China's domestic biotech industry is entering a new phase of international influence, as homegrown innovative drugs increasingly meet global clinical demand. One recent example is Dizal Pharma, a Wuxi-based biotech firm that has emerged as a model for China's evolving pharmaceutical ambitions.
On July 10, Dizal's lung cancer drug, sunvozertinib, was officially included in the US National Comprehensive Cancer Network treatment guidelines. The recognition followed approval from the US Food and Drug Administration a week earlier, making it the first-ever China-originated innovative medicine approved for EGFR exon20ins-mutated lung cancer in the US.
Sunvozertinib targets a rare but difficult-to-treat form of non-small cell lung cancer caused by EGFR exon20ins mutations. While these mutations only occur in about 2 to 4 percent of NSCLC cases, the sheer number of lung cancer patients worldwide makes that percentage substantial.
This subset of patients has few safe and effective options. The mutation itself is heterogeneous, with more than 130 different mutant subtypes. Most existing therapies don't work.
According to Dizal founder and CEO Zhang Xiaolin, what sets Dizal apart is its "original innovation". Rather than modifying an existing drug, Dizal's scientists designed an entirely new molecule from scratch. A 2022 study in Cancer Discovery underscored this breakthrough, showing that sunvozertinib's efficacy stems from its uniquely flexible chemical scaffold, tailored to tackle mutation diversity head-on.
"From the very beginning, we didn't outsource critical trials," Zhang said.
"We believed in building an in-house, globally capable team—culturally attuned, scientifically rigorous, and willing to face failure."
This team led sunvozertinib through rigorous international multi-center clinical trials—including collaborations with Harvard-affiliated hospitals—offering early-phase data across both Asian and non-Asian populations, a key requirement for FDA acceptance.
"Sunvozertinib is not just a scientific breakthrough—it's proof that China's homegrown innovation can meet global standards," said Zhang.
The achievement comes amid a wave of supportive national policies over the past two years. On July 1, the National Healthcare Security Administration and the National Health Commission jointly announced a series of measures to encourage novel drug development, including the creation of a commercial insurance catalog for innovative medicines that patients could be reimbursed for. Recent reforms to capital markets—such establishing a new segment on the tech-heavy STAR Market to host pre-profit companies—are also helping accelerate the sector's growth.
