三生製藥(01530.HK)：貝伐珠單抗生物類似藥IND申請於中國大陸獲受理
格隆匯 9 月 14日丨三生製藥(01530.HK)宣佈，貝伐珠單抗生物類似藥SB8(公司研發代號：615)的IND申請已獲中國藥品監督管理局受理。根據三生製藥與三星Bioepis在2019年1月7日宣佈的合作協議，三生國健將負責該產品在中國大陸的臨牀研發和商業化。該產品已於2020年8月19日獲得歐盟批准上市，用於多種癌症治療，包括轉移性結直腸癌、轉移性乳腺癌、非小細胞肺癌、晚期/轉移性腎細胞癌，以及上皮性卵巢癌、輸卵管癌、原發性腹膜癌和宮頸癌。
2019年歐洲腫瘤內科學會年會(ESMO)上公佈了SB8III期臨牀研究的結果。該研究以隨機、雙盲、多中心的形式開展，在763名轉移性或複發性非鱗狀非小細胞肺癌(NSCLC)患者中針對SB8和Avastin的療效、安全性、藥代動力學和免疫原性做了比較。數據顯示，SB8在療效、安全性、藥代動力學和免疫原性方面與Avastin沒有臨牀意義的差異。
據瞭解，貝伐珠單抗生物類似藥在中國的適應症將針對轉移性結直腸癌和非小細胞肺癌。國家癌症中心數據顯示，2015年我國結直腸癌新發病例37.6萬，死亡病例19.1萬(發病率26.6╱每十萬人，死亡率13.5╱每十萬人)；結腸癌的發病率上升顯着，且城市地區遠高於農村，多數患者發現時已屬於中晚期；而肺癌是中國發病率和死亡率最高的癌症，2015年新發病例73.3萬人，死亡病例61.0萬人。(發病率51.9╱每十萬人，死亡率43.2╱每十萬人)。超過85%的肺癌病例為非小細胞肺癌。根據弗若斯特沙利文報告，從2019年開始，中國貝伐珠單抗生物類似藥市場的銷售收入預計將以343.5%的複合年增長率增長，2023年這一市場規模約為人民幣64億元，而到2030年，中國貝伐珠單抗生物類似藥的市場規模將達人民幣99億元。
三生製藥董事長婁競博士表示："三生製藥期待加快SB8在中國的臨牀研發，擴大三生製藥在腫瘤領域的產品組合。三生製藥將通過內部研發和戰略合作，繼續加強其在生物製藥領域的領導地位，更快地將高質量的急需產品推向中國和國際市場。"
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