After zebutinib, everyone is looking forward to it: Where is the next truly "world-class" innovative drug in China? Nowadays, with the latest release of the first-line treatment data of iza-bren(BL-B01D1), the answer to this question is becoming clearer than ever. On March 25th, local time, Baili Tianheng reported the phase II research results of the first-line treatment of extensive small cell lung cancer (ES-SCLC) with its EGFR×HER3 dual-antibody ADC drug iza-bren combined with PD-1. The overall objective remission rate (ORR) was as high as 88.3%, and the median progression-free survival time (.

From the world's first molecular design of EGFR×HER3 double antibody ADC to the comprehensive layout of multi-tumor, multi-line and multi-joint schemes, it is no accident that iza-bren's "road to sealing the gods".

EGFR is a classic target for the treatment of solid tumors, and HER3 is the key "accomplice" leading to drug resistance. This target combination naturally conforms to the biological characteristics of many epithelial tumors. In other words, iza-bren aimed at the cornerstone drug status of broad-spectrum solid tumor treatment from the beginning of design.

At ASCO's annual meeting in 2023, iza-bren made her debut, and with the early data of treating patients with non-small cell lung cancer (NSCLC), she surprised the whole industry: among patients with EGFR mutant NSCLC, the ORR was 63.2%, and the disease control rate (DCR) was 89.5%; In patients with EGFR wild-type NSCLC, ORR was 40.5% and DCR was 95.2%.

Moreover, in nasopharyngeal carcinoma, head and neck squamous cell carcinoma, esophageal cancer and many other cancer species lacking traditional means, iza-bren has shown strong curative effect. Whether it is monotherapy for patients with advanced drug resistance or combined with PD-(L)1 inhibitor as the first-line therapy, iza-bren has achieved extremely stable output, proving itself to be a "panacea" base molecule.

By December, 2025, Bailey Tianheng and BMS had conducted more than 40 clinical trials on iza-bren in China and the United States, including 10 phase III registered studies in China (7 were included in breakthrough therapies) and 3 phase II/III registered studies in the United States (1 was recognized by FDA for breakthrough therapies).
If we simply disassemble the "world-class drug" in pharmaceutical history, we can find that it usually contains the following standards:

First, the molecular mechanism is new enough to have differentiated therapeutic barriers; Second, the indication space is wide enough and does not depend on a single outbreak; Third, clinical data can be copied and can be cashed in different people and scenarios; Fourth, the commercial development resources are strong enough to truly penetrate the global market.

Iza-bren has quite convincing answers to these four points.

In the past few years, ADC has been proved to be one of the most promising technical routes for the birth of global super-heavy drugs, and Enhertu is the best example. And the huge potential of "broad spectrum+forward movement+combination" of iza-bren has made the market's expectation for it no longer stay in "China ADC molecule", but refer to the world's heavy platform-level drug.

Industry analysts have predicted that the annual sales peak of iza-bren in the field of lung cancer alone is expected to exceed 5 billion US dollars. Coupled with the expansion of other solid tumors, iza-bren has full potential to hit the "super drug" of 10 billion US dollars.