EGFR Ex20ins mutation is the third largest mutation in EGFR. In the Chinese population, EGFR Ex20ins mutation accounts for 4-12% of EGFR gene mutations and 3% of NSCLC. The EGFR EX20ins mutation has the characteristics of high heterogeneity, refractory nature, poor prognosis, and high malignancy. In recent years, more and more new drugs targeting this mutation have emerged, but the recommendation of targeted therapy in first-line treatment still lacks evidence. NSCLC carrying EGFR Ex20ins urgently needs new therapies. At present, several small molecule drugs have entered the clinical trial stage. Taking this opportunity, Professor Wang Jie from the Cancer Hospital of the Chinese Academy of Medical Sciences is invited by [Tumor Information] to interpret the current clinical treatment status and the most important breakthrough progress in first-line treatment of EGFR EX20ins mutant NSCLC, in order to inspire clinical practice.

Recently, Puhe Biopharma disclosed the development process of its Phase 3 small molecule EGFR inhibitor YK-029A in the European Journal of Medical Chemistry.

Recently, the first clinical study result of the Class I innovative drug YK-029A, originally developed by Puhe Biopharma, was included in the 2023 ASCO poster discussion. The poster presentation and on-site poster discussion session were held on June 4 in the United States time. Professor Duan Jianchun, from Professor Wang Jie's team at the Cancer Hospital of the Chinese Academy of Medical Sciences, attended and gave a keynote presentation.

EGFR mutation, as one of the most common driving genes in NSCLC, has an incidence rate of approximately 50% in lung adenocarcinoma patients in China [1]. In recent years, EGFR-TKI has brought good survival prognosis to EGFR mutation positive patients, but there are still some patients who are not sensitive to EGFR-TKI treatment in clinical practice.

The Phase III national clinical study on the first-line treatment of EGFR 20ins advanced non-small cell lung cancer with YK-029A tablet was officially initiated

On May 13, 2023, Suzhou Puhe Biopharma Co., Ltd. successfully held a national researchers Meeting in Beijing on the Phase III clinical study of YK-029A Tablet, the first independently developed Class I new drug, compared with platinum-containing dual drug chemotherapy for the first-line treatment of locally advanced or metastatic NSCLC with EGFR Ex20ins mutation. Nearly a hundred researchers from 60 Research Centers of China attended the meeting together. This clinical study was led by Professor Wang Jie from the Cancer Hospital of the Chinese Academy of Medical Sciences, with Puhe Biopharma as the Sponsor and Triapex as the Supporter.。

The Annual Meeting of the American Association for Cancer Research (AACR), a global event for basic and translational study on cancer, was grandly held in Orlando, Florida, USA from April 14 to April 19, 2023. The Annual Meeting is the 114th Annual Meeting of AACR. At the meeting, Suzhou Puhe Biopharma submitted two independently developed projects, PH009-1 (the fourth-generation EGFR project) and PH020-803 (a new generation PRMT5 inhibitor), to the AACR Annual Meeting. This is also the first time that the study data of Puhe Biopharma has been publicly disclosed, and both projects have been highly recognized by the Meeting committee. Where, PH009-1 was presented with posters at the Meeting, PH020-803 was invited to give an oral presentation at the meeting. Currently, both abstracts have been made public online.

On April 7, 2023, Suzhou Puhe Biopharma Science and Technology Co., Ltd. has achieved a notable milestone with the successful enrollment of the first patient in the Phase III clinical study of its self-developed Class 1 new drug, YK-029A. This pivotal study, conducted at the Union Hospital affiliated with Tongji Medical College of Huazhong University of Science and Technology, targets locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR Exon 20 insertion mutations, comparing YK-029A to first-line platinum-based doublet chemotherapy. Led by Professor Wang Jie from the Cancer Hospital of the Chinese Academy of Medical Sciences, this large-scale Phase III study involves collaboration across 60 centers nationwide.

Suzhou, China, February 10, 2023- Suzhou Puhe Biopharma announced today that its application for Phase III clinical trial for a small molecule innovative drug (PH001) in the field of lung cancer has been accepted and approved by the National Medical Products Administration for use in advanced NSCLC patients with EGFR Ex20ins who have not undergone systematic treatment.