先声药业

On September 2, 2024, Simcere Pharmaceuticals Group Ltd. (2096.HK) announced that Sanbexin Sublingual Tablets (Edaravone and Dexborneol sublingual tablets), an innovative drug for stroke, has been granted the Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for the treatment of Acute Ischemic Stroke (AIS). Sanbexin sublingual tablets is the first innovative drug in the world to be designated with the Breakthrough Therapy by the FDA for the treatment of stroke. For more information:https://lnkd.in/gfuvCmjZ

On September 02, 2024, Simcere Zaiming announced a collaboration agreement with Shenzhen TargetRx, Inc. The partnership focuses on the ALK/ROS1 dual receptor tyrosine kinase inhibitor TGRX-326, a clinical-stage anti-tumor candidate that holds significant therapeutic potential for ALK/ROS1 fusion gene-positive non-small cell lung cancer (NSCLC) patients, especially those with multiple ALK-resistant mutations, including G1202R. https://lnkd.in/gGB8Ucq8

We are happy announced that SIM0508, a DNA polymerase θ (Pol θ) small molecule inhibitor, and one of Simcere Zaiming's anti-tumor candidates has received Clinical Trial Approval from the National Medical Products Administration of China. This approval allows for the commencement of clinical trials to evaluate the efficacy of SIM0508 in treating locally advanced/metastatic solid tumors. https://lnkd.in/g_zG8ffX

Dear Investors: You are cordially invited to attend the conference on the 2024 interim results of Centrum Pharmaceuticals to be held on August 22nd. The online communication session can be participated by scanning the QR code of the poster below, or by visiting the following website (advance registration is required): https://lnkd.in/gXE62Ju6

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.

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

16 abstracts including 2 orals ! At the upcoming 2024 American Society of Clinical Oncology (ASCO) annual meeting (May 31 - June 4, 2024), Simcere Zaiming will showcase the latest clinical data for 4 pipleline products on 11 tumor types. #ASCO2024 #clinical #oncology

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