<p><strong><em>— PHEXX® 有望成為阿聯酋首個也是唯一的</em></strong> <strong><em>無激素避孕陰道凝膠</em></strong></p>
<p><strong><em>— 計劃於 2026 年在阿聯酋推出無激素避孕產品</em></strong></p>
<p>, /PRNewswire/ -- 女性健康創新者 Evofem Biosciences, Inc.（&#34;Evofem&#34;或&#34;公司&#34;）（OTCID: EVFM）今天宣佈，阿聯酋藥品管理局（EDE）已為 PHEXX®（乳酸、檸檬酸、酒石酸鉀）頒發了有利的定價證書，這是在阿聯酋獲得監管批准的初步行政步驟。</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 頒發這些定價證書是 Evofem 通過進入新市場來擴展和多樣化收入來源的重要一步，&#34;Evofem 首席執行官 Saundra Pelletier 表示。&#34;我們熱切期待 PHEXX®在阿聯酋的批准。這將為 Pharma 1 在阿聯酋推出和商業化 PHEXX®鋪平道路，使阿聯酋女性及其醫療服務提供者能夠獲得按需的無激素避孕，同時也促進 Pharma 1 計劃向其他許可國家提交申請。&#34;</p>
<p>Evofem 的許可方 Pharma 1 預計將在 2026 年在阿聯酋推出 PHEXX®，前提是及時獲得 EDE 的市場批准以及其他監管和商業條件。</p>
<p>Pharma 1 擁有 Evofem 兩款 FDA 批准產品——PHEXX®和 SOLOSEC®（塞克尼達唑）2g 口服顆粒的獨家商業化權利，覆蓋六個海灣合作委員會（GCC）國家，並有潛力擴展到中東和北非（MENA）其他 15 個國家。這兩款產品已於 2025 年提交給 EDE 申請市場批准，Pharma 1 計劃在阿聯酋獲得批准後，向其他許可國家提交產品的市場批准申請。除了獲得和維持所需的監管批准外，Pharma 1 還將處理 PHEXX®和 SOLOSEC®在許可區域內的所有分銷、銷售和市場營銷、藥物警戒以及所有其他商業職能。</p>
<p>自 2019 年成立以來，Pharma 1 一直在執行其使命，提供基於科學研究和準確調查的實用解決方案，以滿足醫療保健需求。Pharma 1 的成功反映了其豐富的專業知識、科學的方法以及適應 GCC 市場動態和增長的靈活性。</p>
<p><strong>關於 PHEXX®</strong></p>
<p>PHEXX®（乳酸、檸檬酸和酒石酸鉀）是 FDA 批准的首個也是唯一的局部作用避孕凝膠。它在性交前 0 到 60 分鐘使用預填充的給藥器塗抹，無需激素，通過維持正常的陰道微生物羣，保持一個對精子以及某些病毒和細菌病原體自然不利的 pH 值。訪問 phexxi.com 瞭解更多信息及重要安全信息。</p>
<p><strong>關於 Evofem Biosciences</strong></p>
<p>Evofem Biosciences, Inc.正在商業化兩款 FDA 批准的產品，以滿足女性性健康和生殖健康的未滿足需求：PHEXX®（乳酸、檸檬酸和酒石酸鉀）和 SOLOSEC®（塞克尼達唑）2g 口服顆粒。</p>
<p><em>PHEXX®、PHEXXI®和 SOLOSEC®是 Evofem Biosciences, Inc.的註冊商標。</em></p>
<p><strong>關於 Pharma 1</strong></p>
<p>Pharma 1 藥品商店是一家阿聯酋公司，致力於提供實用解決方案，基於科學研究和準確調查，滿足 GCC 地區人們不斷變化的醫療保健需求，並支持健康社區的發展。Pharma 1 是越來越多製藥公司的代理，正在與衞生和預防部處理多種商業產品和藥物。瞭解更多信息，請訪問 https://pharma1ds.com/。</p>
<p><strong>前瞻性聲明</strong></p>
<p>本新聞稿包含&#34;前瞻性聲明&#34;，根據 1934 年證券交易法第 21E 條款及 1995 年私人證券訴訟改革法案提供的安全港條款。諸如&#34;預期&#34;、&#34;目標&#34;、&#34;相信&#34;、&#34;繼續&#34;、&#34;可能&#34;、&#34;估計&#34;、&#34;期望&#34;、&#34;打算&#34;、&#34;可能&#34;、&#34;計劃&#34;、&#34;潛在&#34;、&#34;預測&#34;、&#34;項目&#34;、&#34;尋求&#34;、&#34;應該&#34;、&#34;建議&#34;、&#34;戰略&#34;、&#34;目標&#34;、&#34;將&#34;、&#34;會&#34;等詞語或類似表達，或這些表達的否定形式，旨在識別前瞻性聲明，儘管並非所有前瞻性聲明都包含這些識別詞。這些聲明包括但不限於 PHEXX®在阿聯酋的潛在批准及其時機、PHEXX®在阿聯酋的商業推出時機以及在其他許可國家的計劃監管提交。您被警告不要對這些前瞻性聲明過度依賴，這些聲明僅在本新聞稿日期時有效。每一項前瞻性聲明均基於當前的預期和假設，可能面臨風險和不確定性，可能導致實際結果與前述或暗示的結果有重大差異。可能導致實際結果與前瞻性聲明中討論或暗示的結果有重大差異的重要因素包括但不限於：監管批准風險、商業執行風險、對包括 Pharma 1 在內的合作伙伴和許可方的依賴、在新市場競爭環境中的市場接受度，以及公司在 SEC 文件中披露的其他風險因素，包括截至 2024 年 12 月 31 日的年度報告（Form 10-K）於 2025 年 3 月 24 日提交給 SEC，並於 2025 年 3 月 28 日修訂，以及後續的 Form 10-Q 文件。所有前瞻性聲明均完全受到這些因素的限制。除法律要求外，公司不承擔更新任何前瞻性聲明的義務。所有前瞻性聲明僅在本發佈日期時有效。</p>
<p><strong>聯繫方式</strong> Amy Raskopf</p>
<p>Evofem Biosciences, Inc.</p>
<p>araskopf@evofem.com</p>
<p>(917) 673-5775</p>
<p>來源：Evofem Biosciences, Inc.</p>

EVFM

<p>Evofem Biosciences 宣佈，阿聯酋藥品公司已為 PHEXX®（一種無激素避孕膠）頒發了有利的定價證書，這標誌着其在阿聯酋的監管批准和商業化邁出了關鍵一步。Pharma 1 計劃在 2026 年推出 PHEXX®，但需獲得批准。Pharma 1 在海灣合作委員會國家擁有 Evofem 產品的獨家權利，旨在擴展到中東和北非國家。該舉措反映了 Evofem 多元化收入的戰略，併為阿聯酋女性提供無激素避孕的機會</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® 有望成為阿聯酋首個也是唯一的</em></strong> <strong><em>無激素避孕陰道凝膠</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>— 計劃於 2026 年在阿聯酋推出無激素避孕產品</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/ -- 女性健康創新者 Evofem Biosciences, Inc.（&#34;Evofem&#34;或&#34;公司&#34;）（OTCID: EVFM）今天宣佈，阿聯酋藥品管理局（EDE）已為 PHEXX®（乳酸、檸檬酸、酒石酸鉀）頒發了有利的定價證書，這是在阿聯酋獲得監管批准的初步行政步驟。</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 頒發這些定價證書是 Evofem 通過進入新市場來擴展和多樣化收入來源的重要一步，&#34;Evofem 首席執行官 Saundra Pelletier 表示。&#34;我們熱切期待 PHEXX®在阿聯酋的批准。這將為 Pharma 1 在阿聯酋推出和商業化 PHEXX®鋪平道路，使阿聯酋女性及其醫療服務提供者能夠獲得按需的無激素避孕，同時也促進 Pharma 1 計劃向其他許可國家提交申請。&#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 的許可方 Pharma 1 預計將在 2026 年在阿聯酋推出 PHEXX®，前提是及時獲得 EDE 的市場批准以及其他監管和商業條件。</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 擁有 Evofem 兩款 FDA 批准產品——PHEXX®和 SOLOSEC®（塞克尼達唑）2g 口服顆粒的獨家商業化權利，覆蓋六個海灣合作委員會（GCC）國家，並有潛力擴展到中東和北非（MENA）其他 15 個國家。這兩款產品已於 2025 年提交給 EDE 申請市場批准，Pharma 1 計劃在阿聯酋獲得批准後，向其他許可國家提交產品的市場批准申請。除了獲得和維持所需的監管批准外，Pharma 1 還將處理 PHEXX®和 SOLOSEC®在許可區域內的所有分銷、銷售和市場營銷、藥物警戒以及所有其他商業職能。</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 年成立以來，Pharma 1 一直在執行其使命，提供基於科學研究和準確調查的實用解決方案，以滿足醫療保健需求。Pharma 1 的成功反映了其豐富的專業知識、科學的方法以及適應 GCC 市場動態和增長的靈活性。</p>
</div><p><strong>About PHEXX®</strong></p>
<div class="lb-trans"><p><strong>關於 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、檸檬酸和酒石酸鉀）是 FDA 批准的首個也是唯一的局部作用避孕凝膠。它在性交前 0 到 60 分鐘使用預填充的給藥器塗抹，無需激素，通過維持正常的陰道微生物羣，保持一個對精子以及某些病毒和細菌病原體自然不利的 pH 值。訪問 phexxi.com 瞭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>關於 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.正在商業化兩款 FDA 批准的產品，以滿足女性性健康和生殖健康的未滿足需求：PHEXX®（乳酸、檸檬酸和酒石酸鉀）和 SOLOSEC®（塞克尼達唑）2g 口服顆粒。</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.的註冊商標。</em></p>
</div><p><strong>About Pharma 1</strong></p>
<div class="lb-trans"><p><strong>關於 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 藥品商店是一家阿聯酋公司，致力於提供實用解決方案，基於科學研究和準確調查，滿足 GCC 地區人們不斷變化的醫療保健需求，並支持健康社區的發展。Pharma 1 是越來越多製藥公司的代理，正在與衞生和預防部處理多種商業產品和藥物。瞭解更多信息，請訪問 https://pharma1ds.com/。</p>
</div><p><strong>Forward-Looking Statements</strong></p>
<div class="lb-trans"><p><strong>前瞻性聲明</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>本新聞稿包含&#34;前瞻性聲明&#34;，根據 1934 年證券交易法第 21E 條款及 1995 年私人證券訴訟改革法案提供的安全港條款。諸如&#34;預期&#34;、&#34;目標&#34;、&#34;相信&#34;、&#34;繼續&#34;、&#34;可能&#34;、&#34;估計&#34;、&#34;期望&#34;、&#34;打算&#34;、&#34;可能&#34;、&#34;計劃&#34;、&#34;潛在&#34;、&#34;預測&#34;、&#34;項目&#34;、&#34;尋求&#34;、&#34;應該&#34;、&#34;建議&#34;、&#34;戰略&#34;、&#34;目標&#34;、&#34;將&#34;、&#34;會&#34;等詞語或類似表達，或這些表達的否定形式，旨在識別前瞻性聲明，儘管並非所有前瞻性聲明都包含這些識別詞。這些聲明包括但不限於 PHEXX®在阿聯酋的潛在批准及其時機、PHEXX®在阿聯酋的商業推出時機以及在其他許可國家的計劃監管提交。您被警告不要對這些前瞻性聲明過度依賴，這些聲明僅在本新聞稿日期時有效。每一項前瞻性聲明均基於當前的預期和假設，可能面臨風險和不確定性，可能導致實際結果與前述或暗示的結果有重大差異。可能導致實際結果與前瞻性聲明中討論或暗示的結果有重大差異的重要因素包括但不限於：監管批准風險、商業執行風險、對包括 Pharma 1 在內的合作伙伴和許可方的依賴、在新市場競爭環境中的市場接受度，以及公司在 SEC 文件中披露的其他風險因素，包括截至 2024 年 12 月 31 日的年度報告（Form 10-K）於 2025 年 3 月 24 日提交給 SEC，並於 2025 年 3 月 28 日修訂，以及後續的 Form 10-Q 文件。所有前瞻性聲明均完全受到這些因素的限制。除法律要求外，公司不承擔更新任何前瞻性聲明的義務。所有前瞻性聲明僅在本發佈日期時有效。</p>
</div><p><strong>Contact</strong> Amy Raskopf</p>
<div class="lb-trans"><p><strong>聯繫方式</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>來源：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

阿聯酋藥品機構為 Evofem 的 PHEXX 頒發的優惠定價證書是其在阿聯酋商業化的起步措施 | EVFM 股票新聞