HQP1351

Innovent Biologics and Eli Lilly announce a Distribution and Promotion Agreement for Lilly's non-covalent BTK inhibitor, Jaypirca®, in Mainland China. Innovent will handle importation, marketing, distribution, and promotion, while Lilly will manage R&D and post-market medical affairs. Jaypirca®, approved by the U.S. FDA in January 2023 and China's NMPA in October 2024, is the first non-covalent BTK inhibitor for mantle cell lymphoma patients previously treated with covalent BTK inhibitors.

Olverembatinib shows potential as a safe and effective second-line treatment for chronic-phase chronic myeloid leukemia (CP-CML) patients resistant or intolerant to first-line TKIs, particularly second-generation TKIs. In a study, 74.1% achieved complete cytogenic response (CCyR) and 40.6% major molecular response (MMR) at a median follow-up of 16 months, with no new safety concerns. The treatment, given orally every other day, improved efficacy over time and was well-tolerated.

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Innovent Biologics announces the inclusion of SINTBILO® (tafolecimab injection) in the 2024 National Reimbursement Drug List (NRDL) for treating primary hypercholesterolemia and mixed dyslipidemia, and the addition of a new indication for olverembatinib, a BCR-ABL inhibitor, effective from January 1, 2025.

Ascentage Pharma appointed Ms. Marina S. Bozilenko and Dr. Debra Yu as independent non-executive directors, effective November 25, 2024.

Olverembatinib, approved in China, showed favorable pharmacokinetics, was well tolerated, and demonstrated strong antileukemic effects in a phase 1b trial of 80 non-Chinese patients with relapsed/refractory chronic myeloid leukemia or Philadelphia chromosome–positive acute lymphoblastic leukemia, including those previously treated with ponatinib and/or asciminib. It may be a viable treatment option after failure of 2 or more tyrosine kinase inhibitors.

Ascentage Pharma's NDA for lisaftoclax, a Bcl-2 selective inhibitor for r/r CLL/SLL, has been accepted by China's NMPA with Priority Review designation, potentially making it the second Bcl-2 inhibitor approved globally.

Ascentage Pharma announced that APG-2449, a FAK/ALK/ROS1 TKI, has been cleared by China's NMPA to enter two Phase III studies for NSCLC patients resistant to or naïve to ALK TKIs. APG-2449 showed preliminary efficacy and safety, with potential to inhibit brain metastases, addressing unmet needs in NSCLC treatment.

Asciminib, a BCR::ABL1 inhibitor targeting the ABL myristoyl pocket, shows efficacy against CML-CP, including T315I mutation, with 40 mg b.i.d. and 200 mg b.i.d. dosing regimens. An 80 mg q.d. regimen is proposed for improved patient compliance, supported by model-informed drug development, demonstrating similar efficacy and safety profiles to 40 mg b.i.d.