July 12, Digene (Jiangsu) Pharmaceutical Co., Ltd. (hereinafter referred to as "Digene Pharmaceutical") held a press conference in Beijing on the approval of Shuvozal® in the United States.

Reporters learned that ZEGFROVY® (generic name: Suvotinib tablets) of Digene Pharmaceuticals has been included in the National Comprehensive Cancer Network (NCCN) non-small cell lung cancer guidelines for the treatment of previously treated epidermal growth factor receptor (EGFR) exon 20 insertion mutation (exon20ins) non-small cell lung cancer (NSCLC). ZEGFROVY® has become the only EGFR exon20ins NSCLC small molecule targeted drug in the world that has been included in the international authoritative lung cancer guidelines.

Earlier, Shuwozhe® was approved for marketing by the U.S. Food and Drug Administration (FDA) through priority review on July 3, becoming the world's first and only EGFRexon20ins NSCLC innovative drug approved in the United States.It is also China’s first independently developed global innovative .

Professor Wang Mengzhao of Peking Union Medical College Hospital, the principal investigator of the Shuwozhe® China registration clinical study (WU-KONG6) and the principal investigator of "WU-KONG1B" (WU-KONG1B), said in his speech: "Suowotinib has overcome the difficulties in drug development from the source, providing a safe and effective targeted treatment for EGFR exon20ins NSCLC patients around the world. From the Chinese registration study 'WU-KONG6' (WU-KONG6) to the international multicenter registration study 'WU-KONG1B' (WU-KONG1B), it marks the first time that China's independently developed source innovative drugs have completed the full chain verification from China to the world in the field of EGFR exon20ins NSCLC."

Dr. Yang Zhenfan, Chief Medical Officer of Digene Pharmaceuticals, shared the experience of Shuwoze® as Digene's first self-declared new drug that successfully passed the FDA from the perspective of "from clinical research and development to registration application". "The realization of 'one-time acceptance' with zero re-issuance, priority review and zero verification defects is based on the product advantages of international competitive positioning, verification of international multi-center clinical studies, high-quality data and systematic preparation work in the early stage according to the most stringent standards in FDA regulations."

Dr. Zhang Xiaolin, founder, chairman and CEO of Digene Pharmaceuticals, summarized the "Digene Path": "First, based on a solid scientific foundation, we should position ourselves to participate in global competition; second, we should cooperate with top international R&D centers at an early stage and verify scientific hypotheses with international multi-center clinical trials; and finally, we should have the company's strategy and determination, believe in your products, and persist in investing in them."

Source：https://finance.eastmoney.com/a/202507133455462627.html