Hydroxychloroquine Sulfate

Donald Trump’s embrace of Robert F. Kennedy Jr. is forcing biotech and pharma leaders to grapple with having US life sciences policy influenced by a figure who has extensively criticized vaccines and the drug industry, routinely embraces many conspiracy theories, and has made threats to force out FDA staff. As Trump has made gains in his bid for the US presidency against Democrat nominee Kamala Harris, he’s embraced Kennedy, who was once considered a fringe candidate expected to gather at most a few percent of the vote in some states. “I’m gonna let him go wild on health,” Trump said of RFK Jr. on Sunday at a campaign event in Madison Square Garden in New York. “I’m gonna let him go wild on the food. I’m gonna let him go wild on the medicines.” While Kennedy would be an unlikely pick for an actual appointment in the administration given the difficulty he might face with a confirmation, he’s worked with Trump’s team to help plan for a new administration, particularly on healthcare issues. And last week, he gave a preview of what that would mean in a post on X, formerly known as Twitter, saying that “FDA’s war on public health is about to end,” and calling for stopping what he called the suppression of  “psychedelics, peptides, stem cells, raw milk, hyperbaric therapies, chelating compounds, ivermectin, hydroxychloroquine, vitamins, clean foods, sunshine, exercise, nutraceuticals and anything else that advances human health and can’t be patented by Pharma.” “If you work for the FDA and are part of this corrupt system, I have two messages for you: 1. Preserve your records, and 2. Pack your bags,” Kennedy said in the post. The remarks weren’t a one-off. Earlier this month , Kennedy made similar comments to television host Phil McGraw, better known as Dr. Phil, saying that the “principal objective of the FDA today is to serve the mercantile interests of pharmaceutical companies.” There would certainly be limits to what an unconventional, RFK Jr.-allied FDA leader could do, given the power of professional staff at the FDA. But Kennedy’s comments have forced the industry to contemplate a very different environment in Washington if Trump wins and embraces a new approach. And RFK Jr.’s planned reforms, like cutting funding or headcount at the FDA, would have to come from Congress. The FDA-pharma industry user fee deal, current through 2027, is renewed once every five years, and the FDA employees reviewing new and generic drugs or new evidence of existing drugs are typically not political appointees but physicians who are employed by the FDA via industry funds. One former Trump health official who has had conversations with the campaign and those preparing for a potential transition said there were aspects of RFK Jr.’s ideas that had merit, including a focus on wellness and health. But they expressed a hope that more mainstream figures in a Trump administration would put guardrails around more extreme concepts, like RFK Jr.’s well-documented anti-vaccine sentiments. The person spoke on condition of anonymity. The FDA and Trump campaign didn’t respond to requests for comment. Others are raising concerns that an RFK Jr.-run FDA might be antithetical to the agency’s mission. “If RFK has a significant influence on the next administration, that could further erode people’s willingness to get up to date with recommended vaccines, and I am worried about the impact that could have on our nation’s health, on our nation’s economy, on our global security,” former Surgeon General Jerome Adams said Monday at a conference in Minneapolis. Holly Fernandez Lynch, a lawyer and bioethicist at the University of Pennsylvania, told Endpoints News that RFK Jr.’s proposals would amount to “a dereliction of duty” by the agency. “FDA leadership cannot wholesale abandon the agency’s public health mission,” she said. “Unfortunately, I can’t imagine that the courts would come to the rescue given what we’ve seen lately. And whether Congress would or could depends on the elections too.” PhRMA, which represents large drugmakers, said in a statement to Endpoints that the US “leads the world in innovative new medicines, in part due to the strength and integrity of the FDA’s human drug review program. The FDA is the gold standard in evaluating the safety, efficacy and quality of medicines prior to and following approval, and its role is critical in providing certainty for patients, health care providers and manufacturers.”

今日，三生国健（688336.SH）自主研发的抗BDCA2单抗（研发代号：626）临床试验申请已获国家药监局批准，用于治疗系统性红斑狼疮（SLE）及皮肤型红斑狼疮（CLE）。此前，该产品已获得美国临床试验批件。 SLE是一种系统性自身免疫病，病因复杂，主要临床特点为全身多系统和脏器受累、反复的复发与缓解、体内存在大量自身抗体等，若不及时治疗，可能会造成受累脏器的不可逆损害，最终导致患者死亡。SLE的病因复杂，与遗传、性激素、环境（如病毒与细菌 感染）等多种因素有关。《2020中国系统性红斑狼疮诊疗指南》显示，SLE患病率地域差异较大，目前全球SLE患病率为0~241/10万，中国大陆地区SLE患病率约为30~70/10万，男女患病比为1∶10~12。 CLE病变主要局限于皮肤，可以进展为系统性红斑狼疮。CLE可分为急性皮肤型红斑狼疮（ACLE）、亚急性皮肤型红斑狼疮（SCLE）、间歇性皮肤型红斑狼疮（ICLE）和慢性皮肤型红斑狼疮（CCLE）等多种亚型。20%的CLE患者在3~5年内会转变为SLE。多达30%的CLE患者会发展出一种以上的亚型。CLE多发于30~40岁人群，男女比例低于SLE。 BDCA2（血液树突状细胞抗原2）主要在浆细胞样树突状细胞（pDC）上表达，BDCA2在pDC中可通过抑制干扰素产生影响免疫应答，进而调控免疫系统。由于pDC产生IFNα/β被认为是狼疮的主要病理生理因素，因此BDCA2是阻断狼疮产生干扰素α/β的潜力靶点。 目前，治疗SLE的基础用药以羟氯喹、糖皮质激素等为主。CLE的局部治疗以糖皮质激素和钙调磷酸酶抑制剂为主，全身治疗则使用羟氯喹和糖皮质激素等。 《2020中国系统性红斑狼疮诊疗指南》指出，对难治性（经常规治疗效果不佳）或复发性SLE患者，使用生物制剂能较为显著地增加患者的完全和部分缓解率，降低疾病活动度、疾病复发率及减少激素用量。2023年发布的《2023年欧洲抗风湿病联盟（EULAR）系统性红斑狼疮管理建议》中，进一步扩大了生物制剂在治疗中的使用范围和重要性。 当前，生物制剂在SLE和CLE领域的研发日趋活跃，其中，BDCA2靶点作为新起之秀，在已发布的疗效数据上显示出一定的优势前景。三生国健发挥在自身免疫疾病领域的综合优势和丰富经验，前瞻性布局抗BDCA2单抗产品，将有望进一步扩大公司自免产品组合，为红斑狼疮患者带来新的治疗获益。 参考文献： 1、《2020中国系统性红斑狼疮诊疗指南》 2、《2023年欧洲抗风湿病联盟（EULAR）系统性红斑狼疮管理建议》 关于三生国健 三生国健是中国第一批专注于抗体药物的创新型生物医药高新技术企业之一。公司拥有研、产、销一体化成熟平台，专注于单抗、双抗、多抗及多功能重组蛋白等新技术研究，拥有丰富的大规模抗体产业化和质量控制经验。公司是“免疫与炎症全国重点实验室”依托单位、拥有抗体药物国家工程研究中心、国家企业技术中心、上海市抗体技术创新中心、上海抗体工程技术研究中心等国家级和上海市级高新技术平台，承担过国家重大新药创制、“863”计划、国家发改委及上海市重大项目及各部委课题百余项，多次获得上海市级和浦东新区科学技术奖。目前，公司拥有18个处于不同开发阶段的自身免疫在研创新药物项目，均为治疗用生物制品1类药品，部分在研药物为中美双报。公司是国家知识产权示范企业、上海市知识产权示范企业，累计申请发明专利近200件，获得发明专利授权近百项，产品覆盖国内32个省、自治区、直辖市，并销往海外十余个国家。欲获得更得信息，请访问www.3s-guojian.com。 警示说明及前瞻性陈述 本新闻稿包含前瞻性陈述，例如涉及业务和产品前景,或公司的意图、计划、认知、预期及策略。该等前瞻性陈述是根据本公司现有的资料，并按本新闻稿发布时的展望陈述。该等前瞻性陈述基于若干预测、假设及前提，其中一些是主观性的或不受我们控制。该等前瞻性陈述可能被证明是不正确的，或将来可能无法实现。就任何新产品或产品的新适应症, 我们无法确保其将能成功开发或最终上市销售。该等前瞻性陈述受各种风险及不明朗因素影响。我们的其他公开披露文件可能提供该等风险及不明朗因素的更多信息。所涉及之科学信息可能只是初步的和研究性的。本公司股东及潜在投资者在买卖本公司股份时，请务必谨慎行事。