10 Studies on InnoCare’s Oncology Pipelines Selected at the Upcoming 65th Annual Meeting of ASH

BEIJING--(BUSINESS WIRE)--InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that 10 studies from InnoCare’s oncology pipeline were selected for presentation at the 65th American Society of Hematology (ASH) Annual Meeting on December 9-12, 2023 in San Diego, California, United States.

Title	Report Information
Oral Presentation
A Prospective Multicenter Phase II Study of Orelabrutinib-Lenalidomide-Rituximab (OLR) in Patients with Untreated Mantle Cell Lymphoma (MCL) in China (POLARIS Study): Preliminary Analysis on Efficacy, Safety, Mutation Spectrum and Impact of Mutation Profiling on Treatment Responses	Abstract Number: 736 Session Name: 623. Mantle Cell, Follicular, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster II Presentation Time: 11:15 AM, Dec. 11, 2023 (Monday, EST) First Presenter/Corresponding Presenter: Huilai Zhang
Poster Presentation
Orelabrutinib, Fludarabine, Cyclophosphamide, and Obinutuzumab (OFCG) for First-Line Treatment of Chronic Lymphocytic Leukemia: A Multicenter, Investigator-Initiated Study (cwCLL-001 Study)	Abstract Number: 4642 Session Name: 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster III Presentation Time: 6:00 PM - 8:00 PM, Dec. 11, 2023 (Monday, EST) First Presenter: Huayuan Zhu
Orelabrutinib Monotherapy in Patients with Relapsed or Refractory Waldenström's Macroglobulinemia in a Single-Arm, Multicenter, Open-Label, Phase 2 Study: Long Term Follow-up Results	Abstract Number: 3039 Session Name: 623. Mantle Cell, Follicular, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster II Presentation Time: 6:00 PM - 8:00 PM, Dec. 10, 2023 (Sunday, EST) First Presenter: Xinxin Cao
Online Publication
Preliminary Safety, Pharmacological, and Efficacy Data from Patients with Relapsed or Refractory B-cell Malignancies Treated with the ICP-248, a Next Generation BCL2 Inhibitor	Abstract Number: 6149 First Presenter/Corresponding Presenter: Shuhua Yi
Effectiveness and Safety of Orelabrutinib Combined with Rituximab As First-Line Treatment in Marginal Zone Lymphoma	Abstract Number: 6146 First Presenter: Jiadai Xu Corresponding Presenter: Peng Liu
Orelabrutinib plus R-CHOP Regimen in Treatment-Naïve Patients with TP53-Mutated Diffuse Large B-Cell Lymphoma (DLBCL)	Abstract Number: 6289 First Presenter/Corresponding Presenter: Yi Xiao
Efficacy and Safety of Orelabrutinib - Containing TORM Regime as First-Line Therapy in Primary Central Nervous System Lymphoma (PCNSL): A Retrospective Analysis	Abstract Number: 6322 First Presenter: Shaojie Wu Corresponding Presenter: Yuhua Li
Phase 1 Trial of Orelabrutinib in Combination with Rituximab, Methotrexate, and Dexamethasone in Patients with Newly Diagnosed Primary CNS Lymphoma Implementing Bayesian Design for Dose-Seeking	Abstract Number: 6225 First Presenter: Yan Yuan Corresponding Presenter: Tong Chen
Effectiveness and Safety of Orelabrutinib in Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma: A Retrospective, Real-World Study in China	Abstract Number: 6552 First Presenter: Kaiyang Ding Corresponding Presenter: Chunyan Ji
Pomalidomide, Rituximab, Orelabrutinib, and Minichop-like (PRO-miniCHOP) in Elderly Patients with Newly Diagnosed Diffuse Large-B Cell Lymphoma: Preliminary Results from a Phase II Study	Abstract Number: 6238 First Presenter: Nana Ping Corresponding Presenter: Zhengming Jin

About Orelabrutinib

Orelabrutinib is a highly selective BTK inhibitor developed by InnoCare for the treatment of cancers and autoimmune diseases.

On Dec. 25, 2020, orelabrutinib received approval from the China National Medical Products Administration (NMPA) in two indications: the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and the treatment of patients with relapsed/refractory mantle cell lymphoma (MCL). At the end of 2021, orelabrutinib was included into the National Reimbursement Drug list, allowing it to benefit more lymphoma patients. On Nov. 22, 2022, orelabrutinib was approved for the treatment of R/R MCL in Singapore. On April 20, 2023, orelabrutinib was approved for the treatment r/r MZL in China.

In addition to the approved indications, multi-center, multi-indication clinical trials are underway in the US and China with orelabrutinib as monotherapy or in combination therapies, such as for the first line treatment of MCD subtype of diffuse large B-cell lymphoma (DLBCL).

Orelabrutinib was granted Breakthrough Therapy Designation for the treatment of r/r MCL by U.S. Food and Drug Administration (FDA). Patient enrollment of the phase II registrational trial for R/R MCL was completed in the U.S. The Company expects to submit the NDA to the U.S. Food and Drug Administration (US FDA) in the middle of 2024.

In addition, orelabrutinib is being advanced in other autoimmune trials, worldwide, including: a phase III registrational trial for the treatment of primary immune thrombocytopenia purpura (ITP) ongoing in China, a global phase II study for the treatment of Multiple Sclerosis (MS), a phase II study for the treatment of SLE in China that has achieved proof of concept (PoC), and a phase II study for the treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD) ongoing in China.

About InnoCare

InnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancer and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and United States.