China’s National Medical Products Administration (NMPA) has approved felzartamab (Jingfei®, 境斐®), a CD38-directed monoclonal antibody, in combination with lenalidomide and dexamethasone for adult patients with multiple myeloma who have received at least one prior line of therapy. The approval granted to TJ Biopharma on August 13, 2026, is significant for two reasons that, on the surface, have nothing to do with each other but converge in the same market. It is the first approved indication for felzartamab anywhere in the world, a molecule that spent 9 years moving between companies before reaching a regulator’s desk. And it marks Biogen’s entry into oncology commercialization in China, a business the company, known chiefly for its neurology and immunology franchises, has not previously operated. According to a new analysis from GlobalData, a leading intelligence and productivity platform, the approval intensifies competition in China’s already crowded multiple myeloma market.
The Third CD38 Inhibitor in China
Felzartamab is now the third anti-CD38 monoclonal antibody approved for multiple myeloma in China, following Johnson & Johnson’s daratumumab (Darzalex®), approved in the country in 2019, and Sanofi’s isatuximab (Sarclisa®), approved in 2025. All three drugs target CD38, a protein highly expressed on the surface of malignant plasma cells, and all three are administered alongside standard backbone regimens rather than as monotherapy. TJ Biopharma’s own registrational data describe felzartamab’s efficacy as comparable to existing CD38-directed therapies, with what the company calls a differentiated clinical profile built around a shorter infusion.
The regulatory approval rests on a randomized, open-label Phase 3 trial (NCT03952091) conducted in Greater China, which compared felzartamab plus lenalidomide and dexamethasone against lenalidomide and dexamethasone alone in patients with relapsed or refractory multiple myeloma who had received at least one prior line of treatment, with progression-free survival as the primary endpoint. The trial, run originally by I-Mab under the compound’s earlier designation TJ202, completed enrollment in 2021, and TJ Biopharma submitted a Biologics License Application (BLA) to the NMPA in December 2024, which the agency accepted in January 2025. Neither TJ Biopharma nor Biogen has yet published the trial’s hazard ratio, response rate, or a detailed adverse-event table in a peer-reviewed journal; the efficacy and safety claims released so far come from company statements rather than a published manuscript.
Mechanistically, felzartamab is a fully human IgG1 monoclonal antibody derived from MorphoSys’s HuCAL antibody platform that clears CD38-expressing plasma cells predominantly through antibody-dependent cellular cytotoxicity and phagocytosis rather than complement-dependent cytotoxicity. That mechanistic profile was first described in the drug’s first-in-human Phase 1-2a trial in relapsed or refractory multiple myeloma, published in The Lancet Haematology in 2020 (PMID: 32171061), and has been cited by industry observers as a plausible explanation for the comparatively low rate of infusion-related reactions reported with the antibody in early combination studies.
From MorphoSys to Biogen: A Nine-Year Path to Approval
Felzartamab’s road to a first approval says as much about the economics of antibody licensing as it does about multiple myeloma. The molecule, originally developed by the German biotech MorphoSys under the code name MOR202, was licensed out in pieces to different companies for different territories and different diseases. In November 2017, I-Mab obtained exclusive rights to develop and commercialize the antibody, under the designation TJ202, across Greater China, where the company pursued it specifically for multiple myeloma.
In February 2024, as I-Mab refocused its portfolio toward its ex-China pipeline, the company divested its China assets and operations, including the Greater China rights to felzartamab, to I-Mab Biopharma (Hangzhou) Co., Ltd., an unconsolidated affiliate that continued the drug’s China development and now operates as TJ Biopharma, retaining the Hangzhou manufacturing facility that supplies the antibody today. Separately, in June 2022, MorphoSys licensed rights to felzartamab across the rest of the world, excluding Greater China, to Human Immunology Biosciences (HI-Bio), a company that redirected the molecule’s development away from oncology and into a set of immune-mediated kidney diseases: antibody-mediated rejection in kidney transplant recipients, IgA nephropathy, and primary membranous nephropathy.
Biogen acquired HI-Bio in a transaction that closed in July 2024, a deal reported at roughly $1.8 billion, gaining felzartamab’s global rights outside Greater China along with a slate of Phase 2 and Phase 3 programs in nephrology. Then, in April 2026, Biogen went back and closed the remaining gap, acquiring TJ Biopharma’s Greater China rights to felzartamab for $100 million upfront and up to $750 million in additional commercial and sales milestones, for a total deal value of up to $850 million, plus royalties in the mid-single to low-double-digit percentage range. The agreement consolidated worldwide development and commercialization rights to felzartamab under Biogen for the first time, while leaving TJ Biopharma responsible for manufacturing the antibody through its Good Manufacturing Practice (GMP) facility in Hangzhou. It was that April 2026 acquisition, closed roughly four months before the NMPA’s decision, that positioned Biogen to become the commercial sponsor of felzartamab’s first approved product worldwide.
A Market Size at 14.6% Share by 2029
GlobalData’s Pharma Intelligence Center projects that the number of diagnosed prevalent cases of multiple myeloma in China will grow at a compound annual growth rate of 1.56% between 2026 and 2031, underscoring a disease burden the firm describes as substantial and growing. Against that backdrop, GlobalData’s patient-based forecast projects that felzartamab will capture 14.6% of the Chinese multiple myeloma market by 2029, entering a competitive field the firm counts at 85 drugs currently in clinical development for multiple myeloma in China across Phase 1 through Phase 3: six in Phase 3, 29 in Phase 2, and 50 in Phase 1.
Abhishake Peyyeti, Pharma Analyst at GlobalData, framed the approval’s clinical rationale around a persistent gap in care.
“Felzartamab addresses critical gaps in care by reducing CD38 monoclonal antibody infusion times to 30-90 minutes,” Peyyeti said. “This substantial reduction minimizes clinic burden and enhances quality of life, delivering a vital clinical benefit to elderly populations.”
That framing speaks directly to a population multiple myeloma disproportionately affects: an elderly patient demographic for whom repeated infusion visits carry real-time toxicity, on top of the disease’s near-inevitable pattern of relapse and the ongoing challenge of maintaining treatment adherence and quality of life over years of therapy.
TJ Biopharma has separately characterized the reduction in comparable terms, describing felzartamab’s infusion time as cut from roughly six hours, a figure in line with the first-dose infusion time for standard intravenous CD38 antibody regimens, down to about 90 minutes. For context, daratumumab’s original intravenous formulation takes about 7 hours for the first infusion and 3 to 5 hours for subsequent doses, not counting check-in and check-out time, according to the drug’s own patient-facing dosing information. J&J subsequently developed a subcutaneous formulation, daratumumab and hyaluronidase (Darzalex Faspro), that reduces the injection itself to roughly three to five minutes.
That comparison is the crux of Peyyeti’s second, more pointed observation about where felzartamab actually sits competitively. “While the Chinese multiple myeloma market remains crowded, felzartamab’s shorter infusion narrows the gap with intravenous Darzalex, but J&J’s subcutaneous Darzalex Faspro remains the convenience benchmark Biogen has to price and position against,” Peyyeti said. In other words, a 30- to 90-minute intravenous infusion is a real improvement over a multi-hour one, but it is still an infusion-chair appointment, not a five-minute injection. Whether felzartamab can compete with daratumumab and hyaluronidase on convenience in China will likely depend on pricing and on whether Biogen or TJ Biopharma pursue a subcutaneous formulation of their own, neither of which has been disclosed.
Beyond Oncology: The Kidney Disease Pipeline Biogen Actually Bought
The multiple myeloma approval covers only the Greater China market and only the indication TJ Biopharma originally pursued. The rest of felzartamab’s clinical program, the reason Biogen was willing to pay $1.8 billion for HI-Bio in 2024, sits entirely outside oncology, in a set of immune-mediated kidney diseases where CD38-expressing plasma cells and natural killer cells drive pathology through antibody production rather than malignant proliferation.
Two recent peer-reviewed publications illustrate where that program stands. In a randomized, double-blind, placebo-controlled Phase 2a trial in IgA nephropathy called IGNAZ (NCT05065970), reported in Kidney International in October 2025, felzartamab produced a rapid and sustained reduction in proteinuria compared with placebo across three ascending dosing schedules in 54 patients with biopsy-confirmed disease despite maximal renin-angiotensin system blockade. The reduction in urine protein-to-creatinine ratio reached -29.5% in the nine-dose arm at nine months, compared with -5.7% for placebo, and the benefit was sustained at 18 months after the end of treatment, with adverse events described as predominantly grade 1 or 2 (Floege J, et al. Kidney Int. 2025;108(4):695-706).
A second study, published in Nature Medicine in May 2025, examined the molecular effects of felzartamab in kidney transplant patients with antibody-mediated rejection, using genome-wide microarray analysis of paired biopsies from a completed randomized trial. Six months of treatment suppressed interferon gamma-inducible and natural killer cell transcripts associated with rejection activity in all nine treated patients who had baseline rejection activity, though the researchers found that suppression was often incomplete when rejection activity was intense at baseline, and that molecular recurrence of rejection activity was nearly universal by one year after treatment ended. The same analysis found that felzartamab slowed the trajectory of molecular injury markers beyond the treatment period, suggesting a potential to delay progression toward kidney failure even after rejection activity partially returns (Diebold M, et al. Nat Med. 2025;31(5):1668-1676).
Biogen has said it plans to advance felzartamab into Phase 3 trials across all three kidney indications, antibody-mediated rejection, IgA nephropathy, and primary membranous nephropathy, positioning the multiple myeloma approval in China as, commercially, a separate and comparatively narrow line of business relative to the nephrology program that drove the original acquisition. China is also among the countries with the largest populations of patients with IgA nephropathy and primary membranous nephropathy, which gives Biogen a second reason, beyond oncology, to want commercial infrastructure established in the country.
What Is Not Yet Known
Several details relevant to how felzartamab will actually perform in the Chinese multiple myeloma market have not been made public. The magnitude of the Phase 3 benefit, expressed as a hazard ratio or an absolute difference in progression-free survival between the felzartamab and control arms, has not been disclosed in a peer-reviewed publication; the trial’s completeness and the strength of its result are known only through company statements. Pricing has not been announced by either TJ Biopharma or Biogen, and pricing will directly affect Peyyeti’s competitive framing, since felzartamab’s infusion-time advantage over standard intravenous daratumumab is real but incomplete relative to the subcutaneous Darzalex Faspro standard. Whether Biogen intends to develop a subcutaneous formulation of felzartamab, for either the oncology or nephrology indications, has also not been disclosed. And felzartamab’s approval in China does not extend to its use in immune-mediated kidney diseases, which represent the larger share of its global development program; those indications remain in Phase 2 and Phase 3 testing outside China.
A Crowded Market, Now With a Fourth Owner
Multiple myeloma treatment in China has, in a little over six years, gone from a single approved CD38 antibody to three, alongside 85 additional agents at various stages of clinical development. Felzartamab’s approval does not change the disease biology or introduce a fundamentally new mechanism; it introduces a third variation on an established one, differentiated chiefly by infusion time, into a market already served by two large multinational originators.
What makes the approval notable is less the drug itself than the company now selling it. Biogen, a business built on neurology and immunology, is, for the first time, a commercial oncology company in China, having assembled the rights to felzartamab through two separate acquisitions totaling well over $2 billion since 2024. Whether that entry proves durable will depend on data not yet published, a price not yet set, and a convenience gap against subcutaneous daratumumab that, on GlobalData’s own account, has narrowed but not closed.
Related Onco’Zine Coverage
- Head-to-Head Study Supports Adding Daratumumab to Standard Regimen in Treatment of Multiple Myeloma [Article]
- Study: Isatuximab Combination Provides Unprecedented Median PFS in Treatment of Multiple Myeloma [Article]
- ASCO 2025: A New Standard of Care Emerges for the Treatment of Multiple Myeloma [Article]
- ASH 2025: Combination of Teclistamab and Daratumumab Offers Substantial Improvement Over Standard Second-Line Therapies for R/R Multiple Myeloma [Article]
References
[1] GlobalData. Biogen’s felzartamab approval to intensify competition in crowded multiple myeloma market in China, says GlobalData. Press release, August 2026.
[2] TJ Biopharma. Announcement of NMPA approval of felzartamab (Jingfei) for multiple myeloma. Press release, August 13, 2026. Online last accessed on August 28, 2026
[3] TJ Biopharma. TJ Biopharma Announces NMPA Acceptance of BLA for Felzartamab in Multiple Myeloma. Press release, January 2025.
[4] Biogen Inc. Biogen Enters into Agreement with TJ Biopharma for Felzartamab Assets in the Greater China Region. Press release, April 20, 2026.
[5] Biogen Inc. Biogen Completes Acquisition of Human Immunology Biosciences. Press release, July 2024.
[6] Biogen Inc. Biogen Highlights the Potential of Felzartamab for a Range of Immune-Mediated Diseases Including Three Phase 3 Programs in Rare Kidney Diseases. Press release, 2026.
[7] I-Mab. I-Mab Advances Late-stage Development of Its Differentiated CD38 Antibody Felzartamab (TJ202) in China. Press release, October 2021.
[8] I-Mab. I-Mab Signs Agreement to Divest its Assets and Business Operations in China. Press release, February 7, 2024.
[9] ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of TJ202/MOR202 in Combination With Lenalidomide/Dexamethasone in Chinese Patients With Relapsed or Refractory Multiple Myeloma. Identifier NCT03952091.
[10] MOR202, a novel anti-CD38 monoclonal antibody, in patients with relapsed or refractory multiple myeloma: a first-in-human, multicentre, phase 1-2a trial. Lancet Haematol. 2020. PMID: 32171061.
[11] Floege J, Lafayette R, Barratt J, Schwartz B, Manser PT, Patel UD, Shah M, Kivman L, Faulhaber N, Kräft T, Thakur A, Härtle S, Barbour SJ. Randomized, double-blind, placebo-controlled phase 2a study assessing the efficacy and safety of felzartamab for IgA nephropathy. Kidney Int. 2025 Oct;108(4):695-706. PMID: 40581166.
[12] Diebold M, Gauthier PT, Mayer KA, Mackova M, Hinze C, Chang J, Patel UD, Schütz E, Jilma B, Schrezenmeier E, Budde K, Böhmig GA, Halloran PF. Effect of felzartamab on the molecular phenotype of antibody-mediated rejection in kidney transplant biopsies. Nat Med. 2025 May;31(5):1668-1676. PMID: 40301559; PMCID: PMC12092283.
[13] J&J Innovative Medicine (Janssen). DARZALEX® and DARZALEX FASPRO® Frequently Asked Questions, administration times.
[14] DengYueMedicine. Felzartamab Approved for Multiple Myeloma: Another CD38 Monoclonal Antibody Enters the Chinese Market. 2026.
[15] VCBeat. Felzartamab (MOR202), a CD38-Targeting Monoclonal Antibody, Approved in China for Multiple Myeloma Following a Multi-Billion-Dollar Global Licensing Journey. 2026.
This article is intended for informational purposes for healthcare professionals and does not constitute medical advice. Felzartamab is approved in China for the indicated multiple myeloma; it remains investigational and is not approved by the FDA, the European Medicines Agency, or any regulatory authority outside Greater China, including for the kidney disease indications discussed here.
Featured image © 2026 CH/JCO Used with permission.
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