Felzartamab (MOR202), a CD38-Targeting Monoclonal Antibody, Approved in China for Multiple Myeloma Following $2.6 Billion Global Licensing Journey

In a Phase I-IIa clinical trial involving 91 patients with relapsed/refractory multiple myeloma, fezertamab demonstrated noteworthy characteristics.

Most notably, its infusion time allows for safe completion of intravenous administration within 30 minutes.

In the monotherapy group without corticosteroid premedication, 14 out of 35 patients (40%) experienced infusion-related reactions; whereas with the addition of dexamethasone, only 4 out of 56 patients (7%) experienced such reactions.

The maximum tolerated dose was not reached; the recommended dose can be up to 16 mg/kg.

In terms of safety, the most common grade ≥3 adverse events were lymphopenia (38%), neutropenia (33%), and leukopenia (30%).

51 patients (56%) reported serious adverse events, but no deaths were related to MOR202.

Notably, no anti-MOR202 antibodies were detected in patients; this finding of "no immunogenicity" is uncommon among monoclonal antibody therapies.

Fesoteromab was initially developed by MorphoSys AG of Germany.In November 2017, TJ Biopharma entered into a licensing agreement with MorphoSys, securing exclusive rights for all indications in the Greater China region.

In June 2022, HI-Bio secured global rights outside Greater China from MorphoSys.

In May 2024, Biogen acquired HI-Bio for $1.8 billion.

April 2026,Biogen Acquires Greater China Rights from TJ Biopharma for $100 Million Upfront Payment Plus Up to $750 Million in Milestones, Totaling $850 Million

With this, the global rights to this CD38 monoclonal antibody have finally been “unified” under Biogen.

TJ Biopharma retained the commercial supply rights for its Hangzhou GMP manufacturing facility, charting a path of “retaining production while divesting rights.”

Fizerotumab has entered a crowded competitive landscape.

Johnson & Johnson’s daratumumab achieved global sales exceeding $11.67 billion in 2024, capturing a substantial 43.3% share of the global multiple myeloma drug market.

In such a landscape, if the battlefield is limited to multiple myeloma alone, it would be difficult for latecomers to challenge the dominant position of the market leader.

The true strategic intent lies in indication expansion.

Biogen has initiated global Phase III clinical trials of fezokizumab for autoimmune diseases, including IgA nephropathy, primary membranous nephropathy, and antibody-mediated rejection in kidney transplantation.

China is one of the countries with the largest number of IgAN and PMN patients globally.

Fraser Hall, President of Biogen’s International Region, described it as having the potential of a “pipeline-in-a-product”:One Product, Multiple Indications in Bloom.