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STAMFORD, CT--(BUSINESS WIRE)--Philip Morris International Inc. (PMI) (NYSE: PM) on October 20 submitted Premarket Tobacco Product Applications (PMTAs) and Modified Risk Tobacco Product Applications (MRTPAs) for IQOS ILUMA heated tobacco products with the U.S. Food and Drug Administration (FDA).
康涅狄格州斯坦福德-(商业电信)-菲利普莫里斯国际公司(PMI)(纽约州:下午)于10月20日提交了IQOS-ILUMA加热的上市前烟草产品申请(PMTA)和改良风险烟草产品申请(MRTPA)美国食品和药物管理局(FDA)的烟草产品。
A PMTA marketing order is required to commercialize any new tobacco product in the United States. The company is also seeking an order to market IQOS ILUMA products as modified risk products that reduce exposure to harmful, and potentially harmful chemicals, a claim authorized for previous versions of IQOS..
PMTA营销订单需要在美国商业化任何新的烟草产品。该公司还寻求将IQOS ILUMA产品作为改进的风险产品销售的订单,以减少暴露于有害和潜在有害化学品的风险,这是对以前版本的IQOS授权的声明。。
Unlike conventional cigarettes, IQOS products heat — but do not burn — tobacco
与传统卷烟不同,IQOS产品加热但不燃烧烟草
IQOS ILUMA products are PMI’s most-innovative heated tobacco products. They deliver substantially similar reductions in the formation of harmful and potentially harmful constituents as earlier versions of IQOS products authorized by FDA
IQOS ILUMA产品是PMI最具创新性的加热烟草产品。与FDA授权的早期版本的IQOS产品相比,它们在有害和潜在有害成分的形成方面提供了大致相似的减少
IQOS ILUMA has demonstrated higher rates of full switching by adults who smoke and improved consumer satisfaction in countries around the world
IQOS-ILUMA在世界各国吸烟和提高消费者满意度的成年人中表现出更高的完全转换率
IQOS ILUMA products rely on a fundamentally different heating technology from previous versions of IQOS products and contain numerous technological advancements including improved device and battery longevity
IQOS ILUMA产品依赖与以前版本的IQOS产品根本不同的加热技术,并包含许多技术进步,包括改进的设备和电池寿命
IQOS ILUMA products are currently available in 27 markets internationally
IQOS ILUMA产品目前在国际27个市场上销售
PMI’s applications are supported by a thorough scientific assessment, including aerosol chemistry, in vitro toxicology, a pharmacokinetic study, and consumer perception and behavior studies, as well as the comprehensive scientific dataset generated with previous versions of the IQOS system
PMI的应用得到了全面的科学评估的支持,包括气溶胶化学,体外毒理学,药代动力学研究,消费者感知和行为研究,以及以前版本的IQOS系统生成的综合科学数据集
The IQOS ILUMA devices operate on the SMARTCORE INDUCTION SYSTEM that heats tobacco from within TEREA SMARTCORE STICKS—heated tobacco sticks designed to be used only with IQOS ILUMA devices
IQOS ILUMA设备在SMARTCORE感应系统上运行,该系统通过TEREA SMARTCORE STICKS加热烟草,该系统仅设计用于IQOS ILUMA设备
PMI has submitted applications for three ILUMA devices and five variants of the tobacco sticks: TEREA BLUE, TEREA GREEN, TEREA SIENNA, TEREA BRONZE, TEREA AMBER
PMI已提交三种ILUMA设备和五种烟草棒的申请:TEREA BLUE,TEREA GREEN,TEREA SIENNA,TEREA BRONZE,TEREA AMBER
Commenting on the IQOS ILUMA submission, Stacey Kennedy, President Americas & CEO PMI U.S. Business, said:
Stacey Kennedy,美洲总裁兼首席执行官PMI美国企业对IQOS-ILUMA提交的评论说:
“Tens of millions of American adults today smoke cigarettes and will likely continue to do so. They should have a range of scientifically substantiated better alternative nicotine products to choose from, and PMI is committed to providing them with new choices.
“今天有数千万美国成年人吸烟,并可能继续这样做,他们应该有一系列科学证实的更好的替代尼古丁产品可供选择,PMI致力于为他们提供新的选择。
Internationally, IQOS ILUMA products have demonstrated how ground-breaking consumer-centric innovation can lead more adults to stop smoking. We believe that same success can be replicated in the U.S. and drive a rapid decrease in smoking rates among adults. These are strong applications, and we urge the FDA to prioritize them for review..
在国际上,IQOS ILUMA产品已经展示了以消费者为中心的创新如何能够导致更多成年人戒烟。我们相信,同样的成功可以在美国复制,并推动成年人吸烟率迅速下降。这些都是强有力的应用,我们敦促FDA优先考虑它们进行审查。。
Since 2008 PMI has invested more than $10.5 billion to scientifically research, develop, and commercialize smoke-free products, an investment that was further bolstered last year through our acquisition of Swedish Match. We are focused on providing adults who smoke with alternatives that can reduce their risks compared with smoking and help make America cigarette-free.”.
自2008年以来,PMI已投入超过105亿美元用于科学研究,开发和商业化无烟产品,这一投资去年通过我们收购瑞典火柴进一步得到支持。我们专注于为成年人提供与吸烟相比可以降低风险的替代品,并帮助美国免费吸烟“。
Note to Editor
编者注
PMI will have the full rights to commercialize all IQOS products in the U.S. as of April 30, 2024, per the terms of an agreement with Altria Group, Inc. ending the companies’ commercial relationship covering IQOS in the U.S.
根据与Altria Group,Inc。签订的协议条款,PMI将拥有截至2024年4月30日在美国商业化所有IQOS产品的全部权利,终止该公司在美国涵盖IQOS的商业关系。
Previous versions of IQOS products have been authorized by the FDA both for sale in the U.S., and as modified risk tobacco products with “reduced exposure” claims
以前版本的IQOS产品已经被FDA授权在美国销售,并且作为具有“减少暴露”声明的改良风险烟草产品
PMI has announced plans to commercialize these versions of IQOS in two U.S. states in select key cities in Q2 next year
PMI已宣布计划在明年第二季度在美国两个州的部分关键城市将这些版本的IQOS商业化
IQOS was first launched internationally in 2014, is now available in 70 markets globally, and has not triggered worrisome levels of use by unintended audiences, including those beneath the legal age of purchase
IQOS于2014年首次在国际上推出,现已在全球70个市场上市,并未引发意外受众(包括未满法定购买年龄的受众)令人担忧的使用水平
Philip Morris International: Delivering a Smoke-Free Future
菲利普·莫里斯国际:提供无烟的未来
Philip Morris International (PMI) is a leading international tobacco company working to deliver a smoke-free future and evolving its portfolio for the long term to include products outside of the tobacco and nicotine sector. The company’s current product portfolio primarily consists of cigarettes and smoke-free products.
Philip Morris International(PMI)是一家领先的国际烟草公司,致力于提供无烟未来并长期发展其投资组合,以将产品纳入烟草和尼古丁领域之外。该公司目前的产品组合主要由卷烟和无烟产品组成。
Since 2008, PMI has invested more than USD 10.5 billion to develop, scientifically substantiate and commercialize innovative smoke-free products for adults who would otherwise continue to smoke, with the goal of completely ending the sale of cigarettes. This includes the building of world-class scientific assessment capabilities, notably in the areas of pre-clinical systems toxicology, clinical and behavioral research, as well as post-market studies.
自2008年以来,PMI已投入超过105亿美元开发,科学证实和商业化创新的无烟产品,否则将继续吸烟,目标是完全结束卷烟销售。这包括建立世界一流的科学评估能力,特别是在临床前系统毒理学,临床和行为研究以及上市后研究领域。
In November 2022, PMI acquired Swedish Match – a leader in oral nicotine delivery – creating a global smoke-free champion led by the companies’ IQOS and ZYN brands. The U.S. Food and Drug Administration has authorized versions of PMI’s IQOS Platform 1 devices and consumables and Swedish Match’s General snus as Modified Risk Tobacco Products.
2022年11月,PMI收购了瑞典火柴公司-口服尼古丁交付的领导者-创建了由公司IQOS和ZYN品牌领导的全球无烟冠军。美国食品和药物管理局已授权PMI的IQOS平台1设备和消耗品以及瑞典火柴的一般鼻烟作为改良风险烟草产品。
As of September 30, 2023, PMI's smoke-free products were available for sale in 82 markets, and PMI estimates that approximately 19.7 million adults around the world had already switched to IQOS and stopped smoking. Smoke-free products accounted for approximately 36.2% of PMI’s total third-quarter 2023 net revenues.
截至2023年9月30日,PMI的无烟产品已在82个市场销售,PMI估计全球约有1970万成年人已转用IQOS并停止吸烟。无烟产品约占PMI 2023年第三季度净收入的36.2%。
With a strong foundation and significant expertise in life sciences, PMI announced in February 2021 its ambition to expand into wellness and healthcare areas and, through its Vectura Fertin Pharma business, aims to enhance life through the delivery of seamless health experiences. For more information, please visit www.pmi.com and www.pmiscience.com..
PMI凭借坚实的基础和丰富的生命科学专业知识,于2021年2月宣布其扩展到健康和医疗保健领域的雄心壮志,并通过其Vectura Fertin Pharma业务,旨在通过提供无缝健康体验来增强生活。欲了解更多信息,请访问www.pmi.com和www.pmiscience.com。。
Forward-Looking and Cautionary Statements
前瞻性和警示性陈述
This press release contains projections of future results and goals and other forward-looking statements, including statements regarding expected financial or operational performance; capital allocation plans; investment strategies; regulatory outcomes; market expectations; and business plans and strategies.
本新闻稿包含对未来成果和目标以及其他前瞻性声明的预测,包括有关预期财务或运营绩效的声明;资本分配计划;投资战略;监管成果;市场预期;和业务计划和策略。
Achievement of future results is subject to risks, uncertainties and inaccurate assumptions. In the event that risks or uncertainties materialize, or underlying assumptions prove inaccurate, actual results could vary materially from those contained in such forward-looking statements. Pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, PMI is identifying important factors that, individually or in the aggregate, could cause actual results and outcomes to differ materially from those contained in any forward-looking statements made by PMI..
未来结果的实现受到风险,不确定性和不准确假设的影响。如果风险或不确定性具体化,或基本假设证明不准确,实际结果可能与此类前瞻性陈述中包含的结果有很大差异。根据1995年“私人证券诉讼改革法”的“安全港”规定,PMI正在确定个别或总体上可能导致实际结果和结果与任何前瞻性陈述中所包含的结果和结果大不相同的重要因素。由PMI。。
PMI's business risks include: excise tax increases and discriminatory tax structures; increasing marketing and regulatory restrictions that could reduce our competitiveness, eliminate our ability to communicate with adult consumers, or ban certain of our products in certain markets or countries; health concerns relating to the use of tobacco and other nicotine-containing products and exposure to environmental tobacco smoke; litigation related to tobacco use and intellectual property; intense competition; the effects of global and individual country economic, regulatory and political developments, natural disasters and conflicts; the impact and consequences of Russia's invasion of Ukraine; changes in adult smoker behavior; the impact of COVID-19 on PMI's business; lost revenues as a result of counterfeiting, contraband and cross-border purchases; governmental investigations; unfavorable currency exchange rates and currency devaluations, and limitations on the ability to repatriate funds; adverse changes in applicable corporate tax laws; adverse changes in the cost, availability, and quality of tobacco and other agricultural products and raw materials, as well as components and materials for our electronic devices; and the integrity of its information systems and effectiveness of its data privacy policies.
PMI的业务风险包括:消费税增加和歧视性税收结构;增加营销和监管限制,可能会降低我们的竞争力,消除我们与成年消费者沟通的能力,或在某些市场或国家禁止我们的某些产品;与使用烟草和其他含尼古丁产品以及暴露于环境烟草烟雾有关的健康问题;与烟草使用和知识产权有关的诉讼;激烈的竞争;全球和个别国家经济,监管和政治发展,自然灾害和冲突的影响;俄罗斯入侵乌克兰的影响和后果;成人吸烟者行为的变化;COVID-19对PMI业务的影响;假冒,禁忌和跨境购买造成收入损失;政府调查;不利的货币汇率和货币贬值,以及收回资金能力的限制;适用公司税务法的不利变化;烟草和其他农产品和原材料的成本,可用性和质量以及我们电子设备的组件和材料的不利变化;以及其信息系统的完整性和数据隐私政策的有效性。
PMI's future profitability may also be adversely affected should it be unsuccessful in its attempts to produce and commercialize reduced-risk products or if regulation or taxation do not differentiate between such products and cigarettes; if it is unable to successfully introduce new products, promote brand equity, enter new markets or improve its margins through increased prices and productivity gains; if it is unable to expand its brand portfolio internally or through.
如果降低风险产品的生产和商业化尝试失败,或者监管或税收不能区分这些产品和卷烟,PMI未来的盈利能力也可能受到不利影响;如果无法成功引进新产品,促进品牌公平,进入新市场或通过提高价格和提高生产力来提高利润率;如果它无法在内部或通过内部扩展其品牌组合。
PMI is further subject to other risks detailed from time to time in its publicly filed documents, including PMI's Annual Report on Form 10-K for the fourth quarter and year ended December 31, 2022, Quarterly Report on Form 10-Q for the second quarter ended June 30, 2023 and Quarterly Report on Form 10-Q for the third quarter ended September 30, 2023, which will be filed in the coming days.
PMI还不时在其公开提交的文件中详述其他风险,包括第四季度和2022年12月31日结束年份的PMI 10-K年度报告,第二季度10-Q年度报告截至2023年6月30日,第三季度截至2023年9月30日的第三季度10-Q季度报告将在未来几天提交。
PMI cautions that the foregoing list of important factors is not a complete discussion of all potential risks and uncertainties. PMI does not undertake to update any forward-looking statement that it may make from time to time, except in the normal course of its public disclosure obligations..
PMI警告说,上述重要因素清单并不是对所有潜在风险和不确定性的完整讨论。PMI不承诺不时更新任何前瞻性声明,除非在其公共披露义务的正常过程中。。