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      CStone Pharmaceuticals (2616 HK) - Positive clinical data at 2019 CSCO

      作者: Hayden Zhang,Sam HU,Marcella Cheung
      時間: 2019年10月04日
      重要性: 一般報告
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      摘要: Report title:CStone Pharmaceuticals (2616 HK) - Positive clinical data at 2019 CSCO
      Analyst:Hayden Zhang,Sam HU,Marcella Cheung
      Report type:Company

      ■ 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 HK$19.83

      Company on track to deliver R&D catalysts for its three TKI assets
      CStone has submitted NDA for Ivosidenib (TIBSOVO) in Taiwan, and expects the drug to be launched in 2020E. In addition, we learned Ivosidenib has commenced first 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 Ia/Ib 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-301&302 (for Stage III&IV NSCLC), Co. expected the trials data available in 2020E. Besides, we learned that a Phase III 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 T1/2 of 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, NCT03809767) for advanced solid tumors & lymphoma and released positive preliminary efficacy data in Phase Ia stage (ORR=18.8% (3/16), DCR=43.8% (7/16)), and supportive safety with overall Grade≥3 irAE at 15.8% (3/19). In addition, a Phase III SoC-combo trial for 1L HCC will start by end-2019.

      Maintain BUY and rNPV-based TP unchanged at HK$19.83
      We maintain BUY rating on CStone’s leading clinical stage IO backbone candidates, extensively experienced in-house clinical team and strong BD capabilities.

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