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3 weeks ago CAR-T

China’s CSPC Pharmaceutical Group CAR-T Therapy: Targeted Treatment for Myasthenia Gravis

Myasthenia Gravis

#CARTTherapy #MyastheniaGravis #ChinaPharma #CSPC #CART

China’s CAR-T cell therapies are attracting international attention. Recently, CSPC Pharmaceutical Group secured another clinical trial approval for a CAR-T therapy, marking a significant milestone in the treatment of autoimmune diseases. China’s National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) officially approved CSPC’s innovative therapy, SYS6020-CAR-T cell injection, for the treatment of refractory generalized myasthenia gravis. This advancement offers new hope for patients with neuromuscular autoimmune diseases.

Chinese Innovation: An mRNA-LNP-Driven CAR-T Product

SYS6020 is a chimeric antigen receptor (CAR-T) cell injection based on mRNA-LNP technology, representing CSPC Pharmaceutical’s first innovation in cell therapy. It is designed to precisely target BCMA-positive B cells and plasma cells, thereby blocking harmful antibody production, significantly alleviating symptoms, and improving patients’ quality of life. Previously, this product had obtained clinical trial approval for systemic lupus erythematosus, and this recent approval marks another successful expansion into the autoimmune disease field.

New Hope for Myasthenia Gravis Treatment: Addressing Long-Term Relapse Issues

Myasthenia gravis is an autoimmune neuromuscular disease caused by autoantibodies, leading to neuromuscular transmission impairment. Some patients struggle with inadequate control under existing treatments, facing recurring relapses and a need for hospitalization. By selectively depleting BCMA-positive cells, SYS6020 aims to achieve long-term symptom improvement and reduce patients’ dependency on immunosuppressants and cholinesterase inhibitors.

CAR-T Therapy in China: More Effective, Safer

SYS6020 demonstrates high cellular activity and CAR-positive rates while significantly reducing risks associated with traditional CAR-T therapies, such as genome integration-related oncogenic risks and cytokine release syndrome (CRS), offering enhanced safety. In June of this year, the therapy received its first clinical approval for relapsed or refractory multiple myeloma, followed by clinical trial approval for systemic lupus erythematosus, laying the foundation for further expansion into myasthenia gravis treatment.

Summary: Future Developments

CSPC Pharmaceutical has stated that the clinical approval of SYS6020 for myasthenia gravis is a landmark achievement in cell therapy. In the future, CSPC will continue advancing SYS6020’s development for oncology, autoimmune connective tissue diseases, and neuromuscular autoimmune diseases, aiming to provide breakthrough treatment options and tangible clinical benefits for more patients. This groundbreaking progress not only drives CAR-T therapy development in China but also brings new treatment hope to autoimmune disease patients worldwide.

🎉🎉To assess whether the condition is suitable for CAR-T therapy, you can submit pathology reports, treatment history, and discharge summaries to the Medical Department of <Advanced Medicine in China> for preliminary evaluation!

WhatsApp: Https://wa.me/+8613717959070

Email: doctor.huang@globecancer.com

#CAR-TTherapy #MyastheniaGravis #ChinaPharma #AutoimmuneDisease #NeuromuscularDisorders #mRNALNP #MedicalBreakthrough #Immunotherapy #ClinicalApproval

6 months ago Solid tumor

Chinese Innovation in Medicine: A New Milestone in Small Cell Lung Cancer Treatment!

Small Cell Lung Cancer

In the field of medicine, each new drug represents a leap forward in disease treatment, bringing new light and hope to patients. On May 9, 2024, the highly anticipated novel PD-L1 inhibitor, Bevosubab Single Monoclonal Antibody, officially received approval from the National Medical Products Administration (#NMPA) of China! This marks a vibrant addition to the treatment options for patients with extensive-stage small cell lung cancer, adding a brilliant rainbow to the sky of treatment.

Bevosubab Single Monoclonal Antibody is a Class I innovative drug declared by the Chinese biopharmaceutical subsidiary, Sinda Pharmaceuticals, for first-line treatment of extensive-stage small cell lung cancer.

Bevosubab Single Monoclonal Antibody is extraordinary—it is a brand-new PD-L1 inhibitor that directly targets the immune escape mechanism of tumor cells, awakening the body’s immune system to eradicate cancer cells invisibly. Combined with Anlotinib Hydrochloride, Etoposide, and Carboplatin, it forms a powerful treatment alliance, bringing new hope to small cell lung cancer.

This is not just a treatment regimen, but a redemption. In the ETER701 study, this four-drug combination therapy has rewritten the history of first-line treatment for small cell lung cancer! Survival has nearly doubled, greatly increasing the chances of survival and bringing more hope to patients.

What’s even more exciting is that, while using the combination therapy, the occurrence of adverse reactions is extremely manageable. This means that while gaining a longer life span, patients do not have to overly worry about the potential negative impacts of treatment.

The approval of Bevosubab Single Monoclonal Antibody not only opens new treatment doors for patients with extensive-stage small cell lung cancer but also brings new directions for exploration in the medical field. We are full of anticipation and believe that this new drug will shine brightly in future clinical practice, bringing endless hope and vitality to more patients!

To assess whether the condition is suitable for new durg therapy, you can submit pathology reports, treatment history, and discharge summaries to the Medical Department of <#AdvancedMedicineinChina> for preliminary evaluation!

WhatsApp: +8613717959070

Email: doctor.huang@globecancer.com

#SmallCellLungCancerTreatment #BevosubabSingleMonoclonalAntibody #NewDrugApproval #MedicalBreakthrough #cancer #cancertreatment #lung #lungcancer

8 months ago CAR-T

No Tumor Recurrence for Nearly 3 Years, China’s National Research #TIL Therapy #GC101 Targets Various Solid Tumors!

TIL Therapy

In recent years, immunotherapy has emerged as a pivotal direction in the future of cancer treatment. Tumor-infiltrating lymphocytes (#TILs) are hailed as the “natural enemies” of cancer cells. TIL therapy developed based on patients’ own tumor-infiltrating lymphocytes boasts advantages such as rich tumor-specific targets, excellent tumor homing capabilities, strong infiltration abilities, and a high safety profile.

On February 16, 2024, #Iovance Biotherapeutics announced the #FDA approval of Lifileucel (LN-144) for the treatment of advanced melanoma progressing after PD-1 antibody therapy, marketed as #AMTAGVI™. This marks the global first approval of a TIL therapy and the first approval worldwide for T-cell therapy for solid tumors, marking a significant milestone! #LN144

On the domestic front in China, several companies have announced good news regarding the clinical approval of TIL pipelines. Overall, the enthusiasm for TIL therapies is on the rise and increasingly intense. Today, let me introduce to you the first independently developed TIL cell therapy #GC101 from Juncell Therapeutics.

With no tumor recurrence for nearly 3 years, GC01TIL is the first autologous natural tumor-infiltrating lymphocyte injection developed by Juncell Therapeutics, which officially obtained clinical trial implicit approval from the National Medical Products Administration (#NMPA) on April 24, 2022.

Distinguished from Iovance’s approved AMTAGVI™ (#Lifileucel), innovative GC101TIL therapy requires patients to be treated in ordinary wards without the need for high-intensity pre-conditioning before TIL cell infusion or any IL-2 dosage post-infusion. This simplified clinical protocol ensures effective TIL cell proliferation within patients, greatly avoiding the risks associated with AMTAGVI™’s black box warnings (such as treatment-related deaths, persistent severe cytopenia, severe infections, cardiopulmonary and renal function damage), substantially improving the safety, convenience, and accessibility of TIL therapy.

Currently, according to the latest revelations from Juncell Therapeutics, the Phase I clinical trial of Juncell Therapeutics’ autologous natural TIL cell injection GC101 is underway in eight authoritative tertiary hospitals in China, achieving significant efficacy.

GC101, targeting various types of advanced solid tumors including malignant melanoma, cervical cancer, and lung cancer, has demonstrated an objective response rate of over 35%. Four patients have achieved complete tumor remission (#CR), with the longest no-recurrence survival period approaching 3 years, without experiencing any severe adverse reactions related to treatment, significantly improving the safety, applicability, and accessibility of #TILtherapy. Let us look forward to more surprises that GC101 will bring in the future!

Currently, #Juncell Therapeutics’ GC101 clinical trial for the treatment of advanced solid tumors is actively recruiting :

FOR FREE

Key Inclusion Criteria:

1. Aged 18-75 years, regardless of gender;

2. Definitive diagnosis of malignant solid tumors (including but not limited to #melanoma, #lungcancer, #cervicalcancer, #esophagealsquamouscellcarcinoma, #headandnecksquamouscellcarcinoma, #endometrialcancer);

3. Standard treatment failure or lack of effective treatment options;

4. At least 2 lesions, with the physical condition supporting minimally invasive surgical sampling.

This clinical trial is free of charge for participants. If you wish to participate in this clinical trial, you need to submit your treatment history, recent imaging and blood test reports, infectious disease reports, and discharge summaries to <@Advanced Medicine in China for preliminary assessment.

Email: doctor.huang@globecancer.com,

WhatsApp: +8613717959070

#JuncellTherapeutics #chinesereseach #clinicaltrial #tumor #solidtumor

9 months ago Myeloma

Breaking News Alert! Exciting news for multiple myeloma patients! A groundbreaking CAR-T therapy has been approved for launch in China!

🚀 Breaking News Alert! 🚀

🎉 Exciting news for multiple myeloma patients! A groundbreaking CAR-T therapy has been approved for launch in China! 🎉

multiple myeloma

CARsgen

🔍On March 1st, 2024, CARsgen, a leading Chinese pharmaceutical company, proudly announced the official approval by the National Medical Products Administration (NMPA) of their innovative CAR-T cell immunotherapy product, Zevor-cel, targeting BCMA. This revolutionary treatment is specifically designed for adult patients with relapsed or refractory multiple myeloma who have undergone at least three prior lines of treatment, including a proteasome inhibitor and an immunomodulatory agent.

Zevor-cel

🌟 Zevor-cel marks CARsgen’s debut commercial product, promising a new ray of hope for patients. While the price remains undisclosed, anticipation is high as it is expected to be competitive with its counterparts. Stay tuned as we eagerly await the reveal of its pricing strategy!

💪At the 2023 ASH Annual Meeting, Zevor-cel’s impressive three-year follow-up data stole the spotlight, boasting a remarkable Overall Response Rate (ORR) of 100% and a median Progression-Free Survival (PFS) of 25.0 months. With a median Overall Survival (OS) yet to be reached, the two-year OS rate has already hit 100%, and the three-year OS rate stands at a remarkable 92.9%, underscoring its outstanding safety profile and offering renewed hope for patients battling relapsed or refractory multiple myeloma.

Multiple Myeloma

👍In terms of approved indications, it’s worth noting that the current portfolio of domestic CAR-T therapies in China caters to various hematologic malignancies. While FOSUNKITE and JW Therapeutics target lymphomas, JUVENTAS focuses on leukemia. CARsgen and IASO Bio, however, have set their sights on multiple myeloma, aligning perfectly with the pressing medical needs of patients in this category.

👏Let’s celebrate this remarkable milestone in the fight against multiple myeloma, as we continue to strive for better, more effective treatments to improve patients’ lives worldwide! 🌍 #TogetherWeCanBeatCancer

If you are interested in the latest cancer-fighting technologies and treatment methods in China, or if any of patients wish to learn more, our team is available to support and advise you and your patients at any time.

Website：[https://www.medtourcn.com/]

Whatsapp：+8613717959070

Email: doctor.huang@globecancer.com

🔍 #Zevorcel #CARsgen #MultipleMyeloma #CARTTherapy #MedicalBreakthrough #NMPAApproval #HopeForPatients #HealthcareInnovation #CancerTreatment #MedicalAdvancement

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Tags Archives: NMPA