Pfizer's ZEJULA® (Sugemalimab) Approved as the First Global PD-L1 Inhibitor for First-Line Treatment of Esophageal Squamous Cell Carcinoma

ShanghaiDecember 8, 2023PR Newswire -- December 8, 2023, Pfizer, Inc. announced the innovative oncology immunotherapy Zejia Stone.^®(General name: Sugemalimab Injection) has been approved by the National Medical Products Administration (NMPA) for use in combination with fluorouracil and platinum-based chemotherapy drugs for the first-line treatment of unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC). As the world's first approved PD-L1 monoclonal antibody for this indication, Zejia Stone.^®To provide more patients with upper gastrointestinal tumors innovative immunotherapy combination options, helping patients achieve long-term survival benefits. This is Zhejietong.^®The fourth approved indication after Phase IV and Phase III non-small cell lung cancer (NSCLC), relapsed or refractory extranodal NK/T-cell lymphoma (R/R ENKTL), and the second approved indication within this year.

President of Pfizer China,Jean-Christophe Pointeau, Chairman of the RDPAC Executive Committee and Vice President of the China Association of Enterprises with Foreign InvestmentStated: "The field of oncology has always been a strategic focus for Pfizer. In line with the mission of 'bringing breakthrough innovations that change patients' lives,' Pfizer provides solutions that fill clinical gaps for common and highly prevalent tumor types in China through scientific innovation. This time, Zejia Stone..."^®The approval of the new indication has achieved a breakthrough in the field of upper gastrointestinal tumors and further expanded Pfizer's coverage in the field of tumor immunotherapy. In the future, Pfizer will continue to expand tumor immunotherapy with the concept of 'Science for Victory, Overcoming Cancer Together', change the existing treatment pattern while helping patients improve overall survival rate and quality of life, move forward one step, and defeat the formidable enemy of cancer.

Esophageal cancer is a malignant digestive tract tumor originating from the esophageal epithelium, occurring between the starting point of the hypopharyngeal esophagus and the gastroesophageal junction. According to GLOBOCAN 2020 data, the incidence and mortality rates of esophageal cancer rank 9th and 6th globally, respectively.^[1]In 2020, there were over 600,000 new cases of esophageal cancer globally, with esophageal squamous cell carcinoma accounting for approximately 85%; the number of deaths reached 544,000. Notably, China is a country with a high incidence of esophageal cancer, with both the number of cases and deaths accounting for more than half of the global total.^[2]`, and 90% of the patients have esophageal squamous cell carcinoma.`^[3]。

For a long period of time, the treatment of esophageal cancer has been dominated by surgery and radiotherapy. Since most patients with esophageal squamous cell carcinoma are diagnosed at an advanced stage and have lost the opportunity for radical treatment, the prognosis of esophageal cancer remains poor. However, the high mutation rate and strong immunogenicity of esophageal cancer cells offer more hope to patients through advancements in immunotherapy.

Zejie Stone^®Principal Investigator of the GEMSTONE-304 Study, Professor Li Jin, Director of the Department of Oncology at Oriental Hospital Affiliated to Tongji UniversitySaid: "Many esophageal cancer patients have developed locally advanced or distant metastasis at the time of initial diagnosis, which means they are no longer candidates for surgical treatment. As a breakthrough cancer immunotherapy drug, Zejie Stone..."^®With a unique dual mechanism of action, it mobilizes T cells and macrophages within the human body to jointly eliminate tumor cells, exerting a more powerful tumor cell-killing ability. This time, Zhejie Stone^®The approval of a new indication for esophageal squamous cell carcinoma will bring patients a new clinical treatment option.

Since its first approval at the end of 2021, Zejie Stone^®Indications continue to expand, achieving several "world's first" breakthroughs. By the end of 2021 and June 2022, Zejie Stone...^®Approved in China for the treatment of Stage IV and Stage III non-small cell lung cancer (NSCLC) patients successively, becoming the first PD-(L)1 antibody globally to cover both Stage III and Stage IV NSCLC indications; In October 2023, Zejia Stone^®Gained conditional approval in China, becoming the world's first approved PD-L1 monoclonal antibody for the treatment of relapsed or refractory extranodal NK/T-cell lymphoma (R/R ENKTL) indication. In the future, Zhejie Stone^®It will also further expand its indications for digestive tract tumors that are highly prevalent in China, providing doctors with more clinical treatment "weapons" and bringing more survival benefits to patients.

About Zhejie Stone^®(Sugemalimab Injection)

Zejie Stone^®It is an anti-PD-L1 monoclonal antibody developed by CStone Pharmaceuticals, based on the OmniRat licensed from Ligand Corporation in the United States.^®Transgenic animal platform. As a fully human full-length anti-PD-L1 monoclonal antibody, Zejie Stone^®It is a natural immunoglobulin G4 (IgG4) monoclonal antibody drug that is close to the human body, with a lower risk of immunogenicity and related toxicity, which makes Zhejie Stone...^®Compared with similar drugs, it has unique advantages. Furthermore, the retention of antibody-dependent cellular phagocytosis (ADCP) allows Zejie Stone...^®Simultaneously acts on innate immunity and adaptive immunity, featuring a unique dual-mechanism advantage. Zhejie Stone^®In Phase Ia and Ib studies, it demonstrated good anti-tumor activity and tolerability across multiple cancer types. Based on early clinical data, Zhejie Stone^®Actively carry out clinical research in China and internationally.

In December 2021, the National Medical Products Administration of China approved Zhejie Stone.^®Combined chemotherapy is used as the first-line treatment for patients with metastatic stage IV driver gene-negative non-small cell lung cancer (NSCLC). In May 2022, Zhejie Stone^®A new indication for the treatment of patients with unresectable, stage III non-small cell lung cancer (NSCLC) who did not experience disease progression after receiving platinum-based concurrent or sequential chemoradiotherapy has been approved. In 2022, Zejia Stone^®Both Phase III and Phase IV indications have been included in the "CSCO Guidelines for the Diagnosis and Treatment of Primary Non-Small Cell Lung Cancer" (2022).

October 2023, Zejia Stone^®Conditionally approved as a single agent for the treatment of adult patients with relapsed or refractory extranodal NK/T-cell lymphoma (R/R ENKTL). This indication is conditionally approved based on the objective response rate and duration of response results from a single-arm clinical trial. Confirmatory clinical endpoint data from confirmatory studies are not yet available and will be further confirmed post-marketing.

[1] The Global Cancer Observatory（https://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf）

[2] The Global Cancer Observatory（https://gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf）

[3] Yang Z, Zeng H, Xia R, Liu Q Sun K, Zheng R, Zhang S, Xia C, Li H, Liu S et al:Annual cost of illness of stomach and esophageal cancer patients in urban and rural areas in China: A multi-center study. Chinese journal of cancer research = Chung-kuo yen cheng yen chiu 2018, 30(4):439-448.