<ul>
<li>FDA 有直到 2026 年 5 月 25 日的时间对通知提出异议，之后公司将可以自由销售其提议的含有澳大利亚栗提取物的膳食补充剂</li>
<li>公司已与佛罗里达州立大学（FSU）签署了一项选项协议，以许可胶囊配方，扩展其最近行使的大规模生产许可选项</li>
</ul>
<p>华盛顿，2026 年 3 月 18 日（GLOBE NEWSWIRE）-- 60 Degrees Pharmaceuticals, Inc.（纳斯达克：SXTP；SXTPW）（“60 Degrees Pharma” 或 “公司”），一家专注于开发针对媒介传播疾病的新药的制药公司，今天宣布于 2026 年 3 月 11 日向美国食品药品监督管理局（FDA）提交了澳大利亚栗提取物的新膳食成分通知（NDIN）。FDA 有直到 2026 年 5 月 25 日的时间对通知提出异议，之后公司将可以自由销售其计划中的含有澳大利亚栗提取物的膳食补充剂。</p>
<p>公司还签署了一项选项协议，以许可佛罗里达州立大学（FSU）与澳大利亚栗提取物的新胶囊配方方法相关的所有权，该所有权与公司共同拥有。这扩展了公司在 2026 年 1 月与 FSU 行使的独占权利许可选项，涉及非处方用途的大规模纯化 Castanospermine 的权利。</p>
<p>澳大利亚栗提取物来源于 <em>Castanospermum australe</em> 的种子（通常称为澳大利亚栗、莫顿湾栗和黑豆树）。澳大利亚栗提取物的主要分子成分是 castanospermine。</p>
<p>根据最近的科学文献，在低剂量下，castanospermine 调节碳水化合物代谢，改变糖原、葡萄糖水平和其他临床指标。在动物模型中，高剂量已被证明通过免疫调节影响多个治疗领域的疾病结果。</p>
<p>Castanospermine 也是 celgosivir 的一种代谢物，该产品在超过 500 名患者中针对 HIV 和丙型肝炎进行临床试验，但目前不再针对这些适应症进行商业开发。该安全记录表明，castanospermine 在可实现的剂量下对人类是安全的，并且对与动物研究中相同的药理靶点具有活性。</p>
<p><strong>关于 60 Degrees Pharmaceuticals, Inc.</strong></p>
<p>60 Degrees Pharmaceuticals, Inc. 成立于 2010 年，专注于开发和商业化用于治疗和预防媒介传播疾病的新药。公司于 2018 年获得美国食品药品监督管理局对其主打产品 ARAKODA®（<strong>tafenoquine</strong>）的批准。ARAKODA 在美国和澳大利亚均可商业销售。60 Degrees Pharmaceuticals, Inc. 还与美国和澳大利亚的知名研究和学术机构合作。60 Degrees Pharmaceuticals, Inc. 总部位于华盛顿特区，在澳大利亚设有子公司。了解更多信息请访问 www.60degreespharma.com。</p>
<p>此处包含的声明可能包括前景、未来期望的陈述和其他基于管理层当前观点和假设的前瞻性陈述，并涉及已知和未知的风险和不确定性。实际结果、表现或事件可能与这些前瞻性陈述中所表达或暗示的内容有实质性差异。</p>
<p><strong>关于前瞻性陈述的警示说明</strong></p>
<p>本新闻稿可能包含根据 1995 年美国私人证券诉讼改革法案的安全港条款定义的 “前瞻性声明”。前瞻性声明反映了对未来事件的当前看法。在本新闻稿中使用的 “预期”、“相信”、“估计”、“期望”、“未来”、“打算”、“计划” 或这些术语的否定形式及类似表达，涉及我们或我们的管理层时，标识为前瞻性声明。前瞻性声明既不是历史事实，也不是对未来业绩的保证。相反，它们仅基于我们对未来业务、未来计划和战略、预测、预期事件和趋势、经济、监管机构活动及未来法规和其他未来条件的当前信念、期望和假设。由于前瞻性声明涉及未来，因此它们受到固有的不确定性、风险和难以预测的情况变化的影响，其中许多超出了我们的控制范围。我们的实际结果和财务状况可能与前瞻性声明中所指示的结果有重大差异。因此，您不应依赖任何这些前瞻性声明。可能导致我们的实际结果和财务状况与前瞻性声明中所指示的结果有重大差异的重要因素包括但不限于以下几点：我们是否能够持续经营存在重大疑虑；我们可能不符合澳大利亚政府的研究和开发税收减免资格；如果我们无法及时成功开发、获得 FDA 批准并为 <strong>tafenoquine</strong>（ARAKODA®或其他方案）或澳大利亚栗子或 Celgosivir 的非疟疾预防适应症的商业化提供支持，我们可能无法扩展我们的业务运营；我们可能无法成功进行计划中的临床试验，或患者招募可能缓慢或微不足道；我们没有生产能力，这使我们面临将产品推向市场的漫长而昂贵的延误风险。有关公司及可能影响前瞻性声明实现的风险因素的更详细信息已在公司向证券交易委员会（“SEC”）提交的文件中列出，包括我们于 2025 年 3 月 27 日向 SEC 提交的 10-K 表格年度报告中的信息及我们后续的 SEC 文件。投资者和证券持有人被敦促在 SEC 网站 www.sec.gov 上免费阅读这些文件。由于这些事项、事实变化、假设未实现或其他情况，公司实际结果可能与本新闻稿中讨论的预期结果有重大差异。我们在本新闻稿中所做的任何前瞻性声明仅基于当前可用的信息，并仅在声明做出之日有效。我们没有义务公开更新任何前瞻性声明，无论是书面还是口头，可能会不时做出，无论是由于新信息、未来发展还是其他原因。</p>
<p>媒体联系人：</p>
<p>Sheila A. Burke</p>
<p>SheilaBurke-consultant@60degreespharma.com</p>
<p>(484) 667-6330</p>
<p>投资者联系人：</p>
<p>Patrick Gaynes</p>
<p>patrickgaynes@60degreespharma.com</p>
<p><img src="https://imageproxy.pbkrs.com/https://www.globenewswire.com/newsroom/ti/query-bmY9T1RZM05ERTBOU00zTkRrd09USTVJekl4T0RJek16Zz0?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" original-src="https://imageproxy.pbkrs.com/https://www.globenewswire.com/newsroom/ti/query-bmY9T1RZM05ERTBOU00zTkRrd09USTVJekl4T0RJek16Zz0"/></p>
<p><img src="https://imageproxy.pbkrs.com/https://ml.globenewswire.com/media/MjhhZDg5NDMtNzA5MS00NDE1LTliYTMtZTM3ZmM5NTFlOTk1LTExOTM5MDctMjAyNi0wMy0xOC1lbg==/tiny/Sixty-Degrees-Pharmaceuticals.png?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" original-src="https://imageproxy.pbkrs.com/https://ml.globenewswire.com/media/MjhhZDg5NDMtNzA5MS00NDE1LTliYTMtZTM3ZmM5NTFlOTk1LTExOTM5MDctMjAyNi0wMy0xOC1lbg==/tiny/Sixty-Degrees-Pharmaceuticals.png"/></p>

2 倍做多纳斯达克生物技术 ETF - ProShares

SXTPW

标普全球医疗股指数 ETF - iShares

<p>60 Degrees Pharmaceuticals, Inc. 已向 FDA 提交了澳大利亚栗提取物的新膳食成分通知（NDIN），FDA 有直到 2026 年 5 月 25 日的时间提出异议。该公司还与佛罗里达州立大学签署了一项选项协议，以许可一种胶囊配方。澳大利亚栗提取物来源于 Castanospermum australe，显示出在调节碳水化合物代谢和影响动物模型中的疾病结果方面的潜力。该公司专注于开发针对媒介传播疾病的药物，并且之前已获得 FDA 对其主打产品 ARAKODA® 的批准</p>

<ul>
<li>FDA has until May 25, 2026 to object to the notification, after which the Company will be free to market its proposed dietary supplement containing Australian Chestnut Extract</li>
<li>Company has signed an option agreement with Florida State University (FSU) to license a capsule formulation, expanding on its recent exercise of a license option for large-scale production</li>
</ul>
<div class="lb-trans"><ul>
<li>FDA 有直到 2026 年 5 月 25 日的时间对通知提出异议，之后公司将可以自由销售其提议的含有澳大利亚栗提取物的膳食补充剂</li>
<li>公司已与佛罗里达州立大学（FSU）签署了一项选项协议，以许可胶囊配方，扩展其最近行使的大规模生产许可选项</li>
</ul>
</div><p>WASHINGTON, March 18, 2026 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (“60 Degrees Pharma” or the “Company”), a pharmaceutical company focused on developing new medicines for vector-borne disease, today announced it submitted a New Dietary Ingredient Notification (NDIN) to the U.S. Food and Drug Administration (FDA) for Australian Chestnut Extract on March 11, 2026. FDA has until May 25, 2026, to object to the notification, after which the Company will be free to market its planned dietary supplement containing Australian Chestnut Extract.</p>
<div class="lb-trans"><p>华盛顿，2026 年 3 月 18 日（GLOBE NEWSWIRE）-- 60 Degrees Pharmaceuticals, Inc.（纳斯达克：SXTP；SXTPW）（“60 Degrees Pharma” 或 “公司”），一家专注于开发针对媒介传播疾病的新药的制药公司，今天宣布于 2026 年 3 月 11 日向美国食品药品监督管理局（FDA）提交了澳大利亚栗提取物的新膳食成分通知（NDIN）。FDA 有直到 2026 年 5 月 25 日的时间对通知提出异议，之后公司将可以自由销售其计划中的含有澳大利亚栗提取物的膳食补充剂。</p>
</div><p>The Company has also signed an option agreement to license Florida State University’s (FSU) ownership rights related to new capsule formulation methods for Australian Chestnut Extract, which FSU jointly owns with the Company. This expands on the Company’s January 2026 exercise of a license option with FSU for exclusive rights to large-scale purification of Castanospermine for non-prescription uses.</p>
<div class="lb-trans"><p>公司还签署了一项选项协议，以许可佛罗里达州立大学（FSU）与澳大利亚栗提取物的新胶囊配方方法相关的所有权，该所有权与公司共同拥有。这扩展了公司在 2026 年 1 月与 FSU 行使的独占权利许可选项，涉及非处方用途的大规模纯化 Castanospermine 的权利。</p>
</div><p>Australian Chestnut Extract is derived from the seeds of <em>Castanospermum australe</em> (commonly known as the Australian Chestnut, the Moreton Bay Chestnut, and the Black Bean Tree). The dominant molecular constituent of Australian Chestnut Extract is castanospermine.</p>
<div class="lb-trans"><p>澳大利亚栗提取物来源于 <em>Castanospermum australe</em> 的种子（通常称为澳大利亚栗、莫顿湾栗和黑豆树）。澳大利亚栗提取物的主要分子成分是 castanospermine。</p>
</div><p>According to recent scientific literature, at low doses, castanospermine modulates carbohydrate metabolism, altering glycogen, glucose levels, and other clinical markers. In animal models, high doses have been shown to impact disease outcomes in several therapeutic areas through immunomodulation.</p>
<div class="lb-trans"><p>根据最近的科学文献，在低剂量下，castanospermine 调节碳水化合物代谢，改变糖原、葡萄糖水平和其他临床指标。在动物模型中，高剂量已被证明通过免疫调节影响多个治疗领域的疾病结果。</p>
</div><p>Castanospermine is also a metabolite of celgosivir, a product evaluated in clinical trials in more than 500 patients against HIV and Hepatitis C, but which is no longer in commercial development for those indications. That safety record suggests castanospermine is safe at achievable doses in humans and is active against the same pharmacological targets as in animal studies.</p>
<div class="lb-trans"><p>Castanospermine 也是 celgosivir 的一种代谢物，该产品在超过 500 名患者中针对 HIV 和丙型肝炎进行临床试验，但目前不再针对这些适应症进行商业开发。该安全记录表明，castanospermine 在可实现的剂量下对人类是安全的，并且对与动物研究中相同的药理靶点具有活性。</p>
</div><p><strong>About 60 Degrees Pharmaceuticals, Inc.</strong></p>
<div class="lb-trans"><p><strong>关于 60 Degrees Pharmaceuticals, Inc.</strong></p>
</div><p>60 Degrees Pharmaceuticals, Inc., founded in 2010, specializes in developing and commercializing new medicines for the treatment and prevention of vector-borne disease. The Company achieved U.S. Food and Drug Administration approval of Its lead product, ARAKODA® ( <strong>tafenoquine</strong>) in 2018. ARAKODA is commercially available in the U.S. and Australia. 60 Degrees Pharmaceuticals, Inc. also collaborates with prominent research and academic organizations in the U.S. and Australia. 60 Degrees Pharmaceuticals, Inc. is headquartered in Washington, D.C., with a subsidiary in Australia. Learn more at www.60degreespharma.com.</p>
<div class="lb-trans"><p>60 Degrees Pharmaceuticals, Inc. 成立于 2010 年，专注于开发和商业化用于治疗和预防媒介传播疾病的新药。公司于 2018 年获得美国食品药品监督管理局对其主打产品 ARAKODA®（<strong>tafenoquine</strong>）的批准。ARAKODA 在美国和澳大利亚均可商业销售。60 Degrees Pharmaceuticals, Inc. 还与美国和澳大利亚的知名研究和学术机构合作。60 Degrees Pharmaceuticals, Inc. 总部位于华盛顿特区，在澳大利亚设有子公司。了解更多信息请访问 www.60degreespharma.com。</p>
</div><p>The statements contained herein may include prospects, statements of future expectations and other forward-looking statements that are based on management’s current views and assumptions and involve known and unknown risks and uncertainties. Actual results, performance or events may differ materially from those expressed or implied in such forward-looking statements.</p>
<div class="lb-trans"><p>此处包含的声明可能包括前景、未来期望的陈述和其他基于管理层当前观点和假设的前瞻性陈述，并涉及已知和未知的风险和不确定性。实际结果、表现或事件可能与这些前瞻性陈述中所表达或暗示的内容有实质性差异。</p>
</div><p><strong>Cautionary Note Regarding Forward-Looking Statements</strong></p>
<div class="lb-trans"><p><strong>关于前瞻性陈述的警示说明</strong></p>
</div><p>This press release may contain “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward‐looking statements reflect the current view about future events. When used in this press release, the words “anticipate,” “believe,” “estimate,” “expect,” “future,” “intend,” “plan,” or the negative of these terms and similar expressions, as they relate to us or our management, identify forward‐looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy, activities of regulators and future regulations and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: there is substantial doubt as to our ability to continue on a going-concern basis; we might not be eligible for Australian government research and development tax rebates; if we are not able to successfully develop, obtain FDA approval for, and provide for the commercialization of non-malaria prevention indications for <strong>tafenoquine</strong> (ARAKODA® or other regimen) or Australian Chestnut or Celgosivir in a timely manner, we may not be able to expand our business operations; we may not be able to successfully conduct planned clinical trials or patient recruitment in our trials might be slow or negligible; and we have no manufacturing capacity which puts us at risk of lengthy and costly delays of bringing our products to market. More detailed information about the Company and the risk factors that may affect the realization of forward- looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (“SEC”), including the information contained in our Annual Report on Form 10-K filed with the SEC on March 27, 2025 and our subsequent SEC filings. Investors and security holders are urged to read these documents free of charge on the SEC’s website at www.sec.gov. As a result of these matters, changes in facts, assumptions not being realized or other circumstances, the Company’s actual results may differ materially from the expected results discussed in the forward-looking statements contained in this press release. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.</p>
<div class="lb-trans"><p>本新闻稿可能包含根据 1995 年美国私人证券诉讼改革法案的安全港条款定义的 “前瞻性声明”。前瞻性声明反映了对未来事件的当前看法。在本新闻稿中使用的 “预期”、“相信”、“估计”、“期望”、“未来”、“打算”、“计划” 或这些术语的否定形式及类似表达，涉及我们或我们的管理层时，标识为前瞻性声明。前瞻性声明既不是历史事实，也不是对未来业绩的保证。相反，它们仅基于我们对未来业务、未来计划和战略、预测、预期事件和趋势、经济、监管机构活动及未来法规和其他未来条件的当前信念、期望和假设。由于前瞻性声明涉及未来，因此它们受到固有的不确定性、风险和难以预测的情况变化的影响，其中许多超出了我们的控制范围。我们的实际结果和财务状况可能与前瞻性声明中所指示的结果有重大差异。因此，您不应依赖任何这些前瞻性声明。可能导致我们的实际结果和财务状况与前瞻性声明中所指示的结果有重大差异的重要因素包括但不限于以下几点：我们是否能够持续经营存在重大疑虑；我们可能不符合澳大利亚政府的研究和开发税收减免资格；如果我们无法及时成功开发、获得 FDA 批准并为 <strong>tafenoquine</strong>（ARAKODA®或其他方案）或澳大利亚栗子或 Celgosivir 的非疟疾预防适应症的商业化提供支持，我们可能无法扩展我们的业务运营；我们可能无法成功进行计划中的临床试验，或患者招募可能缓慢或微不足道；我们没有生产能力，这使我们面临将产品推向市场的漫长而昂贵的延误风险。有关公司及可能影响前瞻性声明实现的风险因素的更详细信息已在公司向证券交易委员会（“SEC”）提交的文件中列出，包括我们于 2025 年 3 月 27 日向 SEC 提交的 10-K 表格年度报告中的信息及我们后续的 SEC 文件。投资者和证券持有人被敦促在 SEC 网站 www.sec.gov 上免费阅读这些文件。由于这些事项、事实变化、假设未实现或其他情况，公司实际结果可能与本新闻稿中讨论的预期结果有重大差异。我们在本新闻稿中所做的任何前瞻性声明仅基于当前可用的信息，并仅在声明做出之日有效。我们没有义务公开更新任何前瞻性声明，无论是书面还是口头，可能会不时做出，无论是由于新信息、未来发展还是其他原因。</p>
</div><p>Media Contact:</p>
<div class="lb-trans"><p>媒体联系人：</p>
</div><p>Sheila A. Burke</p>
<div class="lb-trans"><p>Sheila A. Burke</p>
</div><p>SheilaBurke-consultant@60degreespharma.com</p>
<div class="lb-trans"><p>SheilaBurke-consultant@60degreespharma.com</p>
</div><p>(484) 667-6330</p>
<div class="lb-trans"><p>(484) 667-6330</p>
</div><p>Investor Contact:</p>
<div class="lb-trans"><p>投资者联系人：</p>
</div><p>Patrick Gaynes</p>
<div class="lb-trans"><p>Patrick Gaynes</p>
</div><p>patrickgaynes@60degreespharma.com</p>
<div class="lb-trans"><p>patrickgaynes@60degreespharma.com</p>
</div><p><img src="https://imageproxy.pbkrs.com/https://www.globenewswire.com/newsroom/ti/query-bmY9T1RZM05ERTBOU00zTkRrd09USTVJekl4T0RJek16Zz0" alt="" original-src="https://www.globenewswire.com/newsroom/ti?nf=OTY3NDE0NSM3NDkwOTI5IzIxODIzMzg="/></p>
<p><img src="https://imageproxy.pbkrs.com/https://ml.globenewswire.com/media/MjhhZDg5NDMtNzA5MS00NDE1LTliYTMtZTM3ZmM5NTFlOTk1LTExOTM5MDctMjAyNi0wMy0xOC1lbg==/tiny/Sixty-Degrees-Pharmaceuticals.png" alt="" original-src="https://ml.globenewswire.com/media/MjhhZDg5NDMtNzA5MS00NDE1LTliYTMtZTM3ZmM5NTFlOTk1LTExOTM5MDctMjAyNi0wMy0xOC1lbg==/tiny/Sixty-Degrees-Pharmaceuticals.png"/></p>

60 Degrees Pharmaceuticals Files New Dietary Ingredient Notification (NDIN) with FDA for Australian Chestnut Extract | SXTP Stock News

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60 DEGREES PHARMACEUTICALS INC C/WTS 12/07/2028 (TO PUR COM)

标普生物技术 3 倍做多 - Direxion

基因改革 ETF - ARK

60 Degrees Pharmaceuticals

美国制药 ETF - iShares

动态生物技术与基因组 ETF - Invesco

标普生物技术 ETF - SPDR

纽交所高增长板生物技术指数 ETF - First Trust

纳斯达克生物科技指数 ETF - iShares Nasdaq

生物科技 ETF - VanEck Vectors

医疗业 ETF - SPDR

医药突破 ETF - ALPS

医疗业 ETF - Vanguard

60 Degrees Pharmaceuticals 向美国食品药品监督管理局（FDA）提交了关于澳洲栗提取物的新膳食成分通知（NDIN）| SXTP 股票新闻