普萊柯(603566.SH)：獲得新獸藥註冊證書
格隆匯2月13日丨普萊柯(603566.SH)公佈，根據《獸藥管理條例》和《獸藥註冊辦法》規定，經農業部審查，批准公司及子公司洛陽惠中生物技術有限公司等單位共同申報的“兔病毒性出血症、多殺性巴氏桿菌病、產氣莢膜梭菌病(A型)三聯滅活疫苗(VP60蛋白+SC0512株+LY株)”為三類新獸藥，農業農村部於近日公示了核發《新獸藥註冊證書》(農業農村部公告第266號)的事項。
獸藥名稱：兔病毒性出血症、多殺性巴氏桿菌病、產氣莢膜梭菌病(A型)三聯滅活疫苗(VP60蛋白+SC0512株+LY株)；註冊分類：三類；主要成分：重組兔出血症病毒VP60蛋白、兔多殺性巴氏桿菌SC0512株、兔產氣莢膜梭菌(A型)LY株。作用用途：用於預防兔病毒性出血症(兔瘟)、兔多殺性巴氏桿菌病和兔產氣莢膜梭菌病(A型)。免疫期為6個月。用法用量：皮下注射。45日齡以上兔，2.0ml/只。
該產品於2016年3月31日向農業農村部首次提交臨牀試驗申請，經後續臨牀試驗、新獸藥註冊等階段，農業農村部於近日公告核發新獸藥註冊證書。截至目前，該產品開發累計投入研發費用486.82萬元。
兔病毒性出血症、兔多殺性巴氏桿菌病、兔產氣莢膜梭菌病(A型)是養兔業所面對的三種主要傳染病，均具有發病急、傳染性強、死亡快等特點。其中兔病毒性出血症是由兔出血症病毒(Rabbit Hemorrhagic Disease Virus，“RHDV”)所引起的一種急性、烈性、高度接觸性、致死性傳染病，給養兔業帶來巨大的經濟損失。針對該類疫病防控主要依靠疫苗接種，臨牀上均以傳統組織滅活疫苗為主，但存在以下缺點：生產中使用強毒，需要配套負壓動物房，生物安全性差；生產工藝複雜，雜蛋白含量高，副反應大；用於抗原製備的抗體陰性兔日漸稀有，導致生產成本處於上升趨勢。
公司利用新一代基因工程技術開發的兔病毒性出血症、多殺性巴氏桿菌病、產氣莢膜梭菌病(A型)三聯滅活疫苗(VP60蛋白+SC0512株+LY株)具有以下優勢：1、採用基因工程技術構建可高效表達的RHDV-VP60蛋白的重組桿狀病毒，表達產物產量高，可組裝成病毒樣顆粒，免疫原性好；2、採用國內流行的兔多殺性巴氏桿菌菌株和產氣莢膜梭菌，預防效果好；3、一針三防，降低接種的人工成本，減少應激反應次數；4、疫苗使用鋁膠佐劑，有效降低副反應。
截至目前，公司從公開渠道未能查詢到市場上流通的同類產品的銷售情況及具體市場份額。
按照《獸藥管理條例》、《獸藥產品批准文號管理辦法》等相關規定，該產品在上市之前，還應取得農業部核發的獸藥產品批准文號，預計1至3個月能夠獲得獸藥產品批准文號。
該新獸藥證書的取得是公司持續重視科技創新、加大研發投入的結果，進一步體現了公司的創新實力，同時也豐富了公司的產品結構。該產品的開發，有效提升了公司在行業內的競爭力，將為公司帶來新的業績增長點。
Follow us
Find us on
Facebook,
Twitter ,
Instagram, and
YouTube or frequent updates on all things investing.Have a financial topic you would like to discuss? Head over to the
uSMART Community to share your thoughts and insights about the market! Click the picture below to download and explore uSMART app！
Disclaimers
uSmart Securities Limited (“uSmart”) is based on its internal research and public third party information in preparation of this article. Although uSmart uses its best endeavours to ensure the content of this article is accurate, uSmart does not guarantee the accuracy, timeliness or completeness of the information of this article and is not responsible for any views/opinions/comments in this article. Opinions, forecasts and estimations reflect uSmart’s assessment as of the date of this article and are subject to change. uSmart has no obligation to notify you or anyone of any such changes. You must make independent analysis and judgment on any matters involved in this article. uSmart and any directors, officers, employees or agents of uSmart will not be liable for any loss or damage suffered by any person in reliance on any representation or omission in the content of this article. The content of the article is for reference only and does not constitute any offer, solicitation, recommendation, opinion or guarantee of any securities, virtual assets, financial products or instruments. Regulatory authorities may restrict the trading of virtual asset-related ETFs to only investors who meet specified requirements. Any calculations or images in the article are for illustrative purposes only.
Investment involves risks and the value and income from securities may rise or fall. Past performance is not indicative of future performance. Please carefully consider your personal risk tolerance, and consult independent professional advice if necessary.
