CICC Maintains "Outperform" Rating on ASCENTAGE-B (06855) as POLARIS-1 Gains Approval in US and EU

Stock News11:57

CICC has reiterated its "Outperform" rating on ASCENTAGE-B (06855) with a target price of HK$89, citing positive progress in the company's R&D pipeline. The global Phase III study (POLARIS-1) for Olverembatinib (HQP1351) as a first-line treatment for Ph+ ALL has been approved by US FDA and European EMA, with promising preliminary data released. Additionally, APG-2575 (Lisaftoclax) demonstrated strong efficacy and safety in high-risk baseline populations, further validating the company's advancing internationalization strategy.

Key updates include: 1) POLARIS-1, a global registrational Phase III trial for Olverembatinib in 1L Ph+ ALL, received approvals from both FDA and EMA. 2) At the 2025 ASH Annual Meeting, the company presented multiple datasets, including an oral report on APG-2575's domestic Phase II registrational data and initial POLARIS-1 results.

POLARIS-1, now the second globally approved registrational Phase III study for Olverembatinib, showed impressive preliminary efficacy. As of July 18, 2025, the combination of Olverembatinib with low-intensity chemotherapy achieved a 94.3% CR/CRi rate within three months in 53 1L Ph+ ALL patients, with best MRD-negative and MRD-negative CR rates at 66.0% and 64.2%, respectively. CICC highlights Olverembatinib’s expanding indications and potential catalysts, including Takeda’s opt-in decision.

For APG-2575 in R/R CLL/SLL, the domestic registrational trial showed robust efficacy in high-risk subgroups. As of July 25, 2025, the ORR was 62.5% (72 patients), mPFS 23.89 months, and MRD negativity rate 21.8%. Notably, nearly half of patients had complex karyotypes, underscoring its therapeutic potential in poor-prognosis cases. Safety remained favorable with no TLS incidents reported.

Updated data from the APG2575AU101 study (APG-2575 + azacitidine) in myeloid neoplasms also showed promise: ORR 40.4% (47 R/R AML/MPAL patients), CR 29.8%, mPFS 7.6 months; and ORR 80.0% (15 untreated high-risk MDS/CMML patients), with CR and marrow CR rates at 40% each.

Risks include R&D setbacks, commercialization delays, competitive pressures, and partnership uncertainties.

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