BEIGENE LTD(BGNE.US)：POSITIVE ALPINE BODES WELL FOR BRUKINSA‘S NEXT PDUFA

Co. announces positive topline results from final analysis of Brukinsa in ph3 ALPINE trial, showed superior PFS vs. Imbruvica
The full data is expected to be presented at an upcoming medical congress; the nearest possible meeting would be ASH in mid-Dec
We maintain SOTP-based TP at USD400. Maintain BUY as our top pick on Co.’s strong growth, multiple catalysts and BD capabilities
　　Positive ALPINE topline PFS results; Full data readout and PDUFA is the next major catalyst for Brukinsa
　　On Oct 13th, BeiGene announced positive topline results of Brukinsa from ph3 MRCT ALPINE trial (n=652, NCT03734016) for r/r CLL/SLL. The final analysis showed Brukinsa achieved superior PFS compared to J&J/AbbVie’s Imbruvica. This is the new supportive evidence on top of its positive final ORR analysis reported on Apr 11th. Safety profile at the final PFS analysis were consistent with prior reports. We believe the positive ALPINE results should further underpin its upcoming sNDA approval by FDA (PDUFA data on Jan 20th, 2023) for r/r CLL/SLL, which is a major indication in lymphoma space. Co. expects to present the full results at a medical congress and for publication. We think the nearest possible major meeting would be 2022 American Society of Hematology (ASH) during Dec 10-13 at New Orleans, LA.
　　Major catalysts in 2H22E-23E
　　Tislelizumab: 1) release of rescheduled PDUFA date for 2L ESCC in '22E; 2) multiple BLA filings in U.S./EU during '22-23E, including NSCLC/ESCC/GC/HCC; 3) sBLA approval of 1L ESCC in China in '23E; Zanubrutinib: 1) full data for ph3 ALPINE global head-to-head trial in r/r CLL/SLL in 2H22E/23E and 2) FDA sNDA approval for CLL/SLL, w/ PDUFA data on Jan 20th, 2023; Ociperlimab: Ph1 data from expansion cohorts in 2H22E.
　　Maintain BUY with SOTP-based TP remained at USD400
　　We maintain FY22E/23E financial forecast and SOTP TP unchanged. We retained 20% M&A premium on top of its derived equity valuation given Co.’s BD capability (cash-rich position of USD4.3bn in YE22E and proven track records) and potential global M&A recovery in 2H22E to help restore market sentiment. Investment risks: clinical delay/failure, lower- than-expected sales, regulatory risks, NRDL-driven price cut risk.
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   【免责声明】本文仅代表第三方观点，不代表和讯网立场。投资者据此操作，风险请自担。