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December 9, 2024
eMedClub News
Recently, Chongqing Precision Biotech Co., Ltd. (referred to as "Precision Biotech") announced that its independently developed MC-1-50 cell preparation has received tacit approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) to conduct clinical trials for the treatment of refractory systemic lupus erythematosus (SLE) in patients aged ≥18 years.
▲ Source of the image: CDE official websiteMC-1-50 cell preparation is based onPrecision BiotechPRIMCAR, independently developed®The second-generation CD19-targeted CAR-T cell therapy developed by the platform adopts a novel, faster, and more efficient CAR-T preparation protocol, featuring lower dosage, fewer side effects, and longer persistence.Chongqing Precision Biotech Co., Ltd. said,SLEIndications are MC-1-50 cell preparation.B-cell Acute Lymphoblastic LeukemiaAndNon-Hodgkin's LymphomaFurther expanded applications after the indications, while also extending the company's product coverage to the field of autoimmune diseases.。SLE is a chronic autoimmune disease involving multiple organ systems, known as the "never-ending cancer," affecting the health and quality of life of millions of people in China. Traditional treatments mainly focus on controlling disease activity, improving clinical symptoms, preventing and reducing relapses, with less than 1% of patients achieving complete drug-free remission, often accompanied by severe side effects. In recent years, CAR-T cell therapy has shown remarkable success in the field of autoimmune diseases. This innovative treatment strategy will undoubtedly play a significant role in the management of SLE, offering patients more effective and long-lasting therapeutic options, thereby significantly improving their quality of life and addressing current treatment challenges.2025 (3rd) Biologics Innovation Conference
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MC-1-50 Cell PreparationThe Phase I clinical trial data for the proof-of-concept study, presented orally for the first time by Professor Jianhua Mao's team from the Children’s Hospital of Zhejiang University School of Medicine at the 2024 American Society of Nephrology Kidney Week (ASN Kidney Week).SLEDAI-2K scores significantly decreased in 11 SLE patients after receiving MC-1-50 treatment.Ten patients reached the SRI-4 response criteria, five patients achieved a low lupus disease activity state (LLDAS), and three patients met the DORIS remission criteria (as shown in the figure below). As of the data cut-off date, they remained in a medication-free remission state, with all adverse reactions being mild and quickly improved after symptomatic treatment.
▲ All patients showed significant improvement in SLEDAI-2K scores after infusion.Autoimmune diseases, such as systemic lupus erythematosus, rheumatoid arthritis, and antiphospholipid antibody syndrome, are the second largest disease category globally, second only to cancer, and have always presented significant opportunities.In 2023, among the top ten best-selling drugs globally, three were for autoimmune diseases.According to Frost & Sullivan data forecasts,By 2030, the global market size for autoimmune disease drugs is expected to reach $176 billion.China's autoimmune disease drug market size is expected to reach 250 billion US dollars, becoming an important incremental source for the global autoimmune disease drug market. With the successful application of CAR-T in the autoimmune field, a new chapter has been opened for the application of this disruptive technology and product in more fields.To date, Precision Biotech has obtained four Class I biological new drug clinical approvals for CAR-T cell therapies in China, covering 10 indications including hematological tumors, solid tumors, and autoimmune diseases.1. Chongqing Precision Biotech Co., Ltd. Official WeChatPublic information such as ASN official websiteWelcome everyone to register for the 2025 IBI EXPO conference and keep pace with the times. Below is the 2024 IBI EXPO.Video Highlights of the Event.Registration and Event Inquiry
IBI EXPO 2025 (3rd) Biopharmaceutical Innovation Industry ConferenceWill beMarch 1, 2025 to March 2, 2025InSuzhou International Expo CenterGrandly held. The theme of the conference isCollaboratively Building the Full Chain, Innovating a New Ecosystem for Transformation。
The conference will invite300+Guest Speaker, Opening30+Field forum activities, covering hundreds of hot topics, aroundCell and Gene Therapy, Radiopharmaceuticals, Antibody Innovative Conjugation, Targeted Protein Degradation, Stem Cell Regeneration, mRNA Vaccines and Nucleic Acid Drugs, Exosomesetc.New Molecular Drugs,AI Drug Discovery, Organoids, Novel Delivery Vehiclesetc.Cutting-edge Technology，Engage in exchange and discussion, and collaboratePharmaceutical companies, research institutions, clinical resources, supply chain enterprises, investment and financing institutions, park governmentsBy leveraging multiple forces, we can drive the transformation of cutting-edge innovations from scientific research to industrial applications, injecting a source of development into the biopharmaceutical market.Free Participation:Teacher Yang 15517201185Free Exhibition:Teacher Yuan 15572286596Speech & Media:Teacher Wang 18717836231Click"Read the original text"Lock in Early Bird DiscountsExciting Live Broadcast Preview
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