Simcere Pharmaceutical Group Limited (2096.HK) is a pharmaceutical company driven by innovative R&D. We are committed to "providing today's patients with medicines of the future" across the following core therapeutic areas: oncology, central nervous system, autoimmunity and anti-infection. Furthermore, we are also actively expanding our presence in disease areas with significant clinical needs in the future. Our industry-leading capabilities and commitment to synergistic innovation have also enabled various strategic collaborations and we are seen as partner of choice by innovative biopharmaceutical companies, medical institutes, and research teams in China and globally.
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Enlituo® (generic name: cetuximab beta injection), a new generation EGFR antibody drug that Simcere Zaimimg collaborated with Mabpharm Limited (2181.HK), has recently received approval from the China National Medical Administration (NMPA) for marketing. Enlituo represents the first home-grown EGFR monoclonal antibody drug in China that are approved for the first-line treatment of metastatic colorectal cancer. for details:https://lnkd.in/gi-UPz5E
On May 30, 2024, Simcere Pharmaceutical Group Limited (Simcere; 2096.HK) announced that the Chinese Phase III clinical study of Daridorexant Hydrochloride Tablets (Daridorexant), for the treatment of insomnia patients in China, has met the primary study endpoint. For more information:https://lnkd.in/g4n_r8b8
On May 31, 2024, the Phase III clinical meeting of a multicenter, randomized, double-blind, double-simulation, positively-controlled study to evaluate the safety, pharmacokinetics, and efficacy of Deunoxavir Marboxil Tablets(ADC189) in pediatric patients with influenza between the ages of 2-11 years old was held in Beijing. Prof. Ni Xin, President of Beijing Children's Hospital of Capital Medical University, and Prof. Zhao Chengsong, Vice President of Beijing Children's Hospital, served as the Leading PI of the project, covering 35 clinical trial centers. This marks that the Phase III clinical trial of Deunoxavir Marboxil Tablets for the treatment of influenza in children has reached the critical stage.
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The latest findings from the registrational phase 3 clinical study of suvemcitug for the treatment of platinum-resistant ovarian cancer were shared as a Late-Breaking Abstract (LBA) oral presentation at the annual meeting of the American Society of Clinical Oncology (ASCO) in 2024. The experimental arm showed a significant extension in PFS compared to the control arm, with a median PFS of 5.49 months versus 2.73 months (hazard ratio [HR] 0.46, P<0.0001). Professor Yuan Guangwen disseminated the latest data from the trial during an oral presentation at the ASCO 2024 conference in Chicago, United States. Suvemcitug is an innovative, next-generation recombinant humanized anti-VEGF rabbit monoclonal antibody, jointly developed by Simcere Pharmaceutical Group and Apexigen, Inc. Simcere Zaiming holds exclusive development and commercialization rights for this product within Greater China. https://lnkd.in/ga8NRNyN #suvemcitug #ovariancancer #ASCO
The 10th European Stroke Organization Congress (ESOC), held in Basel, Switzerland from May 15 to 17, 2024, showcased six studies on Sanbexin® (Edaravone and Dexborneol Concentrated Solution for Injection) and a new dosage form of sublingual tablets under development. These presentations brought new medical evidence on the mechanism of action and clinical application of Sanbexin® in treating stroke. For more information:https://lnkd.in/gTjwywhV
On April 29, 2024, Simcere Pharmaceutical(2096.HK) and AnDiCon Biotech Co., Ltd. announced that the Phase III clinical trial of their anti-influenza innovative drug, Deunoxavir Marboxil Tablets (ADC189), has achieved its primary endpoint with significant efficacy and safety results. Deunoxavir Marboxil Tablets is a novel treatment for influenza A and B in adults and adolescents, requiring only one oral dose to inhibit the influenza virus replication within 24 hours. For more information: https://lnkd.in/gHfsk5bj
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We are happy to announce that COSELA (Trilaciclib hydrochloride for injection) has received an enhanced recommendation by the Chinese Society of Clinical Oncology (CSCO) in 2024 CSCO Guidelines for the Diagnosis and Treatment of Small Cell Lung Cancer (SCLC), based on latest data from a randomized, double-blind, placebo-controlled Phase III clinical trial(TRACES study). Recommendations for the prophylactic use of Trilaciclib prior to platinum-based chemotherapy ± immune checkpoint inhibitors for first-line treatment in patients with Extensive SCLC have been upgraded from Class II recommendation and Class 2A evidence to Class I recommendation with Class 1A evidence. In the second-line treatment of recurrent SCLC, the recommendation of Trilaciclib has also been upgraded from Class 2A evidence to Class 1A evidence. COSELA® is a first-in-class short-acting and reversible cyclin-dependent kinase CDK4/6 inhibitor co-developed by Simcere Pharmaceutical Group and G1 Therapeutics, Inc., and currently marketed in China by Simcere Zaiming. https://lnkd.in/gt-SdrJt
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We are happy to announce that SIM0500, Simcere Zaiming’s Tri-specific Antibody Candidate for Multiple Myeloma Received FDA Fast Track Designation. Designed with three different specific antigen-binding sites, SIM0500 can activate T cells while also binding and acting on myeloma cells, thereby having a more powerful and precise tumor-killing effect. https://lnkd.in/gG6nC2A9
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6 posters, including one Late breaking Results at AACR ! We are happy to announce that Simcere Zaiming will be presenting on its innovative preclinical programs at the 2024 American Association for Cancer Research (#AACR) Annual Meeting. https://lnkd.in/gXaXhC3j