Chia Tai Tianqing's EGFR/c-Met Bispecific Antibody TQB2922 Wins CDE Acceptance Amid Intensifying Race

China's National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) has accepted a new drug application from Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. for TQB2922 injection (subcutaneous), an investigational EGFR/c-Met bispecific antibody. The application, filed under acceptance number CXSL2600667, marks the latest milestone in a drug program that has been accelerating through clinical development since late 2025.

The acceptance, recorded on June 24, 2026, follows a clinical trial implicit approval in November 2025 and a combination therapy indication clearance in March 2026. For Chia Tai Tianqing Pharmaceutical Group Co., Ltd.—one of China's largest generic and innovative drug makers—the steady regulatory progress signals a serious push into a competitive space where only one product has reached market so far.

TQB2922 is a humanized bispecific antibody co-developed in-house, targeting both EGFR and c-Met. What sets it apart is its dual mechanism: it blocks tumor growth by inhibiting the EGFR and c-Met signaling pathways while simultaneously recruiting the body's own immune defenses—natural killer cells and macrophages—to directly kill cancer cells through antibody-dependent cellular cytotoxicity and phagocytosis.

That two-pronged approach is designed to tackle one of oncology's most stubborn problems: resistance to third-generation EGFR tyrosine kinase inhibitors (TKIs). These drugs, which include AstraZeneca's osimertinib, have transformed outcomes for patients with EGFR-mutant non-small cell lung cancer (NSCLC). But resistance inevitably emerges, and treatment options thin out fast.

Early Data Show Promise

Phase I clinical results presented at the 2026 European Lung Cancer Congress (ELCC) offer early evidence that the strategy may work. In patients with advanced NSCLC who had progressed on EGFR-TKI therapy, TQB2922 as a single agent produced an objective response rate (ORR) of 23.7%.

When combined with chemotherapy and bevacizumab, the ORR jumped to 64.7%, with a disease control rate (DCR) of 97.1%. Treatment-related adverse events were mostly Grade 1 or 2, with Grade 3 or higher events occurring in just 12.9% of patients—suggesting a manageable safety profile even in a heavily pretreated population.

Subcutaneous Ambitions

Chia Tai Tianqing is developing TQB2922 in both intravenous and subcutaneous formulations. The subcutaneous version uses a proprietary technology platform designed to overcome the volume limitations that have historically constrained subcutaneous delivery of large-molecule antibody drugs. If successful, the formulation could significantly reduce infusion times and improve patient convenience—a meaningful differentiator in a market where lengthy IV infusions are the norm.

A Crowded but High-Stakes Race

In the global EGFR×c-Met bispecific antibody space, Johnson & Johnson's amivantamab remains the only approved product. The competitive landscape is intensifying, however, with several Chinese biotech firms racing to challenge the incumbent. Chia Tai Tianqing's sustained investment in TQB2922—pushing through regulatory checkpoints at a rapid pace—positions the company as a serious contender. For Chinese patients facing EGFR-TKI resistance, more options on the horizon could mean the difference between running out of choices and finding a new path forward.