CStone Announces the Announcement of the Results of the Phase IV Non-Small Cell Lung Cancer Registration Clinical Study Results of Zejimay(R) (Sugelimumab Injection) in The Lancet-Oncology

The study was designed to evaluate the efficacy and safety of Zejimet® plus chemotherapy versus placebo plus chemotherapy in first-line treatment-naïve, stage IV NSCLC ^patients

In 2020, in a prespecified PFS interim analysis (median follow-up of 8.

Professor Zhou Caicun, the principal investigator of the GEMSTONE-302 study, the corresponding author of the article, and director of the Department of Oncology, Shanghai Pulmonary Hospital, said: "I am very pleased that the results of the GEMSTONE-302 study were invited to be published in The Lancet-Oncology, which fully demonstrates the international Recognized by the academic community for its innovative and reasonable research design, high-quality research quality and outstanding research results

Dr.

In addition, the NDA of Zejimei® for the treatment of locally advanced (stage III) NSCLC has been accepted by the China National Medical ^Products Administration in September 2021 and is currently under review

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-302 study

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

In August 2020, the GEMSTONE-302 study met the prespecified primary endpoint of the combination of Zejimet® plus chemotherapy compared with placebo plus chemotherapy as assessed by an independent data monitoring committee (iDMC) in a prespecified 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 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 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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