Co. announced an interim analysis showed sugemalimab has met primary endpoint at registration study for stage III NSCLC pts
Co. expects 2021E to be an eventful year (i.e. 4-5 NDA approvals; 5+ NDA filings; deepening collaboration with Pfizer, etc.)
We continued to flag CStone as a decent overlooked play in the biotech space, w/ multiple NT catalysts ahead. Reiterated BUY
Global first αPD-L1 mAb covers both stage III/IV NSCLC
The positive interim analysis was based on GEMSTONE-301 study (n=402) for stage III NSCLC patients (~1/3 NSCLC pts are diagnosed at stage III, as per AZ) without disease progression after concurrent or sequential chemoradiotherapy (CRT). The findings showed sugemalimab met its PFS primary endpoints reviewed by the independent Data Monitoring Committee (iDMC), with consistent safety profile. Data details will be presented at an upcoming academic conference in 2H21E. Besides the expected approval of stage IV NSCLC in 2H21E, Co. plans to file NDA to NMPA for stage III NSCLC in 2H21E and EQRx is advancing toward NDA submissions to FDA for both stage III and IV NSCLC in 2H21E/22E.
Well-positioned in the global stage-III NSCLC market
Currently, AZ’s durvalumab (Imfinzi) is the only FDA approved αPD-1/L1 class drug for stage III NSCLC based on PACIFIC trial but only covers concurrent CRT pts (~30% of stage III NSCLC pts in China; ~50% in the U.S. and EU, as per mgmt.). Of note, those pts in the PACIFIC (mOS data was 47.5mo vs 29.1mo for placebo, per ESMO20) received durvalumab for up to 12mo (GEMSONE-301 up to 24mo), reflecting a potential of longer median treatment course than stage IV treatment (KEYNOTE024’s 5yr data shows pembrolizumab median treatment duration for 1L stage IV NSCLC was 7.9mo, as per J Clin Oncol 2021). We believe the positive interim data enhances sugemalimab’s commercial outlook, thanks to its differentiated clinical strategy in less crowded stage III NSCLC space and a potential approval with much wider indication over duravlumab.
2021E to be an eventful year
Multiple catalysts ahead: 1) sugemalimab’s first NMPA’s NDA approval in 2H21E for 1L sq-/nsq-NSCLC; potential NDA submission in the U.S. by EQRx; 2) Ivosidenib’s NDA approval by 2021E, following pralsetinib and avapritinib’s NDA approval in Mar; 3) two “pipeline 2.0” INDs, CS5001 (a ROR1 ADC) and CS2006 (a multi-specific targeting PD-L1x4-1BBxHSA).
Maintain BUY, SOTP-based TP maintained at HKD19.1
SOTP-TP unchanged at HKD19.1. Co. is at the forefront of transformation from a biotech to a multi-commercial products biopharma. Maintain BUY.