先声再明

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

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

We are pleased to announce that SIM0500, our GPRC5D-BCMA-CD3 tri-specific antibody, has dosed the first patient of a global Phase 1 clinical trial. This milestone event took place at the Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC, China. https://lnkd.in/gHS92X2N

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

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

Simcere Zaiming doses the first patient in a Phase 1 clinical study of SIM0501, Zaiming’s USP1 inhibitor, in patients with advanced solid tumors in Shandong Cancer Hospital and Institute in China. This study has obtained approval to be carried out both in China and the United States. SIM0501 is also the first USP1 inhibitor to enter the clinical research stage in China. Simcere Zaiming is actively working with clinical experts toward clinical validation and development of this therapeutic pipeline program for the benefit of a broad population of cancer patients globally. https://lnkd.in/gg9m9TAi

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

The New Drug Application of Suvemcitug for Injection has been accepted by the China NMPA. Suvemcitug is being developed to benefit platinum-resistant ovarian cancer patients.   Suvemcitug is a new-generation recombinant humanized anti-VEGF rabbit monoclonal antibody co-developed by Simcere and Apexigen, Inc., now part of Pyxis Oncology. https://lnkd.in/eMxQcyVh

Within this week, SIM0500 achieved concurrent IND approvals from the US FDA and China NMPA! This humanized GPRC5D-BCMA-CD3 tri-specific antibody candidate developed by Simcere Zaiming will perform clinical trials in patients with relapsed or refractory multiple myeloma (MM) in both countries. For more details:https://lnkd.in/gD7s24EH #multiplemyeloma #MM #BCMA #GPRC5D #Trispecificantibody