手握司美格魯肽生物類似藥的九源基因公布港股上市后首份業(yè)績公告。
3月26日晚間，杭州九源基因工程股份有限公司（九源基因，2566.HK）公布了上市后首份年度業(yè)績公告，公司2024年總收入為13.69億元，同比增長6.4%；凈利潤1.39億元，同比增長15.7%。
九源基因成立于1993年，2024年11月港股上市，業(yè)務(wù)覆蓋骨科、代謝疾病、腫瘤及血液等四大治療領(lǐng)域，已有9款商業(yè)化產(chǎn)品。2024年，生物藥（械）產(chǎn)品收入為10.77億，占總收入超過78%，其中骨科收入同比增長超19%，2021年至2024年其復(fù)合增長率超33%，再創(chuàng)歷史新高。
生物活性骨修復(fù)材料骨優(yōu)導(dǎo)是九源基因骨科領(lǐng)域的核心產(chǎn)品，用于骨缺損、骨不連、骨延遲愈合的填充修復(fù)以及脊柱融合、關(guān)節(jié)融合等。財(cái)報(bào)顯示，截至2024年底，該產(chǎn)品在國內(nèi)市場目標(biāo)醫(yī)療機(jī)構(gòu)覆蓋率達(dá)到32.5%。
由于手握國內(nèi)潛在首款司美格魯肽生物類似藥，代謝一直是九源基因最為外界所關(guān)注的領(lǐng)域。司美格魯肽是一款GLP-1受體激動劑，原研藥來自丹麥制藥企業(yè)諾和諾德。九源基因司美格魯肽JY29-2治療糖尿病適應(yīng)證于2024年4月國內(nèi)第一家申報(bào)生產(chǎn)文號，治療肥胖和超重適應(yīng)證進(jìn)入三期臨床，并完成全部病例入組。
在3月27日的業(yè)績交流會上，九源基因相關(guān)負(fù)責(zé)人提到，減重適應(yīng)證2026年上半年報(bào)產(chǎn)（即提交藥品上市申請）。對于司美格魯肽的市場布局和渠道規(guī)劃，將強(qiáng)化院內(nèi)市場先發(fā)優(yōu)勢，通過藥店網(wǎng)絡(luò)下沉擴(kuò)大可及性，聯(lián)合電商平臺戰(zhàn)略合作，加速品牌建設(shè)與用戶觸達(dá)。
九源基因還將司美格魯肽的海外權(quán)益授權(quán)給了其他國內(nèi)藥企：與科興生物簽署了司美格魯肽在拉美主要國家的市場獨(dú)家許可合作協(xié)議；與復(fù)星醫(yī)藥簽署了產(chǎn)品許可協(xié)議關(guān)鍵條款，給予復(fù)星醫(yī)藥司美格魯肽在內(nèi)的多款產(chǎn)品在中東和北非、撒哈拉以南非洲全部國家及部分東盟國家的獨(dú)家臨床開發(fā)、注冊和商業(yè)化權(quán)利。預(yù)計(jì)2025年內(nèi)向巴西、沙特遞交司美格魯肽的新藥申請。
除了司美格魯肽，九源基因還在推進(jìn)長效胰淀素類似物JY54的開發(fā)，目前已進(jìn)入中試和動物試驗(yàn)階段，預(yù)計(jì)年內(nèi)遞交IND（新藥臨床研究）申請。
三月以來，多家跨國藥企通過交易獲得胰淀素類似物，如羅氏宣布與丹麥制藥企業(yè)Zealand Pharma簽訂獨(dú)家合作和許可協(xié)議，合作共同開發(fā)和商業(yè)化胰淀素類似物petrelintide，此次交易的潛在最高總金額達(dá)到53億美元。美國藥企艾伯維也宣布，與丹麥生物科技公司Gubra達(dá)成共同開發(fā)胰淀素類似物GUB014295的許可協(xié)議，協(xié)議總額最高超過22億美元。http://3g.89878147.com/a1y/detail/f8k
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九源基因方面向澎湃新聞記者表示，今年以來，有多家跨國藥企通過高額BD交易來布局該靶點(diǎn)藥物的開發(fā)，表明行業(yè)內(nèi)看好這個靶點(diǎn)的臨床價(jià)值。九源開發(fā)JY54，可以與在研的司美格魯肽生物類似藥聯(lián)用或制成復(fù)方制劑，來實(shí)現(xiàn)產(chǎn)品的升級換代，產(chǎn)生管線協(xié)同效應(yīng)。在產(chǎn)品設(shè)計(jì)上，與已公開結(jié)構(gòu)的分子相比，九源通過改構(gòu)提高了分子的療效以及分子在中性pH條件下的穩(wěn)定性。公司計(jì)劃今年遞交JY54的IND申請，同時(shí)也有計(jì)劃推進(jìn)BD合作。
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