【Company Research】InnoCare Pharma (9969 HK) – Orelabrutinib showed impressive efficacy in r/r-CLL/SLL

14. Impressive data update of orelabrutinib. At the first national lymphocyte disease academic conference of Chinese Medical Association (中华医学会第一次全国淋巴细胞疾病学术大会) held on 16-18 Apr 2021, InnoCare released orelabrutinib’s updated clinical data in a phase I/II (part II) study (NCT03493217) with 80 r/r-CLL/SLL patients treated with orelabrutinib 150mg QD achieving 21.3% CR and 93.9% ORR, while the pervious update at ASH2020 indicated 10% CR and 91.3% ORR. Furthermore, the median follow-up time was 25.6 months, and the PR rate was 61.3% (PR with lymphocytosis was 11.3%). Median time to response was 1.87 months, while neither PFS nor DOR was achieved. Orelabrutinib also showed good safety profile with low incidence of AEs, good tolerance and no atrial fibrillation. Other AEs due to BTKi off-target effect such as ≥G3 bleeding, hypertension and diarrhea were much lower. We believe the impressive efficacy and superior safety profile make orelabrutinib the potential best-in-class BTK inhibitor.

   

14. Entering into commercial stage with Orelabrutinib’s first NDA approval in China. In Dec 2020, Orelabrutinib (宜诺凯^®) obtained NMPA’s approval for treating r/r-CLL/SLL and r/r-MCL, which made Orelabrutinib the second-to-market domestic BTK inhibitor in China. CLL/SLL and MCL are the two major sub-types of NHL, accounting for approximately 8% of total NHL cases in China. Besides CLL/SLL and MCL, Orelabrutinib is also assessed for treatment of other types of NHLs in China, including WM (plan to file NDA in 1H22), MZL (pivotal trial to complete enrollment in 2H21), 1L CLL/SLL (Ph III ongoing), CNSL (Ph II ongoing), etc. In addition to oncology, InnoCare is exploring the use of orelabrutinib for various autoimmune diseases. Orelabrutinib is being assessed in a Ph IIa trial for SLE and a global Ph II trial for MS in the US, Europe and China.

   

14. Establishing strong commercial team. Given the approval by the NMPA, InnoCare started commercial sales of orelabrutinib in Jan 2021. InnoCare currently has a commercial team of over 150 members, covering more than 500 core hospitals in China. InnoCare plans to expand the commercialization team to 200 members covering over 900 hospitals by the end of 2021.

  

14. Highly differentiated pipelines driven by strong inhouse R&D capabilities. Besides orelabrutinib, InnoCare has three clinical stage assets incl. potential best-in-class pan-FGFR inhibitor ICP-192, potential first-in-class FGFR4 inhibitor ICP-105 and 2nd-generation pan-TRK inhibitor ICP-723. For ICP-192, early efficacy data of the Phase I/II clinical trials were promising. Of the 12 patients with FGF/FGFR gene aberrations who had completed at least one tumor assessment, the ORR was 33.3% including 1 cholangiocarcinoma patient (8.3%) achieving CR and 3 patients (25%) with PR.

  

14. Maintain BUY. Given the promising clinical data, we revised up forecasts for orelabrutinib and upgraded our TP from HK$21.71 to HK$24.59 (WACC: 9.1%, terminal growth rate: 5.0%).