On January 10, 2025 TJ Biopharma ("TJ Bio" or "Company"), a fully integrated biotech company in China that develops, manufactures, and commercializes through partnership on innovative biologics for autoimmune diseases, oncology and metabolic diseases, reported that the Biologics License Application (BLA) submission for felzartamab, an investigational differentiated CD38 antibody, has been accepted for review by China’s National Medical Products Administration (NMPA) for the treatment of multiple myeloma (MM) (Press release, TJ Bio, JAN 10, 2025, View Source [SID1234654001]). This milestone, following the recent BLA submission for eftansomatropin alfa, demonstrates TJ Bio’s proven capability to advance late-stage pipeline products through its full-fledged R&D and manufacturing infrastructure.
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In China, where multiple myeloma affects over 160,000 patients, there remains a significant unmet need for more accessible treatment options. Felzartamab’s Phase 3 registration studies have demonstrated a differentiated profile with comparable efficacy to existing therapies, while offering advantages in safety through lower and less severe infusion-related reactions and improved convenience with shorter infusion time from 6 hours to 1.5 hours, particularly benefiting elderly patients who constitute a large portion of the multiple myeloma population.
With TJ Bio’s state-of-the-art GMP facility in Hangzhou receiving the Drug Manufacturing Permit (License A) in August 2024, felzartamab is on track to become China’s first domestically manufactured CD38 therapy. This manufacturing capability ensures reliable domestic supply to meet the growing demand for innovative biologics while providing Chinese patients with more accessible treatment options.
"This BLA acceptance for felzartamab, coming shortly after eftansomatropin alfa, demonstrates TJ Bio’s strong execution capabilities and our commitment to advancing innovative therapies," said Dr. Jingwu Zang, Founder and Chairman of TJ Bio. "While this first regulatory milestone positions us to potentially deliver China’s first domestically manufactured CD38 therapy, we are particularly excited about felzartamab’s broader potential in autoimmune diseases. As we advance its development as a novel plasma cell depletion therapy across multiple autoimmune indications, these consecutive BLA submissions and our newly licensed manufacturing facility exemplify our ability to execute on our vision of bringing innovative biologics to patients in need."
About Felzartamab
Felzartamab is an investigational therapeutic human monoclonal antibody directed against CD38, a protein expressed on mature plasma cells. Scientific research suggests that anti-CD38 antibodies have therapeutic potential in multiple disease areas across immuno-oncology and autoimmune diseases. Beyond its initial indication in multiple myeloma, felzartamab has been shown in clinical studies to selectively deplete CD38+ plasma cells, which may allow applications that ultimately improve clinical outcomes in a broad range of diseases driven by pathogenic antibodies.
Felzartamab was originally developed by MorphoSys AG (now MorphoSys GmbH, a Novartis company). TJ Bio owns the exclusive rights for development and commercialization of felzartamab for all indications in Greater China, which encompasses Mainland China, Hong Kong, Macao, and Taiwan. Human Immunology Biosciences (HI-Bio) exclusively licensed the rights to develop and commercialize felzartamab across all indications in all countries and territories excluding Greater China. Biogen acquired HI-Bio in July 2024.
About Multiple Myeloma
Multiple myeloma is a hematological malignancy that affects plasma cells, with over 160,000 patients in China requiring treatment. The disease primarily affects elderly patients, who are particularly vulnerable to treatment-related complications. Despite recent therapeutic advances, there remains a significant need for treatments that combine efficacy with improved safety profiles and greater convenience.
The current treatment landscape in China faces challenges including high rates of infusion-related reactions with existing therapies, lengthy infusion times that burden both patients and healthcare systems, and limited access to innovative treatments due to cost considerations. These factors underscore the urgent need for domestically manufactured therapies that can provide effective, safer, and more accessible treatment options.