<p><strong><em>— PHEXX® 有望成为阿联酋首个也是唯一的</em></strong> <strong><em>无激素避孕阴道凝胶</em></strong></p>
<p><strong><em>— 计划于 2026 年在阿联酋推出无激素避孕产品</em></strong></p>
<p>, /PRNewswire/ -- 女性健康创新者 Evofem Biosciences, Inc.（&#34;Evofem&#34;或&#34;公司&#34;）（OTCID: EVFM）今天宣布，阿联酋药品管理局（EDE）已为 PHEXX®（乳酸、柠檬酸、酒石酸钾）颁发了有利的定价证书，这是在阿联酋获得监管批准的初步行政步骤。</p>
<p><img src="https://imageproxy.pbkrs.com/https://mma.prnewswire.com/media/780907/Evofem_Biosciences_Logo.jpg?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://mma.prnewswire.com/media/780907/Evofem_Biosciences_Logo.jpg"/></p>
<p>&#34;EDE 颁发这些定价证书是 Evofem 通过进入新市场来扩展和多样化收入来源的重要一步，&#34;Evofem 首席执行官 Saundra Pelletier 表示。&#34;我们热切期待 PHEXX®在阿联酋的批准。这将为 Pharma 1 在阿联酋推出和商业化 PHEXX®铺平道路，使阿联酋女性及其医疗服务提供者能够获得按需的无激素避孕，同时也促进 Pharma 1 计划向其他许可国家提交申请。&#34;</p>
<p>Evofem 的许可方 Pharma 1 预计将在 2026 年在阿联酋推出 PHEXX®，前提是及时获得 EDE 的市场批准以及其他监管和商业条件。</p>
<p>Pharma 1 拥有 Evofem 两款 FDA 批准产品——PHEXX®和 SOLOSEC®（塞克尼达唑）2g 口服颗粒的独家商业化权利，覆盖六个海湾合作委员会（GCC）国家，并有潜力扩展到中东和北非（MENA）其他 15 个国家。这两款产品已于 2025 年提交给 EDE 申请市场批准，Pharma 1 计划在阿联酋获得批准后，向其他许可国家提交产品的市场批准申请。除了获得和维持所需的监管批准外，Pharma 1 还将处理 PHEXX®和 SOLOSEC®在许可区域内的所有分销、销售和市场营销、药物警戒以及所有其他商业职能。</p>
<p>自 2019 年成立以来，Pharma 1 一直在执行其使命，提供基于科学研究和准确调查的实用解决方案，以满足医疗保健需求。Pharma 1 的成功反映了其丰富的专业知识、科学的方法以及适应 GCC 市场动态和增长的灵活性。</p>
<p><strong>关于 PHEXX®</strong></p>
<p>PHEXX®（乳酸、柠檬酸和酒石酸钾）是 FDA 批准的首个也是唯一的局部作用避孕凝胶。它在性交前 0 到 60 分钟使用预填充的给药器涂抹，无需激素，通过维持正常的阴道微生物群，保持一个对精子以及某些病毒和细菌病原体自然不利的 pH 值。访问 phexxi.com 了解更多信息及重要安全信息。</p>
<p><strong>关于 Evofem Biosciences</strong></p>
<p>Evofem Biosciences, Inc.正在商业化两款 FDA 批准的产品，以满足女性性健康和生殖健康的未满足需求：PHEXX®（乳酸、柠檬酸和酒石酸钾）和 SOLOSEC®（塞克尼达唑）2g 口服颗粒。</p>
<p><em>PHEXX®、PHEXXI®和 SOLOSEC®是 Evofem Biosciences, Inc.的注册商标。</em></p>
<p><strong>关于 Pharma 1</strong></p>
<p>Pharma 1 药品商店是一家阿联酋公司，致力于提供实用解决方案，基于科学研究和准确调查，满足 GCC 地区人们不断变化的医疗保健需求，并支持健康社区的发展。Pharma 1 是越来越多制药公司的代理，正在与卫生和预防部处理多种商业产品和药物。了解更多信息，请访问 https://pharma1ds.com/。</p>
<p><strong>前瞻性声明</strong></p>
<p>本新闻稿包含&#34;前瞻性声明&#34;，根据 1934 年证券交易法第 21E 条款及 1995 年私人证券诉讼改革法案提供的安全港条款。诸如&#34;预期&#34;、&#34;目标&#34;、&#34;相信&#34;、&#34;继续&#34;、&#34;可能&#34;、&#34;估计&#34;、&#34;期望&#34;、&#34;打算&#34;、&#34;可能&#34;、&#34;计划&#34;、&#34;潜在&#34;、&#34;预测&#34;、&#34;项目&#34;、&#34;寻求&#34;、&#34;应该&#34;、&#34;建议&#34;、&#34;战略&#34;、&#34;目标&#34;、&#34;将&#34;、&#34;会&#34;等词语或类似表达，或这些表达的否定形式，旨在识别前瞻性声明，尽管并非所有前瞻性声明都包含这些识别词。这些声明包括但不限于 PHEXX®在阿联酋的潜在批准及其时机、PHEXX®在阿联酋的商业推出时机以及在其他许可国家的计划监管提交。您被警告不要对这些前瞻性声明过度依赖，这些声明仅在本新闻稿日期时有效。每一项前瞻性声明均基于当前的预期和假设，可能面临风险和不确定性，可能导致实际结果与前述或暗示的结果有重大差异。可能导致实际结果与前瞻性声明中讨论或暗示的结果有重大差异的重要因素包括但不限于：监管批准风险、商业执行风险、对包括 Pharma 1 在内的合作伙伴和许可方的依赖、在新市场竞争环境中的市场接受度，以及公司在 SEC 文件中披露的其他风险因素，包括截至 2024 年 12 月 31 日的年度报告（Form 10-K）于 2025 年 3 月 24 日提交给 SEC，并于 2025 年 3 月 28 日修订，以及后续的 Form 10-Q 文件。所有前瞻性声明均完全受到这些因素的限制。除法律要求外，公司不承担更新任何前瞻性声明的义务。所有前瞻性声明仅在本发布日期时有效。</p>
<p><strong>联系方式</strong> Amy Raskopf</p>
<p>Evofem Biosciences, Inc.</p>
<p>araskopf@evofem.com</p>
<p>(917) 673-5775</p>
<p>来源：Evofem Biosciences, Inc.</p>

EVFM

<p>Evofem Biosciences 宣布，阿联酋药品公司已为 PHEXX®（一种无激素避孕胶）颁发了有利的定价证书，这标志着其在阿联酋的监管批准和商业化迈出了关键一步。Pharma 1 计划在 2026 年推出 PHEXX®，但需获得批准。Pharma 1 在海湾合作委员会国家拥有 Evofem 产品的独家权利，旨在扩展到中东和北非国家。该举措反映了 Evofem 多元化收入的战略，并为阿联酋女性提供无激素避孕的机会</p>

<p><strong><em>— PHEXX® Poised to Become First and Only</em></strong> <strong><em>Hormone-Free Contraceptive Vaginal Gel Approved in UAE —</em></strong></p>
<div class="lb-trans"><p><strong><em>— PHEXX® 有望成为阿联酋首个也是唯一的</em></strong> <strong><em>无激素避孕阴道凝胶</em></strong></p>
</div><p><strong><em>— 2026 Launch Planned for Hormone-Free Contraceptive in UAE —</em></strong></p>
<div class="lb-trans"><p><strong><em>— 计划于 2026 年在阿联酋推出无激素避孕产品</em></strong></p>
</div><p>, /PRNewswire/ --Women's health innovator Evofem Biosciences, Inc. (&#34;Evofem&#34; or the &#34;Company&#34;) (OTCID: EVFM) announced today that the Emirates Drug Establishment (EDE) has issued favorable pricing certificates for PHEXX® (lactic acid, citric acid, potassium bitartrate), which is a preliminary administrative step toward regulatory approval in the United Arab Emirates (UAE).</p>
<div class="lb-trans"><p>, /PRNewswire/ -- 女性健康创新者 Evofem Biosciences, Inc.（&#34;Evofem&#34;或&#34;公司&#34;）（OTCID: EVFM）今天宣布，阿联酋药品管理局（EDE）已为 PHEXX®（乳酸、柠檬酸、酒石酸钾）颁发了有利的定价证书，这是在阿联酋获得监管批准的初步行政步骤。</p>
</div><p><img src="https://imageproxy.pbkrs.com/https://mma.prnewswire.com/media/780907/Evofem_Biosciences_Logo.jpg" alt="" original-src="https://mma.prnewswire.com/media/780907/Evofem_Biosciences_Logo.jpg"/></p>
<p>&#34;Issuance of these pricing certificates by the EDE is an important step toward expanding and diversifying Evofem's revenue stream through entry into new markets,&#34;said Saundra Pelletier, CEO of Evofem. &#34;We eagerly await approval of PHEXX® in the UAE. This will pave the way for Pharma 1 to launch and commercialize PHEXX® in the UAE, giving Emirati women and their healthcare providers access to on-demand, hormone-free contraception, while also facilitating Pharma 1's planned submissions to other countries in the licensed territory.&#34;</p>
<div class="lb-trans"><p>&#34;EDE 颁发这些定价证书是 Evofem 通过进入新市场来扩展和多样化收入来源的重要一步，&#34;Evofem 首席执行官 Saundra Pelletier 表示。&#34;我们热切期待 PHEXX®在阿联酋的批准。这将为 Pharma 1 在阿联酋推出和商业化 PHEXX®铺平道路，使阿联酋女性及其医疗服务提供者能够获得按需的无激素避孕，同时也促进 Pharma 1 计划向其他许可国家提交申请。&#34;</p>
</div><p>Evofem's licensee Pharma 1 is expected to launch PHEXX® in the UAE in 2026, subject to timely EDE marketing approval and other regulatory and commercial conditions.</p>
<div class="lb-trans"><p>Evofem 的许可方 Pharma 1 预计将在 2026 年在阿联酋推出 PHEXX®，前提是及时获得 EDE 的市场批准以及其他监管和商业条件。</p>
</div><p>Pharma 1 holds the exclusive commercialization rights for both of Evofem's FDA-approved products—PHEXX® and SOLOSEC® (secnidazole) 2g oral granules—in six Gulf Cooperation Council(GCC) states with potential to expand into 15 other countries in the Middle East and North Africa (MENA). Both products were submitted to the EDE for marketing approval in 2025, and Pharma 1 is on track to submit the products for marketing approval in other licensed countries following approval in the UAE. Inaddition to obtaining and maintaining required regulatory approvals, Pharma 1will handle all aspects of distribution, sales and marketing, pharmacovigilance, and all other commercial functions for PHEXX® and SOLOSEC® in the licensed territory.</p>
<div class="lb-trans"><p>Pharma 1 拥有 Evofem 两款 FDA 批准产品——PHEXX®和 SOLOSEC®（塞克尼达唑）2g 口服颗粒的独家商业化权利，覆盖六个海湾合作委员会（GCC）国家，并有潜力扩展到中东和北非（MENA）其他 15 个国家。这两款产品已于 2025 年提交给 EDE 申请市场批准，Pharma 1 计划在阿联酋获得批准后，向其他许可国家提交产品的市场批准申请。除了获得和维持所需的监管批准外，Pharma 1 还将处理 PHEXX®和 SOLOSEC®在许可区域内的所有分销、销售和市场营销、药物警戒以及所有其他商业职能。</p>
</div><p>Since its inception in 2019, Pharma 1 has continued to execute its mission of offering practical solutions to fulfill health care needs based on scientific studies and accurate surveys. Pharma 1's success reflects its substantial expertise, scientific approach, and agility to adapt to the very dynamic and growing market in the GCC.</p>
<div class="lb-trans"><p>自 2019 年成立以来，Pharma 1 一直在执行其使命，提供基于科学研究和准确调查的实用解决方案，以满足医疗保健需求。Pharma 1 的成功反映了其丰富的专业知识、科学的方法以及适应 GCC 市场动态和增长的灵活性。</p>
</div><p><strong>About PHEXX®</strong></p>
<div class="lb-trans"><p><strong>关于 PHEXX®</strong></p>
</div><p>PHEXX® (lactic acid, citric acid and potassium bitartrate) is the first and only locally-acting contraceptive gel approved by the FDA. It is applied zero-to-60 minutes before intercourse using a pre-filled applicator and works, without hormones, by maintaining the normal vaginal microbiome with a pH that is naturally inhospitable to sperm as well as certain viral and bacterial pathogens. Visit phexxi.com to learn more and for important safety information.</p>
<div class="lb-trans"><p>PHEXX®（乳酸、柠檬酸和酒石酸钾）是 FDA 批准的首个也是唯一的局部作用避孕凝胶。它在性交前 0 到 60 分钟使用预填充的给药器涂抹，无需激素，通过维持正常的阴道微生物群，保持一个对精子以及某些病毒和细菌病原体自然不利的 pH 值。访问 phexxi.com 了解更多信息及重要安全信息。</p>
</div><p><strong>About Evofem Biosciences</strong></p>
<div class="lb-trans"><p><strong>关于 Evofem Biosciences</strong></p>
</div><p>Evofem Biosciences, Inc. is commercializing two FDA-approved products to address unmet needs in women's sexual and reproductive health: PHEXX® (lactic acid, citric acid and potassium bitartrate) and SOLOSEC® (secnidazole) 2g oral granules.</p>
<div class="lb-trans"><p>Evofem Biosciences, Inc.正在商业化两款 FDA 批准的产品，以满足女性性健康和生殖健康的未满足需求：PHEXX®（乳酸、柠檬酸和酒石酸钾）和 SOLOSEC®（塞克尼达唑）2g 口服颗粒。</p>
</div><p><em>PHEXX®, PHEXXI®, and SOLOSEC® are registered trademarks of Evofem Biosciences, Inc.</em></p>
<div class="lb-trans"><p><em>PHEXX®、PHEXXI®和 SOLOSEC®是 Evofem Biosciences, Inc.的注册商标。</em></p>
</div><p><strong>About Pharma 1</strong></p>
<div class="lb-trans"><p><strong>关于 Pharma 1</strong></p>
</div><p>Pharma 1 Drug Store is an Emirati company dedicated to providingpractical solutions, backed by scientific studies and accurate surveys, that cater to the ever-evolving healthcare needs of people in the GCC and support development of a healthier community. Pharma 1 are agents to a growing number of pharmaceutical companies, with a variety of commercial products and medications in process with the Ministry of Health and Prevention. Learn more at https://pharma1ds.com/.</p>
<div class="lb-trans"><p>Pharma 1 药品商店是一家阿联酋公司，致力于提供实用解决方案，基于科学研究和准确调查，满足 GCC 地区人们不断变化的医疗保健需求，并支持健康社区的发展。Pharma 1 是越来越多制药公司的代理，正在与卫生和预防部处理多种商业产品和药物。了解更多信息，请访问 https://pharma1ds.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>This press release includes &#34;forward-looking statements,&#34; within the meaning of the safe harbor for forward-looking statements provided by Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. Words such as, but not limited to, &#34;anticipate,&#34; &#34;aim,&#34; &#34;believe,&#34; &#34;continue,&#34; &#34;could,&#34; &#34;estimate,&#34; &#34;expect,&#34; &#34;intend,&#34; &#34;may,&#34; &#34;might,&#34; &#34;plan,&#34; &#34;possible,&#34; &#34;potential,&#34; &#34;predict,&#34; &#34;project,&#34; &#34;seek,&#34; &#34;should,&#34; &#34;suggest,&#34; &#34;strategy,&#34; &#34;target,&#34; &#34;will,&#34; &#34;would,&#34; and similar expressions or phrases, or the negative of those expressions or phrases, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include but are not limited to potential approval of PHEXX® in the UAE and timing thereof, timing of the PHEXX® commercial launch in the UAE and planned regulatory submissions in additional licensed countries. You are cautioned not to place undue reliance on these forward-looking statements, which are current only as of the date ofthis press release. Each of these forward-looking statements is based on current expectations and assumptions that are subject to risks and uncertainties which could cause actual results to differ materially. Important factors that could cause actual results to differ materially from those discussed or implied in the forward-looking statements include, but are not limited to: regulatory approval risks, commercial execution risks, dependence on partners and licensees including Pharma 1 for marketing and distribution, market acceptance in competitive landscape in new markets, and other Risk Factors that are disclosed in the Company's SEC filings, including its Annual Report on Form 10-K for the year endedDecember 31, 2024filed with the SEC onMarch 24, 2025, as amended onMarch 28, 2025, and subsequent Form 10-Q filings. All forward-looking statements are expressly qualified in their entirety by such factors. The Company does not undertake any duty to update any forward-looking statement except as required by law. All forward-looking statements speak only as of the date of this release.</p>
<div class="lb-trans"><p>本新闻稿包含&#34;前瞻性声明&#34;，根据 1934 年证券交易法第 21E 条款及 1995 年私人证券诉讼改革法案提供的安全港条款。诸如&#34;预期&#34;、&#34;目标&#34;、&#34;相信&#34;、&#34;继续&#34;、&#34;可能&#34;、&#34;估计&#34;、&#34;期望&#34;、&#34;打算&#34;、&#34;可能&#34;、&#34;计划&#34;、&#34;潜在&#34;、&#34;预测&#34;、&#34;项目&#34;、&#34;寻求&#34;、&#34;应该&#34;、&#34;建议&#34;、&#34;战略&#34;、&#34;目标&#34;、&#34;将&#34;、&#34;会&#34;等词语或类似表达，或这些表达的否定形式，旨在识别前瞻性声明，尽管并非所有前瞻性声明都包含这些识别词。这些声明包括但不限于 PHEXX®在阿联酋的潜在批准及其时机、PHEXX®在阿联酋的商业推出时机以及在其他许可国家的计划监管提交。您被警告不要对这些前瞻性声明过度依赖，这些声明仅在本新闻稿日期时有效。每一项前瞻性声明均基于当前的预期和假设，可能面临风险和不确定性，可能导致实际结果与前述或暗示的结果有重大差异。可能导致实际结果与前瞻性声明中讨论或暗示的结果有重大差异的重要因素包括但不限于：监管批准风险、商业执行风险、对包括 Pharma 1 在内的合作伙伴和许可方的依赖、在新市场竞争环境中的市场接受度，以及公司在 SEC 文件中披露的其他风险因素，包括截至 2024 年 12 月 31 日的年度报告（Form 10-K）于 2025 年 3 月 24 日提交给 SEC，并于 2025 年 3 月 28 日修订，以及后续的 Form 10-Q 文件。所有前瞻性声明均完全受到这些因素的限制。除法律要求外，公司不承担更新任何前瞻性声明的义务。所有前瞻性声明仅在本发布日期时有效。</p>
</div><p><strong>Contact</strong> Amy Raskopf</p>
<div class="lb-trans"><p><strong>联系方式</strong> Amy Raskopf</p>
</div><p>Evofem Biosciences, Inc.</p>
<div class="lb-trans"><p>Evofem Biosciences, Inc.</p>
</div><p>araskopf@evofem.com</p>
<div class="lb-trans"><p>araskopf@evofem.com</p>
</div><p>(917) 673-5775</p>
<div class="lb-trans"><p>(917) 673-5775</p>
</div><p>SOURCE Evofem Biosciences, Inc.</p>
<div class="lb-trans"><p>来源：Evofem Biosciences, Inc.</p>
</div>

Favorable Pricing Certificates Issued for Evofem's PHEXX by Emirates Drug Establishment are Launching Step for Commercialization in UAE | EVFM Stock News

阿联酋药品机构为 Evofem 的 PHEXX 颁发的优惠定价证书是其在阿联酋商业化的起步措施 | EVFM 股票新闻