InnoCare Announces the Approval of Minjuvi® (Tafasitamab) in Combination with Lenalidomide for the treatment of Adult Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma in China

InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that the China National Medical Products Administration (NMPA) has granted approval for Minjuvi^® (tafasitamab), a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, 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). This is the first CD19 antibody approved for the treatment of relapsed or refractory DLBCL in China.

“The data from the Chinese clinical study of Minjuvi - similar to the data from the global L-MIND study – reaffirms the significant clinical benefits for DLBCL patients treated with the Minjuvi combination, particularly the notably prolonged duration of response (DOR),” said Professor Jie Jin from the First Affiliated Hospital, Zhejiang University School of Medicine. “The approval of Minjuvi is a crucial milestone for eligible patients with DLBCL in China, and we hope this innovative therapy will benefit patients.”

“The durable responses and consistent safety profile observed in both the Chinese and global studies are encouraging and support the Minjuvi regimen as an effective option for patients with DLBCL,” said Professor Weili Zhao from Shanghai Ruijin Hospital. “We are pleased that the first prescription of the Minjuvi regimen was filled in China at Ruijin Hainan Hospital for an eligible DLBCL patient under the early access program in Bo’ao. Looking ahead, we hope that more eligible patients with DLBCL will benefit from this novel therapy.”

Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare, said, “Today's approval marks another important milestone for InnoCare as we will celebrate our 10^th anniversary this year. I would like to extend my sincere gratitude to all the physicians, patients, partners and employees who have contributed to this achievement. DLBCL is the most common form of non-Hodgkin lymphoma globally, and there are significant unmet needs among patients with DLBCL in China. We believe the Minjuvi regimen will provide a novel therapeutic option to patients with DLBCL in China.”

Tafasitamab, a humanized Fc-modified cytolytic CD19-targeting immunotherapy, in combination with lenalidomide, has already been approved for the treatment of eligible DLBCL patients in the region of Hong Kong, Macau and Taiwan. Furthermore, under the early access program in the Bo’ao Lecheng International Medical Tourism Pilot Zone and the Guangdong-Hong Kong-Macao Greater Bay Area, prescriptions of tafasitamab in combination with lenalidomide have been issued at Ruijin Hainan Hospital and Guangdong Clifford Hospital for eligible DLBCL patients.

Tafasitamab is approved under accelerated approval by the U.S. Food and Drug Administration (FDA), and conditionally approved by the European Medicines Agency (EMA), in combination with lenalidomide for the treatment of relapsed or refractory DLBCL adult patients who are not eligible for ASCT.

DLBCL is the most common type of non-Hodgkin lymphoma (NHL), and its incidence accounts for 31% to 34% of NHL globally. In China, DLBCL accounts for 45.8% of all NHL cases¹.

About Tafasitamab

Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. Tafasitamab incorporates an 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).

MorphoSys and Incyte entered into: (a) in January 2020, a collaboration and licensing agreement to develop and commercialize tafasitamab globally; and (b) in February 2024, an agreement whereby Incyte obtained exclusive rights to develop and commercialize tafasitamab globally.

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.

In the United States, Monjuvi^® (tafasitamab-cxix) received accelerated approval 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 autologous stem cell transplant (ASCT). In Europe, Minjuvi^® (tafasitamab) received conditional Marketing Authorization from the European Medicines Agency 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).

Monjuvi, Minjuvi, the Minjuvi and Monjuvi logos and the “triangle” design are registered trademarks of Incyte.

About InnoCare

InnoCare (HKEX: 09969; SSE: 688428) 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.

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 Hematology Branch of Chinese Medical Association

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