先声再明

The first patient has been dosed in a Phase I clinical study for anti-tumor new drug candidate SIM0609 at Peking University Cancer Hospital. SIM0609 is a CDH17-targeting antibody-drug conjugate (ADC) developed independently by Simcere Zaiming for treatment of solid tumors. This international, multicenter, open-label Phase I study is led by Professor Lin Shen of Peking University Cancer Hospital. The study has been approved to be conducted in both China and the United States. https://lnkd.in/gVVuXi-b 

We are happy to announce that SIM0237 phase 1 NMIBC data were released in an oral presentation at the 45th International Society of Urology Annual Meeting(#SIU2025). All three patients with carcinoma in situ (CIS) NMIBC achieved complete remission (CR), with two patients maintaining their CR status for 6 and 12 months, as of the data cutoff date. Among the 14 patients with papillary-only NMIBC, the median disease-free survival (DFS) was immature, with a 12-month DFS rate of 69.2%. The promising early results highlight the potential of SIM0237 in addressing the unmet medical needs of patients with non-muscle-invasive bladder cancer who do not respond to BCG treatment. https://lnkd.in/e65NN7VP

October 16 2025, Simcere Zaiming and NextCure, Inc. are happy to announce that the first patient in the U.S. has been dosed with SIM0505 in an ongoing Phase 1 trial (NCT06792552) in patients with advanced solid tumors. Proof-of-concept clinical data are expected in H1of 2026. #ADC #CDH6 https://lnkd.in/g-Xtu4GT 

SIM0508, an anticancer candidate targeting DNA polymerase theta (Polθ), has received a new IND approval from the China National Medical Products Administration (NMPA) for the combination use with olaparib in patients with advanced solid tumors in clinical trials. SIM0508, independently developed by Simcere, represents the latest advance in cancer therapy, particularly leveraging the concept of “synthetic lethality”. It is the first Polθ inhibitor approved for clinical development in China. The compound has received IND approvals in both China and the United States and is currently being investigated in Phase I clinical trials. https://lnkd.in/gDyxdgmF

SIM0686, Simcere Zaiming's novel FGFR2b-targeting ADC is approved by the U.S. FDA to enter clinical trials. The project is currently being investigated in a Phase 1 clinical trial in China. The approval of the IND allows the study to be conducted in the US for patients with FGFR2b-positive, locally advanced, or metastatic solid tumors. https://lnkd.in/gYxTiwS8

We are happy to announce that the first US patient has started treatment in the ongoing Phase 1 trial at The Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai, evaluating safety, tolerability, pharmacokinetics and preliminary efficacy of SIM0500 in patients with relapsed/refractory multiple myeloma (RRMM). “In the last few years, BCMA and GPRC5D-targeted therapies have demonstrated significant promise in treating RRMM and have been anticipated as the cornerstones of the next chapter in the pursuit of curing myeloma. SIM0500 is the natural evolution of combining these targets with the aim to optimize outcomes in the RRMM,” said Dr. Joshua Richter, M.D., Associate Professor of Medicine at the Icahn School of Medicine at Mount Sinai, Director of Multiple Myeloma at the Blavatnik Family Chelsea Medical Center at Mount Sinai, and Principal Investigator. "I look forward to participating in the Phase 1 study of SIM0500 to evaluate the safety and efficacy of this potentially transformative therapy in patients with RRMM." commented Prof. Shaji Kumar, M.D. SIM0500 is being developed in partnership with AbbVie. #multiplemyeloma #GPRC5D #BCMA #trispecificantibody #clinicaltrial for more information: https://lnkd.in/gacCbweD

We are very pleased to announce a new collaboration with NextCure, Inc. on the global development of SIM0505, a significantly differentiated CDH6 targeting ADC candidate independently developed by Simcere Zaiming. Phase 1 clinical trial ongoing for SIM0505 in China; U.S. Phase 1 clinical trial is expected to begin in the third quarter of 2025. Together, we aim to accelerate drug development to benefit more cancer patients worldwide! https://lnkd.in/gf3srKaN

The 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, held in Chicago from May 30 to June 3, is one of the most prominent global events in oncology. At this year’s meeting, Simcere Zaiming presented 18 clinical studies across five innovative assets: Suvemcitug, SIM0270, Trilaciclib, envafolimab, and endostatin. https://lnkd.in/gg3hrN39

Simcere Zaiming will present 7 innovative researches at the 2025 #AACR

On April 10, 2025, Simcere Zaiming, an innovative oncology-focused subsidiary of Simcere Pharmaceutical Group (2096.HK), announced that its independently developed antibody-drug conjugate (ADC), SIM0686, which targets FGFR2b (Fibroblast Growth Factor Receptor 2b), has received clinical trial approval from the China National Medical Products Administration. This achievement permits the company to initiate clinical trials involving Chinese patients with FGFR2b-positive, locally advanced, or metastatic solid tumors. FGFR2b is a transmembrane tyrosine kinase receptor expressed in epithelial tissues. Its overexpression or gene fusion has been associated with various solid tumors. SIM0686 is a clinical-stage ADC developed using Simcere Zaiming’s proprietary technology platform. The molecule combines the tumor-specific targeting capabilities of antibodies with the anti-cancer properties of topoisomerase inhibitors. Preclinical studies indicate that it demonstrates significant anti-tumor activity, not only in FGFR2b-positive tumor cells but also in FGFR2b-negative tumor cells via a bystander effect. The preclinical findings will be presented at the 2025 Annual Meeting of the American Association for Cancer Research (AACR), Abstract No. 2964.