July 24, 2024
Source: drugdu
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On July 22, the first batch of SINOPHARM's first antibody drug Sanglijian® (rituximab injection) was officially shipped, marking the company's antibody drug formally entered a new journey of commercialization.
Patient's Gospel, First-line Targeted Drugs for Hematologic Tumors
Lymphoma is a malignant tumor originated from lymphohematopoietic system, which belongs to immune system diseases. Malignant lymphoma is mostly non-Hodgkin's lymphoma, accounting for about 80%-90% of all lymphoma cases. According to the data released by the National Cancer Center, the current incidence rate of lymphoma in China is about 6/100,000, with nearly 100,000 new cases every year, causing serious harm to patients' lives, health and quality of life.
Sanglijian® (rituximab injection) is mainly used for the treatment of non-Hodgkin's lymphoma (follicular non-Hodgkin's lymphoma, CD20-positive diffuse large B-cell non-Hodgkin's lymphoma), chronic lymphoma cell leukemia (CLL) indications, and it is the first-line targeted drug of hematological tumors. According to the research, SUNLIFE® combined with CHOP regimen can significantly improve the long-term survival rate of patients with diffuse large B-cell lymphoma.
Lean quality, safe and reliable clinical efficacy
Shanghai Research Institute of Biological Products (SRIB) has conducted a full range of comparative studies on SUNLIFE®, including pharmacological comparative studies, non-clinical comparative studies and clinical comparative studies. Nearly one hundred pharmaceutical quality indicators were tested during the entire production process to ensure the quality level, safety and efficacy of Sanglijian®.
In the process of development and production, SangliJian® practices the advanced concept of quality by design, and adopts disposable production technology for the whole production, effectively reducing the risk of batch-to-batch crossover, and providing stable and reliable product quality. SUNLIFE® can significantly increase the complete remission rate and prolong the overall survival time of patients, which will create more opportunities for patients to overcome the disease and help them regain confidence in their health and enjoy a quality life.
More than Innovation, Strengthening the Antibody Drug Industry Chain
Focusing on the field of therapeutic antibody innovative drugs, Shanghai Research Institute of Biological Products (SRIB) actively builds an independent innovative R&D system in line with the international standards, and possesses the whole industry chain technical capability from antibody molecular discovery, technology research, process development, clinical research to industrialization, and establishes a high-value R&D pipeline of more than 20 new drug varieties covering the fields of oncology, infectious diseases, autoimmune diseases and metabolic diseases. In the future, Shanghai Research Institute of Biological Products will continue to be driven by innovation and oriented by unmet clinical needs, continue to strengthen the construction of independent R&D capabilities, and strive to research and develop more new products to continuously meet the needs of tumor patients for high-quality biopharmaceuticals.
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