CStone Announces The Lancet-Oncology Announcement of a Phase III Registration Clinical Study of Zejima(R) (Sugalimab Injection) in the Treatment of Non-Small Cell Lung Cancer

The GEMSTONE-301 study was designed to evaluate the efficacy and safety of ^Zejimet® as consolidation therapy in patients with unresectable stage III non-small cell lung cancer (NSCLC) who have not progressed after concurrent or sequential chemoradiotherapy

The GEMSTONE-301 study met the prespecified primary endpoint in a planned interim analysis

Professor Wu Yilong, the principal investigator of the GEMSTONE-301 study, the corresponding author of the article, and the Guangdong Provincial People's Hospital, said: "The publication of the GEMSTONE-301 study in The Lancet-Oncology demonstrates that Chinese researchers have successfully explored and developed a broad scientific perspective.

Jianxin Yang, Chief Medical Officer of CStone, said: "The Lancet-Oncology, as an authoritative professional publication in oncology, has been focusing on major progress in improving the status of global tumor prevention and control, publishing high-quality research results on tumor control and treatment.

Recently, the National Medical Products Administration (NMPA) of China has approved the New Drug Application of ^Zejimei® for the first-line treatment of patients with squamous or non-squamous stage IV non-small cell lung cancer in combination with chemotherapy

About ^Zejimet® (Sugalimumab Injection)

Zejimet® is an investigational anti-PD-L1 monoclonal antibody independently developed by ^CStone

At present, the National Medical Products Administration of China has approved the New Drug Application of ^Zejimet® for the combination of pemetrexed and carboplatin for epidermal growth factor receptor (EGFR) gene mutation-negative and anaplastic lymphoma kinase (ALK) First-line treatment of patients with negative metastatic non-squamous non-small cell lung cancer, and combination paclitaxel and carboplatin for first-line treatment of patients with metastatic squamous non-small cell lung cancer

About the GEMSTONE-301 Study

^{GEMSTONE-301 is a multicenter, randomized, double-blind phase III clinical trial (clinicaltrials.}

In May 2021, the GEMSTONE-301 study met the prespecified primary endpoint as assessed by an independent data monitoring committee (iDMC) at a planned interim analysis

In September 2021, the National Medical Products Administration of China has accepted the NDA of ^Zejimet® for the treatment of stage III NSCLC indications for the treatment of unresectable stage III non-small cell non-small cell disease without disease progression after concurrent or sequential chemoradiotherapy lung cancer patients

About the GEMSTONE-302 study

^{GEMSTONE-302 is a multicenter, randomized, double-blind phase III clinical trial (clinicaltrials.}

In August 2020, the GEMSTONE-302 study met its prespecified primary endpoint of significantly greater efficacy in combination with chemotherapy than ^placebo plus chemotherapy as assessed by an independent data monitoring committee (iDMC) in a planned interim analysis.

In July 2021, the final PFS analysis of the GEMSTONE-302 study showed that ZEJME ^combined with chemotherapy further enhanced the primary efficacy endpoint of progression-free survival, with a 52% reduction in the risk of disease progression or death, and demonstrated overall survival A clear trend of benefit

About CStone

CStone Pharmaceuticals (SEHK: 2616) is a biopharmaceutical company focused on the research, development and commercialization of innovative immuno-oncology and precision medicines to meet the high medical needs of cancer patients in China and around the world

To learn more about CStone , please visit:.

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