from an animal. The first patient of an Ebola outbreak is thought to be infected through contact with an infected animal. From there, the virus can spread to other humans through direct contact with blood or body fluids. Outbreaks often occur in healthcare settings (known as nosocomial transmission), as patients seek treatment in facilities where appropriate infection-control may not be practiced. The symptoms of Ebola are somewhat nonspecific at first. Within 2-21 days of exposure, patients usually experience fever, headache, joint and muscle aches, sore throat, and weakness, later followed by diarrhea, vomiting and stomach pain. Some patients also experience rash, red eyes, hiccups and bleeding. From the onset of symptoms, Ebola can kill a patient within a matter of days.

There is no known treatment for Ebola in humans. Doctors can offer supportive therapy, such as hydration, oxygen and treatment of complicating infections, but mortality rates are still very high. Because the natural reservoir and origin of transmission remains unknown, there are no established methods of primary prevention. Instead, prevention efforts focus on outbreak control in healthcare settings.

Many challenges remain before the treatment can be applied to an outbreak in humans. For example, the amount of antibodies needed to treat a larger group of people would be difficult to manufacture.

China’s Ebola cure bid still lags some way behind US-developed ZMapp and TKM-Ebola, but Beijing Sihuan management said the drug has proven effective during animal testing on mice according to China Daily.

The drug is said to be similar to Japanese flu drug favipiravir, developed by Fujifilm Holdings Corp, which has been used effectively to treat patients with Ebola.

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.

In the case of “jk-05”, the new Chinese invented drug designated to treat Ebola which has been under study and development by Institute of Microbiology and Epidemiology, Academy of Military Medical Sciences for 5 years, has passed the evaluation by health experts at the People’s Liberation Army General Medical Department and is approved as a special drug to meet military needs.

The drug, together with many previously approved scientific achievements such as the Ebola virus detection reagent, has provided key technical means for the prevention and control of the outbreak of Ebola in China.

Experts stressed that although its preclinical research has been completed, and it has also passed the broad spectrum antiviral clinical safety evaluation, the treatment is only available for Ebola hemorrhagic fever under emergency situations.

The Ebola virus has been defined as the most severe biological threat in the world by the World Health Organization. the fatality rate for hemorrhagic fever caused by Ebola virus has been extremely high.

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 cooperation between Beijing Sihuan and AMMS will support further research and development efforts on JK-05 as a broad spectrum antiviral drug, and will ensure its successful manufacture and launch to the market by Beijing Sihuan and addition of the drug to the Chinese national reserve. The successful development of JK-05 can meet the market demand for preventing and treating viral infections, and counter their prevalence according to Beijing Sihuan’s Chairman, Che Fengsheng.

Chinese 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.