22nd Century Accepted to Present Proprietary Smoking Cessation Product at BIOCHINA Partnering Forum in Zhuhai, China

Rule Changes by the Chinese Food and Drug Administration Will Pave the Way for 22nd Century’s Well-Studied X-22 Smoking Cessation Aid

CLARENCE, N.Y.--(BUSINESS WIRE)-- 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.

22nd Century Group
Investor Relations:
IRTH Communications
Andrew Haag, 866-976-4784
xxii@irthcommunications.com

Source: 22nd Century Group, Inc.