Top 5 Target	Count

GPRC5D(G-protein coupled receptor family C group 5member D)	2
BCMA(B-cell maturation protein)	2
CD70(CD70 antigen)	1
VEGFR(Vascular endothelial growth factor receptor)	1
CD16(FcγRIII)	1

Drugs associated with Shandong Simcere Biopharmaceutical Co. Ltd.

Recombinant Human Endostatin (Simcere)

Target

VEGFR

Mechanism

VEGFR antagonists

Active Org.

Shandong Simcere Biopharmaceutical Co. Ltd.

Originator Org.

Simcere Pharmaceutical Group Ltd.

Active Indication

Non-Small Cell Lung Cancer [+2]

Inactive Indication

Advanced Colorectal Adenocarcinoma [+7]

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

First Approval Date12 Sep 2005

Pegylated recombinant human endostatin(Simcere Pharmaceutical Group Ltd.)

Target-

Mechanism

Angiogenesis inhibitors

Active Org.

Shandong Simcere Biopharmaceutical Co. Ltd. [+3]

Originator Org.

Simcere Pharmaceutical Group Ltd.

Active Indication

metastatic non-small cell lung cancer

Inactive Indication-

Drug Highest PhasePhase 1

First Approval Ctry. / Loc.-

First Approval Date-

WO2024160269

Patent Mining

Target

CD3 x MUC17

Mechanism-

Active Org.

Shandong Simcere Biopharmaceutical Co. Ltd.

Originator Org.

Shandong Simcere Biopharmaceutical Co. Ltd.

Active Indication

Infectious Diseases [+1]

Inactive Indication-

Drug Highest PhaseDiscovery

First Approval Ctry. / Loc.-

First Approval Date-

Clinical Trials associated with Shandong Simcere Biopharmaceutical Co. Ltd.

CTR20210869

/ RecruitingPhase 3

重组人血管内皮抑制素注射液(恩度®)联合顺铂对比安慰剂联合顺铂腔内注射治疗恶性胸腹腔积液的随机、对照、双盲的多中心Ⅲ期注册临床研究

[Translation] A randomized, controlled, double-blind, multicenter phase III registration clinical study of recombinant human endostatin injection (Endo®) combined with cisplatin versus placebo combined with cisplatin intracavitary injection in the treatment of malignant pleural and peritoneal effusion

主要研究目的与安慰剂联合顺铂腔内注射比较，以无穿刺和/或引流生存期（Puncture /drainage-Free Survival, PuFS）为指标评价恩度®联合顺铂腔内注射治疗恶性胸腔或腹腔积液的疗效。次要研究目的与安慰剂联合顺铂腔内注射比较，以6个月总生存率为指标评价恩度®联合顺铂腔内注射治疗恶性胸腔或腹腔积液的生存获益（关键次要研究目的）；与安慰剂联合顺铂腔内注射比较，以WHO胸腹腔积液疗效标准评价的胸腹腔积液客观缓解率、3个月无穿刺和/或引流率，至下一次穿刺和/或引流时间（TTNP）、12个月OS率及OS为指标，评价恩度®联合顺铂腔内注射治疗恶性胸腔或腹腔积液的疗效；与安慰剂联合顺铂腔内注射比较，以干预前、后患者报告结局（PRO）评分变化评估的恩度®联合顺铂腔内注射治疗恶性胸腔或腹腔积液对受试者症状及生活质量的变化；与安慰剂联合顺铂腔内注射比较，评价恩度®联合顺铂腔内注射治疗恶性胸腔或腹腔积液的安全性。

[Translation]

Main research purpose Compared with placebo combined with intracavitary cisplatin injection, the efficacy of Endostar® combined with intracavitary cisplatin injection in the treatment of malignant pleural or peritoneal effusion was evaluated using Puncture/drainage-Free Survival (PuFS) as an indicator. Secondary study objectives Compared with placebo combined with intracavitary cisplatin, the survival benefit of Endostar® combined with intracavitary cisplatin in the treatment of malignant pleural or peritoneal effusion was evaluated by the 6-month overall survival rate (key secondary study objective); Compared with placebo combined with intracavitary cisplatin, the efficacy of Endostar® combined with intracavitary cisplatin in the treatment of malignant pleural or peritoneal effusion was evaluated by the WHO pleural and peritoneal effusion efficacy criteria, the 3-month puncture and/or drainage-free rate, the time to the next puncture and/or drainage (TTNP), the 12-month OS rate and OS as indicators to evaluate the efficacy of Endostar® combined with intracavitary cisplatin in the treatment of malignant pleural or peritoneal effusion; Compared with placebo combined with intracavitary cisplatin, the changes in symptoms and quality of life of subjects treated with Endostar® combined with intracavitary cisplatin in the treatment of malignant pleural or peritoneal effusion were evaluated by the changes in patient-reported outcome (PRO) scores before and after intervention; Compared with placebo combined with intracavitary cisplatin, the safety of Endostar® combined with intracavitary cisplatin in the treatment of malignant pleural or peritoneal effusion was evaluated.

Start Date21 Jul 2021

Sponsor / Collaborator

Shandong Simcere Biopharmaceutical Co. Ltd.

CTR20210405

/ CompletedPhase 1

评价恩度标准剂量静滴 4 小时连续 14 天及恩度连续静滴（泵注）72 和 168 小时联合一线含铂两药化疗在晚期非小细胞肺癌患者中的药代动力学特征、安全性及初步有效性的多中心Ⅰ期临床研究

[Translation] A multicenter phase I clinical study to evaluate the pharmacokinetic characteristics, safety and preliminary efficacy of standard-dose Endostatin intravenous drip for 4 hours for 14 consecutive days and continuous intravenous drip (pump infusion) of Endostatin for 72 and 168 hours combined with first-line platinum-containing two-drug chemotherapy in patients with advanced non-small cell lung cancer

主要研究目的评价恩度连续静滴 14 天及恩度连续静滴（泵注）72 和 168 小时的药代动力学特征次要研究目的评价恩度连续静滴 14 天及恩度连续静滴（泵注）72 和 168 小时联合化疗的安全性探索性研究目的初步评价恩度联合化疗的有效性

[Translation]

Primary study objective To evaluate the pharmacokinetic characteristics of 14-day continuous intravenous infusion of Endostar and 72 and 168-hour continuous intravenous infusion (pump infusion) of Endostar Secondary study objective To evaluate the safety of 14-day continuous intravenous infusion of Endostar and 72 and 168-hour continuous intravenous infusion (pump infusion) of Endostar combined with chemotherapy Exploratory study objective To preliminarily evaluate the effectiveness of Endostar combined with chemotherapy

Start Date15 Jul 2021

Sponsor / Collaborator

Shandong Simcere Biopharmaceutical Co. Ltd.

CTR20200345

/ RecruitingPhase 1

聚乙二醇化重组人血管内皮抑制素在晚期/转移性非小细胞肺癌或其他实体瘤的安全性、耐受性和药代动力学研究

[Translation] Safety, tolerability and pharmacokinetics of pegylated recombinant human endostatin in patients with advanced/metastatic non-small cell lung cancer or other solid tumors

主要目的：评价PEG-ENDO治疗晚期/转移性NSCLC或其他实体瘤的安全性、耐受性及药代动力学特征，确定PEG-ENDO联合化疗的后续临床试验推荐剂量。次要目的：初步评价PEG-ENDO联合化疗在晚期/转移性NSCLC或其他实体瘤治疗中的临床疗效。

[Translation]

Primary objective: To evaluate the safety, tolerability and pharmacokinetic characteristics of PEG-ENDO in the treatment of advanced/metastatic NSCLC or other solid tumors, and to determine the recommended dose for subsequent clinical trials of PEG-ENDO combined with chemotherapy. Secondary objective: To preliminarily evaluate the clinical efficacy of PEG-ENDO combined with chemotherapy in the treatment of advanced/metastatic NSCLC or other solid tumors.

Start Date15 Apr 2020

Sponsor / Collaborator

Jiangsu Simcere Pharmaceutical Co., Ltd.

[+3]

100 Clinical Results associated with Shandong Simcere Biopharmaceutical Co. Ltd.

0 Patents (Medical) associated with Shandong Simcere Biopharmaceutical Co. Ltd.

Literatures (Medical) associated with Shandong Simcere Biopharmaceutical Co. Ltd.

01 Aug 2024·GYNECOLOGIC ONCOLOGY

Suvemcitug plus chemotherapy for platinum-resistant epithelial ovarian, fallopian tube and primary peritoneal cancer: A phase 1b dose-escalation trial

Article

Author: Zheng, Hong ; Wu, Yan ; Sun, Haolin ; Yuan, Guangwen ; Zhang, Keqiang ; Zhang, Jiajing ; Sun, Xiyang ; Wu, Lingying

OBJECTIVE:

The use of bevacizumab has been hampered by safety concerns despite demonstrable progression-free survival (PFS) benefit in subjects with platinum-resistant ovarian cancer, highlighting the need for novel effective and safe antiangiogenic agents. This study aimed to characterize the tolerability, safety, and antitumor activities of escalating doses of anti-VEGF antibody suvemcitug plus chemotherapy in platinum-resistant ovarian cancer patients.

METHODS:

This open-label, dose-escalation trial enrolled adult patients (≥18 years) with platinum-resistant histologically or cytologically-confirmed epithelial ovarian, fallopian tube and primary peritoneal cancer. Eligible patients received paclitaxel or topotecan plus escalating doses of suvemcitug 0.5, 1, 1.5, or 2 mg/kg once every two weeks. The primary endpoints were safety and tolerability, and antitumor activities of suvemcitug.

RESULTS:

Twenty-nine subjects received paclitaxel (n = 11) or topotecan (n = 18). No dose-limiting toxicities occurred. The most common adverse events of special interest were proteinuria (41.4%), hypertension (20.7%) and epistaxis (10.3%). No gastrointestinal perforations occurred. Nine subjects (31.0%, 95% CI 15.3-50.8) demonstrated investigators-confirmed objective response, including complete response in 1 and partial response in 8. The median PFS was 5.4 months (95% CI 2.2-7.4).

CONCLUSIONS:

Suvemcitug demonstrated an acceptable safety profile and promising antitumor activities in platinum-resistant ovarian cancer patients, supporting its further clinical development.

01 Jun 2023·ESMO open

Suvemcitug as second-line treatment of advanced or metastatic solid tumors and with FOLFIRI for pretreated metastatic colorectal cancer: phase Ia/Ib open label, dose-escalation trials

Article

Author: Zhang, Y ; Feng, X ; Ji, D ; Zhang, J ; Cao, J ; Xu, N ; Wu, Y ; Mao, C ; Liu, L ; Song, W ; Song, L ; Ding, Y

BACKGROUND:

Suvemcitug (BD0801), a novel humanized rabbit monoclonal antibody against vascular endothelial growth factor, has demonstrated promising antitumor activities in preclinical studies.

PATIENTS AND METHODS:

The phase Ia/b trials investigated the safety and tolerability and antitumor activities of suvemcitug for pretreated advanced solid tumors and in combination with FOLFIRI (leucovorin and fluorouracil plus irinotecan) in second-line treatment of metastatic colorectal cancer using a 3 + 3 dose-escalation design. Patients received escalating doses of suvemcitug (phase Ia: 2, 4, 5, 6, and 7.5 mg/kg; phase Ib: 1, 2, 3, 4, and 5 mg/kg plus FOLFIRI). The primary endpoint was safety and tolerability in both trials.

RESULTS:

All patients in the phase Ia trial had at least one adverse event (AE). Dose-limiting toxicities included grade 3 hyperbilirubinemia (one patient), hypertension and proteinuria (one patient), and proteinuria (one patient). The maximum tolerated dose was 5 mg/kg. The most common grade 3 and above AEs were proteinuria (9/25, 36%) and hypertension (8/25, 32%). Forty-eight patients (85.7%) in phase Ib had grade 3 and above AEs, including neutropenia (25/56, 44.6%), reduced leucocyte count (12/56, 21.4%), proteinuria (10/56, 17.9%), and elevated blood pressure (9/56, 16.1%). Only 1 patient in the phase Ia trial showed partial response, [objective response rate 4.0%, 95% confidence interval (CI) 0.1% to 20.4%] whereas 18/53 patients in the phase Ib trial exhibited partial response (objective response rate 34.0%, 95% CI 21.5% to 48.3%). The median progression-free survival was 7.2 months (95% CI 5.1-8.7 months).

CONCLUSIONS:

Suvemcitug has an acceptable toxicity profile and exhibits antitumor activities in pretreated patients with advanced solid tumors or metastatic colorectal cancer.

INVESTIGATIONAL NEW DRUGS

Anti-PD-L1 envafolimab combined with anti-VEGF suvemcitug in pretreated solid tumors and hepatocellular carcinoma: an open-label phase II study with safety run-in stage

Article

Author: Su, Fang ; Jiang, Da ; Hao, Chunyi ; Liu, Zhenru ; Cheng, Ying ; Fan, Qingxia ; Lu, Liqin ; Sun, Xiyang ; Sun, Shuguang ; Zhang, Yu ; Tian, Ji ; Yang, Chen ; Ma, Lixia ; Fang, Yong

BACKGROUND:

Immune checkpoint inhibitors (ICIs) combined with anti-vascular endothelial growth factor (VEGF) have been the standard first-line treatment of hepatocellular carcinoma (HCC). However, the efficacy of this combination in post-line treatment is still unknown. This study aimed to evaluate the efficacy and safety of the combination of anti-PD-L1 envafolimab and novel humanized anti-VEGF suvemcitug as second-line treatment for patients with HCC.

METHODS:

This open-label, prospective phase II clinical study (NCT05148195) comprised safety run-in stage and dose expansion stage of HCC cohort. Eligible patients were aged ≥ 18 years and had undergone at least a prior line of treatment. Patients received fixed-dose envafolimab and suvemcitug until termination of disease progression, unacceptable toxicities, or withdrawal. The primary endpoint of safety run-in stage was recommended dose (RD), and dose expansion stage was objective response rate (ORR).

RESULTS:

As of August 10, 2023, no dose-limiting toxicity was observed in six patients in the safety-run-in stage, and 2 mg/kg dose every 3 weeks was declared the RD of suvemcitug. Among 20 patients with HCC, the median age was 54.5 (range, 42-70) years. Of these patients, 20 (100.0%) received ≥ one prior line treatment, with 20 (100%) received tyrosine kinase inhibitor (TKI) treatment and 8 (40.0%) received prior ICI treatment. The ORR was 10.0% (95% confidence interval (CI), 1.2-31.7), DCR was 65.0% (95% CI, 40.8-84.6), and DoR was not reached (NR). With a median follow-up of 13.9 months, the median progression-free survival (PFS) and median overall survival (OS) were 4.3 months (95% CI, 1.4-8.1) and 10.7 months (95% CI, 6.0-not evaluable [NE]), respectively. Treatment-related adverse events (TRAEs) of grade ≥ 3 occurred in 40% patients, with proteinuria (20.0%, 4/20) being the most frequent. The ORR of no lung metastasis, prior first-line treatment and IO naïve treatment subgroup was 16.7%.

CONCLUSIONS:

The combination of envafolimab and suvemcitug showed a tolerable safety profile and promising antitumor activity in HCC patients who failed later-line treatment.

100 Deals associated with Shandong Simcere Biopharmaceutical Co. Ltd.

100 Translational Medicine associated with Shandong Simcere Biopharmaceutical Co. Ltd.

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Pipeline Snapshot as of 19 Mar 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

Discovery

Phase 1

Approved

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Pegylated recombinant human endostatin(Simcere Pharmaceutical Group Ltd.)	metastatic non-small cell lung cancer More	Phase 1
CN117244055 ( CD70 )Patent Mining	Hematologic Diseases More	Discovery
WO2023011431 ( CD16 )Patent Mining	Inflammation More	Discovery
WO2023125888 ( GPRC5D )Patent Mining	Neoplasms More	Discovery
WO2023125349 ( GC-C )Patent Mining	Neoplasms More	Discovery

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