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康希諾(06185.HK)近期交流紀要
uSMART盈立智投 09-17 14:29

康希諾(06185.HK)近期交流紀要

總結:

1.上半年新冠疫苗的國內附條件上市,墨西哥、巴基斯坦、智利、阿根廷、馬來西亞等國的EUA,海外出口原液,在當地進行罐裝,當地完成生產。

2.二價腦膜炎、三價多糖疫苗三期臨牀,新冠擴展年齡組、加強針研究和吸入疫苗的研究。股權激勵計劃正在落實,包含約400人。

3.產能方面,上半年天津滿產,上海預計10-11月有產品下線。明年銷售預期13億元,2億MCV2,預計MCV2和MCV4的國內市場佔有率峯值30%。公司認爲兩到三年內MCV2可能變成一類苗。

Q&A:Q:現在新冠疫苗的臨牀數據情況?

注射劑數據:初免6個月有效率70%,6個月加強針,抗體增加8倍,再過6個月也能保持初免28天水平。吸入劑:臨牀數據已經獲得,現在在申請有條件上市,原液是一樣的,機型不一樣。變異毒株抗體滴度下降在4倍以內,如果抗體下降在4倍以內是不需要再次研發,接種加強針即可。Q:上半年新冠疫苗銷量多少?有沒有降價?

10-20美金海外價格,20億元的銷售收入國內國外一半一半,明年有降價可能,未來大趨勢是按人份定價,可能是隻要1針。國內上半年大概發了1000多萬劑。吸入劑理論上副作用比肌肉注射副作用更低,比如紅腫等。未來國家規劃是要求大家打加強針,目前來看更可能是異源加強。Q:預計 MCV2、MCV4 疫苗今年年內獲批?

原計劃三季度,藥監局優先新冠審批,延後至年內獲批。4價銷售推廣與輝瑞合作,其中輝瑞有700人團隊、自身200-300人團隊幫助推廣。2價推廣還是自己做。4 價比國內其他多糖的有效,主要是公司結合疫苗的蛋白設計階段優化較多。Q:新平臺開發情況?

mRNA在做,還沒有臨牀。腺病毒平臺目前沒有應用在細胞治療的打算。Q:PCV13i疫苗4月三期臨牀,什麼進展?

年內入組完成,明年完成三期臨牀。CRM197載體(白喉毒素突變體載體)和TT載體之間雙胳膊不衝突,AC腦膜炎和13家肺炎球菌多糖蛋白結合疫苗。未來是公司自身推廣,不會與輝瑞合作。康希諾在與其他疫苗共注射上有優勢。Q:腺病毒原材料?

病毒培養需要監管審批,公司腺病毒原材料自產。因爲上遊原料(反應袋)替換問題,上半年作廢上千萬劑原液。Q:海外國家選擇新冠疫苗看什麼?

首先是認證情況,其次是公司的產品口碑和pipeline。馬來西亞附條件批準、巴基斯坦、墨西哥、智利、阿根廷、印尼 EUA 等地。Q:產能利用率情況?

上半年天津滿產,上海預計10-11月有產品下線。明年銷售預期13億元,2億 MCV2,預計MCV2和MCV4的國內市場佔有率峯值30%。預計2-3年MCV2可能變成一類苗。

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