By Fineline Cube MediLink Therapeutics announced that the New Drug Application (NDA) for Tam‑Peli (tamatanmab pelidotin for injection; R&D code: YL201), its self‑developed B7‑H3‑targeting antibody‑drug conjugate (ADC), has been accepted by China’s National Medical Products Administration (NMPA) for the treatment of relapsed small cell lung cancer (SCLC), under acceptance number CXSS2600135. The filing marks a pivotal regulatory step for the B7‑H3 ADC and follows the company’s landmark global licensing deal with Roche.
Regulatory Milestone
| Field | Detail |
|---|---|
| Agency | National Medical Products Administration (NMPA), China |
| Filing Type | New Drug Application (NDA) — accepted |
| Acceptance Number | CXSS2600135 |
| Product | Tam‑Peli (tamatanmab pelidotin for injection; YL201) |
| Drug Class | B7‑H3‑targeting antibody‑drug conjugate (ADC) |
| Proposed Indication | Relapsed small cell lung cancer (SCLC) |
| Company | MediLink Therapeutics |
| Date | 02 Sep 2026 |
| Next Steps | NMPA review toward potential approval in China |
Drug Profile & Mechanism of Action
- Molecule: Tam‑Peli (tamatanmab pelidotin for injection, YL201), self‑developed by MediLink Therapeutics.
- Target: B7‑H3, an immunomodulatory checkpoint antigen broadly overexpressed across multiple solid tumors.
- Platform: Built on the company’s proprietary tumor microenvironment‑cleavable camptothecin toxin‑linker platform (TMALIN).
- Mechanism: The tumor microenvironment‑cleavable linker is designed to release the camptothecin payload selectively within tumors, aiming to balance potency with systemic safety.
- Pipeline Expansion: Development is being jointly advanced across multiple solid tumor indications beyond SCLC.
Global Licensing Agreement – Roche Partnership
| Term | Detail |
|---|---|
| Agreement Date | January 2026 |
| Partner | Roche |
| Structure | Exclusive license agreement |
| Rights Granted | Exclusive rights to develop, manufacture, and commercialize Tam‑Peli globally |
| Excluded Territories | Mainland China, Hong Kong, and Macao |
| Upfront & Near‑Term Milestones | USD 570 million received by MediLink Therapeutics |
| Additional Economics | Development, regulatory, and commercial milestone payments, plus tiered royalties on net sales outside the designated territories |
Under the January 2026 exclusive license agreement, Roche obtained the global rights to Tam‑Peli excluding Mainland China, Hong Kong, and Macao. Leveraging their respective strengths, the two parties will join forces to accelerate the B7‑H3 ADC’s global R&D and regulatory filing process, jointly advancing development and commercialization across multiple solid tumor indications. MediLink Therapeutics received an upfront and near‑term milestone payment of USD 570 million and remains eligible for additional milestone payments and tiered royalties on net sales outside the designated territories.
Market Impact & Outlook
- Regulatory Momentum: NDA acceptance by the NMPA moves Tam‑Peli closer to potential approval for relapsed SCLC — a setting with high unmet need and limited effective options.
- Global Validation: The exclusive worldwide partnership with Roche, including USD 570 million in upfront and near‑term payments, underscores external confidence in the TMALIN platform and the B7‑H3 ADC class.
- Dual‑Track Commercialization: MediLink Therapeutics retains Greater China rights while Roche leads the rest of the world, enabling parallel regional and global launches.
- Indication Expansion: Joint development across multiple solid tumor indications positions Tam‑Peli as a potential multi‑label asset within B7‑H3‑expressing cancers.
Forward‑Looking Statements — This brief contains forward‑looking statements regarding MediLink Therapeutics‘ Tam‑Peli (YL201), including the NMPA review of the NDA for relapsed small cell lung cancer, the global collaboration with Roche, and potential milestone payments, royalties, and expansion across solid tumor indications. Such statements are based on current expectations and are subject to risks and uncertainties, including regulatory review, clinical development, and commercialization risks. Actual results may differ materially. Nothing herein constitutes investment advice or an offer to buy or sell any securities.-Fineline Info & Tech