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Dizal Pharmaceutical Submits NDA to FDA for Sunvozertinib as NSCLC Therapy
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Dizal Pharmaceutical Co., Ltd (SHA: 688192), a Chinese pharmaceutical company, has announced the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for sunvozertinib, a targeted therapy for lung cancer. The company is seeking approval for the treatment of locally advanced or metastatic non-small…
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National Reimbursement Drug List (NRDL) Negotiations Conclude with Lower Generic Drug Approval Rate
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The National Reimbursement Drug List (NRDL) negotiations for the year have concluded, with less than 50% of the total 162 participating generic name drugs passing the expert review. This approval rate is a decrease compared to 74.2% in 2022 and 63.8% in 2023. The successful drugs included 117 varieties from…
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Dizal Pharmaceutical’s Q3 2024 Revenues Soar 236% YOY on Strong Product Sales
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has released its financial report for the third quarter of 2024, announcing revenues of RMB 135 million (USD 18.94 million) for the quarter, marking a 236.39% year-on-year (YOY) increase. Revenues for the first three quarters reached RMB 338 million (USD 47.43 million), reflecting…
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Dizal Pharmaceutical’s Sunvozertinib Earns Breakthrough Designation for NSCLC from China’s NMPA
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Dizal Pharmaceutical Co., Ltd (SHA: 688192), a biopharmaceutical company based in China, has announced that it has received Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) for its next-generation epidermal growth factor receptor (EGFR) inhibitor, sunvozertinib. This designation is in relation to the drug’s potential use as…
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Sunvozertinib’s Companion Diagnostic Gets NMPA Nod, Fortifying Targeted Therapy Arsenal for NSCLC in China
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Dizal Pharmaceutical Co., Ltd (SHA: 688192) and Burning Rock Ltd (NASDAQ: BNR, FRA: 6BU0) have announced a significant regulatory milestone in China’s precision medicine space. Their jointly developed companion diagnostic (CDx) for epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins), designed to pair with the targeted therapy sunvozertinib,…
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Dizal Pharmaceutical’s Sunvozertinib Shows Promising Results in WU-KONG Series Study at ESMO 2024
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Dizal Pharmaceutical Co., Ltd (SHA: 688192), a biopharmaceutical company based in China, has presented updates on the WU-KONG series study for its next-generation epidermal growth factor receptor (EGFR) inhibitor, sunvozertinib (DZD9008), at the 2024 European Society of Medical Oncology (ESMO) Congress. Sunvozertinib received approval in China in August of the…
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Dizal Pharmaceutical’s Financial Turnaround Continues with 33% Net Loss Reduction in H1 2024
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Dizal Pharmaceutical Co., Ltd, a pharmaceutical entity listed in Shanghai (SHA: 688192), has unveiled its financial report for the first half of 2024, showcasing a revenue of RMB 204 million. This substantial growth is attributed to the rapid adoption of sunvozertinib, a cutting-edge epidermal growth factor receptor (EGFR) inhibitor, which…
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Dizal Pharmaceutical’s Golidocitinib Breaks Record with Rapid Market Launch in China
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Dizal Pharmaceutical Co., Ltd (SHA: 688192), a biopharmaceutical company based in China, has seen its drug golidocitinib go from marketing approval to first prescriptions in a record time of just two days in China. This marks a significant milestone, as golidocitinib is the first and only approved Janus kinase 1…
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Dizal Pharmaceutical’s Golidocitinib Wins NMPA Approval for Relapsed/Refractory PTCL
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Dizal Pharmaceutical Co., Ltd (SHA: 688192), a spin-off from AstraZeneca China established in 2017, has announced that the National Medical Products Administration (NMPA) has granted approval for its drug golidocitinib. The drug is indicated for the treatment of adult patients with relapsed or refractory (r/r) peripheral T-Cell lymphoma (PTCL) who…
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Dizal Pharmaceutical’s Sunvozertinib Logs RMB 91.29 Million in Sales Following EGFR Inhibitor Approval
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Dizal Pharmaceutical Co., Ltd (SHA: 688192), a spin-off from AstraZeneca China, has announced that its next-generation epidermal growth factor receptor (EGFR) inhibitor, sunvozertinib, which received approval in August 2023 for the treatment of EGFR Exon20ins mutated non-small cell lung cancer in China, has achieved sales of RMB 91.29 million (USD…
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Dizal Pharmaceutical’s Sunvozertinib Earns FDA Breakthrough Therapy Designation for NSCLC
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Dizal Pharmaceutical Co., Ltd (SHA: 688192), a leading Chinese pharmaceutical company, has announced that its next-generation epidermal growth factor receptor (EGFR) inhibitor, sunvozertinib, has received breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA). This designation is in recognition of sunvozertinib’s potential as a first-line treatment for…
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Dizal Pharmaceutical Presents Positive Trial Data for Golidocitinib at ASH Annual Meeting
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China-based Dizal Pharmaceutical Co., Ltd, (SHA: 688192), a spin-off from AstraZeneca (AZ, NASDAQ: AZN) China established in 2017, has presented robust pivotal trial data for its pipeline candidate golidocitinib at the American Society of Hematology (ASH) Annual Meeting. The data was presented in an oral presentation, showcasing the full analysis…
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Dizal Pharmaceutical and Wuxi Gaofa Investment to Establish Joint Venture for Auto-Immune Disease Treatments
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China-based AstraZeneca (AZ, NASDAQ: AZN) spin-out, Dizal Pharmaceutical Co., Ltd (SHA: 688192), has entered into a cooperation framework agreement with Wuxi Gaofa Investment Development Group Co., Ltd to establish a joint venture (JV). The JV will focus on the research, development, manufacturing, and sale of golidocitinib and DZD8586, which are…
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Dizal Pharmaceutical Presents Updates on DZD8586 and Golidocitinib at ASH Annual Meeting
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) provided updates on the clinical development of its drug candidates, DZD8586 and the JAK1 inhibitor golidocitinib (DZD4205), at the 65th American Society of Hematology (ASH) annual meeting. The event showcased the latest findings from the company’s research and development efforts in the field…
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Dizal’s Sunvozertinib Shows Promising Efficacy in Advanced NSCLC at ESMO 2023
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) presented compelling efficacy and safety data for its next-generation epidermal growth factor receptor (EGFR) inhibitor, sunvozertinib, at the European Society for Medical Oncology (ESMO) Congress 2023. The drug is being evaluated for first-line treatment in advanced non-small cell lung cancer (NSCLC) with EGFR…
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Dizal Pharmaceutical’s Golidocitinib NDA Accepted for Review by NMPA
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has announced that the National Medical Products Administration (NMPA) has accepted for review its New Drug Application (NDA) for golidocitinib, a first-in-class JAK1 inhibitor. The drug candidate is filed for the initial indication of treating recurrent refractory peripheral T-cell lymphoma (r/r PTCL). Supporting…
