[{"orgOrder":0,"company":"RemeGen","sponsor":"Lilly Asia Ventures","pharmaFlowCategory":"D","amount":"$100.0 million","upfrontCash":"Undisclosed","newsHeadline":"RemeGen Completes USD $100 Million Plus in Funding\n","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"CHINA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 2020","url1":"","url2":"","graph1":"Immunology","graph2":"Phase III"},{"orgOrder":0,"company":"RemeGen","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Grants Fast Track Designation to RemeGen's Telitacicept as a Treatment for Systemic Lupus Erythematosus","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase II","country":"CHINA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 2020","url1":"","url2":"","graph1":"Immunology","graph2":"Phase II"},{"orgOrder":0,"company":"RemeGen","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"RemeGen Announces US FDA Clearance of IND Application to Initiate Phase II Clinical Trial in Urothelial Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"CHINA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"RemeGen","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"RemeGen Co., Ltd. Announced New RC48-ADC Data in Patients with Advanced Gastric Cancer at ASCO","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"CHINA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"June 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"RemeGen","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"RemeGen Announces US FDA Has Granted Breakthrough Therapy Designation for Disitamab Vedotin (RC48) in Urothelial Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"CHINA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"September 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"RemeGen","sponsor":"Seagen","pharmaFlowCategory":"D","amount":"$2,600.0 million","upfrontCash":"$200.0 million","newsHeadline":"Seagen and 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Announces Preliminary Results of Phase III Confirmatory Study of Telitacicept for Treatment of Systemic Lupus Erythematosus (SLE) in China","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"CHINA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"September 2022","url1":"","url2":"","graph1":"Immunology","graph2":"Phase III"},{"orgOrder":0,"company":"RemeGen","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"RemeGen Releases Phase II Clinical Study Data for Treatment of Myasthenia Gravis in Chinese Patients","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase II","country":"CHINA","productType":"Large molecule","productStatus":"Approved","date":"November 2022","url1":"","url2":"","graph1":"Immunology","graph2":"Phase II"},{"orgOrder":0,"company":"RemeGen","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"RemeGen's RC118 for Injection Targeting Claudin 18.2 in Patients with Gastric and Pancreatic Cancers Granted Two Orphan Drug Designations by U.S. FDA","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"CHINA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"December 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I"},{"orgOrder":0,"company":"RemeGen","sponsor":"Innovent Biologics","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Innovent and RemeGen Enter into Clinical Trial Collaboration Investigating Combination Therapy of TYVYT\u00ae (sintilimab injection) and Novel ADC Candidates for Advanced Solid Tumors in China","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"CHINA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"June 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"RemeGen","sponsor":"Innovent Biologics","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"RemeGen and Innovent Collaborate on Clinical Trials to Evaluate the Potential of RC88 and RC108 Combined with PD-1 Therapy for Advanced Solid Tumors","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"CHINA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"July 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"RemeGen","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"RemeGen's RC88 Obtained FDA Fast Track Designation, Heralds New Hope for Ovarian Cancer Patients","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"CHINA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"January 2024","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"RemeGen","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"RemeGen's Telitacicept (RC18) Granted Fast Track Designation by United States FDA for Treatment of Primary Sj\u00f6gren's Syndrome","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase III","country":"CHINA","productType":"Large molecule","productStatus":"Approved","date":"April 2024","url1":"","url2":"","graph1":"Immunology","graph2":"Phase III"}]
Find Clinical Drug Pipeline Developments & Deals by RemeGen
RC18 (telitacicept) targets two cell-signaling molecules critical for B-lymphocyte development: BLyS and a proliferation inducing ligand, which allows it to effectively reduce B-cell mediated autoimmune responses that are implicated in several autoimmune diseases.
RC88 is a mesothelin (MSLN)-targeting antibody-drug conjugate (ADC), which is under phase 2 clinical development for the treatment of platinum-resistant recurrent epithelial ovarian, fallopian tube, and primary peritoneal cancers.
The collaboration will focus on conducting clinical trials exploring combination therapies of the novel antibody-drug conjugates, RC88 (targeting MSLN) and RC108 (targeting c-MET), along with the PD-1 inhibitor sintilimab injection (TYVYT®).
Under the agreement, Innovent will provide supplies of TYVYT® (sintilimab injection) and RemeGen will conduct Phase 1/2a studies to evaluate the anti-tumor activity of the combination therapy of TYVYT® with RC88 or RC108 in Chinese patients with advanced solid tumors.
RC118 is RemeGen's latest advanced antibody-drug conjugate used to treat patients with solid tumors positive for Claudin 18.2 expressions. ADC product pipeline, with no less than four products, including the latest RC118, entering clinical trials or gaining marketing approval.
RC18 (telitacicept) targets two cell-signaling molecules critical for B-lymphocyte development: BLyS and a proliferation inducing ligand, which allows it to effectively reduce B-cell mediated autoimmune responses that are implicated in several autoimmune diseases.
Preliminary results from the full analysis set (FAS) showed that at week 52, patients who received RC-18 (telitacicept) had a significantly higher rate of SRI-4 (The Systemic Lupus Erythematosus Responder Index 4) response than those who received placebo.
Seagen Licenses Disitamab Vedotin, a Novel HER2-targeted Antibody-Drug Conjugate (ADC) from RemeGen. Disitamab vedotin is a novel ADC that selectively delivers the anti-cancer agent monomethyl auristatin E (MMAE) into HER2-expressing tumor cells.
The approval of Disitamab vedotin has broken the situation that there is no original domestic new drug in the field of ADC drugs, and filled the gap in the global post-line treatment of patients with HER2 over-expression of gastric cancer.
U. S FDA has granted Breakthrough Therapy designation for disitamab vedotin, a novel humanized anti-HER2 antibody drug conjugate, for second-line treatment of patients with HER2+ locally advanced/metastatic urothelial cancer, who had received platinum-based chemotherapy.
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