Puhe announced that PH027-1, a potential best-in-class WRN small-molecule inhibitor, has been approved for IND by the NMPA.

Beijing, China, November 15, 2025 – Bayer Co. Lab was officially launched in Yizhuang BioPark, with Puhe BioPharma settling in as one of the first batch of companies.

Suzhou Puhe BioPharma Co.,Ltd. and Bayer today announced that they have entered into a global license agreement for Puhe BioPharma’s oral, small molecule PRMT5 inhibitor that selectively targets MTAP-deleted tumors

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.。