Dizal, a notable name in the healthcare sector, has officially announced the approval of its groundbreaking drug, sunvozertinib, by the National Medical Products Administration (NMPA) of China. This achievement marks a significant advancement in the treatment of adult patients suffering from locally advanced or metastatic non-small cell lung cancer (NSCLC) with specific genetic mutations. Sunvozertinib, distinguished for its exceptional efficacy and safety attributes, has obtained the prestigious status of being the first and only Category-I Innovative Drug in China for lung cancer treatment, having received breakthrough therapy designations from both the NMPA and the FDA.

Addressing a substantial medical challenge, sunvozertinib has solidified its position as the "best-in-class" solution due to its unmatched effectiveness and safety credentials.

With non-small cell lung cancer (NSCLC) being the most prevalent form of cancer in China, boasting high incidence and mortality rates, Dizal's sunvozertinib aims to address this critical issue. A specific mutation known as EGFR Exon20ins mutation is the most common driver gene mutation in NSCLC, accounting for approximately 12% of all EGFR mutations. However, the unique characteristics and high heterogeneity of this mutation have posed significant challenges in terms of targeted treatment options. Sunvozertinib's approval comes as a major development in this context, offering a beacon of hope for patients with EGFR Exon20ins mutation who have had limited treatment options until now.

The basis for NMPA's approval of sunvozertinib is the outcomes from the pivotal WU-KONG6 study, conducted in China among platinum-pretreated NSCLC patients with EGFR Exon20ins mutations. The study showcased promising results, including a significant improvement in the primary endpoint, an objective response rate (ORR) of 60.8%. Furthermore, the overall safety profile of sunvozertinib was comparable to other EGFR TKIs, signifying its benign nature and clinical manageability.

Prof. Mengzhao Wang, MD, PhD at Peking Union Medical College Hospital, the leading principal investigator of WU-KONG6, expressed, "Monotherapy with sunvozertinib achieved a remarkable ORR of 60.8% in pre-treated advanced NSCLC patients with EGFR Exon20ins mutations. This treatment demonstrated comparable efficacy to traditional EGFR TKIs in treating this specific type of mutation. The approval of sunvozertinib is expected to revolutionize the treatment landscape for patients with EGFR Exon20ins mutant advanced NSCLC, offering them more effective and safer treatment avenues."

Xiaolin Zhang, PhD, Chairman, and CEO of Dizal, shared his enthusiasm for this achievement, stating, "Sunvozertinib represents a groundbreaking achievement as the first Chinese innovative drug approved for EGFR Exon20ins NSCLC, highlighting Dizal's extraordinary efficiency and unwavering dedication to innovation. Obtaining NDA approval within four years from enrolling the first patient sets an unprecedented benchmark for the rapid development of targeted lung cancer treatments. The launch of sunvozertinib marks a significant milestone for Dizal, underscoring our capabilities from research and development to commercialization. Going forward, we are committed to accelerating our efforts to achieve profitability and ensuring the rapid accessibility of Dizal's innovative therapies to patients in China and worldwide."

Dizal continues to advance its global pivotal studies in the realm of EGFR-mutated NSCLC. Preclinical studies have highlighted sunvozertinib's potent inhibitory effects on various EGFR mutation subtypes, including the challenging EGFR Exon20ins mutations. The drug's promising results have been showcased at prestigious international academic conferences, accentuating its importance in addressing EGFR-mutated NSCLC. Dizal remains committed to delivering effective treatments while driving original innovation and efficient commercialization to enhance global access to Chinese innovative drugs.

 

Source: prnewswire.com

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