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LOS ANGELES--(BUSINESS WIRE)--ChromaDex Corp. (NASDAQ:CDXC), the global authority on nicotinamide adenine dinucleotide (NAD+) research and its application to healthy aging, unveils Niagen+, the first-of-its-kind pharmaceutical-grade Niagen® (patented nicotinamide riboside chloride or NRC). Authorized by the U.S.
洛杉矶——(商业新闻短讯)——烟酰胺腺嘌呤二核苷酸(NAD+)研究及其在健康衰老中的应用的全球权威机构ChromaDex Corp.(纳斯达克:CDXC)推出了Niagen+,这是同类药物中第一个Niagen®(专利烟酰胺核糖氯化物或NRC)。美国授权。
FDA for compounding by 503B outsourcing facilities, pharmaceutical-grade intravenous (IV) and injectable NRC will be available in IV, shot, and push forms exclusively at clinics, with a prescription. ChromaDex believes it will be the first company in the U.S. to offer a novel ingredient (Niagen) both as a direct-to-consumer dietary supplement, available globally as Tru Niagen®, and as an intravenous and injectable pharmaceutical-grade product, available only at clinics.
美国食品和药物管理局(FDA)通过503B外包设施配制,药物级静脉注射(IV)和注射用NRC将以IV,shot和push形式提供,仅在诊所提供处方。ChromaDex相信,它将是美国第一家提供新型成分(尼亚根)的公司,该成分既可以作为直接面向消费者的膳食补充剂,也可以作为Tru Niagen®在全球范围内提供,也可以作为静脉注射和注射药物级产品,仅在诊所提供。
Various patents, including a pending patent covering NRC and other NAD+ precursors for intravenous use, offer extensive protection for pharmaceutical-grade Niagen..
各种专利,包括涉及NRC和其他静脉注射用NAD+前体的未决专利,为药物级尼亚根提供了广泛的保护。。
“NAD+ IV has gained popularity amongst celebrities, athletes, and longevity experts because of the substantial benefits but the experience can be unpleasant,” said Rob Fried, CEO of ChromaDex. “Niagen IV is much faster, provides superior tolerability, and importantly elevates NAD+ levels quicker and higher1.
ChromaDex首席执行官罗伯·弗里德(RobFried)表示:“NAD+IV因其巨大的益处而在名人、运动员和长寿专家中广受欢迎,但这种体验可能令人不快。”。“Niagen IV速度更快,耐受性更好,重要的是可以更快更高地提高NAD+水平1。
We believe Niagen IV will transform the NAD+ landscape.”.
我们相信尼亚根四世将改变NAD+的格局。”。
Pharmaceutical-grade Niagen, including Niagen IV, will debut in limited quantities at select clinics starting in August and will soon be available for shipping to additional clinics nationwide. Visit www.niagenplus.com to sign up for updates on future clinic availability.
包括Niagen IV在内的制药级Niagen将于8月开始在部分诊所限量上市,并将很快运送到全国其他诊所。访问www.niagenplus.com注册了解未来诊所可用性的最新信息。
Intravenous and injectable Niagen is the new 2024 vertical previously mentioned by ChromaDex. Niagen IV has the potential to reach the global intravenous hydration therapy market, which was valued at “USD $2.32 billion globally and USD $1.15 billion in North America (2022),” according to Grand View Research.
静脉注射和注射尼亚根是ChromaDex之前提到的新2024垂直。大视野研究公司(Grand View Research)表示,尼亚根IV有潜力进入全球静脉补液治疗市场,该市场价值“全球23.2亿美元,北美11.5亿美元(2022年)”。
This includes the NAD+ IV market, which ChromaDex estimates has the potential to be valued at over $100 million in North America alone (2023)..
这包括NAD+IV市场,ChromaDex估计仅在北美(2023年),该市场就有可能估值超过一亿美元。。
Findings from the first-ever human clinical trial recently published as a preprint in MedRxiv demonstrated that 500mg of Niagen IV was well-tolerated, with no adverse side effects. In a head-to-head comparison with the mainstream alternative, NAD+ IV, Niagen IV provided superior tolerability and a 75% shorter infusion time, with blood NAD+ levels peaking sooner and higher three hours post-infusion.
最近在MedRxiv中作为预印本发布的首次人体临床试验的结果表明,500mg的尼亚根IV耐受性良好,没有不良副作用。与主流替代品相比,NAD+IV,Niagen IV具有更好的耐受性,输注时间缩短了75%,血液NAD+水平在输注后三小时达到峰值。
In addition to a longer infusion time, study results showed that NAD+ IV was associated with a high prevalence of uncomfortable side effects such as headaches, stomach pain, diarrhea, and nausea, which were not observed with Niagen IV. ChromaDex looks forward to generating additional data from larger participant groups to quantify and validate these findings..
除了更长的输注时间外,研究结果表明,NAD+IV与头痛,胃痛,腹泻和恶心等不适副作用的高发生率相关,而Niagen IV没有观察到这些副作用。ChromaDex期待着从更大的参与者群体中获得更多数据,以量化和验证这些发现。。
Dr. Charles Brenner, Alfred E. Mann Family Foundation Chair in Diabetes and Cancer Metabolism at the City of Hope, Chief Scientific Advisor to ChromaDex—and the world’s foremost NAD+ expert—commented, “I am pleased that ChromaDex has developed an impeccably pure Niagen IV formulation, which is demonstrating a less stressful experience than NAD+ IV.
查尔斯·布伦纳博士(Charles Brenner)是霍普城(City of Hope)糖尿病和癌症代谢阿尔弗雷德·E·曼(Alfred E.Mann)家族基金会主席,也是ChromaDex的首席科学顾问,也是世界上最重要的NAD+专家,他评论道:“我很高兴ChromaDex开发出了一种无可挑剔的纯净尼亚根IV配方,它比NAD+IV表现出更少的压力体验。
I am confident that Niagen IV will be the gold standard IV material used to test NAD+ boosting for health conditions, and I look forward to future research.”.
我相信尼亚根IV将成为用于测试NAD+促进健康状况的金标准IV材料,我期待着未来的研究。”。
Although a common misconception, supplementing with oral or intravenous NAD+ itself is not the most efficient and effective way to elevate cell and tissue NAD+ levels. As a large, phosphorylated molecule, NAD+ cannot pass through cell membranes and must first be broken down into other NAD+ precursors.
虽然这是一个常见的误解,但补充口服或静脉注射NAD+本身并不是提高细胞和组织NAD+水平的最有效和最有效的方法。作为一个大的磷酸化分子,NAD+不能通过细胞膜,必须首先分解成其他NAD+前体。
Studies suggest that intact NAD+ causes an acute immune inflammatory response, which may be responsible for the uncomfortable side effects associated with NAD+ IV and injection. Oral and intravenous NAD+ supplementation is virtually untested in humans, thus risks, safety, and efficacy are unknown. Unlike the NAD+ molecule itself, or other common NAD+ precursors, NR is the most efficient way to elevate NAD+ levels because it crosses the cell membrane directly and requires fewer steps for conversion into NAD+.
研究表明,完整的NAD+会引起急性免疫炎症反应,这可能是与NAD+IV和注射相关的不舒服副作用的原因。口服和静脉注射NAD+补充剂实际上未经人体测试,因此风险,安全性和有效性尚不清楚。与NAD+分子本身或其他常见的NAD+前体不同,NR是提高NAD+水平的最有效方法,因为它直接穿过细胞膜,需要较少的步骤才能转化为NAD+。
(Nikiforov et al., 2011, Mehmel et al. 2020, Kroptov et al., 2021)..
(Nikiforov等人,2011年,Mehmel等人,2020年,Kroptov等人,2021)。。
“Niagen IV not only has the potential to help millions looking to support healthspan, but also may provide an option for those dealing with health-related conditions,” said Dr. Bal Nandra, Founder and Medical Director at IV Solution and Ketamine Centers of Chicago. “We are thrilled with the clinical study results and look forward to future research as Niagen IV sets a new standard in the NAD+ industry.”.
芝加哥IV Solution and Ketamine Center的创始人兼医疗总监巴尔·南德拉(BalNandra)博士说:“尼亚根IV不仅有可能帮助数百万寻求支持healthspan的人,而且可能为那些与健康相关的人提供一种选择。”。“我们对临床研究结果感到兴奋,并期待着未来的研究,因为尼亚根IV在NAD+行业树立了新的标准。”。
ChromaDex has a robust intellectual property (IP) portfolio of 80+ owned and licensed patents protecting Niagen and other NAD+ precursors. Various patents offer extensive protection for pharmaceutical-grade Niagen. It would be difficult for a company to produce NR, including NR chloride and other salt forms of NR, commercially without violating one or more of these patents.
ChromaDex拥有强大的知识产权(IP)组合,拥有80多个拥有和许可的专利,保护尼亚根和其他NAD+前体。各种专利为药物级尼亚根提供了广泛的保护。一家公司很难在商业上生产NR,包括氯化NR和其他盐形式的NR,而不违反其中一项或多项专利。
ChromaDex has vigorously protected and will continue to protect the hard-earned assets of shareholders..
ChromaDex大力保护并将继续保护股东来之不易的资产。。
For additional updates, please visit www.niagenplus.com.
有关更多更新,请访问www.niagenplus.com。
Forward-Looking Statements:
前瞻性声明:
This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended. Statements that are not a description of historical facts constitute forward-looking statements and may often, but not always, be identified by the use of such words as 'expects,' 'anticipates,' 'intends,' 'estimates,' 'plans,' 'potential,' 'possible,' 'probable,' 'believes,' 'seeks,' 'may,' 'will,' 'should,' 'could' or the negative of such terms or other similar expressions, and include the statements regarding Niagen IV being available starting in August and nationwide thereafter; Niagen IV’s potential to reach the global intravenous hydration therapy market; the potential health benefits of Niagen IV; and the potential for Niagen IV to materially impact the overall NAD+ industry.
本新闻稿包含经修订的《1933年证券法》第27A节和经修订的《1934年证券交易法》第21E节所指的前瞻性声明。不描述历史事实的陈述构成前瞻性陈述,通常(但不总是)可以通过使用“期望”、“预期”、“打算”、“估计”、“计划”、“潜在”、“可能”、“可能”、“相信”、“寻求”、“可能”、“将会”、“应该”、“可能”或这些术语或其他类似表达的否定词来识别,并包括从8月开始在全国范围内提供的关于尼亚根四世的陈述;Niagen IV进入全球静脉补液治疗市场的潜力;尼亚根IV的潜在健康益处;以及尼亚根IV对整个NAD+行业产生重大影响的潜力。
These forward-looking statements are based on the Company’s current expectations and are subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to the Company’s ability to secure adequate pharmaceutical grade quantities of Niagen IV in a timely manner; the Company’s ability to obtain appropriate contracts and arrangements with U.S.
这些前瞻性陈述基于公司目前的预期,并受到可能导致实际结果产生重大差异的风险和不确定性的影响,包括公司及时获得足够药物级尼亚根IV数量的能力的意外发展和相关风险;公司与美国签订适当合同和安排的能力。
FDA-registered 503B outsourcing facilities required to distribute Niagen IV to IV clinics; the Company’s ability to remain on the U.S. FDA Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act Category 1 list; the Company’s ability to maintain and enforce the Company’s existing intellectual property and obtain new patents related to Niagen IV; the Company’s ability to maintain sales, marketing and distribution capabilit.
FDA注册了503B个外包设施,需要将Niagen IV分发给IV诊所;根据《联邦食品、药品和化妆品法案》第1类清单第503B节,公司有能力保留美国FDA指定用于配制的原料药;公司维护和执行公司现有知识产权的能力,以及获得与Niagen IV相关的新专利的能力;公司维持销售、营销和分销能力的能力。
About ChromaDex:
关于ChromaDex:
ChromaDex Corp. (NASDAQ:CDXC) is the global authority on nicotinamide adenine dinucleotide (NAD+), with a focus on the science of healthy aging. The ChromaDex team, comprised of world-renowned scientists, works with independent investigators from esteemed universities and research institutions around the globe to uncover the full potential of NAD+.
ChromaDex Corp.(纳斯达克:CDXC)是烟酰胺腺嘌呤二核苷酸(NAD+)的全球权威,专注于健康衰老科学。ChromaDex团队由世界著名科学家组成,与来自全球知名大学和研究机构的独立研究人员合作,以揭示NAD+的全部潜力。
A vital coenzyme found in every cell of the human body, NAD+ declines with age and exposure to other everyday stressors. NAD+ depletion is a contributor to age-related changes in health and vitality. Setting the benchmark as the gold standard in scientific rigor and quality in the dietary supplement space, ChromaDex is the innovator behind its clinically proven flagship ingredient, Niagen® (patented nicotinamide riboside, or NR).
NAD+是人体每个细胞中发现的一种重要辅酶,随着年龄的增长和暴露于其他日常压力源而下降。NAD+耗竭是与年龄相关的健康和活力变化的原因。ChromaDex将其作为膳食补充剂领域科学严谨性和质量的金标准,是其经临床验证的旗舰成分Niagen®(获得专利的烟酰胺核苷或NR)背后的创新者。
Clinically proven to increase NAD+ levels, Niagen is the most efficient and superior-quality NAD+ booster helping people transform the way they age..
临床证明,尼亚根可以提高NAD+水平,是帮助人们改变衰老方式的最有效和最优质的NAD+助推器。。
Food-grade Niagen is manufactured by Chromadex and is available in the consumer dietary supplement Tru Niagen®, the number one healthy-aging oral NAD+ supplement in the United States* (available at www.truniagen.com). Pharmaceutical-grade Niagen will be available through FDA-registered 503B outsourcing facilities and will be administered at clinics pursuant to a valid prescription (www.niagenplus.com)..
食品级尼亚根由Chromadex生产,可在消费者膳食补充剂Tru Niagen®中获得,Tru Niagen®是美国排名第一的健康衰老口服NAD+补充剂*(可从www.truniagen.com获得)。药物级尼亚根将通过FDA注册的503B外包设施提供,并将根据有效处方(www.niagenplus.com)在诊所进行管理。。
ChromaDex’s robust patent portfolio protects NR and other NAD+ precursors. ChromaDex maintains a website at www.chromadex.com, to which ChromaDex regularly publishes copies of its press releases, news, and financial information.
ChromaDex强大的专利组合保护NR和其他NAD+前体。ChromaDex在www.ChromaDex.com上维护一个网站,ChromaDex定期向其发布新闻稿、新闻和财务信息的副本。
*Based on the top-selling dietary supplement brands by revenue per the largest U.S. e-commerce marketplace (as of 3/1/2023-2/29/2024).
*根据美国最大的电子商务市场(截至2023年3月1日至2024年2月29日)收入最高的膳食补充剂品牌。
1 Hawkins, J., Idoine, R., Kwon, J., Shao, A., Dunne, E., Hawkins, E. et al. (2024) Randomized, placebo-controlled, pilot clinical study evaluating acute Niagen+ IV and NAD+ IV in healthy adults. https://doi.org/10.1101/2024.06.06.24308565
1 Hawkins,J.,Idoine,R.,Kwon,J.,Shao,A.,Dunne,E.,Hawkins,E.等人(2024)随机,安慰剂对照,初步临床研究,评估健康成人急性尿原+IV和NAD+IV。https://doi.org/10.1101/2024.06.06.24308565