Zanubrutinib achieved superior PFS versus ibrutinib: After market close on 12 October, BeiGene (6160 HK/HK$76.80; BGNE US/US$151.30, BUY) announced zanubrutinib’s superior progression-free survival (PFS) versus ibrutinib in R/R CLL/SLL (relapsed or refractory chronic lymphocytic leukemia/ small lymphocytic lymphoma) with a consistent safety profile. The mgmt will further present the detailed topline data at a medical congress. As Zanubrutinib has proved its superiority in ORR (Link) and PFS as well as safety versus ibrutinib in CLL/SLL, while acalabrutinib from AstraZeneca has only demonstrated its non-inferior PFS versus ibrutinib (Link), we believe zanubrutinib is the globally best-in-class BTKi, and will further penetrate the US NHL (non-hodgkin lymphoma) market after its potential approval in CLL/SLL indication from FDA on the target PDUFA date of 20 January 2023.
　　We expect zanu’s sales in the US CLL/SLL market to be BeiGene’s next growth driver. Before zanu’s announcement of its superior PFS result, the NCCN Guidelines have already included zanubrutinib as one of the CLL/SLL’s preferred treatment regimens in the updated version. Besides, BeiGene has a 250-strong salesforce in the US specialised in lymphoma market. We believe zanubrutinib will achieve a quick sales ramp-up after its launch in the US.
　　CLL/SLL a large market to tap into. According to Leukemia & Lymphoma Society, CLL/CLL accounts for nearly 7% of the total NHL patients, while zanu’s other three indications, namely MZL (marginal zone lymphoma), MCL (mantle cell lymphoma), and WM (waldenstrom Macroglobulinemia) account for 7%, 3% and less than 1% of the NHL patients. Hence, zanu’s potential approval of CLL/SLL will largely improve its market share in the US NHL market.
　　Multiple catalysts in the near term. (i) Zanubrutinib: US FDA PDUFA date of January 2023 for CLL/SLL; (ii) Tislelizumab (PD-1): we expect its US FDA PDUFA date is in 1H23 for 2L ESCC; BLA filings to US FDA for 1L GC, 1L ESCC and 1L HCC in 2023; (iii) Ociperlimab (TIGITi): PhI data readouts for multiple solid tumours in 4Q22; (iv) BGB-11417 (BCL-2i): initiate registrational clinical trial in 4Q22.