Dexamethasone Sodium Phosphate

来源：企业公告    编辑：wangxinglai2004 近日，4药企分别发布了产品海外上市进展公告，具体为富士莱医药API获CEP证书、津药药业四API通过巴西GMP认证、海翔药业API获韩国注册证书和华海药业制剂获FDA批准文号。 富士莱医药API获CEP证书 一、药物基本情况     药品名称：THIOCTIC ACID/硫辛酸    药品持有人：苏州富士莱医药股份有限公司    生产地址：江苏省常熟市新材料产业园海旺路16号  发证机构：欧洲药品质量管理局    证书编号：NO.CEP 2023-359-Rev 00    证书有效期：自2025年2月3日起五年内 二、药物其他相情况  硫辛酸原研厂家为德国史达德（STADA），属于维生素类化合物，主要适用于糖尿病多发性周围神经病变。  本次公司硫辛酸原料药获得CEP证书，表明该原料药符合欧洲药典的质量要求，显示欧洲规范市场对该原料药质量的认可和肯定，标志着该原料药可以在欧洲市场及承认CEP证书的其他规范市场进行销售，为公司进一步拓展国际市场带来积极的影响。 津药药业四API通过巴西GMP认证 一、药物基本情况   药品名称：地塞米松磷酸钠、醋酸地塞米松、螺内酯、倍他米松  药品生产商/持有人：津药药业股份有限公司  生产地址：天津开发区西区新业九街19号  证书编号：1037390/23-7、1038120/23-3 发证机构：巴西卫生监督局（ANVISA） 有效期：2027年1月20日 二、药物其他相情况  地塞米松磷酸钠具有抗炎、抗过敏、抗风湿、免疫抑制作用，常用于过敏及自身免疫性疾病；醋酸地塞米松主要用于胶原性疾病，如风湿性关节炎、红斑性狼疮、风湿性心脏病、风湿热、皮肌炎等症。 根据数据库显示，地塞米松系列制剂2022年、2023年全球市场销售额分别为11.98亿美元、12.03亿美元。 华海药业制剂获FDA批准文号 一、药物基本情况   药物名称：多西环素胶囊 ANDA号：217098 剂型：胶囊  规格：40 mg 申请事项：ANDA（美国新药简略申请）  申请人：普霖斯通制药有限公司（Prinston Pharmaceutical, Inc.） 二、药物其他相情况  多西环素胶囊主要用于治疗丘疹脓疱型红斑痤疮。多西环素胶囊原研由 GALDERMA LABS LP研发，最早于2006年5月在美国上市。 2024年该药品美国市场销售额约13,153万美元，截至目前公司在多西环素胶囊研发项目上已投入研发费用约850万元人民币。 海翔药业API获韩国注册证书 一、药物基本情况   化学原料药名称：地夸磷索钠  企业名称：浙江海翔药业股份有限公司  地址：浙江省台州市椒江区外沙支路100号  DMF 注册号：수289-23-ND 发证机构：韩国食品药品监督管理局（韩国MFDS） 二、药物其他相情况  地夸磷索钠是一种P2Y2受体激动剂，其滴眼液制剂用于干眼症的治疗。地夸磷索钠作用于结膜上皮及杯状细胞膜上的P2Y2受体，通过上调细胞内的钙离子浓度，促进水分及黏蛋白的分泌，进而改善干眼病症状。  据数据显示，地夸磷索钠滴眼液2023年在中国城市公立医院的销售额为人民币16,818万元。

SOUTH SAN FRANCISCO, Calif.--( BUSINESS WIRE )--Quince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage biotechnology company dedicated to unlocking the power of a patient’s own biology for the treatment of rare diseases, announced that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Patent Application No. 17/083,771 entitled Process for the Preparation of Erythrocytes Loaded With One or More Substances of Pharmaceutical Interest and So Obtained Erythrocytes . The newly allowed application covers the method of treating patients with Ataxia-Telangiectasia (A-T) and provides patent coverage for preparing erythrocytes loaded with one or more substances of pharmaceutical interest using the EryDex process. The first independent claim of this application is not limited to any particular pharmaceutical product and is broader than currently granted parent patent claims. Supplementing the company’s existing U.S. Patent No. 10,849,858, Quince now has issued patents directed to the process for encapsulating erythrocytes with a therapeutic drug as well as a method of treating a patient with encapsulated erythrocytes. Charles Ryan, J.D., Ph.D., Quince’s President and head of the company’s corporate legal activities and intellectual property portfolio, said, “Our growing intellectual property portfolio strengthens the long-term market position for our lead asset EryDex and further validates our proprietary AIDE technology platform. Importantly, this allowance strengthens market exclusivity and extends our patent claims to 2036 in the U.S. We are very pleased with this Notice of Allowance and intend to continue to prosecute additional patent applications to protect EryDex and our proprietary encapsulation technology.” Quince expects that the resulting patent will be listable in the U.S. Food and Drug Administration’s publication Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). As a result, any generic applicant that references EryDex for the treatment of A-T would be required to certify against the company’s patent. This will provide Quince notice of future generic applicants and give the company other stay provisions under applicable provisions of the Hatch-Waxman Act. This protection is in addition to the expected market exclusivity provided by Orphan Drug Designation in the U.S. and Europe. A Notice of Allowance is issued after the USPTO determines that the prosecution on the merits of a patent has been completed and grants the patent upon payment of the patent issuance fee. As such, Quince expects the U.S. patent to be issued after administrative processes are complete. Quince plans to pursue claims having a similar claim scope in related cases pending before the European Patent Office as well. About Ataxia-Telangiectasia A-T is an inherited autosomal recessive neurodegenerative and immunodeficiency disorder caused by mutations in the ATM gene, which is responsible for cell homeostatic and cell division functions including but not limited to double-stranded DNA repair. Typically, A-T is first diagnosed before the age of five as children begin to develop an altered gait and fall with greater frequency. Neurological symptoms worsen and patients with A-T frequently become wheelchair-bound by adolescence. Teenage years for patients with A-T are typically marked by repeated infections, pulmonary impairment, and malignancies. The median lifespan is approximately 25 to 30 years old with mortality due to infections and malignancy. Based on IQVIA Medical Claims (Dx), PharmetricsPlus (P+), and IQVIA Analytics information, there are approximately 4,600 diagnosed patients with A-T in the U.S. Quince estimates that there are approximately 5,000 patients with A-T in the U.K. and EU4 countries. There are currently no approved therapeutic treatments in any global market for A-T. About EryDex for A-T EryDex is comprised of dexamethasone sodium phosphate (DSP) encapsulated in a patient’s own red blood cells (autologous erythrocytes). DSP is a corticosteroid well known for its anti-inflammatory properties as well as its dose-limiting toxicity due to adrenal suppression. The EryDex System is designed to provide the efficacy of corticosteroids and to reduce or eliminate the significant adverse effects that accompany chronic use of corticosteroid treatment. EryDex leverages Quince’s proprietary Autologous Intracellular Drug Encapsulation, or AIDE, technology platform, which is a novel drug/device combination that uses an automated process designed to encapsulate a drug into the patient’s own red blood cells. Red blood cells have several characteristics that make them a potentially effective vehicle for drug delivery, including potentially better tolerability, enhanced tissue distribution, reduced immunogenicity, and prolongation of circulating half-life. Quince’s AIDE technology is designed to harness these benefits to allow for the chronic administration of drugs that have limitations due to toxicity, poor biodistribution, suboptimal pharmacokinetics, or immune response. About Quince Therapeutics Quince Therapeutics, Inc. (Nasdaq: QNCX) is a late-stage biotechnology company dedicated to unlocking the power of a patient’s own biology for the treatment of rare diseases. For more information on the company and its latest news, visit www.quincetx.com and follow Quince on social media platforms LinkedIn , Facebook , X , and YouTube . Forward-looking Statements Statements in this news release contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 as contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. All statements, other than statements of historical facts, may be forward-looking statements. Forward-looking statements contained in this news release may be identified by the use of words such as “believe,” “may,” “should,” “expect,” “anticipate,” “plan,” “believe,” “estimated,” “potential,” “intend,” “will,” “can,” “seek,” or other similar words. Examples of forward-looking statements include, among others, statements relating to the company’s patent portfolio, the issuance of patents and related implications for the company; plans to pursue claims, including those currently pending with regulatory agencies, current and future clinical development of EryDex; planned regulatory agency submissions and clinical trials and timeline, prospects, and milestone expectations; the company’s future development plans and related timing; the company’s focus, objectives, plans, and strategies; and the potential benefits of EryDex, AIDE technology and the company’s market opportunity. Forward-looking statements are based on Quince’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict and could cause actual results to differ materially from what the company expects. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties described in the section titled “Risk Factors” in the company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 13, 2024, and other reports as filed with the SEC. Forward-looking statements contained in this news release are made as of this date, and Quince undertakes no duty to update such information except as required under applicable law.