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CStone Pharmaceuticals (2616 HK) - A value laggard

作者: Hayden Zhang,Warren DAI
時間: 2020年06月03日
重要性: 一般報告
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摘要: Report title:CStone Pharmaceuticals (2616 HK) - A value laggard
Analyst:Hayden Zhang,Warren DAI
Report type:Company
Date:20200603
[Summary]

■ At ASCO2020, Co. and its partner Blueprint reported promising clinical data across multiple clinical assets
■ With solid R&D delivery, we think CStone is a clear laggard in biotechs (stock fell 16% YTD vs. biotech peer’s avg. ~30% YTD gain)
■ Maintain BUY on Co.’s numerous clinical and regulatory catalysts in 2020E, and rNPV-based TP unchanged at HKD19.83

Pralsetinib (RETi) gets FDA priority review
At ASCO2020, pralsetinib presented positive registrational data for RET+ NSCLC from ARROW trials (n=116). The data shows 61% ORR in patients (pts) received platinum-based chemotherapy and 73% ORR (12% CR) in treatment-na?ve pts, along with consistent well-tolerated safety profile. The median DoR was not reached (95% CI: 11mo, not reached) and the 6mo DoR was 86%. The FDA and EMA have accepted pralsetinib’s NDA for locally advanced or metastatic RET+ NSCLC. In addition, FDA has granted priority review with a PDUFA data on Nov. 23. We are optimistic about its approval as the data shows comparable results to FDA’s lately accelerated approval of Lilly’s selpercatinib for RET+ NSCLC and thyroid cancer. We believe the potential FDA’s approval should enhance its regulatory outlook in China.
CS1001 eyes on top-line data for 1L NSCLC in 2H20E
Co. also released updated efficacy data of CS1001’s ph1b study (n=41) for 1L nsq-NSCLC (47.6% ORR, 6.5mo mPFS, 8.7mo mDoR) and 1L sq-NSCLC (75.0% ORR, 8.4mo mPFS, 6.4mo mDoR) with a benign safety profile. Co. has completed enrollment for ph3 study and expect to announce top-line data in 2H20E. We think the positive ph1 data in both 1L sq- and nsq-NSCLC should enhance its commercial outlook for competitor to domestic PD-1 names, in particular in lung cancer space. Meanwhile, we believe the promising r/r-ENKTL data at ASH19 should has meaningfully differentiation over rivals in NMPA’s review process.
Catch the laggards in the biotech space
Co. expects 1 NDA approval (ivosidenib) and 5 NDA submissions for three core assets (PD-L1, avapritinib and pralsetinib) in 2020E. We thus advise investors to start paying attention to value laggards in the biotech space, which is due to rerate. We maintain BUY rating on CStone’s leading clinical stage I/O backbone candidates, extensively experienced in-house clinical team, and strong BD capabilities.

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