Immunotherapy for malignant tumors is an important means for humans to overcome cancer. On the PD-1 monoclonal antibody track, from O drugs, K drugs to a series of domestic new drugs with independent intellectual property rights have been approved for listing in China. Lung cancer ranks first in the incidence of malignant tumors in China for a long time, and its treatment methods and drug innovation have always attracted much attention. Today, another new drug in this field has been approved for the market, and clinical experts have added a powerful weapon to fight cancer.
On December 21, 2021, Pfizer and CStone Jointly announced that Zejiemei (generic name: Sugli maclizumab injection) has been approved by the State Drug Administration of China. Zejiemei is a PD-L1 antibody drug with a unique dual mechanism of action, combined with pemetrexed and carboplatin for the first-line treatment of patients with negative epidermal growth factor receptor (EGFR) gene mutations and anaplastic lymphoma kinase (ALK) negative metastatic non-squamous non-small cell lung cancer (NSCLC), as well as the combination of paclitaxel and carboplatin for the first-line treatment of patients with metastatic squamous NSCLC, which has brought a major breakthrough in the field of immunotherapy for lung cancer, meeting the scales of China. The urgent clinical needs of patients with non-squamous non-small cell lung cancer.
In November 2021, Zejiemei (Suglizumab injection) was exhibited for the first time at the Pfizer booth of the 4th China International Import Expo.
Strong cooperation to develop original research drugs to benefit cancer patients
Although innovative drugs and therapies in the field of lung cancer diagnosis and treatment are emerging in an endless stream, they still face many medical problems that need to be solved urgently, which require the in-depth participation of all parties in the industry to jointly promote the development of the field.
"Thanks to the implementation of the Chinese government's policy of encouraging innovation and the ingenious clinical trial settings of domestic scientists, Zejiemei has become the first approved drug in the innovation strategic cooperation between Pfizer and China's innovative pharmaceutical companies." Peng Zhenke, President of Pfizer Biopharmaceutical Group China, stressed: "The approval of Zejiemei will further enrich the domestic product portfolio in the field of lung cancer, and with the dual help of precision targeted therapy and immuno-oncology treatment, Pfizer will implement the concept of 'Science Wins and Overcome Cancer', continue to integrate global resource advantages and China's scientific innovation capabilities, and work with all parties in the industry to help achieve the goal of 'Healthy China 2030'." ”
Dr. Jiang Ningjun, Chairman and CEO of CStone, said, "CStone is the third new drug approved for listing by CStone this year. The approval of The Choice Jiemei once again confirms CStone's ability and strength to bring innovative and high-quality drugs to the market. As a product of the major national new drug creation science and technology project, Zejiemei is a PD-L1 antibody with international quality. We will work with Pfizer to leverage the resources and advantages of both sides to comprehensively accelerate the commercialization layout and make this innovative therapy reach more Chinese patients faster." ”
Medical staff are examining the patient's chest CT.
Science helps patients to prolong progression-free survival
The latest global cancer burden data released by the World Health Organization's International Agency for Research on Cancer (IARC) in 2020 shows that lung cancer incidence and mortality rates rank second and first in the world' cancer rankings, respectively. The 2019 National Cancer Report released by China's National Cancer Center shows that lung cancer has the highest incidence and mortality rate in China, bringing a serious burden of disease, of which non-small cell lung cancer accounts for about 80-85% of all lung cancers, and its impact should not be underestimated. With the acceleration of population aging, the incidence of malignant tumors in China has maintained an annual increase of 3.9%, and it is expected that the new cases of lung cancer in China will increase by 60% in 2040, which seriously threatens the social economy and people's health.
With the development of medicine and the development and application of targeted drugs, the prognosis of the treatment of gene-positive lung cancer patients has been greatly improved, and the chronic disease management model has been entered. In recent years, when tumor therapy has entered the era of immunity, as a high proportion of inflammatory hot tumors, patients with non-small cell lung cancer have been able to benefit more from immunotherapy. With the clinical application of immune checkpoint drugs, especially PD-1/PD-L1 inhibitors, the prognosis of non-small cell lung cancer that drives gene-negative has also improved dramatically. Among them, immunocommune combination chemotherapy has become the standard treatment plan for non-small cell lung cancer patients who drive genes negative, bringing new treatment options and hopes to many tumor patients in China.
Professor Zhou Caicun, principal investigator of gemstone-302 registered phase III clinical study and director of the Department of Oncology of Shanghai Pulmonary Hospital affiliated to Tongji University, pointed out: "Zejiemei's unique preservation of antibody-dependent cell-mediated phagocytosis (ADCP) effect, activation of macrophages to exert anti-tumor effect, the efficacy advantages brought by the dual mechanism are significant, whether for squamous or non-scaly advanced non-small cell lung cancer, can prolong the patient's progression-free survival (PFS), Among them, the risk of disease exacerbation in patients with squamous cell carcinoma group decreased by 66%. At the same time, Zejiemei is a fully humanized monoclonal antibody PD-L1, which is safe and reliable, and can bring better survival benefits to patients. ”
Wide spectrum of applications, a number of cancer applications have entered phase III clinical
Immunotherapy is effective not only against lung cancer, but also against other malignant tumors, and is considered a broad-spectrum anti-cancer drug.
Zejiemei is a research-under-development anti-PD-L1 monoclonal antibody developed by CStone Pharmaceuticals. The development of Zejiemei is based on the OmniRat transgenic animal platform authorized by the American company Lind. As a fully human full-length anti-PD-L1 monoclonal antibody, Zejiemei is a natural immunoglobulin G4 (IgG4) monoclonal antibody drug close to the human body, with a lower risk of immunogenicity and related toxicity, which makes Zejiemei a unique advantage compared with similar drugs. Furthermore, the retention of antibody-dependent cell-mediated cell phagocytosis (ADCP) allows Zejiemei to act on both innate and adaptive immunity, with a unique dual mechanism advantage. In phase Ia and IB studies, Zejiemei showed good anti-tumor activity and tolerability in multiple cancer species. Based on the data of early clinical practices, Zejiemei actively carries out clinical research at home and abroad.
At present, the State Drug Administration of China has approved the marketing application of The New Drug for the first-line treatment of patients with metastatic stage IV non-small cell lung cancer (NSCLC). In addition, Zejiemei has conducted several registered clinical trials, including a Phase II registered clinical trial for lymphoma and four Phase III registered clinical trials for stage III non-small cell lung, gastric and esophageal cancers.
Written by: Nandu reporter Wang Daobin correspondent Sun Yu