Award Banner
Award Banner

FDA Grants Breakthrough Therapy Designation for Dizal Pharmaceutical's DZD9008 in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Exon20 Insertion

FDA Grants Breakthrough Therapy Designation for Dizal Pharmaceutical's DZD9008 in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Exon20 Insertion

Breakthrough Therapy Designation further demonstrates excellent clinical profile of DZD9008 (Sunvozertinib)

SHANGHAI, Jan. 27, 2022 /PRNewswire/ -- Dizal Pharmaceutical Co., Ltd. (SHEX:688192) ("Dizal"), today announced that the U.S. Food and Drug Administration ("FDA") has granted Breakthrough Therapy Designation to DZD9008 (Sunvozertinib) for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.

"Lung cancer patients with exon20 insertion mutations need better treatment. Sunvozertinib was specifically designed with high selectivity for inhibiting mutated EGFR, which causes cancers. Available clinical evidence shows that Sunvozertinib has the potential to provide the patients with a new and much improved targeted therapy," said Dr. Xiaolin Zhang, Chief Executive Officer at Dizal. "We are very pleased with FDA's decision. Now Sunvozertinib has received Breakthrough Therapy Designation from both US FDA and China CDE, which validates Sunvozertinib's differentiated profile.  At Dizal, we are committed to discover and develop innovative medicines for the benefit of cancer patients globally."

Breakthrough Therapy designation is a process designed by US FDA, China CDE, and other regulatory agencies to expedite the development and review of drugs that are intended to treat a serious condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s)[1].

About DZD9008 (Sunvozertinib)

DZD9008 is a rationally designed selective, irreversible, novel EGFR inhibitor. In global Phase 1/2 studies, it has demonstrated promising antitumor efficacy in pre-treated NSCLC patients with EGFR exon20 insertion mutations. Its confirmed ORR is 45.5% at 200 mg and 41.9% at 300 mg (data cut-off by July 30, 2021). It also shows efficacy among patients with brain metastasis or previously treated by Amivantamab. It was well tolerated with a manageable AE profile.

Dizal is conducting Phase 2 pivotal clinical trials in China, U.S., EU, Japan, Australia, South Korea and other countries and regions.

About Dizal Pharmaceutical

Dizal Pharmaceutical is a global, science-oriented biotech company dedicated to discovery, development and commercialization of innovative medicines. Dizal has established leading capabilities in translational science, drug design and testing technology platforms. It has developed a diversified portfolio of innovative therapies for the treatment of cancer and immunological diseases.

Forward-Looking Statements

This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Dizal Pharmaceutical, are intended to identify certain of such forward-looking statements. Dizal Pharmaceutical does not intend to update these forward-looking statements regularly.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Dizal Pharmaceutical with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Dizal Pharmaceutical's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Dizal Pharmaceutical's competitive environment and political, economic, legal and social conditions.

Dizal Pharmaceutical, the Directors and the employees of Dizal Pharmaceutical assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect.


[1] U.S. Food and Drug Administration. Breakthrough Therapy. Accessed January 27, 2022.


Investor Relations:
Business Development:

This website is best viewed using the latest versions of web browsers.