The State Food and Drug Administration accepted the marketing application of Dizhesuvortinib, and the national innovative drug broke through the refractory target of lung cancer

SHANGHAI, Jan.
10, 2023 /PRNewswire/ -- Dizhe Pharma (688192.
SH) today announced that its new drug application for suvortinib tablets (DZD9008), an innovative drug in the field of lung cancer, has been accepted by the National Medical Products Administration and included in the proposed priority review for EGFR exon20in carrying epidermal growth factor receptor exon 20 (EGFRexon20in) that has previously received platinum-based chemotherapy s) Mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults
.

Suvortinib is an orally available highly selective tyrosine kinase inhibitor (TKI) for multiple EGFR mutant subtypes, which is the first and only national innovative drug in the field of lung cancer that has been recognized as a "breakthrough therapy" by China and the United States, and the first advanced NSCLC with EGFRexon20ins mutation accepted on the market of China's original innovative drugs
.

The application is based on the first Chinese registered clinical study of suvortinib (Wukong 6, WU-KONG6), the results of which were announced at the 2022 European Society for Medical Oncology (ESMO) Congress: as of July 31, 2022, the tumor response rate (cORR) confirmed by the Evaluation Committee of the Blinded Independent Center (BICR) was 59.
8%, and the cORR was 48.
4% for patients with EGFR exon20ins mutation with stable and asymptomatic brain metastases at baseline Best-in-class efficacy worldwide with an overall
good safety profile.

Dr.
Xiaolin Zhang, Founder, Chairman and Chief Executive Officer of Ditze Pharmaceutical, said: "Suvortinib is the company's first new drug to apply for marketing authorization, and the acceptance of this application represents an important step
towards our goal of bringing the latest and best drugs from the world to Chinese patients in the first place.
Based on best-in-class clinical data worldwide, we believe that suvortinib will bring new hope
to more lung cancer patients.
Ditze has always adhered to innovation at the source, and has established a globally competitive R&D pipeline, and we will continue to strive to fill unmet clinical needs and launch more breakthrough therapies to benefit patients
around the world.
" "

Lung cancer is the second largest malignant tumor in the world, non-small cell lung cancer accounts for about 85%, and the most common mutation is EGFR mutation
.
EGFR exon20ins mutation is a refractory subtype of EGFR mutation, and the objective response rate (ORR) of traditional EGFR-TKI, immunotherapy and chemotherapy for EGFRexon20ins mutation advanced NSCLC is less than 20%^[1].

For new drugs conditionally marketed in the United States last year, the ORR was 28-40% ^[2-3].

References

[1].
Pasi A Janne,et al.
Mobocertinib (TAK-788) in EGFR exon 20 insertion-positive metastatic non–small cell lung cancer: Treatment beyond progressive disease in platinum-pretreated patients with and without intracranial PD.
2022 ASCO abstract 9099
[2] Park, et al.
JCO 2021, 39: 3391
[3] Zhou, et al.
JAMA Oncol.
2021

About suvortinib

Suvortinib is an oral, irreversible, highly selective EGFR tyrosine kinase inhibitor (TKI) against multiple EGFR mutant subtypes, which was recognized as a breakthrough therapy (BTD) in China and the United States in 2020 and 2022 respectively with excellent efficacy and safety, becoming the first and only class I new drug in the field of lung cancer to obtain dual BTD in China and the United States, and is now in the global registration clinical stage
。 The preferred indication of suvortinib is for the treatment of EGFR exon 20 insertion mutation non-small cell lung cancer, which is undergoing registered clinical trials in China, the United States, Europe, South Korea, Australia and other countries and regions, and the main endpoint is the objective response rate (ORR) assessed by the Blinded Independent Center Evaluation Committee (BICR)
according to RECIST 1.
1 。 As of July 31, 2022, data from registered clinical trials in China showed that suvortinib in the treatment of EGFR exon 20 exon insertion mutant (EGFR exon20ins) advanced non-small cell lung cancer (NSCLC) that had failed previous platinum-containing chemotherapy had an ORR of 59.
8% at the recommended dose of phase II (RP2D) of 300 mg; The ORR for patients with brain metastases at baseline was 48.
4%.

In addition, initial efficacy
has been observed with suvortinib in patients with EGFR-sensitive mutations, T790M mutations, and HER2 exon 20 insertion mutations in non-small cell lung cancer.
The translational scientific research results of suvortinib were listed in Cancer Discovery (impact factor: 39.
397)
in April 2022.

About Ditze Pharmaceutical

Ditze Pharma is a global innovative biopharmaceutical company with products in the clinical development stage, focusing on the research, development and commercialization
of innovative drugs in the field of malignant tumors and immune diseases.
The company adheres to the research and development concept of source innovation, is committed to the mining and mechanism verification of new targets, and aims to launch the world's first drug (First-in-class) and treatment methods with breakthrough potential, and strives to fill unmet clinical needs and lead the development direction
of the industry.
At present, two drug candidates are in the global registration clinical stage, and five drugs are in the international multi-center clinical stage
.

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.
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.
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.

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