InnoCare Announces First Patient Dosed in Head-to-Head Registrational Phase III Trial of Mesutoclax with Azacitidine versus Venetoclax with Azacitidine in Treatment Naive AML in China

BEIJING, Nov. 08, 2026 (GLOBE NEWSWIRE) -- InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that the first patient has been dosed in registrational Phase III study of the Company's novel BCL2 inhibitor mesutoclax (ICP-248) in combination with azacitidine versus venetoclax with azacitidine in elderly or unfit patients with treatment naive (TN) acute myeloid leukemia (AML).

Mesutoclax is a novel, oral BCL2 inhibitor developed by InnoCare that can exert anti-tumor activity by selectively inhibiting BCL2 and restoring the normal apoptosis process in cancer cells. Mesutoclax has been granted two Breakthrough Therapy Designations (BTD) in China.

Mesutoclax is accelerating multiple clinical trials in B-cell lymphomas and myeloid malignancies, with five registrational clinical trials currently underway. The Phase III trial of mesutoclax with orelabrutinib in 1L CLL/SLL has completed patient enrollment. The registrational Phase II clinical trial of mesutoclax in BTK inhibitor-treated mantle cell lymphoma (MCL) has completed patient enrollment. The registrational Phase III Trial of Mesutoclax in Combination with Orelabrutinib in Relapsed / Refractory MZL was initiated in China. The registrational Phase III clinical trial of mesutoclax in combination with orelabrutinib in r/r MCL is ongoing in China. In addition, global clinical development of mesutoclax in AML and myelodysplastic syndrome (MDS) is accelerating in China, the U.S., and Australia. The study of mesutoclax in MDS has been selected for an oral presentation at the 68th American Society of Hematology (ASH) Annual Meeting, which will be held on December 12–15 in New Orleans, U.S. The study of mesutoclax in AML and B-cell malignancies have been selected as posters at the upcoming ASH respectively.

Data presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting demonstrated that mesutoclax in combination with azacitidine in patients with AML achieved outstanding efficacy and safety. As of April 13, 2026, among the evaluable TN AML patients, 81.8% achieved composite CR (cCR, CR+CRi). Among cCR responders, 83% achieved cCR in the first treatment cycle, demonstrating that the mesutoclax regimen enables rapid and deep remission. Among patients who achieved overall response, 86.5% were MRD (Minimal Residual Disease) negative. In terms of safety, no dose-limiting toxicities (DLTs) were observed, and the maximum tolerated dose (MTD) was not reached. Notably, both 30-day mortality and 60-day mortality were 0% among TN AML patients. At the recommended dose, the 6-month overall survival (OS) rate was 90.5%. Updated data will be presented at the 68th ASH Annual Meeting.

Dr. Jasmine Cui, the Co-founder, Chairwoman, and CEO of InnoCare, said, “As the first BCL2 inhibitor granted Breakthrough Therapy Designation (BTD) in China, mesutoclax has rapidly advanced across multiple clinical programs throughout China and globally, positioning it to become a globally competitive innovative therapy, further consolidating the Company’s leading position in hemato-oncology. We will continue to accelerate our clinical trials to provide better treatment options for more patients as soon as possible.”

AML is a malignant hematological disease originating from hematopoietic stem/progenitor cells. The risk of developing AML increases with age and is more common among older adults¹.

About InnoCare Pharma

InnoCare (HKEX: 09969; SSE: 688428) is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing innovative drugs for the treatment of cancers and autoimmune diseases, two therapeutic areas with unmet medical needs worldwide. InnoCare has established comprehensive innovation platforms for drug discovery. To date, the Company has developed a robust product pipeline comprising three approved drugs (orelabrutinib, tafasitamab and zurletrectinib), more than ten innovative drug candidates in clinical development, and multiple programs in preclinical stages. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States. For more information about InnoCare, please visit https://www.innocarepharma.com/en and follow us on LinkedIn.

¹ Technical Guideline for Clinical R&D of New Drugs for Acute Myeloid Leukemia