翰森製藥(03692.HK):中國創新藥企,大病慢病龍頭,,給予“買入”評級
機構:國金證券
評級:買入
基本結論
公司首仿藥起家,製劑出口與創新並進。公司前身江蘇豪森於1995年在連雲港成立,主要從事仿製藥(首仿為主)及創新藥的研發、生產與銷售。目前公司產品涵蓋抗腫瘤、CNS、抗感染、糖尿病等領域,已成為國內為數不多的以研發為核心驅動力的中國創新藥企之一。再者,公司佈局多年的創新藥領域步入收穫階段,逐漸有氟馬替尼、聚乙二醇洛塞那肽等新產品上市,形成仿創結合的局面。迎來創新奇點,類比14年恆瑞,藉助於醫保談判新藥放量有望更快。同時,公司海外ANDA陸續獲批,製劑出口未來可期。
集採風險短期可控,在研仿製藥管線豐富,有望整體平穩過度。公司現有已上市仿製藥品種收入較為集中,奧氮平片、培美曲塞注射液、以及吉西他濱注射液合計收入佔比超50%。目前奧氮平片和培美曲塞注射液被納入全國帶量採購目錄,我們預計短期影響相對可控,長期仍需新品上市彌補集採影響。仿製藥在研管線豐富,主要集中在CNS、腫瘤、心腦血管、糖尿病等重要領域,包括帕利哌酮、氟維司羣、來那度胺、利伐沙班等重磅品種。
In-House創新藥陸續獲批上市,預期阿美替尼即將獲批,新藥在研管線可期。公司是國內為數不多In-House研發創新藥的龍頭公司,目前已有嗎林硝唑、聚乙二醇洛塞那肽、氟馬替尼等新品逐步獲批上市,同時公司重磅新藥非小細胞肺癌三代EGFRTKI抑制劑阿美替尼預計即將上市,以上新藥預計今年整體放量,驅動公司業績穩健增長。我們預計阿美替尼有望實現銷售峯值超40億元,聚乙二醇洛塞那肽有望實現銷售峯值超25億,氟馬替尼有望實現銷售峯值超10億。在研管線當中,包括處於三期臨牀的TAF新藥(HS-10234)、腎性貧血新品培化西海馬肽、以及小分子抗腫瘤品種。另外,公司Licensein合作進展順利,引進血液瘤領域抗CD19單抗Inebilizumab,對外License業務進一步豐富公司產品線,未來可期。
盈利預測與估值:
公司在研管線豐富,創新藥陸續獲批上市(聚乙二醇洛塞那肽、氟馬替尼、阿美替尼等),業績穩健增長,長期看好。預計未來三年EPS為0.43/0.54/0.65元,對應PE分別為54.9/44.3/36.6倍,新藥管線估值預計約550-600億元,整體公司對應估值約1600億元。首次覆蓋,給予“買入”評級。
風險提示:
產品線過於集中風險;注射劑一致性評價影響存在不確定性;創新藥研發進度存在不確定性;國家帶量採購存在不確定性;Me-too創新藥競爭激烈。

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