By Fineline Cube TJ Biopharma and Biogen Inc. (NASDAQ: BIIB) announced today that felzartamab for injection (brand name: JINGFEI) has received approval from China’s National Medical Products Administration (NMPA). The anti‑CD38 monoclonal antibody is approved in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior line of therapy.
Regulatory Milestone
| Item | Detail |
|---|---|
| Agency | NMPA (China) |
| Product | Felzartamab for injection (brand name: JINGFEI) |
| Drug Class | Anti‑CD38 monoclonal antibody |
| Indication | Multiple myeloma in adult patients with ≥1 prior line of therapy |
| Regimen | In combination with lenalidomide and dexamethasone |
| Approval Date | 13 Aug 2026 |
Drug Profile & Licensing Structure
- Molecule: Felzartamab, an anti‑CD38 monoclonal antibody with broad therapeutic potential across a range of immune‑mediated diseases and hematologic malignancies
- Licensing Agreement: In April 2026, TJ Biopharma entered into an agreement granting Biogen exclusive rights to felzartamab in Greater China
- Commercialization: Biogen will be responsible for commercializing felzartamab under the agreement following this approval
- Manufacturing Supply: TJ Biopharma will handle commercial supply from its GMP manufacturing facility in Hangzhou
Commercial Division of Responsibilities
| Responsibility | Party |
|---|---|
| Commercialization (Greater China) | Biogen Inc. |
| Commercial Manufacturing Supply | TJ Biopharma (Hangzhou GMP facility) |
| Exclusive Rights Territory | Greater China (licensed to Biogen) |
Market Impact & Outlook
- Established Treatment Backbone: The approved triplet regimen (felzartamab + lenalidomide + dexamethasone) targets the large, recurring population of relapsed/refractory multiple myeloma patients in China, one of the most common hematologic malignancies.
- Anti‑CD38 Class Competition: Felzartamab enters a competitive anti‑CD38 market in China, where differentiation will hinge on clinical performance, pricing, and Biogen’s commercial execution.
- Platform Validation: The approval validates TJ Biopharma’s antibody development and GMP manufacturing capabilities, with the Hangzhou facility positioned to supply commercial demand.
- Pipeline Optionality: Felzartamab’s stated potential across immune‑mediated diseases and hematologic malignancies suggests future indication expansion opportunities beyond multiple myeloma under the Biogen partnership.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding the commercialization of felzartamab by Biogen, manufacturing supply by TJ Biopharma, and potential future indications. Actual results may differ due to risks including market adoption, competitive dynamics, regulatory requirements, and manufacturing performance.-Fineline Info & Tech