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億勝生物公布2021業績

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2022年3月22日 20時14分

億勝生物公布2021業績

年內溢利增長58%至3.46億港元
以及營業額增加67.4%至16.38億港元

香港, 2022年3月22日 – (亞太商訊) – 億勝生物科技有限公司(「億勝生物」或「集團」;股份編號:1061.HK)今日公布截至2021年12月31日止年度的全年財務業績。

業績亮點
— 集團營業額增長67.4%至16.38億港元,年內溢利增長58%至3.46億港元;
— 於中國的銷售覆蓋增加至逾10,500家醫院及醫療機構以及約2,110家藥房;
— 獲得不含防腐劑單劑量鹽酸莫西沙星滴眼液在中國註冊及商業化的批准;
— 研發計劃取得重大進展,共有15項研發計劃處於臨床前至臨床階段,其中以下3項眼科計劃處於臨床階段﹕
SkQ1滴眼液,第二階段三期臨床試驗(美國葯監局)(VISTA-2)頂線數據已於2021年2月24日發布;
阿奇黴素滴眼液,外部關鍵意見領袖正在進行審查(中國國家藥品監督管理局);
濕性AMD貝伐珠單抗玻璃體注射劑,三期臨床試驗(美國葯監局、歐洲藥品管理局、澳大利亞藥物管理局及中國國家藥品監督管理局);
— 持有合共44份專利證書或授權書,包括35項發明專利、4項實用新型專利及5項外觀專利;
— 完成適麗順®(卵磷脂絡合碘膠囊)產品與研發、生產和MAH相關知識產權收購事項(中國)。

財務表現強勁增長

在COVID-19疫情及全球各種不穩定因素下,億勝生物仍實現了強勁增長及表現。於截至2021年12月31日止年度,集團錄得綜合營業額約16.38億港元,較2020年約9.78億港元增加67.4%,顯示強勁恢復至COVID-19疫情之前的營運水平。在營業額增長下,集團錄得除稅後溢利約3.46億港元,較2020年的約2.19億港元增加58%。

眼科及外科分部營業額分別增加60.6%及72.6%
集團的營業額主要由眼科及外科(創傷護理及修復)分部組成。各分部中目前具有增長動力的核心產品為:

1. 眼科-貝復舒系列(貝復舒滴眼液、貝復舒眼用凝膠及貝復舒單劑量滴眼液)、妥布黴素滴眼液、左氧氟
沙星滴眼液、玻璃酸鈉滴眼液、鹽酸莫西沙星滴眼液及適麗順®(卵磷脂絡合碘膠囊);及
2. 外科(創傷護理及修復)-貝復濟系列(貝復濟液體製劑、貝復濟凍乾粉及貝復新凝膠)、Carisolv®齲齒凝
膠、伢典醫生漱口水及伊血安顆粒。

眼科及外科的分部營業額分別約佔集團營業額的41.1%及58.9%。集團的旗艦生物葯貝復舒系列及貝復濟系列(以成纖維細胞生長因子(bFGF)為基礎的生物葯)的合併營業額約佔集團總營業額的84.3%,其中貝復舒系列及貝復濟系列分別占集團營業額的26.1%及58.2%。集團營業額的餘下15.7%主要來自銷售妥布黴素滴眼液、左氧氟沙星滴眼液、玻璃酸鈉滴眼液、鹽酸莫西沙星滴眼液、適麗順®(卵磷脂絡合碘膠囊)、Carisolv®齲齒凝膠、伢典醫生漱口水及伊血安顆粒的共同貢獻。於截至2021年12月31日止年度,眼科為集團營業額貢獻約6.73億港元,較2020年的約4.19億港元增加60.6%。於截至2021年12月31日止年度,外科錄得總營業額約9.64億港元,較2020年的約5.59億港元增加72.6%。有關增加乃中國醫院門診運作恢復正常及銷售擴大所致。

適利達®滴眼液及適利加®滴眼液將於2022年停止銷售,該兩款產品貢獻了截至2021年12月31日止年度約2%的集團毛利。

董事會建議派發末期股息每股普通股0.055港元(2020年:0.05港元),惟有待公司應屆股東周年大會批准後方可作實。

億勝生物主席嚴名熾先生表示﹕「2021年是充滿各種挑戰的一年。即使在其他地區開始重啟時,我們所在地區亦受到COVID清零制度下延長的封鎖和邊境關閉的影響。儘管COVID-19疫情給我們所有人帶來又一個艱難的年度,但我們基因中的韌性、動力及領導力能夠為持份者帶來更大的價值。集團於截至2021年12月31日止財政年度的財務業績表現顯著改善。這證明本集團的業務極具韌性,並能夠自2020年9月起於中國醫院的門診運作重歸正常後,迅速恢復到COVID-19之前的水平。」

重要業務發展活動

集團致力於務實投入新產品及技術以強化集團的產品及研發管線,作為眼科近中期增長動力及腫瘤科新治療領域的長期計劃。於回顧年內,眼科產品的主要投資概述如下:

眼科投資

SkQ1滴眼液第二階段三期臨床試驗重大進展
於2018年,集團與Mitotech S.A.(「Mitotech」)及Mitotech LLC就用於乾眼症之含SkQ1之滴眼液於美國食品藥品監督管理局(「美國葯監局」)進行三期臨床試驗訂立共同開發協議。誠如公司日期2021年2月24日的公布所披露,第二階段三期臨床試驗(VISTA-2)取得正面結果。臨床試驗研究在關鍵預定的次要終點指標(中央角膜熒光素染色)的統計數據重複明顯的正面結果。公司董事會對試驗結果顯示中央角膜恢復透明(定義為中央角膜零染色)感到欣慰,這表明SkQ1具有解決乾眼症氧化應激的潛力。繼VISTA-2的正面試驗結果之後,Mitotech計划進行一項關鍵試驗(VISTA-3),一旦Mitotech的管理層團隊完成全面評估持續的COVID-19疫情期間對試驗中心及患者招募並無潛在干擾,該試驗將開始進行。然而,烏克蘭的最近事態發展導致政府和行業對與俄羅斯的業務關係做出反應,這可能會導致Mitotech的VISTA臨床試驗計劃延遲。

HLX04-O 三期臨床試驗獲批
於2020年,集團與上海復宏漢霖生物技術股份有限公司訂立共同開發及獨家許可協議,共同開發一種內含抗血管內皮生長因子(「抗VEGF」)作為藥性成分的醫藥產品(「抗VEGF許可產品」),該藥品擬用於治療滲出性(濕性)老年性黃斑部病變(「濕性AMD」)。截至2022年3月22日,用於治療濕性AMD之重組抗VEGF人源化單克隆抗體注射液HLX04-O(「HLX04-O」)已獲批准在澳大利亞、美國、新加坡、俄羅斯、塞爾維亞及匈牙利、西班牙、拉脫維亞、捷克共和國及波蘭等歐盟國家開展三期臨床試驗。此外,用以治療濕性AMD之HLX04-O於中國的三期臨床研究已完成首例患者給葯。

收購適麗順®(卵磷脂絡合碘膠囊) 預期進一步加強眼科業務
適麗順®(卵磷脂絡合碘膠囊)產品與研發、生產和MAH相關知識產權收購事項的完成將使集團加強其眼科業務。

市場開發

強勁市場渠道能力
數年來,集團一直不懈投入資源積蓄及強化其市場渠道能力。截至2021年12月31日,集團於中國部署43間地區銷售辦事處網絡及總數約1,265名銷售人員及營銷代表,其中64%為全職員工及36%為合約人員或代理聘請人員。
深化產品處方醫療網絡

於回顧年度,集團的治療產品主要於中國主要城市、省份及縣城的逾10,500家醫院及醫療機構以及約2,110家藥房處方。

更多投資以提升競爭力及擴闊客戶群
為實現現時已上市產品以及近中期正商業化的新產品的可持續增長,集團根據以下計劃啟動投資,以提升其競爭力及擴闊其客戶群:

— 投資臨床觀察計劃以確認其商業化產品的其他臨床適應症;
— 覆蓋較低線城市市場;
— 儘可能培養藥房作為輔助銷售渠道;及
— 通過醫療科技創新,打造在線平台,為慢性病患者提供醫療諮詢和開具電子處方。
於回顧年度,集團擴大在新加坡的業務,將其作為擴展東南亞國家市場渠道的基地。

研發

於回顧年度,集團重申其研發願景,強調致力於科學及創新,肩負使命開發將滿足未滿足的臨床及╱或商業需求的療法。集團同時啟動一項為期五年(2021至2025年)的研發計劃,以進一步加強其研發能力及其在眼科領域的地位。

於2021年12月31日,共有15項研發計劃處於臨床前至臨床階段,其中3項眼科計劃處於臨床階段。下文所列的3項眼科計劃被視為中期增長動力。

1. EB11-18136P:SkQ1滴眼液,第二階段三期臨床試驗(美國葯監局)(VISTA-2)頂線數據已於2021年2月24日發布
2. EB11-15120P:阿奇黴素滴眼液,外部關鍵意見領袖正在進行審查(中國國家藥品監督管理局)
3. EB12-20145P:濕性AMD貝伐珠單抗玻璃體注射劑,三期臨床試驗(美國葯監局、歐洲藥品管理局、澳大利亞藥物管理局及中國國家藥品監督管理局)

於本報告日期,集團持有合共44份專利證書或授權書,包括35項發明專利、4項實用新型專利及5項外觀專利。集團目前已將其研發資源多元化至珠海(中國)、波士頓(美國)、倫敦(英國)及新加坡的多個研究基地,其不僅支持我們對新療法的追求,亦支持我們對全球人才的獲取。

前景

COVID-19仍然是2022年全球關注的主要問題。我們將繼續監測情況發展並將採取適宜行動,以克服任何不可預測的挑戰。集團將繼續專註於執行其計劃,及逐步取得成果。

展望2022年,集團將持續關注COVID-19 帶來的不穩定因素及情況。其強大的團隊精神及高效率的領導團隊使我們在息萬變的社會下仍能克服挑戰,並抓緊每個機遇。集團於來年將積極持續創造價值。

億勝生物主席嚴名熾先生表示﹕「COVID-19仍然是2022年全球關注的主要問題。我們將繼續監測情況發展並將採取適宜行動,以克服任何不可預測的挑戰。除出現不可預測的情況外,本集團將繼續專註於執行其計劃,及逐步取得成果。本人謹藉此機會向本集團所有持份者、業務夥伴及尊貴客戶致以衷心謝意,感謝各位對我們的信任、支持及與我們衷誠合作,並感謝每一位成員作出的不懈努力,致力將本公司打造為一家銳意進取且前途光明的製藥企業。」

億勝生物的2021財政年度業績公告可於本連結下載﹕https://www1.hkexnews.hk/listedco/listconews/sehk/2022/0322/2022032200781_c.pdf

關於億勝生物 (股份編號﹕1061)
億勝生物科技有限公司是一間專註於研發,生產和銷售基因工程藥物rb-bFGF(FGF-2)的生物製藥企業,自1998年起已有六種基因工程藥物在中國上市銷售。此外,公司還擁有一系列不含防腐劑單劑量滴眼液和適麗順®卵磷脂絡合碘膠囊等產品。公司產品主要應用於眼科及皮膚科處方葯領域的創傷修復及疾病治療,目前憑藉在中國主要城市的43個銷售推廣辦事處已成功覆蓋中國逾10,500家醫院。公司依託自身在生長因子和抗體領域的研發平台,擁有多個臨床階段的項目,涵蓋廣泛的領域和適應症。

傳媒查詢:
縱橫財經公關顧問有限公司(網址:http://www.sprg.com.hk
鄭松雪 +852 2864 4857 shelly.cheng@sprg.com.hk
李欣 +852 2114 4320 yan.li@sprg.com.hk
張鍶婷 +852 2114 4870 jill.cheung@sprg.com.hk
媒體關係media@essex.com.cn

投資者查詢:
投資者關係investors@essex.com.cn


News URL: https://www.acnnewswire.com/press-release/simplifiedchinese/73976/

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