SHANGHAI, April 7, 2024 /PRNewswire/ -- On April 7, 2024, Dizhe Pharmaceutical (stock code: 688192.SH) announced that the US Food and Drug Administration (FDA) awarded it the first self-developed novel lung cancer targeted drug, Schwarzer(Generic name: sulvortinib tablets)Groundbreaking Therapies Accreditation，Used for first-line treatment carrying epidermal growth factor receptors (EGFR)20exon insertion (Exon20ins) Mutated advanced non-small cell lung cancer (NSCLC) patients. This is a follow-up to the treatment of EGFR Exon20ins mutant advanced NSCLC, SchwarzheIt became another important milestone in the field of lung cancer after being “recognized as a breakthrough therapy” by both China and the US. Currently, SchwarzerYesThe only full-line winner in the worldFDAGroundbreaking Therapies AccreditationMedications to treat EGFR exon20ins mutant nsCLC.
EGFR exon20ins mutation is a rare and intractable target for non-small cell lung cancer, and the incidence rate is about 2%-4% of NSCLC. Due to its special spatial conformation, variety of mutation subtypes, and strong heterogeneity, traditional EGFR TKI is basically ineffective against this target. The median progression-free survival (mPFs) and median overall survival (MoS) are less than half of the advanced EGFR-sensitive mutant NSCLC. Over the past 20 years, research and development of new drugs for EGFR exon20ins mutant NSCLC has mostly gone to waste, and there has been a lack of safe and effective targeted treatments for a long time.
Shu WozheIn China in August 2023Initial listing through priority review，It has filled this field almost20There has been a gap in clinical treatment over the years,It's currentlyThe only one approved in the worldSmall molecule TKI for EGFR exon20ins mutant advanced NSCLC. With a unique and flexible innovative molecular design, SchwarzerBreak through the curse that the EGFR exon20ins mutation target is difficult to develop, and comprehensively improve the efficacy, safety and convenience of this target treatment. According to data from the Chinese registered clinical study “Wukong 6" (WU-KONG6), Shu WozheTreating EGFR exon20ins mutant advanced NSCLC is highly efficient and low in toxicity, and the efficacy and safety are potentially the best in its class. For this indicationGlobal registered clinical study “Goku1 Bpart” (WU-KONG1 PARTB), The enrollment of all patients has been successfully completed, and the latest active research data will be published for the first time2024American Society of Clinical Oncology (ASCO) Presented in the form of an oral report at the annual meeting.
This breakthrough therapy certification is mainly based on SchwarzerA phase I/II, open label, international multicenter clinical study “Goku 1" (WU-KONG1). At the 2023 ESMO conference, Dizhe Pharmaceutical announced the aggregated analysis data for this study and the Phase II study “Wukong 15” (WU-KONG15) initiated by Chinese researchers: Shu WozheThe confirmed objective remission rate (CorR) of advanced EGFR exon20ins mutant advanced NSCLC with single-agent first-line treatment reached78.6%, Progression-free survival (MPFs) in the Phase II recommended dose (RP2D) 300mg group was12.4months, once again showing the potential for “efficient, low toxicity, best in class” treatment.
Dr. Zhang Xiaolin, founder, chairman and CEO of Dizhe Pharmaceutical, said, “Shu WozheIt was also recognized as a breakthrough therapy by the FDA, which is a high recognition of Digger's research results in the field of EGFR exon20ins mutant non-small cell lung cancer. At the same time, “Goku 1” (WU-KONG1) is actively researching the latest data, and we are very excited that it was successfully selected for ASCO's oral report. We are still speeding up the promotion of SchwarzerThe global multi-center phase III clinical study “Goku 28” (WU-KONG28) for first-line treatment of EGFR exon20ins mutant advanced NSCLC looks forward to bringing breakthrough treatment options to more patients around the world as soon as possible.”
The US FDA granted “breakthrough therapy certification” to accelerate drug development and regulatory review to treat serious or life-threatening diseases. New drugs need to be proven to have significant clinical advantages over existing treatments through encouraging initial clinical results. New drugs granted “breakthrough therapy certification” will enjoy a series of policies to accelerate drug development, including intervention by FDA experts to guide the entire clinical development process, thereby greatly improving the efficiency of communication with the FDA. When submitting a drug marketing application, you can get priority review if you meet the relevant standards.
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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.
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 industry-leading translational science and new drug molecular design and screening technology platforms, the company has established a globally competitive product pipeline. 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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