SHANGHAI, April 27, 2024/PRNewswire/ -- From April 26 to 27, 2024, the Chinese Society of Clinical Oncology (CSCO) guidelines conference was held in Jinan. In the 2024 CSCO diagnosis and treatment guidelines released at this conference, Dizhe Pharmaceutical (stock code: 688192.SH) independently developed two innovative drugs from the source - Schwarzhe(Generic name: sulvortinib tablets) and golisitinib are both included in the guidelines as recommended medications.

• Shu WozheGet《CSCOGuidelines for diagnosis and treatment of non-small cell lung cancer (2024edition)》ⅠLevel recommendationsThis guideline targets the treatment of epidermal growth factor receptor (EGFR) exon 20 (exon20ins) mutant non-small cell lung cancer (NSCLC)soleILevel recommendation plan.
• Goliximitinib was obtained for the first time《CSCOLymphoma diagnosis and treatment guidelines (2024edition)》ⅡLevel recommendationsIt is used to treat patients with relapsed/refractory (r/r) peripheral T-cell lymphoma (PTCL).

Received the highest level of recommendation, filling a 20-year clinical gap
Shu WozheAs the world's only approved and accessible small-molecule TKI targeting EGFR exon20ins mutant nsCLC, it was first marketed in China last year, filling a 20-year clinical gap in this field. This time, it was included in the CSCO guidelines as secondary/post-line treatment in this field, showing that authoritative experts in the field of lung cancer in China think of SchwarzheHighly recognized for the value of “efficient and low toxicity” clinical treatment.

This recommendation is based on SchwarzerThe clinical study “Wukong 6" (WU-KONG6) was registered in China. The findings were presented orally at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting and published in the top international journal “The Lancet Respiratory Medicine” (The Lancet Respiratory Medicine, IF: 76.2)^[1]The research results were highly recognized by the international academic community. Based on the results of this research, SchwarzerIt was approved for marketing in China through priority review, and has become the standard treatment for EGFR exon20ins mutant nsCLC second/post-line treatment.

Professor Zhou Caicun, director of the Department of Oncology at Shanghai Oriental Hospital, said:“In this CSCO diagnosis and treatment guideline update, suvortinib was included in the “CSCO Non-Small Cell Lung Cancer Diagnosis and Treatment Guidelines (2024 Edition)” as the only Level I recommendation for EGFR exon20ins mutant NSCLC. On the one hand, it benefits from its obvious advantages in second/post-line treatment, the objective remission rate (ORR) is as high as 61%, far superior to similar drugs, and overall safety is good. Adverse reactions are controllable and manageable^[1]It can provide patients with a new, more effective option; on the other hand, it comes from its proven adaptation. It was approved for marketing in China in August 2023, making it an accessible treatment plan for patients. I believe this update will provide a reference for the treatment of more patients with EGFR exon20ins mutant nsCLC in clinical practice and benefit more patients.”

Currently, SchwarzerYesThe only full-line winner in the worldFDAGroundbreaking Therapies AccreditationA therapeutic drug targeting EGFR exon20InS mutant nsCLC. The 2023 European Society of Medical Oncology (ESMO) conference covered SchwarzerResearch results of single-drug first-line treatment of EGFR exon20ins mutant NSCLC have shown the potential for “best-in-class” efficacy.

Professor Wang Mengzhao, director of the Department of Respiratory and Critical Care Medicine at Peking Union Medical College Hospital, said:“I am very happy to see that, based on the results of the “Goku 6” (WU-KONG6) study, suvortinib was included in the “CSCO Guidelines for the Diagnosis and Treatment of Non-small Cell Lung Cancer (2024 Edition)” and became the only Level I recommended treatment for EGFR Exon20INs mutant advanced NSCLC second/post line treatment. Currently, suvortinib has become the standard treatment for EGFR exon20ins mutant advanced NSCLC second/post line treatment, and is also actively exploring first-line treatment for EGFR exon20ins mutant advanced NSCLC. Early findings suggest that the first-line treatment of EGFR exon20ins mutant nsCLC with sulvortinib confirmed ORR as high as 78.6%, the median progression-free survival (mPFS) in the 300 mg group was 12.4 months, and the safety was good^[2]It was once again verified that suvortinib is a potentially better treatment option for EGFR exon20ins mutant nsCLC. We look forward to the early announcement of the results of its global multi-center phase III study “Goku 28” (WU-KONG28), which will provide more reference basis for first-line treatment of EGFR exon20ins mutant NSCLC.”

New mechanics break the deadlock and break throughPTCLTreatment bottlenecks
Goliximitinib is globalFirst and onlyA highly selective JAK1 inhibitor for PTCL pioneered the world's first treatment of PTCL by targeting the JAK/STAT pathwayNew mechanism of action. The recommendation included in the CSCO guidelines is based on a global multi-center registered clinical study (JACKPOT8 Part B). The data showed that golixitinib alone treated r/r PTCL with an ORR of 44.3%, a complete remission (CR) rate of 23.9%, and a median duration of remission (DoR) of up to 20.7 months, all of which were nearly twice as superior to existing treatments. The research results were selected as an oral report at the 2023 American Society of Hematology (ASH) Annual Meeting and simultaneously published in “The Lancet Oncology” (Lancet Oncology, IF: 54.4)^[3].

Professor Zhu Jun of Peking University Cancer Hospital said:“Golisitinib has a new mechanism and new structure. It is the world's first oral JAK1 highly selective inhibitor for PTCL. It has good pharmacokinetic properties, and is the only JAK inhibitor that has made a breakthrough in the hematology field. The mechanism and clinical results have proven its potential to benefit all PTCL subtypes. Excellent clinical performance: high and continuous objective remission rate, good safety and tolerability, expected to break through PTCL treatment bottlenecks^[3].”

Professor Ma Jun of the Harbin Institute of Hematology and Oncology said:“Based on the excellent data shown by golisitinib in clinical research, this year's CSCO lymphoma diagnosis and treatment guidelines include golisitinib as a guideline. It can be used as a single agent to treat r/r PTCL (Level II recommendation), whether it is the soon-to-be approved r/r PTCL single drug or the exploration of future combined applications, including published single-agent maintenance treatment. We look forward to further exploration of golisitinib in the field of PTCL to benefit more lymphoma patients.”

Currently, golisitinib has been granted “Fast Track Designation” (Fast Track Designation) by the US Food and Drug Administration (FDA). Meanwhile, its new drug marketing application has been accepted by the National Drug Administration (NMPA) and included in priority review, which is expected to bring new treatment options to domestic patients as soon as possible.

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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 Goliximitinib
Golisitinib is the world's first and only highly selective JAK1 inhibitor for peripheral T-cell lymphoma (PTCL). The first indication is relapse/refractory (r/r) PTCL, and key clinical trials are being carried out in countries such as China, the United States, South Korea, and Australia. Golisitinib was granted “Fast Track Designation” (Fast Track Designation) by the US Food and Drug Administration (FDA) in February 2022. In September 2023, the marketing application for golisitinib was accepted by the Drug Administration (NMPA) New Drug Evaluation Center (CDE) and included in priority review.

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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