Drugs / SIM0237
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | SMARCA4-deficient sarcoma of thorax | 2022-10-11 | “Simcere has also filed an IND application of SIM0237 to the US FDA to carry out clinical trial in the United States.” simcere.com ↗ |
| Filed | China (NMPA) | — | SMARCA4-deficient sarcoma of thorax | 2022-10-10 | “submitted two new drug clinical trial (IND) applications to China National Medical Products Administration (NMPA) for two immune-oncology bi-specific antibodies (SIM0348, SIM0237).” simcere.com ↗ “In addition, the IND application of SIM0237 in China was accepted by the National Medical Products Administration on October 10, 2022.” simcere.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT06186414 | Jan 2024 → Jan 2027 expected | non-invasive bladder urothelial carcinoma | Jiangsu Simcere Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1 | NCT05781360 | Mar 2023 → May 2024 | — | Jiangsu Simcere Pharmaceutical Co., Ltd. | Terminated | No outcome recorded Stop: Business |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2026-03-17 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Results Phase I/II NMBIC Data of SIM0237 Releases as Oral presentation at the 2026 EAU26 simcere.com ↗
Among 10 subjects with carcinoma in situ (CIS), 8 (80%) achieved a complete response (CR). |
| 2025-11-06 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Results SIM0237 Phase I NMIBC Data Released in an Oral Presentation at SIU2025 simcere.com ↗
The phase I clinical study data of SIM0237, an anti-PD-L1/IL-15 bispecific fusion protein developed by Simcere Zaiming for the treatment of non-muscle-invasive bladder cancer (NMIBC), were released in an oral presentation at the conference. |
| 2023-10-16 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Regulatory Simcere Zaimig announces new IND approval of SIM0237, an anti-PD-L1/IL-15 bispecific antibody by NMPA simcere.com ↗ |
| 2022-12-30 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Regulatory Simcere Received IND Approval for Two Immuno-oncology Bi-specific Antibodies from NMPA simcere.com ↗
Dec 29, 2022, Simcere Pharmaceutical Group (2096.HK) announced that the company has received Investigational New Drug (IND) approval from China National Medical Products Administration (NMPA) for two immune-oncology bi-specific antibodies (SIM0348, SIM0237). |
| 2022-10-27 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Regulatory Simcere Receives IND Approval in the US for Bi-functional Fusion Protein, SIM0237 ——the Second US IND Approval This Year simcere.com ↗
Simcere Pharmaceutical Group (2096.HK), an innovative global pharmaceutical company, today 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. |
| 2022-10-11 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Regulatory Simcere filed 2 INDs for immune-oncology bispecific antibodies to NMPA simcere.com ↗
October 10, 2022, Simcere Pharmaceutical Group (2096.HK) announced that the company has recently submitted two new drug clinical trial (IND) applications to China National Medical Products Administration (NMPA) for two immune-oncology bi-specific antibodies (SIM0348, SIM0237). |
All press releases naming this drug 7 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SIM0237 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06186414 ↗ |
| Route | Intravenous | “administered intravenously” NCT05781360 ↗ |