By Fineline Cube 
China-based Betta Pharmaceuticals (SHE: 300558) announced that China’s National Medical Products Administration (NMPA) has approved its clinical‑trial application for the bispecific antibody MCLA‑129 in combination with the multi‑targeted kinase inhibitor ensartinib to treat patients with advanced solid tumors exhibiting MET amplification or overexpression.
What Is MCLA‑129?
- Bispecific antibody that simultaneously targets the epidermal growth factor receptor (EGFR) and mesenchymal‑epithelial transition factor (c‑Met).
- Blocks both EGFR and c‑Met signaling pathways, curbing tumor growth and survival.
- Enhances antibody‑dependent cell‑mediated cytotoxicity (ADCC), increasing tumor‑cell killing potential.
Ensartinib: A Proven Multi‑Target Inhibitor
- Inhibits c‑Met, ALK, ROS‑1, and additional kinases.
- Co‑developed by Betta and its subsidiary Xcovery Holdings, Inc.
- First NMPA approval in 2020; now approved for two indications.
- Launched in the U.S. in Dec 2024, marking the first globally marketed small‑molecule targeted lung‑cancer drug led by a Chinese company.
Why the Combination Matters
| Feature | Benefit |
|---|---|
| Multi‑pathway synergy | Simultaneous EGFR and c‑Met blockade plus kinase inhibition amplifies antitumor activity. |
| Prolonged PFS | Expected to extend progression‑free survival in MET‑positive solid‑tumor patients. |
| Clinical advantage | Only comparable product approved both in China and internationally is the EGFR/c‑Met bispecific amivantamab. |
Next Steps
- Phase I/II trials will commence in Q4 2025 to evaluate safety, tolerability, and preliminary efficacy.
- Betta plans to explore additional tumor types and biomarker‑driven subpopulations.-Fineline Info & Tech