Looking forward to an eventful 2020E
In 2019, Co. reported an adjusted loss of RMB1.1bn, mainly reflecting the R&D spending of RMB1.2bn
Co. expects 1 NDA approval(ivosidenib) and 5 NDA submissions for three core assets(PD-L1, avapritinib and pralsetinib) in 2020E
Maintain BUY on the delivery of numerous catalysts, and rNPV-based TP unchanged at HKD19.83
Eyeing on multiple NDA catalysts for TKI assets
Co. expected to receive ivosidenib NDA approval for IDH1m r/r AML from Taiwan FDA(TFDA) in 2020E. In addition, on Mar 30, Co. has submitted NDA to TFDA for avapritinib in unresectable or metastatic PDGFRA exon 18 mutant gastrointestinal stromal tumor (GIST)。 Noting FDA ok'd avapritinib NDA on Jan 9,2020, we think this should pave the path for its more NDA approvals across the Greater China area. In China, Co. expected to submit two avapritinib NDAS(PDGFRA exon GIST and 3L GSIT) in 2020E. Meanwhile, Co. expect to submit pralsetinib NDA for 2L RET+ NSCLC in 2H20 and target to dose first 1L RET+ NSCLC patient in 1H20E. With the great partnership with global peers, we think CStone's proven clinical capability should attract collaboration with more MNC names. we expect company to invest RMB1.2-1.4bn in R&D in 2020E, which should be well supported by its RMB2.7bn net cash at end-19.
On schedule for PD-L1 NDA submission in 2020E Co. target to submit CS1001's(PD-L1) NDA in China for cHL and NKTLin 2H20E. At 2019 ASH, the promising r/r-ENKTL data should enhance its PD-L1's approval outlook as the niche indication differentiated fromother approved PD-1/PD-L1, and likely help its PD-L1 to pursue a priority review from CDE to expedite its commercial availability, in our view.
Commercial and manufacturing capability on track In Dec 2019, Co. had a new head of commercial(with 26 yrs exp in MNCs) on board and planned to build up a c.200FTE commercial team.
Meanwhile, Co. is planning its manufacturing facility (100k sqm) in Suzhou with the planned capacity of 26kL for biologics and 1bn tablets/capsules for small molecule.
Maintain BUY with TP unchanged at HKD19.83We maintain BUY rating on CStone's leading clinical stage I/O backbone candidates, extensively experienced in -house clinical team, and strong BD capabilities and multiple R&D catalysts.