(Yicai) July 14 -- Dizal Pharmaceutical has become the first Chinese company to get the US green light for a first-in-class lung cancer treatment, after its self-developed drug was granted the Food and Drug Administration’s accelerated approval.

Sunvozertinib will be marketed in the United States under the brand name Zegfrovy, following its approval by the US Food and Drug Administration on July 3, the Shanghai-based company said at the weekend.

The FDA's accelerated approval pathway allows drugs for serious or life-threatening conditions to be approved based on early evidence of benefit.

Sunvozertinib is the only oral treatment for patients with a rare form of non-small cell lung cancer included in the US National Comprehensive Cancer Network guidelines, addressing a long-standing lack of effective oral treatments for this mutation, the firm added.

The drug is aimed at NSCLC patients with epidermal growth factor receptor exon 20 insertion mutations, a form of the disease that tends to have lower survival rates than other EGFR mutations.

“We are proud to have developed Zegfrovy, a first-in-class oral therapy that offers a more effective treatment option with enhanced safety and ease of administration for NSCLC patients with EGFR exon20ins,” said Dr. Xiaolin Zhang, Dizal Pharma’s chief executive.

“The accelerated approval of Zegfrovy marks a significant milestone that underscores our commitment to developing groundbreaking new medicines for patients with high unmet medical needs around the world," Zhang added.

Dizal Pharma’s shares [SHA: 688192] finished 1.7 percent higher at CNY64.90 (USD9.05) each in Shanghai today. The stock is up more than 56 percent since the end of last year.

Sunvozertinib is the company’s first self-developed product. It was approved in China two years ago, less than four years after its first clinical trial enrollment.

Dizal Pharma was formed in 2017 by UK-based drugs giant AstraZeneca and China’s SDIC Fund. The firm has prioritized global competitiveness, with all its pipeline candidates undergoing global synchronous development starting from Phase I trials. 

Editor: Tom Litting