Scienture, LLC Receives New Patent for SCN-102, Expanding Intellectual Property for Innovative Losartan Liquid Formulation
Scienture, LLC Receives New Patent for SCN-102, Expanding Intellectual Property for Innovative Losartan Liquid Formulation
Scienture, LLC announces new patent issuance for SCN-102, enhancing its Losartan liquid formulation's market position amid FDA review.
Scienture, LLC 宣布针对 SCN-102 新专利的发行,提升其洛卡特利液体配方在 FDA 审查中的市场地位。
Quiver AI Summary
Quiver AI 概要
Scienture, LLC, a subsidiary of Scienture Holdings, Inc., announced the issuance of a new patent by the U.S. Patent and Trademark Office for its SCN-102 product, further enhancing its intellectual property for a liquid formulation of Losartan. This new patent, along with a previously granted patent, covers stable, ready-to-use liquid compositions of Losartan aimed at improving patient convenience in treating hypertension. CEO Shankar Hariharan expressed optimism about the patents and the ongoing FDA review of the New Drug Application (NDA) for SCN-102. The company believes that if approved, SCN-102 will be the first liquid form of Losartan available without compounding, and it aims to address unmet needs in the hypertension treatment market, which has significant prescription volume and sales.
Scienture, LLC 是 Scienture Holdings, Inc. 的子公司,宣布美国专利商标局为其 SCN-102 产品颁发新专利,进一步加强其洛卡特利液体配方的知识产权。这项新专利与之前授予的专利一起,涵盖稳定的、可直接使用的洛卡特利液体配方,旨在提高患者在治疗高血压时的便利性。首席执行官 Shankar Hariharan 对专利及正在进行的 SCN-102 新药申请(NDA)的 FDA 审查表示乐观。公司相信,如果获得批准,SCN-102 将成为第一个无需配制的液体形式洛卡特利,旨在满足高血压治疗市场上的未满足需求,该市场的处方量和销售额都非常可观。
Potential Positives
潜在的积极因素
- The issuance of the new patent, No. 12,156,869, strengthens the Company's intellectual property position for SCN-102, enhancing its competitive edge in the market.
- SCN-102 is positioned to be the first ready-to-use oral liquid formulation of Losartan, addressing a significant patient need for convenience and ease of dosing.
- The product candidate SCN-102 has the potential to capture a share of the $312 million annual sales market for Losartan, indicating strong revenue potential upon approval.
- The ongoing FDA review of SCN-102's NDA reflects confidence in the product's viability and progress towards market entry.
- 新专利的发行,编号 12,156,869,增强了公司对 SCN-102 的知识产权地位,提升了其在市场上的竞争优势。
- SCN-102 的定位是成为第一个可直接使用的洛卡特利口服液体配方,满足患者在便利性和用药方面的重大需求。
- 候选产品 SCN-102 有潜力占据洛卡特利年销售市场 31200万美元的份额,该市场表明在获得批准后具有强大的营业收入潜力。
- 正在进行的 SCN-102 NDA 的 FDA 审查反映了对该产品可行性和市场准入进展的信恳智能。
Potential Negatives
潜在负面因素
- The reliance on newly issued patents for SCN-102 may indicate a lack of existing competitive advantage in the market, raising concerns about the product's differentiation from existing Losartan formulations.
- The announcement emphasizes forward-looking statements regarding FDA approval without providing concrete timelines or assurance, which may create uncertainty among investors and stakeholders.
- The press release mentions potential risks related to funding and ability to maintain stock market listing, which could signal financial instability and concerns over the company's long-term viability.
- 对新发明专利SCN-102的依赖可能表明市场上缺乏现有的竞争优势,这引发了对该产品与现有洛卡特普配方之间差异化的担忧。
- 该公告强调了关于FDA批准的前瞻性声明,但未提供具体的时间表或保障,这可能会在投资者和利益相关者之间造成不确定性。
- 新闻稿提到了与资金和维持股票市场上市能力相关的潜在风险,这可能标志着公司的财务不稳定及对其长期生存能力的担忧。
FAQ
常见问题
What is SCN-102?
SCN-102是什么?
SCN-102 is a ready-to-use oral suspension of Losartan designed for patient convenience and ease of dosing, pending FDA approval.
SCN-102是一种现成可用的洛卡特普口服悬浮液,旨在方便患者并简化给药,正待FDA批准。
What patents has Scienture received for SCN-102?
Scienture为SCN-102获得了哪些专利?
Scienture has received the '869 patent and the '273 patent, both covering Losartan liquid formulations and methods of use.
Scienture已获得‘869专利和‘273专利,均涵盖洛卡特液体制剂及其使用方法。
What benefits does SCN-102 offer patients?
SCN-102为患者提供什么好处?
SCN-102 provides a stable liquid formulation of Losartan that does not require compounding and offers reduced dosing volume.
SCN-102提供一种稳定的洛卡特液体制剂,无需配制,且给药量减少。
What is the current status of SCN-102 with the FDA?
SCN-102在FDA的当前状态是什么?
The NDA for SCN-102 is currently under review by the FDA, which could lead to market approval.
SCN-102的NDA目前正在FDA审查中,这可能导致市场批准。
How significant is Losartan for hypertension treatment?
洛卡特在高血压治疗中有多重要?
Losartan is a widely prescribed ARB for hypertension, with annual sales of $312 million and over 67 million prescriptions in the US.
洛卡特是一种广泛处方的高血压ARb,年销售额为31200万美金,在美国有超过6700万份处方。
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
免责声明:这是由GlobeNewswire分发的新闻稿的人工智能生成摘要。用于总结这份稿件的模型可能会出错。请在这里查看完整发布。
Full Release
完整发布
COMMACK, NY and TAMPA, FL, Dec. 10, 2024 (GLOBE NEWSWIRE) -- SCIENTURE, LLC
("the "Company"), a wholly owned subsidiary of
SCIENTURE HOLDINGS, INC.
(NASDAQ: SCNX),
focused on developing and commercializing novel branded, specialty pharma products, today announced that the U.S. Patent and Trademark Office (USPTO) has issued a new patent, No. 12,156,869 (the '869 patent), further strengthening the intellectual property position and coverage for the Company's SCN-102 product. The '869 patent is in addition to the previously granted patent for SCN-102 by the USPTO, No. 11,890,273 (the '273 patent).
COMMACk, 纽约和坦帕, 佛罗里达州, 2024年12月10日 (全球新闻网) -- SCIENTURE, LLC
(“公司”),为全资子公司
科学特控股公司
(纳斯达克: SCNX),
专注于开发和商业化新型品牌的专业药品产品,今天宣布美国专利商标局 (USPTO) 已发放新的专利,专利号 12,156,869('869专利),进一步加强公司SCN-102产品的知识产权地位和覆盖范围。'869专利是在美国专利商标局为SCN-102之前授予的专利号 11,890,273('273专利)基础上获得的。
The '869 patent and the '273 patent, both titled, "LOSARTAN LIQUID FORMULATIONS AND METHODS OF USE," cover stable, liquid pharmaceutical compositions of Losartan and methods of treating patients in need of Losartan by administration of the novel formulations described.
'869专利和'273专利均以"洛卡特普液体制剂和使用方法"为题,涵盖稳定的洛卡特普液体药物组合物以及通过上述新型制剂治疗需要洛卡特普的患者的方法。
"The two issued patents demonstrate our accomplished development capabilities for novel products and our commitment to bring to market high value products that address unique and underserved patient needs," said Shankar Hariharan, Ph.D., CEO of Scienture, LLC. "We are pleased to note that the NDA filed for SCN-102 is currently under review at the FDA."
"这两项授予的专利展示了我们在新产品开发方面的卓越能力,以及我们致力于推出解决独特且未被满足患者需求的高价值产品的承诺,"科学公司(Scienture, LLC)首席执行官Shankar Hariharan博士表示。"我们很高兴地注意到,已提交的SCN-102新药申请目前正在FDA审查中。"
"We are pleased with the issuance of these two patents supporting SCN-102, a transformative therapy containing Losartan, one of the most widely prescribed molecules in its class," remarked Narasimhan Mani, Ph.D, MBA, President of Scienture, LLC. "SCN-102 on receiving final NDA approval, has the potential to address needs of patients who can benefit from a ready-to-use oral liquid formulation of Losartan."
"我们对这两项支持SCN-102的专利的发布感到高兴,它是一种包含洛卡特普的变革性疗法,是其类别中处方最广泛的分子之一,"科学公司(Scienture, LLC)总裁Narasimhan Mani博士,MBA表示。"SCN-102在最终获得新药申请批准后,有望满足需要即用型洛卡特普口服液制剂的患者需求。"
"This announcement is extremely exciting and reaffirms the optimism of the Board and management team in relation to the recent merger with Scienture. This is a clear demonstration of the value Scienture, LLC brings to the combined company and its shareholders," said Suren Ajjarapu, Chairman of the Board, Scienture Holdings, Inc.
"这一公告令人极为振奋, reaffirmed董事会和管理团队对与Scienture的最近合并的乐观态度。这清楚地展示了Scienture, LLC为合并后的公司及其股东带来的价值," Scienture Holdings, Inc.的董事长Suren Ajjarapu表示。
About SCN-102
关于SCN-102
Scienture LLC's product candidate SCN-102, (Losartan Oral Suspension 10mg/mL), is a ready to use oral suspension of Losartan for increased patient convenience and ease of dosing. The Company believes that SCN-102, if approved by the FDA, would be the first liquid formulation of Losartan on the market that does not require compounding and has reduced dosing volume and long term shelf life at room temperature storage.
Scienture LLC的产品候选SCN-102(洛卡特普口服悬液10mg/mL)是一种现成使用的洛卡特普口服悬液,旨在提高患者的便利性和剂量的易用性。公司认为,如果SCN-102获得FDA批准,将成为市场上第一款不需要调配的洛卡特普液体配方,具有减少的剂量和在室温下存储的长期保质期。
About Losartan
关于洛卡特普
Losartan is an ARB (Angiotensin II Receptor Blocker) for treating hypertension and is one of the highest prescribed molecules for this indication. It is currently available in the market as an oral solid product. IQVIA data (MAT September 2024) indicates a total annual sales of $312 million and an annual prescription volume of 67 million for Losartan in the US market.
洛卡特普是一种用于治疗高血压的ARb(血管紧张素II受体拮抗剂),是这一指征中处方量最高的分子之一。它目前在市场上以口服固体产品的形式提供。IQVIA的数据(截至2024年9月)显示,洛卡特普在美国市场的年销售额为31200万美元,年处方成交量为6700万。
About Hypertension
关于高血压
Hypertension (high blood pressure) is a cardiovascular condition, when the pressure in the blood vessels is too high (140/90 mmHg or higher). According to the CDC, hypertension, or high blood pressure, affects nearly half of adults in the United States, or 119.9 million people. Hypertension is defined as a systolic blood pressure of 140 mmHg or higher, and diastolic blood pressure of 90 mmHg or higher. Hypertension is a risk factor for stroke and heart disease, which are leading causes of death in the U.S. Factors that increase the risk of having high blood pressure include: older age, genetics, being overweight or obese, not being physically active, high-salt diet and drinking too much alcohol. Hypertension is clinically diagnosed if, when blood pressure is measured on two different days, the systolic blood pressure readings on both days is ≥140 mmHg and/or the diastolic blood pressure readings on both days is ≥ 90 mmHg.
高血压(高血压)是一种心血管疾病,指的是血管内的压力过高(140/90 mmHg或更高)。根据CDC的数据显示,高血压影响美国近一半的成年人,即11990万人。高血压的定义是收缩压在140 mmHg或更高,舒张压在90 mmHg或更高。高血压是中风和心脏病的风险因素,这些是美国主要的死亡原因。增加高血压风险的因素包括:年龄较大、遗传、超重或肥胖、缺乏身体活动、高盐饮食以及饮酒过量。如果在两个不同的日子测量血压时,两天的收缩压读数均≥140 mmHg和/或舒张压读数均≥90 mmHg,则临床上诊断为高血压。
About Scienture, LLC
关于Scienture, LLC
Scienture, LLC is a Commack, NY based branded, specialty pharmaceutical company. We are a highly experienced team of industry professionals who are passionate about developing and bringing to market unique specialty products that provide enhanced value to patients and healthcare systems. Our assets in development are across therapeutics areas, indications and cater to different market segments.. Learn more at
.
Scienture, LLC是一家位于纽约Commack的品牌特色药品公司。我们是一支经验丰富的行业专业团队,热衷于开发并推向市场独特的特色产品,旨在为患者和医疗系统提供更高的价值。我们在开发中的资产覆盖多个治疗领域、适应症,并满足不同的市场 segment.. 课堂了解更多信息在
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About Scienture Holdings, Inc.
关于Scienture Holdings, Inc.
SCIENTURE HOLDINGS, INC. (NASDAQ: "SCNX"), through its wholly owned subsidiaries, Scienture, LLC and Integra Pharma Solutions, LLC, is a comprehensive pharmaceutical product company focused on providing enhanced value to patients, physicians and caregivers by offering novel specialty products to satisfy unmet market needs. Our products in development at Scienture, LLC, are across therapeutic areas, indications and cater to different market segments and channels. Integra Pharma Solutions, LLC, is a licensed pharmaceutical wholesaler and sells brand, generic and non-drug products to healthcare markets including government organizations, hospitals, clinics and independent pharmacies nationwide.
SCIENTURE HOLDINGS, INC. (纳斯达克: "SCNX") 通过其全资子公司Scienture, LLC和Integra Pharma Solutions, LLC,致力于提供综合药品产品,专注于通过提供新颖的专业产品来满足未满足的市场需求,以提升患者、医生和护理人员的价值。我们在Scienture, LLC开发的产品涵盖治疗领域、适应症,面向不同的市场细分和渠道。Integra Pharma Solutions, LLC是一家持牌药品批发商,向包括政府机构、医院、诊所和全国各地独立药店在内的医疗市场销售品牌药品、仿制药和非药品产品。
Cautionary Statements Regarding Forward-Looking Statements
关于前瞻性声明的警示性声明
This press release contains certain statements that may be deemed to be "forward-looking statements" within the federal securities laws, including the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Statements that are not historical are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements relate to future events or our future performance or future financial condition. These forward-looking statements are not historical facts, but rather are based on current expectations, estimates and projections about our company, our industry, our beliefs and our assumptions. Such forward-looking statements include, but are not limited to, statements regarding our or our management team's expectations, hopes, beliefs, intentions or strategies regarding the future, including for our SCN-102 product or any other products we may launch. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. In some cases, you can identify forward-looking statements by the following words: "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "ongoing," "plan," "potential," "predict," "project," "should," or the negative of these terms or other similar expressions, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements are subject to a number of risks and uncertainties (some of which are beyond our control) that may cause actual results or performance to be materially different from those expressed or implied by such forward-looking statements. Accordingly, readers should not place undue reliance on any forward-looking statements. These risks include risks relating to agreements with third parties; our ability to raise funding in the future, as needed, and the terms of such funding, including potential dilution caused thereby; our ability to continue as a going concern; security interests under certain of our credit arrangements; our ability to maintain the listing of our common stock on the Nasdaq Capital Market; claims relating to alleged violations of intellectual property rights of others; the outcome of any current legal proceedings or future legal proceedings that may be instituted against us; unanticipated difficulties or expenditures relating to our business plan; and those risks detailed in our most recent Annual Report on Form 10-K and subsequent reports filed with the SEC.
本新闻稿包含某些声明,这些声明可能被认为是根据联邦证券法的 "前瞻性声明",包括1995年《私人证券诉讼改革法》下的安全港条款。非历史性的陈述是根据《1933年证券法》第27A条和《1934年证券交易法》第21E条的定义的前瞻性声明。前瞻性声明与未来事件或我们的未来表现或未来财务状况有关。这些前瞻性声明不是历史事实,而是基于当前的期望、估计和对我们公司、行业、信念和假设的预测。这些前瞻性声明包括但不限于关于我们或我们管理团队对未来的期望、希望、信念、意图或策略的声明,包括针对我们的SCN-102产品或我们可能推出的任何其他产品。此外,任何提及对未来事件或情况的预测、预估或其他表述的声明,包括任何基本假设,都是前瞻性声明。在某些情况下,您可以通过以下词语识别前瞻性声明:"预计"、"相信"、"继续"、"可能"、"估计"、"期望"、"打算"、"或许"、"正在进行"、"计划"、"潜在"、"预测"、"项目"、"应该",或这些术语的否定形式或其他类似表述,但缺少这些词并不意味着该声明不是前瞻性声明。前瞻性声明受若干风险和不确定性(其中一些超出我们的控制)影响,这可能导致实际结果或表现与这些前瞻性声明所表达或暗示的结果有重大差异。因此,读者不应对任何前瞻性声明过度依赖。这些风险包括与第三方协议相关的风险;我们在未来(如有需要)筹集资金的能力及此类资金的条款,包括可能导致的稀释;我们维持持续经营的能力;我们某些信贷安排下的安全权益;我们在纳斯达克资本市场上市的普通股的能力;有关其他知识产权侵权的指控;对我们可能提起的任何当前法律程序或未来法律程序的结果的影响;与我们商业计划相关的不可预见的困难或支出;以及在我们最近的10-K表格年度报告和随后的向SEC提交的报告中详细列出的风险。
Forward-looking statements speak only as of the date they are made. Scienture Holdings, Inc. undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise that occur after that date, except as otherwise provided by law.
前瞻性陈述仅在作出之日有效。Scienture Holdings, Inc. 不承担更新或修订任何前瞻性陈述的义务, 无论是因新信息、未来事件或其他在该日期之后发生的情况,除非法律另有规定。
Contacts
:
联系人
:
SCIENTURE, LLC
SCIENTURE, LLC
Scienture, LLC
20 Austin Boulevard
Commack, New York 11725
Phone: (631) 670-6039
Email:
IR@Scienture.com
Scienture, LLC
20 奥斯丁大道
美国纽约州科马克 11725
电话: (631) 670-6039
电子邮件:
IR@Scienture.com
SCIENTURE HOLDINGS, INC.
科学特控股公司
SCIENTURE HOLDINGS, INC.
6308 Benjamin Rd, Suite 708
Tampa, Florida 33634
Phone: (866) 468-6535
Email:
IR@Rxintegra.com
科学特控股公司
6308本杰明路,708套房
佛罗里达州坦帕市33634
电话: (866) 468-6535
电子邮件:
IR@Rxintegra.com