22nd Century Accepted to Present Proprietary Smoking Cessation Product at BIOCHINA Partnering Forum in Zhuhai, China
25 April 2017 - 11:45PM
Business Wire
Rule Changes by the Chinese Food and Drug
Administration Will Pave the Way for 22nd Century’s Well-Studied
X-22 Smoking Cessation Aid
22nd Century Group, Inc. (NYSE MKT:XXII), a plant
biotechnology company that is focused on tobacco harm reduction and
cannabis research, announced today that James Vail, the Company’s
Director of Business Development, will present the Company’s X-22
smoking cessation aid to high level executives from Chinese and
international pharmaceutical companies at the BIOCHINA Partnering
Forum in Zhuhai, China on May 31 – June 1, 2017.
X-22 is a Very Low Nicotine tobacco-based botanical medical
product under development as a prescription smoking cessation aid.
Independent clinical studies have demonstrated that combustible
cigarettes containing 22nd Century’s Very Low Nicotine tobacco with
non-addictive levels of nicotine enable smokers to disassociate the
act of smoking from the rapid intake of nicotine. X-22 involves the
same smoking behavior as conventional cigarettes and does not
expose smokers to any new drugs or new side effects. In an
independent market research survey of 501 current smokers in the
United States, 89% said X-22 would be their top or first choice to
help them quit smoking.
Recent rule changes by the Chinese Food and Drug Administration
(CFDA) will open an expedited pathway for X-22 in China. Under the
old rules, China lagged behind other countries in approving
important medicines. In announcing the proposed new rules, China’s
CFDA Director, Bi Jingquan, promised to speed up foreign drug
approvals in China and, in support of such desired result, the CFDA
has already quadrupled the CFDA’s staff of Drug Team Reviewers.
Major pharmaceutical giants, including Pfizer (NYSE:PFE),
AstraZeneca (NYSE:AZN), and Novo Nordisk (NYSE:NVO),
have already expressed their approval of the new CFDA rules in
China, which include: (i) expedited regulatory processes for new
drugs, which shorten approval processes in China from over 2-years
to just 12 months, (ii) an expansion of China’s "green channel"
fast-track pathway for important new drugs, and (iii) waiving the
requirement for a China-specific trial when a multi-regional
clinical trial is conducted.
Mr. Vail explained, “The new rule changes by the CFDA will cut
in half the time needed for important drug approvals in China…
which provides 22nd Century with a distinct and timely opportunity
to bring X-22 to China’s smokers.”
22nd Century is aggressively pursuing new partnership
opportunities throughout Asia, with a strategic focus on China,
which is the world’s largest smoking market and the world’s second
largest pharmaceuticals market. Earlier this month the World Health
Organization (WHO) issued a report calling for "increased action to
combat China's tobacco epidemic." Entitled The Bill China Cannot
Afford: Health Economic and Social Costs of China's Tobacco
Epidemic, the report was co-authored by the WHO and the United
Nations Development Programme (UNDP). Dr. Bernhard Schwartlander,
the WHO representative in China, reviewed the report and found:
"The rapid increase in costs associated with tobacco use in China
is unsustainable… the total annual economic cost in 2014 [was] RMB
350 billion (USD $57 billion), an increase of 1,000% since [the
year] 2000."
“With over 275 million adult smokers and nearly 1.5 million
tobacco-related deaths each year in China, it is imperative that
the Chinese government and Chinese smokers have access to X-22,
which we believe is the world’s most effective smoking cessation
aid,” explained Henry Sicignano, III, President and CEO of 22nd
Century Group. “The advent of the new Chinese Food and Drug
Administration rules will be extremely advantageous for 22nd
Century; now we are accelerating our efforts to introduce X-22 to
tens of millions of smokers across China.”
About 22nd Century Group, Inc.
22nd Century is a plant biotechnology company focused on
technology which allows it to increase or decrease the level of
nicotine in tobacco plants and the level of cannabinoids in
cannabis plants through genetic engineering and plant breeding. The
Company’s primary mission in tobacco is to reduce the harm caused
by smoking. The Company’s primary mission in cannabis is to develop
proprietary cannabis strains for important new medicines and
agricultural crops. Visit www.xxiicentury.com and
www.botanicalgenetics.com for more information.
Cautionary Note Regarding Forward-Looking Statements: This press
release contains forward-looking information, including all
statements that are not statements of historical fact regarding the
intent, belief or current expectations of 22nd Century Group, Inc.,
its directors or its officers with respect to the contents of this
press release, including but not limited to our future revenue
expectations. The words “may,” “would,” “will,” “expect,”
“estimate,” “anticipate,” “believe,” “intend” and similar
expressions and variations thereof are intended to identify
forward-looking statements. We cannot guarantee future results,
levels of activity or performance. You should not place undue
reliance on these forward-looking statements, which speak only as
of the date that they were made. These cautionary statements should
be considered with any written or oral forward-looking statements
that we may issue in the future. Except as required by applicable
law, including the securities laws of the United States, we do not
intend to update any of the forward-looking statements to conform
these statements to reflect actual results, later events or
circumstances, or to reflect the occurrence of unanticipated
events. You should carefully review and consider the various
disclosures made by us in our annual report on Form 10-K for the
fiscal year ended December 31, 2016, filed on March 8, 2017,
including the section entitled “Risk Factors,” and our other
reports filed with the U.S. Securities and Exchange Commission
which attempt to advise interested parties of the risks and factors
that may affect our business, financial condition, results of
operation and cash flows. If one or more of these risks or
uncertainties materialize, or if the underlying assumptions prove
incorrect, our actual results may vary materially from those
expected or projected.
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version on businesswire.com: http://www.businesswire.com/news/home/20170425005978/en/
22nd Century GroupInvestor Relations:IRTH CommunicationsAndrew
Haag, 866-976-4784xxii@irthcommunications.com
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