China Securities Journal, cs.com.cn (Reporter: Meng Peijia) - The reporter learned from Sino Biopharm on May 23 that the abstracts for selected studies were announced at the American Society of Clinical Oncology (ASCO) annual meeting on May 22 (local time). Among them, data from the Phase III clinical trial of Sino Biopharm's "Defu Combination" (Benmelstobart + Anlotinib capsules) for the first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer (sq-NSCLC) was announced for the first time. The median progression-free survival (PFS) was 10.12 months, defeating the comparator drug in a head-to-head trial. It is reported that this is also the industry's first Phase III clinical trial to achieve positive results comparing a PD-1 inhibitor combined with chemotherapy for the first-line treatment of squamous non-small cell lung cancer.

Professor Shi Yuankai from the Cancer Hospital of the Chinese Academy of Medical Sciences, the report's author and principal investigator of this clinical trial, stated that the regimen of Benmelstobart combined with chemotherapy followed by sequential combination with Anlotinib has broken through the bottleneck of traditional standard treatments. Anlotinib has accumulated a large body of evidence-based medical evidence and has demonstrated robust anti-tumor activity in multiple indications, including later-line treatment for non-small cell lung cancer. This study adopted an innovative clinical trial protocol design, with sequential Benmelstobart combined with Anlotinib following Benmelstobart combined with chemotherapy.

According to a previous announcement by Sino Biopharm, based on the relevant clinical trial results, the company has submitted a new indication marketing application for the "Defu Combination," which was accepted by the Center for Drug Evaluation (CDE), NMPA on April 22. Currently, Anlotinib has been approved for 8 indications, with another 5 indications in the New Drug Application (NDA) stage. Among them, the "Defu Combination" has been approved for 3 indications, with another 3 indications in the new drug application stage.

Public information shows that the American Society of Clinical Oncology Annual Meeting is a highly anticipated clinical oncology conference in the industry, considered an industry bellwether, and receives attention from the global pharmaceutical industry and investors. At the ASCO Annual Meeting of this year, a total of over 70 original studies by Chinese researchers were selected for oral presentation, including many "First-in-Class" and "Best-in-Class" studies. Among them, Sino Biopharm had a total of 12 clinical studies selected for the "oral presentation" session at the conference, setting a new record for a Chinese pharmaceutical company.