CStone Pharmaceuticals announces that the new drug listing application of sugarizumab for stage III non-small cell lung cancer has been accepted by the National Medical Products Administration

Shuglizumab is the world's first PD-1 or PD-L1 monoclonal antibody that significantly improves the progression-free survival of patients with stage III non-small cell lung cancer without disease progression after concurrent or sequential radiotherapy and chemotherapy

The new drug application for sugarizumab for the treatment of metastatic (stage IV) non-small cell lung cancer is currently under review by the China National Medical Products Administration, making it the world’s first approved to cover locally advanced/unresectable (stage III) ) And metastatic (stage IV) non-small cell lung cancer PD-1 or PD-L1 monoclonal antibodies

(Suzhou, China, September 2, 2021) CStone Pharmaceuticals (Hong Kong Stock Exchange Code: 2616), a leading biopharmaceutical company focused on research, development and commercialization of innovative tumor immunotherapies and precision therapeutic drugs, announced today that China The National Medical Products Administration (NMPA) has accepted a new drug listing application (NDA) for sugarizumab for consolidation therapy in patients with unresectable stage III non-small cell lung cancer (NSCLC) who have not progressed after concurrent or sequential radiotherapy and chemotherapy.

The main investigator of GEMSTONE-301 and Professor Wu Yilong from Guangdong Provincial People's Hospital said:

"Globally, stage III NSCLC faces a huge unmet need for treatment, especially for stage III NSCLC that has not progressed after sequential radiotherapy and chemotherapy

Dr.

"The acceptance of this NDA is the second application for the listing of suglizumab in NSCLC, China's highest tumor type, following the acceptance of the NDA for the treatment of stage IV NSCLC with suglizumab in November last year

The NDA acceptance is based on a study called GEMSTONE-301, which is a multi-center, randomized, double-blind phase III clinical trial designed to evaluate the simultaneous or sequential use of sugarizumab as a consolidation treatment Efficacy and safety in locally advanced/unresectable stage III non-small cell lung cancer patients without disease progression after radiotherapy and chemotherapy

CStone Pharmaceuticals and Pfizer have reached a strategic cooperation, which includes the development and commercialization of suglimumab in mainland China, and a cooperation framework for introducing more oncology products into the greater China region

CStone Pharmaceuticals has reached a strategic cooperation with EQRx of the United States, exclusively authorizing EQRx to develop and commercialize two tumor immunotherapeutic drugs that are in the late stage of research and development outside of Greater China, and CS1003 (anti-PD-1 monoclonal antibody)

About sugarizumab (anti-PD-L1 monoclonal antibody)

Suglizumab is an anti-PD-L1 monoclonal antibody developed by CStone Pharmaceuticals

At present, sugarizumab has undergone a number of registered clinical trials, including one phase II registered clinical trial (CS1001-201) for lymphoma, and four phase III and IV non-small cell lung cancer and gastric cancer.

Among them, CS1001-201 is a single-arm, multi-center phase II registered clinical trial aimed at evaluating sugarizumab as a single agent in the treatment of adult relapsed or refractory extranodal natural killer cell/T cell lymphoma (R/R ENKTL) effectiveness and safety

About the GEMSTONE-301 study

GEMSTONE-301 is a multi-center, randomized, double-blind phase III clinical trial (clinicaltrials.

In May 2021, in the planned interim analysis of the GEMSTONE-301 study, the independent data monitoring committee (iDMC) assessed that it reached the preset primary study endpoint

At present, the China National Medical Products Administration has accepted the new drug application for sugarizumab for the treatment of stage III NSCLC

About the GEMSTONE-302 study

GEMSTONE-302 is a multi-center, randomized, double-blind phase III clinical trial (clinicaltrials.

In August 2020, in the planned interim analysis of the GEMSTONE-302 study, the independent data monitoring committee (iDMC) assessed that it reached the preset primary study endpoint, that is, compared with placebo combined with chemotherapy, sugarizumab combined Chemotherapy significantly prolonged the patient's progression-free survival (PFS) and reduced the risk of disease progression or death by 50% (mPFS: 7.

In November 2020, NMPA accepted a new drug listing application for suglimumab for the first-line treatment of patients with metastatic squamous and non-squamous non-small cell lung cancer in combination with chemotherapy

In July 2021, the updated data of the GEMSTONE-302 study showed that after the primary efficacy endpoint was reached during the previous PFS phase analysis, in the recent final analysis of PFS, sugarizumab combined with chemotherapy further prolonged the patient's PFS
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At the same time, this extended follow-up time data further confirms that suglimumab combined with chemotherapy can bring long-lasting survival benefits to patients
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About CStone Pharmaceuticals

CStone Pharmaceuticals (Hong Kong Stock Exchange code: 2616) is a biopharmaceutical company that focuses on research, development and commercialization of innovative tumor immunotherapy and precision treatment drugs to meet the ardent medical needs of cancer patients in China and around the world
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Established at the end of 2015, CStone Pharmaceuticals has assembled a world-class management team with extensive experience in new drug development, clinical research and commercial operations
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With tumor immunotherapy combination therapy as the core, the company has established a rich product pipeline consisting of 15 tumor drug candidates
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At present, CStone Pharmaceuticals has obtained three new drug marketing approvals worldwide, two new drug marketing approvals in Mainland China, and one new drug marketing approval in Taiwan
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Many late-stage drug candidates are in critical clinical trials or registration stages
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CStone's vision is to become a world-renowned biopharmaceutical company, leading the way to overcome cancer
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For more information about CStone Pharmaceuticals, please visit:
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