Blueprint marked two key FDA NDA’s milestones for avapritinib and pralsetinib, shaping the outlook for their later NDA in China
CS1001 reported a promising 33.3% CR rate and good safety profile in patients with r/r extranodal natural killer/T-cell lymphoma
Maintain BUY on the delivery of numerous catalysts, and rNPV- based TP unchanged at HKD19.83
Enhancing NDA prospective for CStone’s TKI assets
On 9 Jan, FDA granted a NDA approval for avapritinib for patients with unresectable or metastatic gastrointestinal stromal tumor （GIST）， based on the Phase 1 NAVIGATOR trial with an 84% ORR （with 7% CR and 77% PR） and a median duration of response （DOR） not reached. Of note, avapritinib became the first precision therapy for patients with PDGFRA exon 18 mutation GIST, a genomically defined population which previously had very limited treatment options. Meanwhile, on 8 Jan, Blueprint initiated rolling NDA submission to FDA for pralsetinib for 2L RET fusion+ NSCLC, based on ARROW study with a 61% ORR and median DOR not reached （with 73% ORR and 12% CR in treatment- naive patients）. As Blueprint’s key collaborator in China, CStone expected to submit NDAs to CDE for these two molecules by end- 2020E, thanks to solid R&D and regulatory achievements in the U.S. and good trial enrolment progress in China.
Promising CS1001’s data in r/r-ENKTL likely to expedite its commercial availability
In Dec 2019, CStone updated results from CS1001-201 trial at 2019 ASH. The preliminary efficacy data showed 43.3% ORR （with 33.3% CR） with median DOR not reached and a benign safety profile. Co. explained ENKTL represents for c.6% of all lymphoma incidence and r/r-ENKTL patients still lack effective treatment options （with targeted monotherapy only produces <10% CR）. Co. expected to file CS1001’s NDA to CDE in 2H20E. We think the promising data in the niche indication should differentiate from other approved PD-1/PD-L1, and help CS1001 to pursue a priority review from CDE to expedite its commercial availability.
Maintain BUY with TP unchanged at HKD19.83
We maintain BUY rating on CStone’s leading clinical stage I/O backbone candidates, extensively experienced in-house clinical team, and strong BD capabilities. In addition to its solid R&D catalysts, we think the recent BGNE-AMGEN collaboration might also give investors a new reason to warm up to decent Chinese biotechs in 2020E for potential value unlocked from tie-up with MNCs.