• baseline circulating plasma tumorsDNA(ctDNA) Testing for epidermal growth factor receptors (EGFR)20exon insertion (Exon20ins) Patients with positive and negative mutations receive SchwarzerEfficacy benefits were observed after treatment
• Shu WozheIt acts directly onEGFRSignaling pathways can effectively remove plasmactDNAOfEGFR exon20insmutations
• Shu WozheThe mechanism of drug resistance is shownEGFRdependency andEGFRindependent pathway, golisitinib (JAK1inhibitors) combination chemotherapy is a potential solution 

SHANGHAI, May 24, 2024/PRNewswire/ -- Dizhe Pharmaceutical (stock code: 688192.SH) announced the company's first self-developed novel Class I lung cancer target drug, ShuvozheA summary of the latest biomarker exploratory study (generic name: sulvortinib tablets) (ID: 8563) was officially released on the official website of the American Society of Clinical Oncology (ASCO) Annual Meeting. The research results are SchwarzheThe efficacy of EGFR exon 20 insertion (exon20ins) mutation in non-small cell lung cancer (NSCLC) has been further confirmed.

A total of 121 cases were included in the study to receive SchwarzheIn patients with EGFR exon20INs advanced NSCLC treated, the results showed:

• baseline plasmactDNAdetectsEGFR exon20insMutations positive and negativeThe patient accepts SchwarzerEfficacy benefits were observed after treatment
  • Accept SchwarzerAfter treatment, both patients with negative and positive EGFR exon20ins mutations were observed in baseline plasma ctDNA testing. Among them, objective response rates (ORR) were 68.0% and 45.8%, respectively, and median progression-free survival (mPFs) was 7.4 months and 5.5 months.
  • There is a trend of better efficacy benefits for patients with negative EGFR exon20ins mutation in baseline plasma ctDNA testing, which may be related to fewer metastases and lower tumor burden in negative patients.
• Shu WozheIt acts directly onEGFRPathway, can effectively remove plasmactDNAOfEGFR exon20insmutations
  • Accept SchwarzerAfter treatment, the vast majority (85.7%) of patients decreased the number of copies of the EGFR exon20ins mutation in plasma ctDNA.
  • Clearance of the EGFR exon20ins mutation in plasma ctDNA can occur as early as receiving SchwarzerAfter 1 week of treatment.
• Shu WozheThe mechanism of drug resistance is shownEGFRdependency andEGFRindependent pathway, golisitinib (JAK1inhibitors) combination chemotherapy is a potential solution
  • Shu WozheDrug resistance may be related to acquired EGFR C797S mutations, EGFR G724S mutations, and other genetic abnormalities in the EGFR downstream signaling pathway.
  • In vitro and in vivo experiments suggest that the highly selective JAK1 inhibitor golisitinib combined with chemotherapy developed independently by the company may overcome SchwozheA potential treatment option for drug resistance.

Dr. Zhang Xiaolin, founder, chairman and CEO of Dizhe Pharmaceutical, said, “The biomarker research results selected for the ASCO annual conference will help us further optimize the treatment plan for patients with EGFR exon20ins mutant NSCLC, and also confirm SchwotzheIt can efficiently remove EGFR exon20ins mutations. Based on the positive results of the Chinese registered clinical study 'Goku 6' (WU-KONG6), Shu WozheIt was approved for marketing in China last year, making it the only approved and accessible small molecule TKI for EGFR exon20ins mutant nsCLC in the world. Shu WozheData from the international multi-center registered clinical study 'Goku 1 Part B' (WU-KONG1 Part B) for the broader treatment of EGFR exon20ins mutant NSCLC people around the world will also be announced for the first time at this conference. Preliminary analysis results show that the study has reached its intended main research end point and will be SchwarzerIt provides an important basis for filing new drug marketing applications (NDA) in the US, the European Union, etc.”

The “Goku 1 Part B” (WU-KONG1 Part B) research is currently being carried out in 10 countries and regions around the world, including Europe, America, Australia, and Asia. Preliminary research analysis shows that SchwarzerSecond/post-line treatment of EGFR exon20ins mutant nsCLC showed positive anti-tumor efficacy and was safe. The latest research data will be presented in the form of an oral report at this ASCO conference (abstract number: 8513).

About Schwarzer(suvortinib)

Shu WozheIt is an oral, irreversible, and highly selective EGFR tyrosine kinase inhibitor (TKI) for various EGFR mutation subtypes. The first indication was approved for marketing in China through priority review by the State Drug Administration in August 2023. It is used for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have previously progressed through platinum-containing chemotherapy or are intolerant to platinum-containing chemotherapy, and tests have confirmed the presence of epidermal growth factor receptor (EGFR) exon 20 (exon20ins) mutations. April 2024, SchwarzerIt is included in the “Chinese Society of Clinical Oncology (CSCO) Non-Small Cell Lung Cancer Diagnosis and Treatment Guidelines (2024 Edition)” as the only Level I recommended treatment for EGFR exon20ins mutation NSCLC.

About Dizhe Pharmaceuticals

Dizhe Pharmaceutical (stock code: 688192.SH) is an innovative biomedical enterprise focusing on the research, development and commercialization of innovative therapies in the fields of malignant tumors and immune diseases. The company adheres to the innovative R&D concept, with the goal of introducing first-in-class drugs (first-in-class) and treatments with breakthrough potential to fill unmet global clinical needs. Based on the industry-leading translational science and new drug molecular design and screening technology platform, the company has established six globally competitive product pipelines. Two leading products are in critical global clinical trials, and one of them has been approved for marketing. For more information, follow the official WeChat account: Dizal, or visit.

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