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.

Professor Wang Jie from the Cancer Hospital of the Chinese Academy of Medical Sciences was invited as the Chairman of this Meeting. Professor Wang Jie stated in opening speech that effective drugs for EGFR 20ins lung cancer patients are still very scarce. The YK-029A Tablet of Puhe Biopharma has shown outstanding therapeutic effects in previous clinical trials. Based on a comprehensive protocol discussion, Professor Wang Jie extensively listened to the opinions of numerous clinical experts and obtained CDE approval, to conduct Phase III clinical study on the comparison of YK-029A tablets and platinum-containing dual drug chemotherapy for first-line treatment of locally advanced or metastatic NSCLC with EGFR Ex20ins mutation. We hope researchers from all over the country can cooperate to promote the early launch of YK-029A Tablet so that we can benefit more patients.。

"YK-029A Tablet" EGFR 20ins patient new hope

Mr. Guo Yongqi, CEO of Puhe Biopharma, introduced the development model of Puhe Biopharma's innovation and the product pipeline layout with significant advantages. He said that, "Lung cancer is the cancer with the highest incidence rate and mortality in China. The number of EGFR patients in China is over 300,000, which is 4 times higher than that of European and American countries. But in the past, the development of new drugs in this field has always been led by large foreign companies, and we look forward to the emergence of our own innovative drugs in China in the future.
EGFR Ex20ins mutation (referred to as "20ins") is a rare EGFR mutation, and currently there are no first-line treatment targeted drugs approved in China. Therefore, most of these patients receive chemotherapy and immunotherapy. Most 20ins of metastatic NSCLC receive platinum-based first-line chemotherapy, but typically develop to disease progression (PD) within 6 months, and patients have poor response to the existing platinum-containing dual drug chemotherapy regimens. The activity of first and second generation EGFR TKI afatinib, erlotinib, and gefitinib are limited in 20ins positive patients, with a response rate of about 10% and a median progression free survival (PFS) of 1-3 months. The response rate of using immune checkpoint inhibitors alone or in combination with chemotherapy is 0%-25%, with a PFS of 2-3 months.
YK-029 tablet is currently the only Class I innovative drug recognized by BTD in the first-line treatment of NSCLC with EGFR 20ins mutation. It has excellent safety and anti-tumor efficacy in newly treated EGFR 20ins patients. We believe that under the leadership of Professor Wang and his team, and with the promotion of various clinical centers, YK-029A Tablet is striving to become the first domestically developed innovative drug. Puhe Biopharma adheres to the principle of making new drugs and producing good ones, always maintaining a DAYONE mentality, and more efficiently promoting products into clinical practice, benefiting more patients.

Guo Yongqi invited Professor Wang Jie from the Cancer Hospital of the Chinese Academy of Medical Sciences, the team leader, to witness the Launch Ceremony together with the attending guests, marking the official launch of the national Phase III clinical study of this project.

Dr. Zhao Hui, the Clinical Leader of Puhe Biopharma, provided a detailed introduction on the study background of YK-029A Tablet, a summary of clinical trials conducted, the Phase III clinical study plan, and the project schedule.

Ms. Liu Jinghui, an imaging scientist at Taimei Technology, introduced the content of the central imaging and clarified the standards for independent imaging evaluation.

Professor Duan Jianchun from Shanxi Hospital of the Cancer Hospital of the Chinese Academy of Medical Sciences presided over the Discussion Session, and the attending experts had in-depth exchanges and enthusiastic discussions on the Phase III clinical study of YK-029A Tablet.

The National Meeting of Phase III Clinical Researchers of YK-029A Tablet has successfully concluded. Looking forward to achieving good results in this clinical study as soon as possible with the joint efforts of researchers nationwide; looking forward to more patients benefiting from participating in this clinical study; We also hope that YK-029A Tablet can benefit more newly treated EGFR 20ins cancer patients in the future.。

About Suzhou Puhe Biopharma Co., Ltd.

Puhe Biopharma is a small molecule innovative pharmaceutical company jointly funded and incubated by Shiyu Capital and well-known domestic listed pharmaceutical companies. Our focus is on developing groundbreaking drugs in the field of oncology and supportive cancer care, committed to addressing distinct clinical needs. We adopt a multifaceted approach that blends scientific insight, financial acumen, and industrial strategy, alongside a market-oriented, risk-balanced operational method.
Leveraging our domestic clinical strengths through strategies such as company mergers and acquisitions, product introductions, and independent R&D, Puhe Biopharma actively explores commercial opportunities. We capitalize on the benefits of flexible production scale and comparatively low-cost investments, integrating resources to expedite our industrial growth. In 2022, our innovative approach earned us a spot in the Jiangsu Province Science and Technology Small and Medium-Sized Enterprise Database.
Currently, Puhe Biopharma has an impressive portfolio of small molecule drugs for cancer and supportive therapies, targeting unmet clinical needs in lung and pancreatic cancer, among others. A standout in our product pipeline is YK-029A, a leading and rapidly advancing innovative drug. Having received acceptance and approval from the National Medical Products Administration, YK-029A is now progressing into the pivotal Phase III of clinical trials.