<p>~ FDA 回应简化了 PF614 商业生产的路径～</p>
<p>加利福尼亚州圣地亚哥 / ACCESS Newswire /2025 年 11 月 20 日/ Ensysce Biosciences, Inc.（&#34;Ensysce&#34;或&#34;公司&#34;），一家临床阶段的制药公司，致力于开发下一代疼痛和中枢神经系统治疗药物，旨在最小化滥用和过量风险，今天宣布食品药品监督管理局（FDA 或机构）对会议请求提供了书面回应。</p>
<p>Ensysce 请求指导其 PF614 的生产方法，希望了解 PF614 药物成分和原材料（RSMs）的监管起始材料的适当性及其规格。</p>
<p>在书面回应中，机构同意了 Ensysce 提出的所有计划。这些回应为 Ensysce 提供了直接的 PF614 商业生产路径，目前正在与其制造合作伙伴 Purisys, LLC（Noramco, LLC 的子公司）启动该项目。</p>
<p>Ensysce 首席运营官 Jeff Millard 博士表示：“我们对 FDA 的反馈感到非常高兴，这验证了我们的做法，并使我们能够加速 PF614 的市场路径。这个里程碑使我们更接近为需要的患者提供更安全的疼痛缓解选择。”</p>
<p>Ensysce 首席执行官 Lynn Kirkpatrick 博士表示：“FDA 的反馈现在为我们提供了一个清晰的路径，以扩大 PF614 的商业生产。” “PF614 是我们的 TAAP™羟考酮类似物，也是我们下一代镇痛药管线中 TAAP™和 MPAR®产品的领先产品。我们非常高兴我们的会议材料得到了如此良好的反馈，并且我们与 FDA 在生产这种旨在缓解中度至重度疼痛的创新治疗药物的要求上达成了一致，我们相信这将为需要这种程度疼痛缓解的公众提供更安全的品质。”</p>
<p><strong>关于 Ensysce Biosciences</strong></p>
<p>Ensysce Biosciences 是一家临床阶段公司，旨在通过引入一种新型高度创新的阿片类药物来颠覆镇痛药市场，以治疗重度疼痛。公司利用其胰蛋白酶激活的滥用保护（TAAP™）和多药滥用抵抗（MPAR®）平台，开发独特的防篡改疼痛治疗选项，最大限度地减少药物滥用和过量的风险。Ensysce 的产品预计将为遭受重度疼痛的患者提供更安全的治疗选择，并帮助防止因药物滥用导致的死亡。有关更多信息，请访问 www.ensysce.com。</p>
<p><strong>前瞻性声明</strong></p>
<p>本新闻稿中包含的声明如果不是纯粹的历史性声明，可能被视为根据 1995 年《私人证券诉讼改革法案》和其他联邦证券法的安全港条款的前瞻性声明。在不限制前述内容的情况下，使用 “可能”、“打算”、“可以”、“可能”、“将”、“期望”、“计划”、“可能”、“相信” 等词语及其他类似表达，旨在识别前瞻性声明。讨论的产品候选者正在进行临床试验，尚未获得批准，不能保证临床项目将成功证明安全性和/或有效性，Ensysce 不会在临床开发中遇到问题或延误，或任何产品候选者将获得监管批准或成功商业化。所有前瞻性声明均基于 Ensysce 管理层的估计和假设，尽管 Ensysce 认为这些估计和假设是合理的，但本质上是不确定的。所有前瞻性声明均面临可能导致实际结果与 Ensysce 预期结果显著不同的风险和不确定性。此外，Ensysce 的业务还面临其他风险和不确定性，包括可能的纳斯达克退市、前临床研究和临床试验的启动和进行；前临床研究和临床试验的数据时机和可用性；监管提交和批准的预期；与 Ensysce 的产品候选者相关的潜在安全问题或有效性；产品候选者的可用性或商业潜力；政府资金的持续性；Ensysce 资助其持续运营的能力，包括其计划的临床试验；我们融资中股票发行的稀释效应；以及 Ensysce 及其合作伙伴在其许可、合作和制造安排下的履行能力。这些声明还面临 Ensysce 最近在 Form 10-Q 上的季度报告和 Form 8-K 上的当前报告中描述的若干重大风险和不确定性，这些报告可在 SEC 网站 www.sec.gov 上免费获取。任何前瞻性声明仅在作出之日有效。Ensysce 没有义务公开更新或修订任何前瞻性声明，无论是由于新信息、未来事件还是其他原因，除非适用法律要求。</p>
<p><strong>Ensysce Biosciences 公司联系方式：</strong></p>
<p>Lynn Kirkpatrick 博士</p>
<p>首席执行官</p>
<p>(858) 263-4196</p>
<p><strong>Ensysce Biosciences 投资者关系联系方式：</strong></p>
<p>Shannon Devine</p>
<p>MZ North America</p>
<p>电话：203-741-8811</p>
<p>ENSC@mzgroup.us</p>
<p><strong>来源：</strong> Ensysce Biosciences Inc.</p>
<p>查看 ACCESS Newswire 上的原始新闻稿</p>

ENSC

<p>Ensysce Biosciences 收到了 FDA 对其 PF614 制造方法的积极反馈，简化了其商业生产的路径。FDA 同意了 Ensysce 的计划，允许该公司与 Purisys, LLC 合作进行制造。这个里程碑加速了 PF614 的市场进入，提供了更安全的疼痛缓解选择。Ensysce 的首席执行官 Lynn Kirkpatrick 博士对 FDA 与他们的生产要求保持一致表示满意</p>

<p>~ FDA Response Streamlines Path to Commercial Production of PF614~</p>
<div class="lb-trans"><p>~ FDA 回应简化了 PF614 商业生产的路径～</p>
</div><p>SAN DIEGO, CA / ACCESS Newswire / November 20, 2025 / Ensysce Biosciences, Inc.  (&#34;Ensysce&#34; or the &#34;Company&#34;), a clinical-stage pharmaceutical company pioneering next-generation pain and central nervous system therapeutics designed to minimize abuse and overdose risk, today announced that the Food and Drug Administration (FDA or Agency) provided Written Responses to a meeting request.</p>
<div class="lb-trans"><p>加利福尼亚州圣地亚哥 / ACCESS Newswire /2025 年 11 月 20 日/ Ensysce Biosciences, Inc.（&#34;Ensysce&#34;或&#34;公司&#34;），一家临床阶段的制药公司，致力于开发下一代疼痛和中枢神经系统治疗药物，旨在最小化滥用和过量风险，今天宣布食品药品监督管理局（FDA 或机构）对会议请求提供了书面回应。</p>
</div><p>Ensysce had requested guidance on its approach to the manufacture of PF614, wanting to understand the appropriateness of regulatory starting materials (RSMs) and specifications for PF614 drug substance and the RSMs.</p>
<div class="lb-trans"><p>Ensysce 请求指导其 PF614 的生产方法，希望了解 PF614 药物成分和原材料（RSMs）的监管起始材料的适当性及其规格。</p>
</div><p>In its written responses, the Agency agreed with all of Ensysce's proposed plans. These responses provide Ensysce with a direct path to commercial production of PF614, which is currently being initiated with its manufacturing partner, Purisys, LLC, a subsidiary of Noramco, LLC.</p>
<div class="lb-trans"><p>在书面回应中，机构同意了 Ensysce 提出的所有计划。这些回应为 Ensysce 提供了直接的 PF614 商业生产路径，目前正在与其制造合作伙伴 Purisys, LLC（Noramco, LLC 的子公司）启动该项目。</p>
</div><p>Dr. Jeff Millard, Chief Operating Officer of Ensysce who lead the CMC effort stated &#34;We are extremely pleased with the FDA's feedback, which validates our approach and enables us to accelerate PF614's path to market. This milestone brings us closer to providing safer pain relief options for patients in need.&#34;</p>
<div class="lb-trans"><p>Ensysce 首席运营官 Jeff Millard 博士表示：“我们对 FDA 的反馈感到非常高兴，这验证了我们的做法，并使我们能够加速 PF614 的市场路径。这个里程碑使我们更接近为需要的患者提供更安全的疼痛缓解选择。”</p>
</div><p>&#34;The feedback from the FDA now provides us with a clear path to scaling our manufacture of PF614 for its commercial production,&#34; said Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce. &#34;PF614 is our TAAP™ oxycodone analogue and the leading product in our Next Generation Analgesic pipeline of TAAP™ and MPAR® products. We are exceptionally pleased that our meeting package was so well received and that we are aligned with the FDA requirements for producing this novel therapeutic that is designed to alleviate moderate to severe pain while providing what we believe are safer qualities for the general public who require this level of pain relief.&#34;</p>
<div class="lb-trans"><p>Ensysce 首席执行官 Lynn Kirkpatrick 博士表示：“FDA 的反馈现在为我们提供了一个清晰的路径，以扩大 PF614 的商业生产。” “PF614 是我们的 TAAP™羟考酮类似物，也是我们下一代镇痛药管线中 TAAP™和 MPAR®产品的领先产品。我们非常高兴我们的会议材料得到了如此良好的反馈，并且我们与 FDA 在生产这种旨在缓解中度至重度疼痛的创新治疗药物的要求上达成了一致，我们相信这将为需要这种程度疼痛缓解的公众提供更安全的品质。”</p>
</div><p><strong>About Ensysce Biosciences</strong></p>
<div class="lb-trans"><p><strong>关于 Ensysce Biosciences</strong></p>
</div><p>Ensysce Biosciences is a clinical-stage company with a goal of disrupting the analgesic landscape by introducing a new class of highly novel opioids for the treatment of severe pain. Leveraging its Trypsin-Activated Abuse Protection (TAAP™) and Multi-Pill Abuse Resistance (MPAR®) platforms, the Company is developing unique, tamper-proof treatment options for pain that minimize the risk of both drug abuse and overdose. Ensysce's products are anticipated to provide safer options to treat patients suffering from severe pain and assist in preventing deaths caused by medication abuse. For more information, please visit www.ensysce.com.</p>
<div class="lb-trans"><p>Ensysce Biosciences 是一家临床阶段公司，旨在通过引入一种新型高度创新的阿片类药物来颠覆镇痛药市场，以治疗重度疼痛。公司利用其胰蛋白酶激活的滥用保护（TAAP™）和多药滥用抵抗（MPAR®）平台，开发独特的防篡改疼痛治疗选项，最大限度地减少药物滥用和过量的风险。Ensysce 的产品预计将为遭受重度疼痛的患者提供更安全的治疗选择，并帮助防止因药物滥用导致的死亡。有关更多信息，请访问 www.ensysce.com。</p>
</div><p><strong>Forward-Looking Statements</strong></p>
<div class="lb-trans"><p><strong>前瞻性声明</strong></p>
</div><p>Statements contained in this press release that are not purely historical may be deemed to be forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. Without limiting the foregoing, the use of words such as &#34;may,&#34; &#34;intends,&#34; &#34;can,&#34; &#34;might,&#34; &#34;will,&#34; &#34;expect,&#34; &#34;plan,&#34; &#34;possible,&#34; &#34;believe&#34; and other similar expressions are intended to identify forward-looking statements. The product candidates discussed are in clinic and not approved and there can be no assurance that the clinical programs will be successful in demonstrating safety and/or efficacy, that Ensysce will not encounter problems or delays in clinical development, or that any product candidate will ever receive regulatory approval or be successfully commercialized. All forward-looking statements are based on estimates and assumptions by Ensysce's management that, although Ensysce believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Ensysce expected. In addition, Ensysce's business is subject to additional risks and uncertainties, including among others, possible NASDAQ delisting, the initiation and conduct of preclinical studies and clinical trials; the timing and availability of data from preclinical studies and clinical trials; expectations for regulatory submissions and approvals; potential safety concerns related to, or efficacy of, Ensysce's product candidates; the availability or commercial potential of product candidates; continuation of government funding; the ability of Ensysce to fund its continued operations, including its planned clinical trials; the dilutive effect of stock issuances from our fundraising; and Ensysce's and its partners' ability to perform under their license, collaboration and manufacturing arrangements. These statements are also subject to a number of material risks and uncertainties that are described in Ensysce's most recent quarterly report on Form 10-Q and current reports on Form 8-K, available free of charge at the SEC's website at www.sec.gov. Any forward-looking statement speaks only as of the date on which it was made. Ensysce undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required under applicable law.</p>
<div class="lb-trans"><p>本新闻稿中包含的声明如果不是纯粹的历史性声明，可能被视为根据 1995 年《私人证券诉讼改革法案》和其他联邦证券法的安全港条款的前瞻性声明。在不限制前述内容的情况下，使用 “可能”、“打算”、“可以”、“可能”、“将”、“期望”、“计划”、“可能”、“相信” 等词语及其他类似表达，旨在识别前瞻性声明。讨论的产品候选者正在进行临床试验，尚未获得批准，不能保证临床项目将成功证明安全性和/或有效性，Ensysce 不会在临床开发中遇到问题或延误，或任何产品候选者将获得监管批准或成功商业化。所有前瞻性声明均基于 Ensysce 管理层的估计和假设，尽管 Ensysce 认为这些估计和假设是合理的，但本质上是不确定的。所有前瞻性声明均面临可能导致实际结果与 Ensysce 预期结果显著不同的风险和不确定性。此外，Ensysce 的业务还面临其他风险和不确定性，包括可能的纳斯达克退市、前临床研究和临床试验的启动和进行；前临床研究和临床试验的数据时机和可用性；监管提交和批准的预期；与 Ensysce 的产品候选者相关的潜在安全问题或有效性；产品候选者的可用性或商业潜力；政府资金的持续性；Ensysce 资助其持续运营的能力，包括其计划的临床试验；我们融资中股票发行的稀释效应；以及 Ensysce 及其合作伙伴在其许可、合作和制造安排下的履行能力。这些声明还面临 Ensysce 最近在 Form 10-Q 上的季度报告和 Form 8-K 上的当前报告中描述的若干重大风险和不确定性，这些报告可在 SEC 网站 www.sec.gov 上免费获取。任何前瞻性声明仅在作出之日有效。Ensysce 没有义务公开更新或修订任何前瞻性声明，无论是由于新信息、未来事件还是其他原因，除非适用法律要求。</p>
</div><p><strong>Ensysce Biosciences Company Contact:</strong></p>
<div class="lb-trans"><p><strong>Ensysce Biosciences 公司联系方式：</strong></p>
</div><p>Lynn Kirkpatrick, Ph.D.</p>
<div class="lb-trans"><p>Lynn Kirkpatrick 博士</p>
</div><p>Chief Executive Officer</p>
<div class="lb-trans"><p>首席执行官</p>
</div><p>(858) 263-4196</p>
<div class="lb-trans"><p>(858) 263-4196</p>
</div><p><strong>Ensysce Biosciences Investor Relations Contact:</strong></p>
<div class="lb-trans"><p><strong>Ensysce Biosciences 投资者关系联系方式：</strong></p>
</div><p>Shannon Devine</p>
<div class="lb-trans"><p>Shannon Devine</p>
</div><p>MZ North America</p>
<div class="lb-trans"><p>MZ North America</p>
</div><p>Main: 203-741-8811</p>
<div class="lb-trans"><p>电话：203-741-8811</p>
</div><p>ENSC@mzgroup.us</p>
<div class="lb-trans"><p>ENSC@mzgroup.us</p>
</div><p><strong>SOURCE:</strong> Ensysce Biosciences Inc.</p>
<div class="lb-trans"><p><strong>来源：</strong> Ensysce Biosciences Inc.</p>
</div><p>View the original press release on ACCESS Newswire</p>
<div class="lb-trans"><p>查看 ACCESS Newswire 上的原始新闻稿</p>
</div>

Ensysce Biosciences 获得了美国食品药品监督管理局（FDA）对其 PF614 制造方法的正面反馈