SIM0237 / Simcere - LARVOL DELTA

SIM0237 Phase I/II Clinical Study Data in Non-muscle-invasive Bladder Cancer Presented at the European Association of Urology Annual Congress 2026 (HKEXnews) - "As of the data cut-off date (November 28, 2025), a total of 49 patients had received intravesical instillation of SIM0237 monotherapy. Among patients with carcinoma in situ (CIS) who had at least one post-baseline tumor assessment, 80% achieved the complete response (CR). Among patients with papillary-only disease, the 12-month disease-free survival (DFS) rate was 65.8%. Overall, the results demonstrate a promising clinical efficacy signal of SIM0237 in patients with BCG-unresponsive high-risk NMIBC."

P1/2 data • Bladder Cancer

Phase 1/2 study of an anti-PD-L1/IL-15 variant fusion protein (SIM0237) in BCG-unresponsive high-risk non-muscle-invasive bladder cancer (NMIBC) (AUA 2026) - No abstract available

P1/2 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • IL15

Phase 1/2 study of an anti-PD-L1/IL-15 variant fusion protein (SIM0237) in BCG-unresponsive high-risk non-muscle-invasive bladder cancer (NMIBC). (ASCO-GU 2026) - P1 | "Intravesical SIM0237 was safe and well tolerated with promising clinical efficacy in patients with BCG-UR high-risk NMIBC. The Phase 3 study of SIM0237 monotherapy in this patient population is under plan."

P1/2 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • IL15

Phase 1/2 study of an anti-PD-L1/IL-15 variant fusion protein (SIM0237) in BCG-unresponsive high-risk non-muscle-invasive bladder cancer (NMIBC) (EAU 2026) - No abstract available

P1/2 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • IL15

Phase 1 Study of an Anti-PD-L1/IL-15 Fusion Protein (Sim0237) in BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer (NMIBC) (SIU 2025) - No abstract available

P1 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • IL15

A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SIM0237 Alone or in Combination with BCG in NMIBC (clinicaltrials.gov) - P1 | N=152 | Recruiting | Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd. | N=108 ➔ 152

Enrollment change • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0237 in Adult Participants with Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=192 | Terminated | Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd. | Trial completion date: Jan 2026 ➔ May 2024 | Recruiting ➔ Terminated | Trial primary completion date: Apr 2025 ➔ May 2024; An internal business decision, not based on safety or regulatory considerations.

Metastases • Trial completion date • Trial primary completion date • Trial termination • Oncology • Solid Tumor

Simcere Zaimig announces new IND approval of SIM0237, an anti-PD-L1/IL-15 bispecific antibody by NMPA (Simcere Press Release) - "Simcere Zaiming, an innovative oncology-focused biopharmaceutical company and a subsidiary of Simcere Pharmaceutical Group announced that a new indication of SIM0237 for injection, an anti-PD-L1/IL-15 bispecific antibody independently developed by the company has obtained Clinical Trial Approval issued by the National Medical Products Administration (NMPA) of China, which is intended to be used in patients with Non-muscle Invasive Bladder Cancer (NMIBC)."

New trial • Bladder Cancer

A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SIM0237 Alone or in Combination With BCG in NMIBC (clinicaltrials.gov) - P1 | N=108 | Recruiting | Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SIM0237 Alone or in Combination With BCG in NMIBC (clinicaltrials.gov) - P1 | N=108 | Not yet recruiting | Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.

Combination therapy • New P1 trial • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0237 in Adult Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=192 | Recruiting | Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.

Metastases • New P1 trial • Oncology • Solid Tumor

Simcere Pharmaceuticals (02096): SIM0237 for Injection is intended to be used in the treatment of advanced solid tumors and has been issued a drug clinical trial approval notice by NMPA [Google translation] (Zhitong Finance) - "Zhitong Finance APP News, Simcere Pharmaceutical (02096) announced that...the group's self-developed anti-PD-L1/IL-15 bispecific antibody injection SIM0237 has been approved by the State Drug Administration of China (NMPA) issued a drug clinical trial approval notice, intended for advanced solid tumors."

New trial • Oncology • Solid Tumor

Simcere Receives FDA Clearance of Investigational New Drug Application (IND) for Bi-functional Fusion Protein, SIM0237 (PRNewswire) - "Simcere Pharmaceutical Group...announced that the U.S. Food and Drug Administration (FDA) has cleared the company's investigational new drug (IND) application for SIM0237, an anti-PD-L1/IL-15 bi-functional fusion protein, for the treatment of adult patients with advanced solid tumors. It is the second IND approval Simcere obtained in the US this year. In addition, the IND application of SIM0237 in China was accepted by the National Medical Products Administration on October 10, 2022....SIM0237-101 is a phase 1, first-in-human, open-label, multicenter study to investigate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of SIM0237 in adult participants with advanced solid tumors."

IND • New P1 trial • Oncology • Solid Tumor