| 作者： | Hayden Zhang,Warren DAI |
| 时间： | 2020年08月24日 |
| 重要性： | 一般报告 |
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| 阅读权限： | 该文章钻石卡、金卡、银卡客户可阅读全文 |
| 摘要： | Report title:InnoCare Pharma (9969 HK) - Orelabrutinib on track for regulatory approval in 4Q20E Analyst:Hayden Zhang,Warren DAI Report type:Company Date:20200824 [Summary] ■ Co. reported 1H20 adj. net loss of RMB85mn, mainly reflecting R&D spending and rising selling expenses ■ Mgmt. guided orelabrutinib remains on track for regulatory review and expects to receive NDA approvals from NMPA in 4Q20E ■ We kept SOTP-based TP unchanged at HKD17.9, and maintain BUY on its NT regulatory catalyst and expanding in-house pipelines 1H20 net loss as expected Innocare reported 1H20 adjusted loss of RMB85mn, excluding the SBC expenses (RMB160mn) and the fair value change from the conversion of preferred shares (RMB142mn). Such loss was primarily due to steady ex-SBC R&D expenses (RMB78mn vs. RMB64mn in 1H19) and rising selling expenses (RMB7mn vs. RMB1mn in 1H19). ICP-022 remains on track for NDA approval in 4Q20E Co. expects a closer pre-approval on-site inspection by NMPA in Sept for orelabrutinib (ICP-022, BTK inhibitor), and eyes on the potential NDA approvals for r/r CLL/SLL and r/r MCL in 4Q20E. The timeline is still in line with mgmt.’s prior target of orelabrutinib’s market launch in 2020E. Co. has built a commercial team of ~40 sales reps and aims to expand to 120-140 reps by end-2020 with a coverage of 300 major hospitals nationwide. We also noted Co.’s continuous efforts in BTK’s indication expansion and combo opportunities: 1) ongoing registrational trials for r/r WM and 1L CLL/SLL in China; 2) early-stage basket trials for combo with MIL-62 (a 2nd generation anti-CD20 mAb akin to obinutuzumab, as per mgmt.); 3) completion of ph1 basket trial in the U.S. by end-2020E. Multiple INDs ahead to widen Co.’s R&D pipelines Co. flagged multiple pre-clinical stage assets with first-in-class potential, which are planned for IND filings in 2021E: 1) ICP-332 (TYK2) for autoimmune disease; 2) ICP-189 (SHP2) for solid tumors; and 3) ICP-490 (E3 Ligase) for haematology. Co. expects these assets to add potential synergy benefit with its existing pipeline in combo optionality and commercial strategy. Meanwhile, we think the recent IPO proceeds should offer external BD opportunities to widen Co.’s pipelines. Maintained BUY, SOTP-based TP unchanged at HKD17.9 Co.’s NT catalysts include ICP-022’s 1) NDA approvals for r/r CLL/SLL and r/r MCL in 4Q20E and 2) 12mo follow-up data readout for both indications at ASH20. Despite NRDL rule updates likely accelerating inclusion timeline of peer‘s BTKi, we think a dynamic NRDL inclusion should also reward Co.’s BTKi in the long run, thanks to its consistent efforts in indication expansion and combo strategy. Maintain BUY. |
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