<p><strong><em>BGM0504 顯示出總體良好的耐受性</em></strong></p>
<p><strong><em>總體安全性、藥代動力學和療效特徵支持每日一次口服給藥</em></strong></p>
<p>, /PRNewswire/ -- 博瑞醫藥（SSE: 688166，&#34;博瑞&#34;或&#34;公司&#34;）今天宣佈了 BGM0504 的第一階段臨牀研究的積極頂線結果，該藥物是一種正在研究的口服 GLP-1/GIP 雙受體激動劑，參與者為中國和美國的成年人，包括健康志願者和超重或肥胖個體。</p>
<p>在這兩項研究中，BGM0504 總體耐受性良好，沒有嚴重不良事件。當觀察到胃腸道不良事件時，主要為輕度至中度，且為短暫性，與該類藥物的已知特徵一致。基於意向治療分析的初步療效結果顯示，體重有顯著減少，在中國研究中，四周治療後平均體重減少範圍為 1.0% 至 5.6%，而在美國研究中，五至八週治療後平均體重減少範圍為 2.7% 至 8.2%。</p>
<p>中國第一階段研究（CTR20253763 / NCT07239973）是一項隨機、雙盲、安慰劑對照試驗，旨在評估 BGM0504 在健康參與者和非糖尿病超重或肥胖個體中的安全性、耐受性、藥代動力學和初步療效。共有 75 名參與者入組並完成了研究。BGM0504 每日一次給藥，劑量範圍為 10 mg 至 80 mg，持續四周。該化合物在所有劑量水平上總體耐受性良好，沒有報告嚴重或意外的不良事件。胃腸道不良事件大多為輕度（1 級）且為短暫性。藥代動力學分析顯示，穩態暴露在給藥約兩至三週後達到，並且暴露量一般呈劑量比例增加。經過四周治療，接受 BGM0504 的參與者相較基線顯示出體重減少，平均減少範圍為 1.0% 至 5.6%（最小二乘均值）在各劑量組中。</p>
<p>美國第一階段研究（NCT07166081）是一項隨機、安慰劑對照的多次遞增劑量試驗，評估 BGM0504 的安全性、耐受性和初步療效。共有 80 名參與者入組，其中 64 名接受了 BGM0504，16 名接受了安慰劑。參與者每日一次給藥，劑量範圍為 20 mg 至 80 mg，治療持續時間為五至八週，具體取決於劑量組，並且在目標劑量下至少給藥四周。BGM0504 總體耐受性良好，沒有報告嚴重不良事件。最常觀察到的不良事件主要為胃腸道性質，通常為輕度至中度，且為短暫性。初步療效分析顯示體重減少的劑量反應，經過五至八週治療後，平均體重減少範圍為 2.7% 至 8.2%（最小二乘均值）。</p>
<p>這些研究的詳細結果預計將在今年晚些時候的科學會議上公佈。</p>
<p><strong>BGM0504 項目概述</strong></p>
<p>BGM0504 正在開發口服和皮下給藥形式，作為公司在肥胖及相關代謝疾病領域更廣泛戰略的一部分。皮下給藥形式已處於開發的高級階段，中國第二階段研究和美國橋接研究已完成，目前正在進行多項第三階段研究。</p>
<p>本公告中披露的數據基於正在進行的臨牀研究的初步分析。隨着額外數據的可用性和進一步分析的進行，結果和解釋可能會發生變化。</p>
<p>BGM0504 仍然是一種研究藥物，尚未在任何國家獲得市場批准。藥物開發涉及重大風險和不確定性，臨牀試驗結果可能無法預測未來結果。需要進一步研究以確定 BGM0504 的安全性和有效性。</p>
<p>來源：博瑞醫藥</p>
<p><img src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwMzI1Jk5ld3NJdGVtSWQ9Q04xODgzMyZUcmFuc21pc3Npb25fSWQ9MjAyNjAzMjUwMjMyUFJfTkVXU19VU1BSX19fX19DTjE4ODMz?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://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwMzI1Jk5ld3NJdGVtSWQ9Q04xODgzMyZUcmFuc21pc3Npb25fSWQ9MjAyNjAzMjUwMjMyUFJfTkVXU19VU1BSX19fX19DTjE4ODMz"/></p>

博瑞醫藥

<p>博瑞醫藥（BrightGene Bio-Medical Technology Co., Ltd.）宣佈了其口服 GLP-1/GIP 雙受體激動劑 BGM0504 在中國和美國的第一階段臨牀研究的積極頂線結果。該藥物耐受性良好，沒有嚴重不良事件。初步療效結果顯示，在中國治療後體重減少了 1.0% 至 5.6%，在美國減少了 2.7% 至 8.2%。BGM0504 仍處於研究階段，尚未獲得上市批准。需要進一步研究以確認其安全性和有效性</p>

<p><strong><em>BGM0504 shown to be generally well tolerated</em></strong></p>
<div class="lb-trans"><p><strong><em>BGM0504 顯示出總體良好的耐受性</em></strong></p>
</div><p><strong><em>Overall safety, pk, and efficacy profile supports once-daily oral dosing</em></strong></p>
<div class="lb-trans"><p><strong><em>總體安全性、藥代動力學和療效特徵支持每日一次口服給藥</em></strong></p>
</div><p>, /PRNewswire/ -- BrightGene Bio-Medical Technology Co., Ltd. (SSE: 688166, &#34;BrightGene&#34; or &#34;the Company&#34;) today announced positive topline results from Phase 1 clinical studies of BGM0504, an investigational oral GLP-1/GIP dual receptor agonist, in adult participants in China and the United States, including healthy volunteers and individuals with overweight or obesity.</p>
<div class="lb-trans"><p>, /PRNewswire/ -- 博瑞醫藥（SSE: 688166，&#34;博瑞&#34;或&#34;公司&#34;）今天宣佈了 BGM0504 的第一階段臨牀研究的積極頂線結果，該藥物是一種正在研究的口服 GLP-1/GIP 雙受體激動劑，參與者為中國和美國的成年人，包括健康志願者和超重或肥胖個體。</p>
</div><p>Across both studies, BGM0504 was generally well tolerated, with no serious adverse events. Gastrointestinal adverse events, when observed, were predominantly mild to moderate in severity and transient, consistent with the known profile of this class. Preliminary efficacy results based on an intent-to-treat analysis showed meaningful reductions in body weight, with mean body weight reductions ranging from 1.0% to 5.6% after four weeks of treatment in the China study and from 2.7% to 8.2% after five to eight weeks of treatment in the U.S. study.</p>
<div class="lb-trans"><p>在這兩項研究中，BGM0504 總體耐受性良好，沒有嚴重不良事件。當觀察到胃腸道不良事件時，主要為輕度至中度，且為短暫性，與該類藥物的已知特徵一致。基於意向治療分析的初步療效結果顯示，體重有顯著減少，在中國研究中，四周治療後平均體重減少範圍為 1.0% 至 5.6%，而在美國研究中，五至八週治療後平均體重減少範圍為 2.7% 至 8.2%。</p>
</div><p>The China Phase 1 study (CTR20253763 / NCT07239973) was a randomized, double-blind, placebo-controlled trial designed to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of BGM0504 in healthy participants and non-diabetic individuals with overweight or obesity. A total of 75 participants were enrolled and completed the study. BGM0504 was administered once daily at doses ranging from 10 mg to 80 mg for four weeks. The compound was generally well tolerated across all dose levels, with no serious or unexpected adverse events reported. Gastrointestinal adverse events were mostly mild (Grade 1) and transient. Pharmacokinetic analyses showed that steady-state exposure was achieved after approximately two to three weeks of dosing and that exposure increased in a generally dose-proportional manner. After four weeks of treatment, participants receiving BGM0504 demonstrated reductions in body weight relative to baseline, with mean reductions ranging from 1.0% to 5.6% (least squares mean) across dose groups.</p>
<div class="lb-trans"><p>中國第一階段研究（CTR20253763 / NCT07239973）是一項隨機、雙盲、安慰劑對照試驗，旨在評估 BGM0504 在健康參與者和非糖尿病超重或肥胖個體中的安全性、耐受性、藥代動力學和初步療效。共有 75 名參與者入組並完成了研究。BGM0504 每日一次給藥，劑量範圍為 10 mg 至 80 mg，持續四周。該化合物在所有劑量水平上總體耐受性良好，沒有報告嚴重或意外的不良事件。胃腸道不良事件大多為輕度（1 級）且為短暫性。藥代動力學分析顯示，穩態暴露在給藥約兩至三週後達到，並且暴露量一般呈劑量比例增加。經過四周治療，接受 BGM0504 的參與者相較基線顯示出體重減少，平均減少範圍為 1.0% 至 5.6%（最小二乘均值）在各劑量組中。</p>
</div><p>The U.S. Phase 1 study (NCT07166081) was a randomized, placebo-controlled, multiple ascending dose trial evaluating safety, tolerability and preliminary efficacy of BGM0504. A total of 80 participants were enrolled, including 64 who received BGM0504 and 16 who received placebo. Participants received once-daily dosing across dose levels ranging from 20 mg to 80 mg, with treatment durations of five to eight weeks depending on dose cohort and at least four weeks of dosing at the target dose. BGM0504 was generally well tolerated, with no serious adverse events reported. The most commonly observed adverse events were gastrointestinal in nature, were generally mild to moderate, and were transient. Preliminary efficacy analyses demonstrated does response in weight reduction, with mean body weight reductions ranging from 2.7% to 8.2% (least squares mean) after five to eight weeks of treatment.</p>
<div class="lb-trans"><p>美國第一階段研究（NCT07166081）是一項隨機、安慰劑對照的多次遞增劑量試驗，評估 BGM0504 的安全性、耐受性和初步療效。共有 80 名參與者入組，其中 64 名接受了 BGM0504，16 名接受了安慰劑。參與者每日一次給藥，劑量範圍為 20 mg 至 80 mg，治療持續時間為五至八週，具體取決於劑量組，並且在目標劑量下至少給藥四周。BGM0504 總體耐受性良好，沒有報告嚴重不良事件。最常觀察到的不良事件主要為胃腸道性質，通常為輕度至中度，且為短暫性。初步療效分析顯示體重減少的劑量反應，經過五至八週治療後，平均體重減少範圍為 2.7% 至 8.2%（最小二乘均值）。</p>
</div><p>Detailed results from these studies are expected to be presented at a scientific conference later this year.</p>
<div class="lb-trans"><p>這些研究的詳細結果預計將在今年晚些時候的科學會議上公佈。</p>
</div><p><strong>BGM0504 Program Overview</strong></p>
<div class="lb-trans"><p><strong>BGM0504 項目概述</strong></p>
</div><p>BGM0504 is being developed in both oral and subcutaneous formulations as part of the Company's broader strategy in obesity and related metabolic diseases. The subcutaneous formulation is at an advanced stage of development, with China Phase 2 studies and a U.S. bridging study completed and multiple Phase 3 studies currently ongoing.</p>
<div class="lb-trans"><p>BGM0504 正在開發口服和皮下給藥形式，作為公司在肥胖及相關代謝疾病領域更廣泛戰略的一部分。皮下給藥形式已處於開發的高級階段，中國第二階段研究和美國橋接研究已完成，目前正在進行多項第三階段研究。</p>
</div><p>The data disclosed in this announcement are based on preliminary analyses of ongoing clinical studies. As additional data become available and further analyses are conducted, the results and interpretations may be subject to change.</p>
<div class="lb-trans"><p>本公告中披露的數據基於正在進行的臨牀研究的初步分析。隨着額外數據的可用性和進一步分析的進行，結果和解釋可能會發生變化。</p>
</div><p>BGM0504 remains an investigational drug and has not been approved for marketing in any country. Drug development involves substantial risks and uncertainties, and clinical trial results may not be predictive of future outcomes. Further studies are required to establish the safety and efficacy of BGM0504.</p>
<div class="lb-trans"><p>BGM0504 仍然是一種研究藥物，尚未在任何國家獲得市場批准。藥物開發涉及重大風險和不確定性，臨牀試驗結果可能無法預測未來結果。需要進一步研究以確定 BGM0504 的安全性和有效性。</p>
</div><p>SOURCE BrightGene</p>
<div class="lb-trans"><p>來源：博瑞醫藥</p>
</div><p><img src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwMzI1Jk5ld3NJdGVtSWQ9Q04xODgzMyZUcmFuc21pc3Npb25fSWQ9MjAyNjAzMjUwMjMyUFJfTkVXU19VU1BSX19fX19DTjE4ODMz" alt="" original-src="https://rt.prnewswire.com/rt.gif?NewsItemId=CN18833&amp;Transmission_Id=202603250232PR_NEWS_USPR_____CN18833&amp;DateId=20260325"/></p>

博瑞醫藥宣佈其口服藥物 BGM0504 在中國和美國的肥胖症 1 期試驗中取得了積極的頂線結果