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創新藥行業有望迎來多重拐點,看好頭部公司
uSMART盈立智投 01-05 10:40

今天(5日),國家醫保藥品目錄調整的現場談判正式開始。此次談判的藥品涉及腫瘤、罕見病、新冠病毒感染治療等上百種臨牀用藥。

展望2023年,機構看好頭部創新藥公司恆瑞醫藥、信達生物、百濟神州、榮昌生物、康方生物、諾誠健華、君實生物、再鼎醫藥等,關注重點品種潛在進展豐富的和黃醫藥、康諾亞、科濟藥業、亞盛醫藥、澤璟製藥、益方生物、貝達藥業、首藥控股等。

創新藥行業迎來多重拐點。21年7月以來,創新藥顯著跑輸恆生綜指,既有外部加息因素的困擾,也有內部定價不及預期、行業競爭加劇以及出海遭遇不順等多方面原因。經過一段時間的調整,行業迎來多方面改觀,政策面醫保談判規則進一步明確,鼓勵和加速創新藥進醫保的態度更加明確,行業面內部“出清”加速進行,構建多層次健康生態。2022年,創新藥領域迎來諸多突破,阿茲海默病、血友病、減肥領域進展矚目,個性化癌症mRNA疫苗也讀出IIb期臨牀結果,技術進步推動生物技術創新持續進行。國內企業也即將在2023年迎來多方面催化。

繼續看好新型生物技術和平臺型biopharma。回顧雙抗、ADC、GCT等領域發展歷程,從概念提出到產品上市這幾十年中,能夠順利突圍的企業除了在技術領域能力突出,還需要具備相匹配的臨牀開發能力、商業化能力以及國際化視野,因此繼續看好具有新型生物技術和平臺型企業。

免疫創新藥漸入佳境,國際化依然值得期待。自免及II型炎症類疾病全球市場中,TNF-α抑制劑銷售額仍位居前列,但近5年來,IL12/23、 IL17、JAK、IL4/13等新靶點藥物加速放量,市場規模快速擴張。近年來,諸多免疫類創新藥在國內加速獲批納入醫保,2021年以來,達必妥、可善挺在中國市場開始快速放量。預計2022年達必妥、可善挺在國內銷售額有望達到20億和35億。

重點公司2023年展望:創新藥行業迎來多重拐點,展望2023年,我們看好頭部創新藥公司$恆瑞醫藥(600276.SH)$、$信達生物(01801.HK)$、$百濟神州(06160.HK)$、$榮昌生物-B(09995.HK)$、$康方生物-B(09926.HK)$、$諾誠健華-B(09969.HK)$、$君實生物(01877.HK)$、$再鼎醫藥(09688.HK)$等,關注重點品種潛在進展豐富的$和黃醫藥(00013.HK)$、$康諾亞-B(02162.HK)$、$科濟藥業-B(02171.HK)$、$亞盛醫藥-B(06855.HK)$、$澤璟製藥-U(688266.SH)$、$益方生物-U(688382.SH)$、$貝達藥業(300558.SZ)$、$首藥控股-U(688197.SH)$等。

風險提示:

行業政策風險:因行業政策調整帶來的研究設計要求變化、價格變化、帶量採購政策變化、醫保報銷範圍及比例變化等風險;研發不及預期風險:新藥在研發過程中,從藥物發現、臨牀前研究、臨牀試驗到商業化上市,既存在因企業技術、流程等不達標可能面臨的問題,也存在與監管方溝通不及時,不合規等風險;銷售不及預期風險:藥物上市後在銷售過程中會受到可能的疫情影響、物流運力不足、生產產能不足等風險;核心技術人員變動風險;市場競爭加劇風險;供應鏈風險;出海情況不及預期風險。

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