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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.
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