BEIJING, China (February 15, 2024) – CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company specializing in the development and commercialization of innovative therapeutic and pharmaceutical products, proudly announced the administration of the first dose of FOLOTYN^® (Pralatrexate Injection) to a patient in China. This remarks a pivotal step in CASI's commitment to addressing critical medical needs in peripheral T-cell lymphoma in China market.

FOLOTYN^® (Pralatrexate) is a dihydrofolate reductase inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (“PTCL”). Compared with methotrexate, pralatrexate could be more effectively internalized into tumor cells which may translate to a greater anti-cancer effect. Clinical studies have demonstrated that pralatrexate has significant activity against PTCL¹. With the results of an overall response rate (“ORR”) of 52% and a median progression-free survival (“PFS”) of 4.8 months from the Chinese registrational study², in comparison to an ORR of 29% and a median PFS of 3.5 months from PROPEL study³ in the US, pralatrexate is a promising treatment option for Chinese patients with relapsed or refractory PTCL. Pralatrexate was approved in the United States in September 2009, as a treatment for PTCL. Pralatrexate was subsequently approved in Japan and China in 2017 and 2020, respectively.

Dr. Wei-Wu He, CEO of CASI, expressed his enthusiasm for this milestone, "The dosing of the first patient with FOLOTYN^® in China marks a significant achievement for CASI. It reflects our unwavering commitment to bringing advanced therapeutic options to patients, particularly in therapeutic areas with substantial unmet medical needs. This is a proud moment for our team and a step forward in our mission to transform patient care through innovation.”

Reference

1.  Casanova, M., et al. Critical appraisal of pralatrexate in the management of difficult-to-treat peripheral T cell lymphoma. Ther Clin Risk Manag. 2011; 7: 401–408.

2. Hong X., et al. Pralatrexate in Chinese Patients with Relapsed or Refractory Peripheral T-cell Lymphoma: A Single-arm, Multicenter Study. Target Oncol. 2019 Apr;14(2):149-158.

3. O'Connor OA, et al. Pralatrexate in patients with relapsed or refractory peripheral T-cell lymphoma: results from the pivotal PROPEL study. J Clin Oncol, 2011, 29(9):1182-1189.