BEIJING and SHANGHAI, Sept. 6, 2023 /PRNewswire/ -- Guangzhou Gloria Biosciences ("GloriaBio"), a commercial stage biopharmaceutical company focusing on the discovery, development and commercialization of biologics in immuno-oncology, today announced that its fully human anti-PD-1 monoclonal antibody, Zimberelimab injection (YuTuo®, GLS-010) has received marketing approval from the China National Medical Products Administration (NMPA), as monotherapy for the treatment of recurrent or metastatic cervical cancer (R/M CC) patients with positive PD-L1 expression (CPS≥1) who progressed on or after platinum-based chemotherapy. Zimberelimab is the first and only immune checkpoint inhibitor (ICI) antibody approved in China for cervical cancer, and third one globally.  

As a differentiated next-generation, fully human antibody developed by the transgenic rat platform OmniRat®, Zimberelimab has demonstrated high affinity, selectivity and potency in various tumor types with excellent safety profile. Zimberelimab was designated as Breakthrough Therapy for cervical cancer by China's Center of Drug Evaluation (CDE) in March 2021, and was included in the "Guidelines for Cervical Cancer Treatment" as recommendation by The Chinese Society of Clinical Oncology (CSCO) in 2022, and most recently in the "Guidelines for the Clinical Application of Immune Checkpoint Inhibitors in Gynecological Tumors" by the Gynecologic Oncology Branch of Chinese Medical Association in 2023. In addition, Zimberelimab was included in and recommended by the CSCO "Guidelines for Lymphoma Treatment" from 2020 to 2023 for four consecutive years.

The approval of Zimberelimab by NMPA was based on the positive results from a pivotal Phase 2 clinical trial "Efficacy and Safety of Zimberelimab (GLS-010) Monotherapy in Patients with Recurrent or Metastatic Cervical Cancer: A Multicenter, Open-Label, Single-Arm, Phase II Study" (YH-S001-05, NCT03972722) ^{[1], [2]}, led by Xiaohua Wu, M.D., Professor of Department of Gynecologic Oncology at Fudan University Shanghai Cancer Center, and Director of Oncology and Gynecology at the Cancer Hospital Affiliated to Fudan University. The results were presented at various medical conferences, including Society for Immunotherapy of Cancer (SITC), European Society for Medical Oncology (ESMO) IO and ESMO Asia in 2022 in poster and oral presentation sessions, respectively.

• As of April 29, 2022, among 90 evaluable patients with tumor assessment, the Objective Response Rate (ORR) of Zimberelimab as monotherapy reached 27.8%. A total of 5 patients (5.6%) achieved Complete Remission (CR), and 20 patients (22.2%) achieved Partial Remission (PR). The median Progression-free Survival (mPFS) was 3.7 months, and the median Overall Survival (mOS) was 16.8 months. The median duration of response (DOR) had not been reached.

"China has the second largest patient population of cervical cancer in the world, with higher incidence and mortality rates than developed countries. But the treatment options for patients with R/M CC who failed first-line platinum-based therapy are limited, as there is currently no standard treatment, and the conventional chemotherapy has poor efficacy and severe side effects - only less than 10% ORR and 5 to 9 months mOS -, suggesting an unmet medical need for new therapies to improve clinical outcomes," said Prof. Wu.

"The approval of Zimberelimab for R/M CC represents the next significant step to fight against cervical cancer in China. This is the first and only ICI antibody available for this indication in the country," Prof. Wu noted. "In the pivotal trial YH-S001-05, Zimberelimab has demonstrated potentially the best-in-class clinical results with highest ORR achieved among other ICIs antibodies as monotherapy in R/M CC, which provides this patient population better treatment option of improved survival benefit and safety, compared to the conventional chemotherapy."

"We are committed to providing high quality cancer care to patients. Immunotherapy has emerged as a therapeutic possibility for cervical cancer and has been clinically approved. ICIs regimen has already been recommended as the first-line treatment option for R/M CC by the 2022 National Comprehensive Cancer Network (NCCN) guidelines ^[3]," said Jiman Zhu, the founder of GloriaBio. "We have initiated a Phase 3 trial (VICT-004) to evaluate Zimberelimab in combination with platinum-based chemotherapy +/- bevacizumab as first-line treatment of R/M CC, and look forward to providing a better first-line treatment option to benefit more patients."

China has a population of 582.4 million women ages 15 years and older who are at risk of developing cervical cancer. Current estimates indicate that every year 109,741 women are diagnosed with cervical cancer and 59,060 die from the disease. Cervical cancer ranks as the 6th most frequent cancer among women in China and the 3rd most frequent cancer among women between 15 and 44 years of age ^[4].

About Zimberelimab (YuTuo®, GLS-010)

Zimberelimab is the world's first fully human anti-PD-1 monoclonal antibody in market developed by the transgenic rat platform, OmniRat®. The first indication of relapsed or refractory classical Hodgkin's lymphoma (r/r HL) was approved in China in August 2021. Zimberelimab has been selected into the "Chinese Society of Clinical Oncology (CSCO) Diagnosis and Treatment Guidelines for Malignant Lymphoma" for 4 consecutive years since 2020. Zimberelimab's second indication for recurrent or metastatic cervical cancer (r/m CC) was designated for Breakthrough Therapy and was approved in China in 2023, which was the first and only PD-1 antibody approved for this indication in China, and was the third one globally.

Achieved clinical data of zimberelimab has demonstrated best-in-class potentials and has been published in various international medical conferences. In the pivotal clinical study of r/r HL, patients were observed with the Objective Response Rate (ORR) of 92.68%, the Disease Control Rate (DCR) of 96.43%, and 12-month Overall Survival (OS) rate of 99%. And in the pivotal clinical trial of r/m CC, the ORR of zimberelimab as monotherapy reached 27.8%. A total of 5 patients (5.6%) achieved Complete Remission (CR), and 20 patients (22.2%) achieved Partial Remission (PR). The median Progression-free Survival (mPFS) was 3.7 months, and the mOS was 16.8 months.

About Gloria Biosciences

Founded in 2016, Gloria Biosciences is a commercial stage biopharma company focused on development and commercialization of novel or highly differentiated immunotherapies and biologics for oncology. Toward the Company's ultimate goal of improving accessibility, affordability and availability for patients with innovation, Gloria Biosciences is striving to build a pipeline of more efficacious and patient-centered treatments to address unmet medical needs, driven by the Company's efficient execution of clinical development, proven fast-to-market commercialization capability, world-class GMP-compliant manufacturing capability and global partnerships.

Company contact:
Corporate Development
IR@gloriabio.com 

SOURCE:- PR Newswire