Wednesday, February 10, 2021

The Chinese Communist Party Industrial and Military Espionage Modus Operandi ... Naive and Foolish Canada

"The National Research Council retains the intellectual property related to the cell line, while CanSino, in turn, owns all intellectual property rights for the vaccines it develops."
then-Industry Minister Navdeep Bains, August 
"Under this agreement, CanSino was to provide candidate vaccine doses and transfer their vaccine technology, free of charge, for Phase 1 and 2 clinical trials in Canada, and grant the NRC a non-exclusive right to use, produce, and reproduce the vaccine for emergency pandemic use [NRC in  response to a question in the House of Commons]." 
Question raised by Conservative Health critic Michelle Rempel Garner
The Chinese embassy in Ottawa (Jolson Lim/iPolitics)
 
This, of a contractual agreement signed by the Canadian government with a Chinese pharmaceutical company whose founder and CEO had ties with Canada, having attended university and received his doctorate in Canada, and worked for a large Canadian pharmaceutical company before returning to China and launching his own business, linked to the People's Republic of China's military laboratories. 

This has a familiar ring. Canada's hugely successful communications giant Nortel, employed Chinese IT personnel, some of whom managed to infiltrate its highest echelons of executive management to secure trade secrets which made their way back to China as competitors to Nortel. A scenario that led to the company's demise while Huawei, where many of the former Nortel employees were then employed, began to rise becoming China's premier communications giant.

Infiltration by Chinese nationals who studied in Canada and became employed at Canadian companies securing classified data later transferred to China is not exactly new; industrial and military espionage is an acknowledged Chinese Communist Party specialty. Two years ago at Canada's National Microbiology Laboratory in Winnipeg, Xiangguo Qiu, then head of the vaccine development and antiviral therapies section, along with her husband also employed there, and a Chinese student in microbiology were escorted out of the facility.

They had somehow managed to send to China Canadian formulas not meant to leave the country much less fall into the hands of any entity outside the Microbiology Laboratory in Winnipeg. An investigation was launched by the RCMP after they were removed from their positions for "policy breaches" linked to a laboratory in Wuhan, China known to conduct research into deadly pathogens. The background of the situation and the findings of the investigation were never made public.

Yet despite these sinister and blatant events at purloining trade and industrial secrets from other countries that China is infamous for, the Canadian government under Justin Trudeau chose to sign a contract with another Chinese company for the critical development of a vaccine to inoculate against a global pandemic. The vaccine, once developed, was to be tested at laboratories at Dalhousie University in Halifax.

The National Research Council was to begin producing the vaccine in Canada. Bearing in mind that the NCC transferred Canadian intellectual property for use by CanSino to enable it to create the vaccine for Ebola and SARS-CoV-2. The final product was to have been delivered to Canada, but it never passed Chinese customs to arrive in Canada. Although the product was sent on to Pakistan, Russia, Mexico and Chile for trials, simply not to Canada.
"Due to lengthy delays in the shipment of the vaccine doses to Canada, the fact that CanSino’s candidate had already entered advanced testing in other countries, and the new clinical-trial data that had emerged from other jurisdictions, it was decided in late August that the opportunity to conduct clinical trials in Canada for Ad5-nCoV had passed, and the government decided to focus on more promising candidates."
National Research Council
That setback meant that Canada had no recourse to any vaccines in development and completing their trials, so at that later date in August of 2020 the Trudeau government hurriedly began making deals with U.S. and British pharmaceuticals for vaccine doses, long after most G7 countries had already made their arrangements, sending Canada to the back of the line. The result of which is that Canada has received scant few vaccine doses while other countries which either produce their own or signed contracts to keep them well supplied are inoculating their populations at a rate Canadians can only envy.

Canada, it would seem, from its then-minister of industry, 'owns' the intellectual property relating to the CanSino Biologics vaccine, but cannot access it (punishment courtesy of the CCP for having the effrontery to detain Huawei's CEO on an extradition warrant from the U.S.) because China 'owns' the vaccine now in use by the Chinese military and sent abroad elsewhere.

Canada had, it seems, also seen fit to sign the contract with CanSino that contains the proviso that: "Canada cannot claim any revenue if the vaccine proves successful". At the time of the contract signing, CanSino was trading at HK$87.45 in the Hong Kong Exchange. At the present time CanSino stock is trading at an all-time high of HK$365. Clearly, Prime Minister Justin Trudeau neglected to read former U.S.President's "Art of the Deal".
 
Faisal Sultan
@fslsltn
Feb 8, 2021
Clinical trial data (phase-3) of a one-dose Ad5-nCoV vaccine for Covid (Cansino Bio) received. Interim analysis by the Independent Data Monitoring Committee shows 65.7% efficacy at preventing symptomatic cases and 90.98% at preventing severe disease (multicountry analysis).
Faisal Sultan
@fslsltn
In the Pakistani subset, efficacy at preventing symptomatic cases is 74.8% & 100% at preventing severe disease. The IDMC didn't report any serious safety concerns. Data incld 30,000 participants & 101 virologically confmd COVID cases Well done Pak team for conducting this trial

 

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Wednesday, January 27, 2021

China's Contractual Obligations

Immunogenicity and safety of a recombinant adenovirus type-5-vectored COVID-19 vaccine in healthy adults aged 18 years or older: a randomised, double-blind, placebo-controlled, phase 2 trial
This randomised, double-blind, placebo-controlled, phase 2 trial of the Ad5-vectored COVID-19 vaccine was done in a single centre in Wuhan, China. Healthy adults aged 18 years or older, who were HIV-negative and previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection-free, were eligible to participate and were randomly assigned to receive the vaccine at a dose of 1 × 1011 viral particles per mL or 5 × 1010 viral particles per mL, or placebo. Investigators allocated participants at a ratio of 2:1:1 to receive a single injection intramuscularly in the arm. The randomisation list (block size 4) was generated by an independent statistician. Participants, investigators, and staff undertaking laboratory analyses were masked to group allocation. The primary endpoints for immunogenicity were the geometric mean titres (GMTs) of specific ELISA antibody responses to the receptor binding domain (RBD) and neutralising antibody responses at day 28. The primary endpoint for safety evaluation was the incidence of adverse reactions within 14 days. All recruited participants who received at least one dose were included in the primary and safety analyses. This study is registered with ClinicalTrials.gov, NCT04341389.
CanSino Biologics, China   The Lancet
Courtesy of CanSino Biologics

China-based CanSino Biologics is the brainchild of Yu Xuefeng, who studied in Canada and earned his doctorate at McGill University. He later was in the employ of Sanofi Pharmaceutical based in Toronto and eventually returned to China where he launched his vaccine business. His links to Canada gained him an insider status. The National Research Council agreed to allow the use of a Canadian-created cell line to aid in the development of a vaccine first for Ebola and following that, SARS-CoV-2. 

For reasons known only to Canada's prime minister an agreement was signed with CanSino for collaboration in the development of a COVID vaccine, at a time when relations with Beijing were beyond  strained and bad faith was redolent and in full view when the Chinese Communist Party launched its hostage diplomacy initiative by arresting and charging two Canadians in China with security breaches endangering China, and then initiating a trade war. 
 
Canada been burned in the past when dealing with China when Chinese technologists were hired to work for Canada's then-telecommunications giant Nortel Networks attaining positions of trust enabling them to lift trade secrets for their own, and Chinese hackers infiltrated and gained access to Nortel's top executive accounts spiriting away additional Nortel data which eventually helped lead to the company's demise but gaining China's telecommunications industry through Huawei where former Nortel employees worked, the edge they looked for, linked with China's military.

Once again the trusting Canadian government of Prime Minister Justin Trudeau who was personally transfixed with the notion that Canada would benefit hugely by association with China, in lucrative trade deals and investment, laid itself open to expropriation of Canadian technical and scientific expertise, signing a contract with CanSino to test their vaccine at Dalhousie University in conjunction with the National Research Council, which could produce samples of the vaccine. A vaccine which never arrived in Canada, as per the agreement.
Inside the CanSino Phase 3 COVID-19 vaccine trial at Pakistan’s Shifa Hospital
A general view of Shifa International Hospital in Islamabad, Pakistan where a Phase 3 trial of CanSino's COVID-19 vaccine is undergoing trials. (Reuters)
 
A vaccine that Beijing refused to allow entry to Canada, while shipping it off elsewhere for testing. "In June, the vaccine (based on the Canadian cell line) was approved for use by Chinese military forces. As for the rights to the cell-line, a comment to Global News from Innovation, Science and Industry Minister Navdeep Bains was 'The NRC (National Research Council) retains the intellectual property related to the cell line, while CanSino in turn owns all intellectual property rights for the vaccines it develops.' Canada cannot claim any revenue if the vaccine proves successful", wrote Radio Canada International journalist Mark Montgomery.

"What exactly motivated Canada to enter into such an unstable partnership in the first place given the dire state of Canada-China relations and the scandalous history of China's vaccine industry?" questioned science writer Iris Kulbatski in the health-care journal Healthy Debate. She quoted Margaret McCuaig-Johnston, former assistant deputy minister in charge of Canada's vaccine collaboration with Beijing, that China's history of creating customs 'obstacles' in any trade disagreements, as leverage was well known.

"McCuaig-Johnston further said that 'China's success in vaccines is standing on the back of Canadian researchers and scientists. Over the years we helped China develop its capacity. But China is no longer a reliable partner." There is, in fact, nothing new about China's penchant for infiltration, sabotage and subterfuge along with the stealth mining of technological and scientific data originating elsewhere, than the ill-gotten gains used by China to further its own interests. 
 
This is merely one more instance in a long history of unprincipled looting of other nations' research and development. With China taking the short-cut route to using others' intellectual property, parading it as their own, and reaping the financial benefits thereof. The question remains: why would this Canadian government see fit, all this being well known, to engage in a contractual agreement with a country that cannot be trusted, with a pharmaceutical company that has direct links to the People's Republic of China's Military?

https://static.reuters.com/resources/r/?m=02&d=20201221&t=2&i=1545302862&r=LYNXMPEGBK0Y0&w=1600
Vials of a COVID-19 vaccine candidate, a recombinant adenovirus vaccine named Ad5-nCoV, co-developed by Chinese biopharmaceutical firm CanSino Biologics Inc and a team led by Chinese military infectious disease expert, are pictured in Wuhan, Hubei province, China. China Daily via REUTERS

 

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Tuesday, July 07, 2020

China's Vision of a New World Order

"[CanSino] deserves credit for the speed with which they pushed the vaccine through pre-clinical studies and human testing."
"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."
"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."
"There's no shortage of histories where promising efforts made it to the last stage of testing only to see things fall apart."
Wang Ruizhe, pharmaceutical industry analyst, Capital Securities Corp, Shanghai
Cansino Biologics INC.

"Most of our families stayed in Canada, and we could only see them a few times a year."
"When you think about your young kids and teenagers growing up without dads, when you know your wife had to shovel out of ten inches of deep snow early morning in -20C wind chill all by herself -- these were the tough moments."
Yu Xuefeng, chief executive, CanSino

"CanSino is in the game and it's about where the other so-called leaders are."
"Whether anybody will cross the finish line where we ever can see safety data that we would like to see is unknown."
William Haseltine, former HIV researcher, Harvard University
Credit: Cansino
In the desperate race to develop a vaccine to immunize populations against the SARS-CoV-2 virus which causes COVID-19, CanSino, a Chinese pharmaceutical company with ties to Canada boasts the reputation of having been the first to publish results of an initial trail with a product they developed with mixed results where its efficacy failed to impress and its alarming side-effects indicate that they're not quite there yet. The CEO of CanSino formerly worked for a Canadian pharmaceutical company, Sanofi as senior executive of vaccine operations.

The 57-year-old CEO of CanSino, born in China, took his doctorate at McGill Univrsity in microbiology. He became the head of vaccine development and production at Sanofi Pasteur in Canada. And now that he heads his own pharmaceutical company in China, relations in Canada with former colleagues have been maintained, at a time when both countries have seen their relations considerably cooled, in trade and diplomacy.

The U.S./Canada/Huawei affair where Huawei's CFO was taken into custody in Vancouver on an extradition warrant from the U.S. and where Meng Wanzhou awaits extradition to the U.S. to stand trial on charges of misleading U.S. banks on her company's sanction-breaking business with Iran, led to Beijing arresting two Canadians in China on trumped-up charges of espionage. Ms.Meng lives in her luxury Vancouver mansions on bail, while Michael Kovrig and Michael Spavor languish in a Chinese prison with no legal representative, unable to communicate with their families and rarely permitted consular visits.

Canada has not yet stated whether or not the government has decided to permit the telecommunications giant Huawei to provide some of the content of Canada's 5G upgrade while Beijing has darkly warned Ottawa of 'consequences' should Huawei be shut out based on fears of the potential based on prior such incidents of Chinese cyber espionage. This is a country whose nationals infiltrated Canadian technology, in working exchanges with Canada's giant successful telecommunications giant, Nortel Industries.

Nortel was subjected to infiltration, to commercial espionage, to a ransacking of secret data by Chinese insiders working for Nortel whose activities eventually concluded in the complete collapse of Nortel Networks, with the one and sole beneficiary being Huawei which took on former Nortel employees and milked their experience and the trade secrets they brought with them, to launch Huawei as a world heavyweight in global telecommunications technology.

Now, CanSino's Yu appears to be following a similar trajectory, substituting bioengineering and pharmaceutical production for advanced communications technology. Yu, whose company has not yet generated revenue, facing a $22 million deficit in 2019 given its enormous investments, has linked his company an its scientific advances with Canada's largest research organization, the National Research Council.

A researcher works at a lab of a Chinese vaccine maker CanSino Biologics in Tianjin, China November 20, 2018.
Lab of Chinese vaccine maker CanSino Biologics in Tianjin. Stringer/Reuters files

While in China, Mr. Yu collaborates closely with prominent military scientist Chen Wei, a major general in China's People's Liberation Army who heads the Institute of Biotechnology at China's Academy of Military Medical Sciences. She has lent her expertise to working with CanSino in the development of an Ebola vaccine approved in 2017 for emergency use and national stockpiling in China. During the SARS outbreak of 2003 she succeeded in developing a therapy for Chinese health workers.

Credit: Cansino
More latterly, CanSino alongside Dr.Chen's team of researchers sped through pre-clinical studies on the coronavirus vaccine, named Ad5-nCoV, starting human clinical trials in Wuhan in mid-March. When CanSino published a study in the medical journal Lancet, the vaccine appeared safe, generating a level of immune response, but with severe shortcomings. But CanSino's Canadian ties has enabled it to receive approval for conducting Phase III tests on its vaccine in Canada where researchers at the Canadian Centre for Vaccinology out of Dalhousie University are leading the clinical trials.

Yu had previously licensed a technology from the National Research Council of Canada in HEK 293 cell lines required to produce large quantities reliably of a vaccine, underpinning CanSino's viral vector technology. At the time few Chinese companies possessed that technology. The National Research Council has the option of producing doses of the vaccine for emergency pandemic use in Canada, should the vaccine candidate be approved by authorities.

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Wednesday, November 29, 2017

Mixed Messages : Bioscience : NRC Squelching Startup Biotech

"The company was, in June 2017, in arrears on its land lease payments by almost three years [35 months]."
"The company has since settled its debt with the NRC [National Research Council], on November 16, 2017, and is a valued client in good standing."
"In the conduct of its business, the NRC respects the proper stewardship of financial resources and is accountable for their management to Canadians in accordance with Treasury Board policy."
National Research Council, Ottawa
The National Research Council Canada at 100 Sussex Drive in Ottawa .. Errol McGihon / Postmedia

"We knew we were getting a grant [$30-million from the Gates Foundation] in September and we did."
"We just asked them [the NRC] to give us the summer [to get the financial fundamentals in order]."
Dr. Don Gerson, founder, CEO, PnuVax SL Biopharmaceuticals., Montreal
The startup biotech company contracted with the National Research Council in 2012 to rent a previously abandoned bio-tech facility in Montreal on federally-owned land, administered by the NRC agency. This facility had been leased to a Dutch company for the princely sum of $1 annually previously, but when the company closed up shop in 2005 the facility was again vacant. When Pnu Vax expressed interest in the site, the NRC was disinterested in offering it to the start-up on the same terms offered to the Dutch company.

Father Don and son Jonas Gerson were busy developing a low-cost vaccine against pneumonia, recognized as a deadly disease that is the largest killer of children under five years, world-wide. The costs in developing the vaccine were astronomical, and at one point the Gersons were faced with a conundrum; pay their rent and come up short in their research costs, or suspend their rent payments and focus on their research. They chose the latter route.

After all, the National Research Council is the very government agency whose existence fosters scientific excellence. Research coming out of the NRC is often proudly hailed for its scientific firsts in many areas of scientific endeavour. It is a national crown jewel of scientific research. So it stands to reason that scientists engaged in developing a vaccine as significant as that the Gersons were involved in would be given a break.

But that was not to be. Their pioneering work close to a breakthrough, convincing enough to the Gates Foundation to offer the largest investment ever given to any Canadian biomedical company failed to convince NRC management that they might be patient in awaiting arrears in rental back-payment in favour of giving the start-up a break. PnuVax received 30 day's written notice to either make good on the outstanding rental, represent $1-million, or be prepared to demolish the manufacturing facility and evacuate the premises.
 
Father and son decided to go to Ottawa to personally speak with NRC president Iaian Stewart, hoping to persuade him that when the Gates grant came through at the end of summer, the past-due rent would be paid, and to put off the order of evacuation. What they found, when they made their case, was scorn and refusal when Stewart laughed off the suggestion that PnuVax and the NRC could work out the problem with a positive conclusion.

Close to clinical trials of the new drug they had developed, the Gersons hardly knew what next to do. Health Canada approval was pending, allowing the vaccine to be commercialized. The NRC had even supplied one of the chemicals and as such would have received royalty payments. "But he [Stewart] didn't want to listen", Mr. Gerson recounted. Donald Gerson had  helped to develop and manufacture the first childhood pneumonia vaccine produced at Wyeth, an American pharmaceutical company, in 2000.

He went on to found PnuVax in 2008, with a view to developing a pneumonia vaccine for children world-wide, that would cost a dollar-a-dose. When, in 2012, the arrangement was made to lease the Montreal facility, the Gersons invested in renovating the facility to the tune of $10-million, passing a Health Canada inspection. The lease cost came to $300,000 annually, on top of which was $600,000 yearly in city taxes.

PnuVax found its financial resources strained, though it had already received funding from the Gates Foundation which stipulated that the funding was to be used for research only. And then came news that a larger grant would be forthcoming, that would cover vaccine development, clinical trials and facility overheads. Received in September of this year, it enabled PnuVax to pay off its rental arrears, but before that, because of the NRC threat due to non-payment of rent, the company had been on the cusp of insolvency.

Bridge financing and desperate determination kept them going. The company now has in its employ 25 well-paid scientists moving the process forward.

It costs the Government of Canada $160-million on childhood pneumonia vaccine annually. According to PnuVax, $100-million of that total could be saved if its low-cost alternative is approved.

This government partners with the Gates Foundation in its battle of infectious diseases globally.
Canada pledged $785-million to the Foundation to combat AIDS, tuberculosis and malaria. Yet the federal agency responsible to lead the innovation agenda of the government cavalierly dismissed a reasonable request by a biotech company to enable it to proceed with its goal to produce a drug badly needed to help fight deadly disease at a reasonable cost.
african baby is vaccinated.
Counterfeit drugs include products that have not been approved by regulators, fail to meet quality standards or deliberately misrepresent an ingredient. Photograph: Alamy

And the final irony can be found in the World Health Organization bemoaning cases of fake medicines it discovered in developing countries held to be responsible for the deaths of tens of thousands of children from malaria and pneumonia every year. One hundred studies of over 48,000 medicines were reviewed by experts who reached the conclusion that drugs to treat malaria and bacterial infections represented close to 65 percent of fake medicines.

It is mostly poor countries that are affected, according to WHO's director-general. Between 72,000 and 169,000 children die from pneumonia annually resulting from bad drugs, counterfeit medications held responsible for an additional 115,000 deaths from malaria in sub-Saharan Africa, according to scientists at the University of Edinburgh and London School of Hygiene and Tropical Medicine whom the WHO commissioned to conduct research in the matter.

Drugs on sale at a market in Mali. Photo: Bert Spiertz/Hollandse Hoogte/Redux

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