Zhitong Finance App News, Kang Fang Biotech (09926) announced that the new drug marketing application (SNDA) for first-line treatment of advanced squamous non-small cell lung cancer (SqnsCLC) with the world's first bispecific antibody (PD-1/VEGF), developed independently by the company, has been approved for listing by the China National Drug Administration (NMPA). This is the third indication that Evosi has been approved for marketing.
The new indications for first-line treatment of SQ-nsCLC were approved and marketed based on the significant positive results obtained in a randomized, controlled, multicenter phase III clinical study (Harmoni-6/AK112-306, NCT05840016, CTR20231272) with evosil combined chemotherapy compared with tirelizumab in first-line chemotherapy in the first-line treatment of advanced SQ-nsCLC. The positive results of the study's overall survival (OS) mid-term analysis were released at the 2026 American Society of Clinical Oncology (ASCO) Presidential Meeting (ASCO); the positive results of the progression-free survival (PFS) mid-term analysis were announced at the 2025 European Society of Medical Oncology (ESMO) Presidential Meeting:
Among ITT people, the median overall survival (OS) was 27.89 months and 23.69 months, respectively, with OS HR = 0.66 (95% CI: 0.50-0.87), and P = 0.0017 (<0.0049).
Among ITT people, the median progression-free survival (m PFS) was 11.1 months and 6.9 months in the Ivorian group and the control group, respectively, with PFS HR = 0.60 (95% CI: 0.46—0.78), and P<0.0001.
The overall safety of evosil in combination with chemotherapy is good. The overall safety characteristics are comparable to those of tirelizumab in combination with chemotherapy.
The results of this clinical study comprehensively proved that the combined chemotherapy regimen with evasil has transformative clinical value compared to the PD-1 combination chemotherapy regimen, and filled the clinical gap of the anti-angiogenic drug bevacizumab in the treatment of SQ-nsCLC. The results show the excellent efficacy and safety of evosil therapy, and with the approval of the NMPA, it will bring new hope to more patients with advanced squamous cell NSCLC in China.