Ivosidenib’s global AGILE met primary endpoints, adding supports for its label expansion and NDA approval in China
Co.’s R&D validated by Pfizer collaboration and EQRx Nasdaq listing (4QE) which late-stage pipeline backed by Co.’s sugemalimab
We continued to flag CStone as a decent overlooked play in the biotech space, w/ multiple NT catalysts ahead. Reiterated BUY
Ivosidenib global AGILE study met primary endpoint
Servier, CStone’s partner on ivosidenib development, announced the global ph3 AGILE study for ivosidenib has met primary endpoint of event- free survival (EFS) for 1L IDH1-mutated acute myeloid leukemia (AML).
Servier reported the treatment combo (ivosidemab plus azacitidine) demonstrated a statistically significant improvement in EFS over placebo (azacitidine plus placebo). The study also met all the secondary endpoints including complete remission rate, OS, CR and complete remission with partial hematologic recovery rate (CRh rate) and ORR. The safety profile was consistent with previous published data. Based on the positive results, the AGILE study was halted further enrolment on the recommendation of the Independent Data Monitoring Committee (IDMC).
Servier plans to present full analysis of the AGILE trial at a future medical conference.
Ivosidenib on course for market approval in China
Ivosidenib is currently approved in the U.S. as monotherapy for IDH1- mutant r/r AML. In addition, ivosidenib's has been granted priority review by the FDA for 2L IDH1-mutated cholangiocarcinoma. In China, the NMPA has accepted the ivosidenib’s NDA for r/r AML patients who have a susceptible IDH1 mutation and this NDA has been granted priority review.
Based on the recent positive AGILE study, CStone plans to submit NDA to NMPA for 1L IDH-1 mutated AML in 2022E.
R&D strength validated by Pfizer collaboration extension
CStone and Pfizer in 3Q20 forged a strategic partnership for development and commercialization CStone’s sugemalimab (PD-L1 inhibitor) in mainland China. In Jun 15, Pfizer extended its collaboration with CStone on development of lorlatinib (3rd Gen ROS1/ALK TKI) for 1st global pivotal study in ROS1+ NSCLC patients. We believe the extension of collaboration reflects Pfizer’s trust on CStone’s clinical R&D strength.
Expecting a fruitful 2H21E and maintain BUY at HKD19.1
Major catalysts in 2H21E: 1) sugemalimab 1st China NDA approval; potential US NDA submission by EQRx; 2) ivosidenib’s China NDA approval. The SOTP-TP is unchanged at HKD19.1. Co. is at the forefront of transformation from a biotech to a biopharma. Maintain BUY.