Ms. Samira Sakhia reports

KNIGHT THERAPEUTICS ANNOUNCES APPROVAL AND LAUNCH OF MINJUVI® (TAFASITAMAB) IN ARGENTINA

Knight Therapeutics Inc.'s Argentine affiliate, Laboratorio LKM S.A., has obtained the regulatory approval and has launched Minjuvi in Argentina. Knight obtained approval from the Argentinian health regulatory agency, ANMAT, for Minjuvi (tafasitamab) 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 transplantation (ASCT).

DLBCL is the most common subtype of non-Hodgkin lymphoma, presenting an aggressive clinical profile. While a significant number of patients can be cured with standard front-line therapy, many will develop refractory disease or relapse following an initial response, and these individuals are often ineligible for ASCT. Such patients face a very poor prognosis, emphasizing the need for treatment options to improve their outcomes1.

The approval is based on the data from L-MIND trial, an open label, multicentre, single-arm phase 2 study, that evaluated Minjuvi in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL ineligible for ASCT. The primary analysis results demonstrated an objective response rate (ORR, primary end point) of 60 per cent, including a complete response rate (CR) of 43 per cent and a disease control rate (DCR) of 74 per cent. According to the 2024 National Comprehensive Cancer Network (NCCN) guidelines, Minjuvi is listed as one of the preferred second-line treatments for DLBCL patients who are ineligible for transplantation.

"Minjuvi has a unique and innovative mechanism of action targeting CD19 and represents a significant advancement in the treatment of DLBCL. It is a targeted immunotherapy which offers sustained remission for non-transplant eligible adult patients who have relapsed or are refractory to at least one previous line of treatment. I am enthusiastic about the transformative potential of Minjuvi in improving patient outcomes," said Dr. Amalia Cerutti, hematologist and co-ordinator of the CENHyT bone marrow transplant center at the Sanatorio Britanico in Rosario, Argentina.

"With the approval and launch of Minjuvi in Argentina, we mark the third country launch in Latin America for this innovative product. This milestone reflects our ongoing commitment to expanding access to innovative therapies and doing better for patients and physicians by offering new treatment choices," said Samira Sakhia, president and chief executive officer of Knight.

In September, 2021, Knight entered into a supply and distribution agreement with Incyte (Nasdaq: INCY), for the exclusive rights to distribute tafasitamab (sold as Monjuvi in the United States and Minjuvi ex-U.S.) in Latin America. In addition, in July, 2025, Knight announced that it had submitted a supplemental application to ANVISA, the Brazilian health regulatory agency, seeking approval for an additional indication for Minjuvi (tafasitamab) in combination with rituximab and lenalidomide for the treatment of adult patients with previously treated follicular lymphoma (FL). The supplemental application for the additional indication was selected for review under Project Orbis.

About Minjuvi (tafasitamab)

Minjuvi (tafasitamab) is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. 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). Incyte licenses exclusive worldwide rights to develop and commercialize tafasitamab from Xencor Inc.

Monjuvi received accelerated approval by the United States Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low-grade lymphoma, and who are not eligible for 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 DLBCL who are not eligible for ASCT.

Additionally, in the U.S., Monjuvi (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL).

Monjuvi is not indicated and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials.

XmAb is a registered trademark of Xencor.

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

About Knight Therapeutics Inc.

Knight Therapeutics, headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing and commercializing pharmaceutical products for Canada and Latin America. Knight's Latin American subsidiaries operate under United Medical, Biotoscana Farma and Laboratorio LKM. Knight Therapeutics Inc.'s shares trade on Toronto Stock Exchange under the symbol GUD.

We seek Safe Harbor.