
一 | CVS Health is planning to remove one type of a common decongestant from shelves after an advisory committee to the U.S. Food and Drug Administration said it was ineffective earlier this year.The products contain the oral formulation of phenylephrine (PE), which is found in several over-the-counter (OTC) medications.Although PE has been used as a decongestant for nearly a century, experts have been questioning its efficacy for years.The FDA Nonprescription Drugs Advisory Committee unanimously voted in September that PE did not improve nasal congestion any more than a placebo at the dosage given for OTC use.In response, CVS said it is removing products, in which PE is the only active ingredient from store shelves. This means products like Dayquil, which used a combination of active ingredients, will remain available for purchase."We are aware of the FDA Advisory Committee's position on oral phenylephrine (PE) and will follow direction from the FDA to ensure products we sell comply with all laws and regulations," CVS Health said in a statement. "We are removing certain oral cough and cold products that contain phenylephrine as the only active ingredient from CVS Pharmacy stores. Other oral cough and cold products will continue to be offered to meet consumer needs."CVS did not give specifies on brands that will be removed.The FDA told ABC News it has not yet determined whether it no longer considers PE to be a safe and effective medication and has not ordered the product to be removed from shelves. CVS's move is voluntary."The FDA has no further information to provide at this time regarding the timing of any decision the agency may make following the advisory committee meeting," the federal health agency said.The Consumer Healthcare Products Association told ABC News that the advisory committee's recommendation is a non-binding decision and not a change in regulation."FDA is currently in the process of reviewing the regulatory status of oral phenylephrine (PE) following September's advisory committee meeting," CHPA said in a statement. "Until FDA makes a determination on the committee's recommendation, oral PE remains a Category 1 OTC ingredient, which is generally recognized as safe and effective."Concerns were first raised about PE in 2007. Since then, evidence has accumulated showing that the drug offers little to no relief for nasal congestion.Experts believe this is because the body processes the drug before it reaches the nasal passages where it needs to work.It's unclear if other major retail pharmacy chains will follow in CVS's footsteps.Walgreens Boots Alliance would not disclose whether it was planning to remove products with PE from store shelves and said it would defer to the FDA."Walgreens follows FDA regulations. We are closely monitoring the situation and actively partnering with the Walgreens Office of Clinical Integrity and suppliers on appropriate next steps," a Walgreens spokesperson told ABC News.Other major pharmacy chains including Albertsons, Costco and Kroger did immediately reply to ABC News' request for comment. Walmart did not have an answer immediately available.ABC News' Sasha Pezenik and Sony Salzman contributed to this report.。

二 | 两只热门概念股,双双发布股价异动公告。

三 |
受海外医药巨头默沙东与Moderna(莫德纳)合作研发的个性化mRNA抗癌疫苗intismeran的III期临床试验研究成功的消息影响,键凯科技(688356)于8月20日和8月21日连续“20cm”涨停。
8月21日晚间,键凯科技披露异动公告称,经公司自查,公司目前生产经营活动一切正常。市场环境、行业政策没有发生重大调整,生产成本和销售等情况没有出现大幅波动,内部生产经营秩序正常。公司控股股东、实控人也不存在涉及公司应披露而未披露的重大信息。 针对市场传闻情况,公告称,经公司自查,公司未直接向Moderna提供LNP核心原料。mRNA肿瘤疫苗的商业化对公司业务的影响主要体现在两个方面。 第一是材料销售业务方面,2025年,公司LNP类产品收入约751.21万元,占公司当年营业收入的比例较小,约为2.36%。公司预计短期内LNP相关的产品销售业务不会对公司材料销售收入情况产生重大影响。

四 | 第二是研发管线方面,公司与康希诺(688185)合作的针对胶质母细胞瘤的mRNA疫苗项目,以及公司自研的mRNA肿瘤疫苗项目,目前均处于临床前研究阶段,存在较大不确定性。公司与康希诺共同开发的三组分LNP递送系统ISL-3C-LNP目前已向第三方授权,由于授权方项目尚处在临床前早期研究阶段,也存在较大不确定性。 证券时报记者注意到,键凯科技异动公告中所提到的康希诺,在8月21日晚间同样发布了异动公告。二级市场上,康希诺同样于8月20日和8月21日连续两个交易日“20cm”涨停。
康希诺公告称,公司关注到近期市场上关于mRNA技术的发展。mRNA平台是公司布局的技术平台之一,公司正在进行mRNA预防用疫苗及治疗性生物制品的开发,以及相关递送系统的开发。治疗领域方面,公司正在推进mRNA疫苗用于治疗胶质母细胞瘤、横纹肌肉瘤及宫颈癌等适应症的研发工作,以及InVivoCAR相关疗法的开发,目前均处于早期阶段。 除此之外,康希诺强调,公司目前生产经营活动正常,内部经营秩序正常。公司及公司控股股东、实控人不存在应披露而未披露的重大事项。

五 |
(文章来源:证券时报)。
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