SIM0500 / Simcere, AbbVie - LARVOL DELTA

SIM0500-101: Study of SIM0500 Alone in Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1 | N=130 | Recruiting | Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd. | Trial primary completion date: Jun 2026 ➔ Sep 2027

First-in-human • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology

BTL-101, A FULLY HUMAN TRISPECIFIC BCMA×GPRC5D×CD3 T-CELL ENGAGER FOR THE TREATMENT OF MULTIPLE MYELOMA (EHA 2026) - "In myeloma co-cultures (H929, MM.1S, U266), BTL-101 mediated potent killing exceeding talquetamab+teclistamab, depleted dual- and single-antigen–positive cells (including low-to-intermediate BCMA expressers), and retained activity against BCMA- or GPRC5D-knockdown targets, consistent with efficacy under heterogeneous antigen expression...In 48-h PBMC–H929 co-cultures (E:T=5:1), BTL-101 showed higher-potency killing with attenuated cytokines and outperformed JNJ-79635322, SIM0500, and MBS-314...Summary/Conclusion BTL-101 demonstrates strong dual-antigen cytotoxicity with an attenuated cytokine profile and resistance to soluble BCMA. A Phase I/II clinical study is currently ongoing to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of BTL-101 in patients with relapsed/refractory multiple myeloma."

IO biomarker • Trispecific • Hematological Malignancies • Multiple Myeloma • CD69 • IL2RA • IL6

Simcere Pharmaceutical Group…announced it has received a USD 40 million near‑term milestone payment from AbbVie…following positive clinical progress for SIM0500, a humanized trispecific antibody targeting GPRC5D, BCMA, and CD3 for multiple myeloma (flcube.com) - "The payment was triggered under a licensing agreement signed in January 2025 that could total up to USD 1.055 billion in milestones plus tiered royalties on ex‑Greater China sales."

Financing • Multiple Myeloma

A Phase I First-in-Human, Open-Label Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0500, a Humanized GPRC5D-BCMA-CD3 Trispecific Antibody, in Participants with Relapsed or Refractory Multiple Myeloma (ASH 2024) - P1 | "Study Endpoints The primary endpoint is safety and tolerability of the SIM0500, in terms of DLTs and treatment-emergent adverse events (TEAEs) for part 1, overall response rate and TEAEs for Part 2. Secondary endpoints are duration of response, clinical benefit rate, time to response, progression-free survival, overall survival, minimal residual disease status, pharmacokinetics, pharmacodynamics and incidence of anti-drug antibodies."

Clinical • First-in-human • P1 data • PK/PD data • Trispecific • Anemia • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Oncology • Plasmacytoma • Renal Disease • Solid Tumor • GPRC5D

Simcere Zaiming Announces First Patient Dosed in the US in a Phase 1 Trial of Trispecific Antibody SIM0500 in Patients with Relapsed/Refractory Multiple Myeloma (PRNewswire) - "Simcere Zaiming...announced the first US patient has started treatment in the ongoing Phase 1 trial (SIM0500-101, NCT06375044) 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)."

Trial status • Multiple Myeloma

Simcere Zaiming and AbbVie Announce Partnership to Develop a Novel Trispecific Antibody Candidate in Multiple Myeloma (PRNewswire) - "Simcere Zaiming...and AbbVie...announced an option to license agreement to develop SIM0500, an investigational new drug candidate. SIM0500 is currently in Phase 1 clinical trials in patients with relapsed or refractory multiple myeloma (MM), in both China and the U.S....Simcere Zaiming will receive an upfront payment from AbbVie and is eligible to receive option fees and milestone payments of up to $1.055B, as well as tiered royalties on net sales outside of the Greater China territory. AbbVie is eligible to receive tiered royalties on net sales in the Greater China territory."

Licensing / partnership • Multiple Myeloma

SIM0500-101: Study of SIM0500 Alone in Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1 | N=130 | Recruiting | Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Trispecific • Hematological Malignancies • Multiple Myeloma • Oncology

Study of SIM0500 Alone in Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1 | N=130 | Not yet recruiting | Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.

New P1 trial • Trispecific • Hematological Malignancies • Multiple Myeloma • Oncology

SIM0500 FOR INJECTION (A HUMANIZED GPRC5D-BCMA-CD3 TRISPECIFIC ANTIBODY) WAS GRANTED U.S. FDA FAST TRACK DESIGNATION (HKEXnews) - "The board...of directors of the Company...is pleased to announce that, on April 9, 2024, Beijing Time, SIM0500 for injection, a humanized GPRC5D-BCMA-CD3 trispecific antibody, which is a new investigational anti-tumor drug independently developed by the Group, has been granted a Fast Track Designation by the U.S. Food and Drug Administration ('FDA') for patients with multiple myeloma, who are refractory to, or intolerant of, established therapies known to provide clinical benefit and have received ≥3 prior lines of therapy including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD) and an anti-CD38 monoclonal antibody."

Fast track designation • Hematological Malignancies • Multiple Myeloma • Oncology

SIM0500, Simcere Zaiming’s Tri-specific Antibody Candidate for Multiple Myeloma Achieved Concurrent Approval for Clinical Trials in both the United States and China (Simcere Press Release) - "Simcere Zaiming, an innovative oncology company and a subsidiary of Simcere Pharmaceutical Group Ltd., announced that it has received approval both from the U.S. Food and Drug Administration (FDA) and the China National Medical Products Administration (NMPA) for the investigational new drug candidate SIM0500, to carry out clinical trials in patients with relapsed or refractory multiple myeloma (MM)."

IND • New trial • Hematological Malignancies • Multiple Myeloma • Oncology