Shanghai Xianshang Pharmaceutical Technology Co., Ltd. operates as a subsidiary under the larger umbrella of Xiansheng Pharmaceuticals. This entity was established in September 2022 and primarily concentrates on the development in areas such as oncology, neurology, autoimmune diseases, and anti-infective treatments.

Tags

Neoplasms

Immune System Diseases

Hemic and Lymphatic Diseases

Small molecule drug

Antibody drug conjugate (ADC)

Trispecific T-cell engager (TriTE)

Disease domain score

A glimpse into the focused therapeutic areas

Technology Platform

Most used technologies in drug development

Targets

Most frequently developed targets

Disease Domain	Count

Neoplasms	5
Hemic and Lymphatic Diseases	1
Immune System Diseases	1

Top 5 Drug Type	Count

Small molecule drug	2
Antibody drug conjugate (ADC)	1
Fusion protein	1
Trispecific T-cell engager (TriTE)	1

Top 5 Target	Count

USP1(ubiquitin specific peptidase 1)	1
IL-15 x PDL1	1
CDH6 x Top I	1
BCMA x CD3 x GPRC5D	1
POLQ(DNA polymerase theta)	1

Drugs associated with Shanghai Xianxiang Medical Technology Co., Ltd.

SIM-237

Target

IL-15 x PDL1

Mechanism

IL-15 inhibitors [+1]

Active Org.

Shanghai Xianxiang Medical Technology Co., Ltd. [+2]

Originator Org.

Simcere Pharmaceutical Group Ltd.

Active Indication

Non-Muscle Invasive Bladder Neoplasms [+1]

Inactive Indication

Advanced Malignant Solid Neoplasm [+1]

Drug Highest PhasePhase 1

First Approval Ctry. / Loc.-

First Approval Date-

SIM-0500

Target

BCMA x CD3 x GPRC5D

Mechanism

BCMA inhibitors [+2]

Active Org.

Shanghai Xianxiang Medical Technology Co., Ltd.

Originator Org.

Simcere Pharmaceutical Group Ltd.

Active Indication

Relapse multiple myeloma [+1]

Inactive Indication-

Drug Highest PhasePhase 1

First Approval Ctry. / Loc.-

First Approval Date-

SIM-0508

Target

POLQ

Mechanism

POLQ inhibitors

Active Org.

Simcere Pharmaceutical Group Ltd. [+2]

Originator Org.

Simcere Pharmaceutical Group Ltd.

Active Indication

Advanced Malignant Solid Neoplasm [+3]

Inactive Indication-

Drug Highest PhasePhase 1

First Approval Ctry. / Loc.-

First Approval Date-

Clinical Trials associated with Shanghai Xianxiang Medical Technology Co., Ltd.

NCT06686745

/ RecruitingPhase 1

A Phase I, First-in-Human, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0508 Monotherapy and Combination Therapy in Adult Participants With Locally Advanced/Metastatic Solid Tumors

This is a multicenter, open-label, first-in-human study to evaluate the safety,efficacy, and PK/PD characteristics of SIM0508 as a single agent and in combination with olaparib in participants with locally advanced/metastatic solid tumors.

Start Date06 Dec 2024

Sponsor / Collaborator

Jiangsu Simcere Pharmaceutical Co., Ltd.

[+1]

CTR20244105

/ RecruitingPhase 1

评价SIM0508单药治疗及联合治疗在局部晚期/转移性实体瘤成人受试者的安全性、耐受性、药代动力学和初步抗肿瘤活性的首次人体、开放性、多中心I期研究

[Translation] A first-in-human, open-label, multicenter Phase I study to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of SIM0508 as monotherapy and in combination therapy in adult subjects with locally advanced/metastatic solid tumors

主要目的：第1a部分-SIM0508单药治疗的剂量递增：评价SIM0508单药治疗的安全性和耐受性，并确定最大耐受剂量（MTD）/最大给药剂量（MAD）/潜在推荐剂量（RD1）（如有）。次要目的：进一步确定SIM0508单药治疗或与奥拉帕利联合治疗的安全性和耐受性。探索性目的：评价SIM0508单药治疗或与奥拉帕利联合治疗的药效学（PD）效应。探索PK与PD、疗效和安全性的潜在相关性。

[Translation]

Primary objective: Part 1a - Dose escalation of SIM0508 monotherapy: Evaluate the safety and tolerability of SIM0508 monotherapy and determine the maximum tolerated dose (MTD)/maximum administered dose (MAD)/potential recommended dose (RD1) (if any). Secondary objective: Further determine the safety and tolerability of SIM0508 monotherapy or in combination with olaparib. Exploratory objective: Evaluate the pharmacodynamic (PD) effect of SIM0508 monotherapy or in combination with olaparib. Explore the potential correlation between PK and PD, efficacy and safety.

Start Date27 Nov 2024

Sponsor / Collaborator

Shanghai Xianxiang Medical Technology Co., Ltd.

NCT06375044

/ RecruitingPhase 1

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 Tri-specific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma

This is an open-label, multicenter phase 1 clinical trial to evaluate the safety and tolerability, efficacy, and pharmacokinetics of SIM0500 in adult participants with Relapsed or Refractory Multiple Myeloma(RRMM). The trial is consisted of two parts, Part 1 (dose escalation) and Part 2 (dose optimization). In both parts, SIM0500 will be administered until disease progression, intolerable toxicity, withdraw of consent or end of trial.

Start Date24 May 2024

Sponsor / Collaborator

Jiangsu Simcere Pharmaceutical Co., Ltd.

[+1]

100 Clinical Results associated with Shanghai Xianxiang Medical Technology Co., Ltd.

0 Patents (Medical) associated with Shanghai Xianxiang Medical Technology Co., Ltd.

Literatures (Medical) associated with Shanghai Xianxiang Medical Technology Co., Ltd.

05 Nov 2024·Blood

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

Author: Tian, Ji ; Qiu, Lugui ; Xia, Zhongjun ; Chen, Jia ; Zhu, Zewen ; Sun, Haolin ; Cui, Ailing ; Xu, Yan ; Zhang, Nating ; Yang, Chen ; Cai, Zhen ; Jing, Xiaojuan ; Tang, Jianxing

BackgroundMultiple myeloma (MM) is a malignancy of plasma cells that is characterized by the clonal expansion of neoplastic plasma cells, leading to the production of paraprotein, anemia, renal impairment, bone metastases, and humoral and cellular immunosuppression. MM represents 1% of all cancers, and is estimated to account for 10% of all hematologic malignancies globally. Although therapeutic options have expanded substantially in the past decade, MM remains an incurable disease with limited options for patients who have relapsed or are refractory to standard therapies, i.e., proteasome inhibitors (PIs), immunomodulatory imide drugs (IMiDs), and monoclonal antibodies. Thus, identification and characterization of new therapeutic targets and treatment modalities are areas of active investigation.SIM0500 is an IgG4-based tri-specific T-cell engager that consists of a CD3-specific single-chain Fv flanked by anti-BCMA and anti-GPRC5D antibodies with the molecular weight of about 186.9 kDa. SIM0500 binds to human T-cells through CD3, and to MM cells that expresses BCMA and/or GPRC5D, thereby recruiting activated T cells to kill BCMA or GPRC5D expressing MM cells. Based on results from the nonclinical studies, the anti-tumor activity, tolerability, safety, pharmacokinetic (PK) /toxicokinetic (TK) properties of SIM0500 support the clinical development for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM). The study design has been approved by both the China Center for Drug Evaluation (CDE) and the US Food and Drug Administration (FDA). Fast Track Designation was granted by the FDA in the patients with RRMM.Study Design and MethodsThis global, Phase I, open-label, multi-cohort study (NCT06375044) consists of two parts, Part 1 (dose escalation) and Part 2 (dose optimization). In both parts, SIM0500 will be administered until disease progression, intolerable toxicity, withdraw of consent or end of trial.Estimated total enrollment is up to 130 patients. The study will accrue patients with RRMM who have received at least ≥3 prior lines of anti- multiple myeloma therapy and prior lines of therapy must include a PI, an IMiD, and an anti-CD38 monoclonal antibody. Eligible patients must be aged ≥18 years, have an Eastern Cooperative Oncology Group performance status ≤1, and have adequate kidney and liver function. Key exclusion criteria are previous treatment with concurrent or sequential GPRC5D and BCMA antibody and the presence of known active, or prior history of CNS involvement or exhibits clinical signs of meningeal involvement of MM. This study is actively recruiting patients at sites across China and three patients have been enrolled thus far.Part 1: SIM0500 Dose Escalation:The SIM0500 will be administered subcutaneously. Dose escalation will be guided by 2-parameter Bayesian Logistic Regression Model with escalation with overdose control.Dose escalation will begin with an accelerated phase in which 1-3 participants will be enrolled into each dose cohort. Accelerated dose escalation will be ended and the standard dose escalation will be started in the event of the occurrence of one Grade 2 or higher adverse events (AEs) in the dose-limiting toxicity (DLT) evaluation period, or at dose level 4 if no ≥ Grade 2 AEs are observed in the first three dose levels during accelerated dose escalation. Then 3-6 participants will be enrolled into each dose cohort in the standard dose escalation phase. A total of 6-12 participants may be enrolled in the potential recommended doses (RDs)/ maximum tolerated dose (MTD) level. A priming dose may be implemented if a Grade ≥2 CRS event occurs during the DLT assessment window.Part 2: SIM0500 Dose Optimization:The RD(s) will be further explored in the Part 2 dose optimization: Approximately 40 participants will be treated with two potential RD levels to further characterize preliminary antitumor activity and safety profile. Participants will be randomized at 1:1 ratio to either dose level.Study EndpointsThe 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.

10 Jun 2024·Journal of Clinical Oncology

A phase III randomized, double-blinded, placebo-controlled study of suvemcitug combined with chemotherapy for platinum-resistant ovarian cancer (SCORES).

Author: Wu, Lingying ; Li, Jundong ; Sun, Shuguang ; Lou, Ge ; Wang, Danbo ; Liu, Xiaowei ; Li, Qingshui ; Yang, Chen ; Yuan, Guangwen ; Zhang, Jiajing

LBA5516 Background: Suvemcitug is a new-generation recombinant humanized anti-VEGF rabbit monoclonal antibody. In the previous P1b study, Suvemcitug demonstrated its favorable safety profile and efficacy signals when combo with chemotherapy in platinum-resistant ovarian cancer (PROC). SCORES is the first randomized, double-blind, placebo-controlled phase III clinical trial to confirm the efficacy of Suvemcitug combo with chemo in PROC, whether or not previously received antiangiogenic agents or PARP inhibitors. Methods: Eligible patients had progressed during platinum-based therapy or within 6 months after ≥4 cycles of platinum-based therapy with at least one measurable lesion. After the investigators chose chemotherapy (CT) (weekly paclitaxel 80 mg/ m2 d1, 8, 15 & 22 q4w, pegylated liposomal doxorubicin 40 mg/m2 d1 q4w or topotecan 4 mg/m2 d1, 8 & 15 q4w), patients were randomly assigned (2:1) to either Suvemcitug (1.5 mg/kg q2w) or placebo combine with CT until progression or unacceptable toxicity. The primary endpoint was progression-free survival (PFS) by blinded independent review committee (BIRC) according to the RECIST 1.1. Key secondary end point is the overall survival (OS). Results: A total of 421 patients were enrolled between June 2021 and June 2023 in China. As the data cut off of the primary efficacy analysis (8 December 2023), 197 PFS events (70.1%) in Suvemcitug arm and 111 PFS events (79.3%) in placebo arm had occurred with the median follow-up of 14.36 and 14.26 months, respectively. The median PFS by BIRC was 5.49 months in Suvemcitug arm versus 2.73 months in placebo arm (hazard ratio[HR] 0.46, p<0.0001). OS data are immature. 42.7% and 50.7% of patients are deceased in Suvemcitug arm or placebo arm respectively, and there is a trend of OS benefit trend: median OS 16.07 months vs. 14.88 months, HR 0.79, p=0.1244. Efficacy results are summarized below. Treatment-emergent adverse events (TRAEs) occurred in all patients in Suvemcitug arm, with the most common being neutrophil count decreased, white blood cell count decreased and platelet count decreased. No Suvemcitug-related grade 5 TEAE occurred. Conclusions: To the best of our knowledge, this is the first double-blinded phase III study demonstrated promising antitumor activity of anti-angiogenic agent in patients with PROC. The improvement in PFS, ORR and DCR gained by adding Suvemcitug to single-agent CT was observed with no new safety concern. Clinical trial information: NCT04908787 . [Table: see text]

100 Deals associated with Shanghai Xianxiang Medical Technology Co., Ltd.

100 Translational Medicine associated with Shanghai Xianxiang Medical Technology Co., Ltd.

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Pipeline

Pipeline Snapshot as of 02 Apr 2025

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

IND Approval

Phase 1 Clinical

Current Projects

Drug(Targets)	Indications	Global Highest Phase

SIM-0501 ( USP1 )	Advanced Malignant Solid Neoplasm More	Phase 1
SIM-0500 ( BCMA x CD3 x GPRC5D )	Relapse multiple myeloma More	Phase 1
SIM-0508 ( POLQ )	Advanced Malignant Solid Neoplasm More	Phase 1
SIM-0505 ( CDH6 x Top I )	Advanced Malignant Solid Neoplasm More	Phase 1
SIM-237 ( IL-15 x PDL1 )	Non-Muscle Invasive Bladder Neoplasms More	Phase 1

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