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.

"YK-029A Tablet" - New Hope for EGFR 20ins Patients

The EGFR Exon 20 insertion mutation (referred to as 20ins) is a rare EGFR mutation. Currently, there are no approved first-line targeted therapies for this mutation in China, leaving most patients to receive chemotherapy and immunotherapy. The majority of patients with metastatic NSCLC harboring the 20ins mutation are treated with platinum-based first-line chemotherapy. However, these patients typically experience disease progression (PD) within six months, showing poor responses to the existing platinum-based doublet chemotherapy regimen. The response rates for first and second-generation EGFR TKIs, such as afatinib, erlotinib, and gefitinib, in 20ins positive patients are limited, around 10%, with a median progression-free survival (PFS) of 1 to 3 months. The response rate for the sole use of immune checkpoint inhibitors or in combination with chemotherapy ranges from 0% to 25%, with a PFS of 2 to 3 months.
Suzhou Puhe Biopharma Co., Ltd. has independently developed the next-generation EGFR small molecule inhibitor YK-029A. On September 5, 2022, YK-029A was designated as a breakthrough therapy for untreated advanced NSCLC patients with the 20ins mutation. This makes it the only Class 1 innovative drug in the first-line treatment of EGFR 20ins mutation NSCLC to receive Breakthrough Therapy Designation (BTD). Preliminary clinical studies have already demonstrated YK-029A’s excellent safety profile and clear, outstanding anti-tumor efficacy in patients with initial treatment of EGFR 20ins.

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.