InnoCare Announces Approval to Conduct a Phase II Clinical Trial of Orelabrutinib in Combination with Tafasitamab + Lenalidomide in China

BEIJING–(BUSINESS WIRE)–InnoCare Pharma (HKEX: 09969; SSE: 688428) announced today that the Company has received approval from the Center for Drug Evaluation (CDE) to conduct a single-arm, open-label, multi-cohort phase II clinical trial evaluating the efficacy and safety of orelabrutinib in combination with tafasitamab + lenalidomide for the treatment of patients with relapsed or refractory Non-Hodgkin’s lymphoma (NHL).

Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare said, �We are dedicated to building a leading hematology-oncology franchise with orelabrutinib and tafasitamab + lenalidomide as backbone therapies. NHL remains an area of strong unmet medical need in China, and we will accelerate this clinical trial along with the registrational trial of tafasitamab in combination with lenalidomide for relapsed or refractory diffuse large B-Cell lymphoma (DLBCL) in China.”

Tafasitamab, a humanized Fc-modified cytolytic CD19-targeting immunotherapy, is not approved by the National Medical Products Administration (NMPA) for any indication in China, except that tafasitamab in combination with lenalidomide has been approved by the Health Commission and Medical Products Administration of Hainan Province for the treatment of eligible DLBCL patients, under the early access program in Boao Lecheng International Medical Tourism Pilot Zone. As part of this early access program, the first prescription of tafasitamab in combination with lenalidomide was filled in July at the Ruijin Hainan Hospital for an eligible DLBCL patient.

Tafasitamab is conditionally approved by both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) in combination with lenalidomide for the treatment of relapsed or refractory DLBCL patients who are not eligible for autologous stem cell transplantation (ASCT).

Orelabrutinib received conditional approval from the NMPA in two indications: the treatment of patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma, and the treatment of patients with relapsed or refractory mantle cell lymphoma. Orelabrutinib was approved for the treatment of patients with relapsed or refractory MCL in Singapore.

NHL is one of the most common cancers in China, including DLBCL, follicular lymphoma, etc. Data shows that there were 92,834 new cases of NHL with 54,351 deaths in 2020 in China¹.

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 (r/r) chronic lymphocytic leukemia (CLL) /small lymphocytic lymphoma (SLL), and the treatment of patients with r/r mantle cell lymphoma (MCL). At the end of 2021, orelabrutinib was included into National Reimbursement Drug list to benefit more lymphoma patients. On Nov. 22, 2022, orelabrutinib was approved for the treatment of patients with relapsed or refractory MCL in Singapore.

The supplemental New Drug Application of orelabrutinib for the treatment of relapsed or refractory Marginal Zone Lymphoma (MZL) was 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 relapsed or refractory 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 Systemic Lupus Erythematosus (SLE), Primary Immune Thrombocytopenia (ITP) and Neuromyelitis Optica Spectrum Disorder (NMOSD) in China.

About Tafasitamab

Tafasitamab is a humanized Fc-modified CD19 targeting immunotherapy.

In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc.

Tafasitamab incorporates an XmAb^® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).

In the United States, Monjuvi^® (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for ASCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s).

In Europe, Minjuvi^® (tafasitamab) received conditional approval, in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in several ongoing combination trials.

Monjuvi^® and Minjuvi^® are registered trademarks of MorphoSys AG. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name Monjuvi^® in the U.S., and marketed by Incyte under the brand name Minjuvi^® in Europe and Canada. As part of its agreement with MorphoSys, Incyte received exclusive commercialization rights for tafasitamab outside the United States, and in August 2021, Incyte entered into a collaboration and license agreement with InnoCare for the development and exclusive commercialization of tafasitamab in hematology and oncology in Greater China.

XmAb^® is a registered trademark of Xencor, Inc.

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. We strategically focus on lymphoma, solid tumors, and autoimmune diseases with high unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and United States.

InnoCare Forward-looking Statements

This report contains the disclosure of some forward-looking statements. Except for statements of facts, all other statements can be regarded as forward-looking statements, that is, about our or our management’s intentions, plans, beliefs, or expectations that will or may occur in the future. Such statements are assumptions and estimates made by our management based on its experience and knowledge of historical trends, current conditions, expected future development and other related factors. This forward-looking statement does not guarantee future performance, and actual results, development and business decisions may not match the expectations of the forward-looking statement. Our forward-looking statements are also subject to a large number of risks and uncertainties, which may affect our short-term and long-term performance.

¹ ?????????(2021??) Guidelines for the Treatment of Lymphoma in China (2021 Edition)

Contacts

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Chunhua Lu

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chunhua.lu@innocarepharma.com

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