We attended 2019 CSCO in Xiamen and CStone's Investors & Analysts Presentation Day last week
Company updated its R&D progress with positive clinical data for its three I/O backbone assets' in various indications
Maintain BUY on the delivery of numerous catalysts, and rNPV-based TP unchanged at HKS19.83
Company on track to deliver R&D catalysts for its three TKl assets CStone has submitted NDA for lvosidenib（TIBSOVO） in Taiwan, and expects the drug to be launched in 2020E. In addition, we learned lvosidenib has commencedfirst human dose in a registrational trial for 1L IDH1m AML in China in Jul.
　　Meanwhile, Avapritinib （BLU-285） has started first human dose in two registrational trials for 3L GIST（in Jul） and PDGFRa D842V mutated GIST（in Aug） in China. Meanwhile, Pralsetinib （BLU-667） has started first human dose in a registrational trial for 2L NSCLC in China in Aug. Co. expected to complete the enrolment of abovementioned trials in 2020E. We think these R&D progresses are on track and expect these assets to commercialize in 2021-23E.
　　Positive clinical data at 2019 cScO CS1001（anti-PD-L1 mAb）， Gemstone 101 （NCT03312842） showed positive Phase la/lb trial data in 4 cohorts:a） chemo-combo for ESCC reached ORR=77.8%（14/18）， DCR=88.9%（16/18）；b） chemo-combo for 1L GC/GEJ reached ORR=62.1%（18/29）， DCR=82.8%（24/29）；c） monotherapy for CC/GBC reached ORR=10.3%（3/29）， DCR=37.9%（11/29）；d） and monotherapy for MSI-H/dMMR reached ORR=38.1%（8/21）， DCR=57.1%（12/21）。 Meanwhile, for Gemstone-3018302（for Stage lll&V NSCLC）， Co. expected the trials data available in2020E. Besides, we learned that a Phase ll chemo-combo trial for 1L EC will be initiated by year-end 2019.
　　CS1002（anti-CTLA-4 mAb） showed positive safety profile in Phase I trial（CS1002-101, NCT03523819） with no dose-limiting toxicity （DLT） or treatment-related SAE, and demonstrated acceptable dose-proportional PK profile with T1/2of 12～15 days. Mgmt. stated they will later focus on combination trials with CS1003 in patients with solid tumors（Phase Ib）。
　　CS1003（anti-PD-1 mAb） is currently in a China Phase I bridging study （CS1003-102, NCTO3809767） for advanced solid tumors & lymphoma and released positive preliminary efficacy data in Phase la stage （ORR=18.8%（3/16）， DCR=43.8%（7/16））， and supportive safety with overall Grade23 irAE at 15.8%（3/19）。 In addition,a Phase ll SoC-combo trial for 1L HCC will start by end-2019.
　　Maintain BUY and rNPV-based TP unchanged at HK$19.83We maintain BUY rating on CStone's leading clinical stage I0 backbone candidates, extensively experienced in-house clinical team and strong BD capabilities.