10 Studies on Orelabrutinib Selected at the Upcoming 64th Annual Meeting of ASH

BEIJING

InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that 10 studies on the BTK inhibitor orelabrutinib developed by InnoCare were selected at the 64th American Society of Hematology (ASH) Annual Meeting on December 10-13, 2022, which will be held online and offline in New Orleans, United States.

Oral Presentation

Title: Orelabrutinib, Rituximab, and High-Dose Methotrexate (HD-MTX) in Newly Diagnosed Primary Central Nervous System Lymphoma (PCNSL): A Retrospective Analysis on Efficacy, Safety, and Biomarker

Abstract Number: 558

Session Name: 627. Aggressive Lymphomas: Clinical and Epidemiological: Real World Evidence for Management of CNS Lymphoma and Post CAR T-cell relapse for aggressive B-cell NHL

Presentation Time: 1:15 PM, Dec. 11, 2022 (Sunday)

First Author: Shihua Zhao

Corresponding Author: Wenrong Huang

Poster Presentation 1

Title: A Multicenter, Single-Arm, Prospective Phase Ⅱ Study of Orelabrutinib Combined with High-Dose Methotrexate and Rituximab Sequential Autologous Hematopoietic Stem Cell Transplantation in Newly-Diagnosed Primary Central Nervous System Lymphoma

Abstract Number: 1624

Session Name: 626. Aggressive Lymphomas: Prospective Therapeutic Trials: Poster I

Presentation Time: 5:30-7:30 PM, Dec. 10, 2022 (Saturday)

First Author: Ji Ma

Poster Presentation 2

Title: Efficacy and Safety of Lenalidomide, Anti-PD-1 Antibody Combined with Orelabrutinib or Rituximab in the Treatment of Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Abstract Number: 1636

Session Name: 626. Aggressive Lymphomas: Prospective Therapeutic Trials: Poster I

Presentation Time: 5:30-7:30 PM, Dec. 10, 2022 (Saturday)

First Author: Yuqing Miao

Corresponding Author: Hao Xu

Poster Presentation 3

Title: Preliminary Result of 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: 2951

Session Name: 626. Aggressive Lymphomas: Prospective Therapeutic Trials: Poster II

Presentation Time: 6:00-8:00 PM, Dec. 11, 2022 (Sunday)

First Author: Yan Yuan

Corresponding Author: Tong Chen

Poster Presentation 4

Title: Thiotepa, Orelabrutinib, and Methotrexate Combined with or without the Rituximab Regimens in the Treatment of Patients with Central Nervous System Lymphoma

Abstract Number: 4291

Session Name: 627. Aggressive Lymphomas: Clinical and Epidemiological: Poster Ⅲ

Presentation Time: 6:00-8:00 PM, Dec. 12, 2022 (Monday)

First Author: Ruolan Zeng

Corresponding Author: Hui Zhou

Poster Presentation 5

Title: Orelabrutinib in Combination with Rituximab and chemotherapy for Newly Diagnosed Aggressive B-Cell Lymphoma: A Multicenter, Single-Arm, Prospective Study

Abstract Number: 4295

Session Name: 627. Aggressive Lymphomas: Clinical and Epidemiological: Poster Ⅲ

Presentation Time: 6:00-8:00 PM, Dec. 12, 2022 (Monday)

First Author: Xiangxiang Zhou

Corresponding Author: Xin Wang

Online Abstract 1

Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study Evaluating the Efficacy and Safety of Orelabrutinib Plus R-CHOP Versus Placebo Plus R-CHOP in Treatment-Naive Patients with Mcd Subtype Diffuse Large B-Cell Lymphoma

Abstract Number: 5525

First Author: Weili Zhao

Corresponding Author: Pengpeng Xu

Online Abstract 2

Title: A Phase I/II Study of Orelabrutinib Combined with Anti-Programmed Cell Death Protein-1 Antibody and Fotemustine for Patients with Newly Diagnosed Primary Central Nervous System Lymphoma (PCNSL)

Abstract Number: 5508

First Author: Xudong Zhang

Corresponding Author: Mingzhi Zhang

Online Abstract 3

Title: Preliminary Outcomes of Orelabrutinib Plus RCHOP in Treatment-Naïve Patients with Double-Expression Diffuse Large B Cell Lymphoma

Abstract Number: 5521

First Author: Yang Yang

Corresponding Author: Zhen Cai

Online Abstract 4

Title: Orelabrutinib and Venetoclax Show Synergistic Lethality in Double-Hit Lymphoma By Interfering with the Crosstalk between the PI3K/AKT and p38/MAPK Signaling

Abstract Number: 5248

First Author: Mengya Zhong

Corresponding Author: Bing Xu

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 conditional 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 National Reimbursement Drug list to benefit more lymphoma patients.

The supplemental New Drug Applications of orelabrutinib for the treatment of R/R WM and R/R Marginal Zone Lymphoma were accepted 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 first line treatment of MCD subtype of diffuse large B-cell lymphoma (DLBCL).

Orelabrutinib was granted as Breakthrough Therapy Designation for the treatment of r/r MCL by U.S. Food and Drug Administration (FDA).

In addition, orelabrutinib is also being evaluated in global phase II studies for the treatment of Multiple Sclerosis (MS), and clinical trials for the treatment of SLE, Primary Immune Thrombocytopenia (ITP) and Neuromyelitis Optica Spectrum Disorder (NMOSD) in China.

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