A Prospective, Single-arm Clinical Study of Endostar Combined With Stereotactic Body Radiation Therapy and Envafolimab in the Treatment of Advanced Gastrointestinal Tumors After Multi-line Treatment

This is a single-arm, prospective, exploratory clinical study to evaluate the efficacy and safety of endostar combined with stereotactic body radiation therapy (SBRT) and Envafolimab in patients with advanced gastrointestinal cancer after multi-line treatment.

Start Date21 Feb 2024

Sponsor / Collaborator

Jiangsu Provincial People's Hospital

ChiCTR2300079203 / RecruitingPhase 2IIT

A Single-arm, Open-label Clinical Study of Enbrelizumab Combined with Endostar and Concurrent Chemoradiotherapy for Locally Advanced Cervical Cancer

Start Date01 Jan 2024

Sponsor / Collaborator

Henan Provincial Peoples Hospital

NCT05879796 / Not yet recruitingNot ApplicableIIT

A Controlled Clinical Study of Envafolimab (PD-L1 Antibody) Subcutaneous Injection Combined With Endostar and Concurrent Chemoradiotherapy in Treatment of Locally Advanced Primary Cervical Cancer

The goal of this study is to determine efficacy and safety of envafolimab combined with Endostar and concurrent chemoradiation in the treatment of locally advanced primary cervical cancer.
Thirty participants will be divided into control group (n = 15) and experimental group (n = 15). The control group received concurrent chemoradiation, and the experimental group received envafolimab combined with endostar and concurrent chemoradiation.

Start Date16 May 2023

Sponsor / Collaborator

Peking University Third Hospital

100 Clinical Results associated with Recombinant Human Endostatin (Simcere)

100 Translational Medicine associated with Recombinant Human Endostatin (Simcere)

100 Patents (Medical) associated with Recombinant Human Endostatin (Simcere)

454

Literatures (Medical) associated with Recombinant Human Endostatin (Simcere)

01 Nov 2023·Advances in skin & wound care

Peripherally Inserted Central Catheter-Related Skin Injury in Patients with a Chest Tumor: Characteristics and Risk Factors

Article

Author: Wan, Guang-Ming ; Xu, Min-Shan ; Wang, Yan ; Miao, Miao

ABSTRACT:

OBJECTIVE:

To investigate the characteristics and risk factors of skin injury in patients with chest tumors who have peripherally inserted central catheters (PICCs).

METHODS:

This study included a total of 252 patients with chest tumors with PICC placement who were treated from March 2018 to December 2021 in a tertiary hospital in Shanghai, China. Investigators used univariate analysis and multivariate logistic regression to identify the risk factors.

RESULTS:

Among the included patients, 40.8% had skin injuries (n = 103). Skin injury occurred between 2 and 361 days after PICC placement, with a median time of 56.0 days (interquartile range, 20.75–99.25 days). Skin injury may occur during catheter retention and be concentrated in the first 3 months after PICC placement; the occurrence trajectory of skin injury exhibits a downward trend. Logistic regression analysis shows that skin injury is more likely to occur if the patient has a history of smoking, allergy history, use of recombinant human endostatin, or an excessive duration of catheter retention.

CONCLUSIONS:

The incidence of PICC-related skin injury in patients with chest tumors remains high. Medical practitioners should be aware of its characteristics and risk factors and adopt effective solutions early to mitigate the occurrence of skin injury and improve patients’ safety.

13 Oct 2023·Medicine

A real-world study of recombinant human endostatin combined with PD-1/PD-L1 blockade and chemotherapy for patients with advanced non-small cell lung cancer negative for actionable molecular biomarkers.

Article

Author: Gu, Hang-Yu ; Zheng, Ai-Hong ; Wang, Yin-Shuang ; Meng, Zhuo-Nan ; Wu, Guo-Qing ; Zhao, Jing-Wen ; Wang, Fu-Wei

The ongoing ENPOWER study exploring the efficacy and safety of the recombinant human endostatin (endostar) combined with programmed cell death 1 antibody sintilimab and chemotherapy showed encouraging efficacy and safety in advanced non-squamous non-small cell lung cancer. To evaluate the real-world efficacy and safety of endostar combined with immune checkpoint inhibitor and chemotherapy (EIC) for advanced non-squamous non-small cell lung cancer patients negative for actionable molecular biomarkers (NSCLCnm), patients with advanced NSCLCnm hospitalized to Zhejiang Provincial People's Hospital from January 2020 to December 2022 were screened for eligibility. The included patients were analyzed for the objective response rate (ORR) and disease control rate (DCR). The pre- and posttreatment expression levels of serum tumor associated biomarkers, chemokines and subpopulations of immune cells in peripheral blood were compared. For the 31 patients with advanced NSCLCnm treated with EIC, the median follow-up and treatment cycles were 18.0 months and 4, respectively. The ORR and DCR were 38.7% and 90.3%, respectively. For those who received EIC as first-line treatment, the ORR and DCR were 63.2% and 94.7%, respectively. EIC significantly decreased expression levels of carcinoma antigen 125, carcinoma embryonic antigen and cytokeratin 19 (P<0.05) in patients who were partial remission or stable disease. Among the 31 patients, 27 (87.1%) experienced at least 1 treatment-related adverse events, and 13 (41.9%) had the treatment-related adverse events of grade 3 or higher. No antiangiogenesis-related adverse events were observed. The current study showed that EIC was potentially effective for patients with NSCLCnm, especially when used as first-line therapy, and well tolerated.

21 Jul 2023·Medicine

Comparison between different treatment regimens of vascular targeting drug to malignant pleural effusion in patients with lung cancer: A Bayesian network meta-analysis.

Article

Author: Xue, Zhan-Tu ; Huang, Peng ; Guo, Zhi-Kai

BACKGROUND:

The presence of malignant pleural effusion in lung cancer patients often suggests a poor prognosis. We plan to investigate which regimen of vascular targeting drug is preferable to control the malignant pleural effusion in such patients.

METHODS:

Two investigators dependently searched and screened for randomized controlled trials in PubMed, Embase, Web of Science and China National Knowledge Infrastructure from the database inception to August 2022. R software was applied to build a network model in Bayesian method. Objective response rate of malignant pleural effusion is the primary outcome measure. Besides, the incidence of 3 adverse events were compared, including gastrointestinal reaction, leukopenia and hypertension. Due to the disconnection of network, we analysis and discuss the short-term treatment (3-4 weeks) and long-term treatment (6-12 weeks) respectively.

RESULTS:

31 studies with 2093 patients were identified. Four targeting drugs contain bevacizumab (Bev), anlotinib, apatinib and Endostar. Two administration routes include intracavity perfusion (icp) and intravenous injection. Based on the current evidence, for short-term treatments, compared with single-agent chemotherapy (CT), Bev_icp + CT, anlotinib + CT, Bev_icp and anlotinib + endorstar_icp present better objective response, and no statistical significance was found in objective response between Bev_icp + CT, anlotinib + CT and Bev_icp. For long-term treatments, compared with doublet or triplet chemotherapy (2CT or 3CT), Bev_icp + 2CT, apatinib + 2CT, Bev_icp + 3CT, and Bev_intravenous injection + 2CT are more effective option, but no statistical significance was found in objective response between the 4 combination regimens with chemotherapy.

CONCLUSION:

Our findings suggest that no statistical significance between above vascular targeting regimens. Pathological type of lung cancer may affect the effect of bevacizumab intracavity infusion plus chemotherapy. The influence of different administration routes of vascular targeting drugs on efficacy remains to be investigated. There are some concerns with the quality of the studies, and some limitations should be considered when interpreting these results, which includes limited geographical region and sample size of studies. Despite these limitations, this study may inform vascular targeting therapy choice in such a patient population.

News (Medical) associated with Recombinant Human Endostatin (Simcere)

26 Jun 2024

·www.prnewswire.com

Simcere Zaiming Announce Approval of Cetuximab Beta in China by the NMPA

NANJING, China, June 26, 2024 /PRNewswire/ -- On June 25, 2024, Simcere Zaiming, an innovative oncology company and a subsidiary of Simcere Pharmaceutical Group (2096.HK), announced that Enlituo® (generic name: cetuximab beta injection), a new generation anti-epidermal growth factor receptor (EGFR) antibody drug developed in collaboration with Mabpharm Limited (2181.HK), has recently received approval from the China National Medical Administration (NMPA) for marketing. Enlituo® is indicated for use in combination with the FOLFIRI regimen as a first-line treatment for RAS/BRAF wild-type metastatic colorectal cancer (mCRC). According to the 'Cancer Incidence and Mortality in China, 2022' by the National Cancer Center, colorectal cancer ranks as the second most common cancer in China. Annually, there are 1.571 million new cases and 240,000 deaths, imposing a substantial disease burden on the society. When colorectal cancer patients develop metastasis, the primary treatment options often include chemotherapy and targeted drugs. Previous clinical studies have demonstrated the effectiveness of EGFR-targeting antibody drugs in treating malignant tumors, particularly mCRC, in patients without RAS/BRAF mutations (wild-type). Enlituo® (cetuximab beta, originally known as CMAB009) is a recombinant EGFR monoclonal antibody developed independently in China. Classified as a 2.4 class modified biological new drug, cetuximab beta is prepared using a proprietary protein expression technique, effectively avoiding glycosylation modification that may lead to hypersensitivity. Enlituo® received approval based on robust evidence from a phase 2/3 study and a phase 3 confirmatory clinical trial. In an open-label, randomized, controlled, multicenter, prospective phase 3 study, 505 subjects with RAS/BRAF wild-type mCRC were treated and analyzed. Clinical data revealed that combining cetuximab beta with FOLFIRI significantly extended progression-free survival (PFS) compared to FOLFIRI alone (13.133 months vs. 9.567 months, P = 0.004). Additionally, the combination increased the objective response rate (ORR) (69.1% vs. 42.3%, P < 0.001) and overall survival (OS) (2.322 years vs. 1.900 years, P = 0.024). Dr. Renhong Tang, Chairman of Simcere Zaiming, emphasized Enlituo®'s unique clinical value in targeted therapy: "Its initial indication for colorectal cancer addresses a large patient population. The product synergizes well with Simcere Zaiming's existing offerings, and efforts are underway to accelerate its commercialization, benefiting more cancer patients." Dr. Hao Wang, Chief Executive Officer of Mabpharm, expressed excitement as Enlituo® bridged the gap in colorectal cancer treatment with domestically developed EGFR-targeted drugs. "This provides clinicians and patients with updated therapeutic options. By collaborating with Simcere Zaiming's Marketing Team, we are able to rapidly realize the clinical value of Enlituo®, benefiting hundreds of thousands of patients in China with an effective and affordable biological new drug. " Enlituo represents the first EGFR monoclonal antibody drug developed in China with independent intellectual property rights that are approved for the first-line treatment of mCRC. The successful launch of Enlituo® will provide high quality and affordable biological targeted remedy for Chinese cancer patients. In March 2023, the drug marketing application of Enlituo® was accepted by the NMPA. On August 18, 2023, the Group entered into a cooperation agreement with Mabpharm, pursuant to which the Group obtained the exclusive commercial rights in respect of Enlituo® in Chinese mainland. About Mabpharm Mabpharm (stock code: 2181) focuses on the development of monoclonal antibodies and has an experienced R&D team, multiple core technologies, leading domestic large-scale antibody preparation system and excellent quality control system. Mabpharm strives to bring high quality and affordable innovative biologics through its efficient R&D system and low-cost pharmaceutical production capability to the market, and develops various therapeutic products by fully utilizing its extensive R&D experience. About Simcere Zaiming Simcere Zaiming, an oncology-centric biopharmaceutical subsidiary of Simcere Pharmaceutical Group Limited (HKEX: 2096), was established in 2023. The company is devoted to crafting groundbreaking therapies aimed at fulfilling the unmet clinical needs of cancer patients globally. With a robust and innovative R&D pipeline featuring distinct clinical assets, Simcere Zaiming has successfully launched several products in China, including COSELA®, Endostar®, and Envafolimab. The company is determined to deliver potentially transformative treatment options to cancer patients worldwide through its internal R&D, manufacturing, and commercialization capabilities, complemented by strategic collaborations with leading partners in the field of innovative cancer therapeutics. SOURCE Simcere

Drug ApprovalPhase 3License out/inClinical ResultCSCO

13 Apr 2023

·www.prnewswire.com

Simcere Zaiming will Present 8 Research Abstracts at the 2023 AACR Annual Meeting

Just four months after Simcere Zaiming's founding, the organization is sharing details on targets and technologies, including two oral presentations BOSTON, April 13, 2023 /PRNewswire/ -- Simcere Zaiming (Company), a pharmaceutical company focused on developing drugs to address unmet clinical needs for cancer patients around the globe, and subsidiary of Simcere Pharmaceutical Group Limited (2096.HK) (Simcere), a global pharmaceutical company, today announced two oral and six poster presentations will be presented on the Company's preclinical programs at the 2023 American Association for Cancer Research (AACR) Annual Meeting, taking place April 14-19, 2023, in Orlando, FL. The AACR annual meeting is one of the most influential oncology conferences of the year and attracts tens of thousands of scientists and clinical experts to share and discuss the latest progress in basic research, translational research, clinical research and prevention research in the field of oncology. Today's announcement marks a significant milestone for the company as it will be the first time Simcere Zaiming will participate in an international academic conference as an independent oncology entity with multiple studies, including on-site oral presentations. The eight studies cover several targets including SMARCA2, CBL-b, Polθ, SOS1, MUC17, USP1, SIRPα, GPRC5D, and involve multiple novel technologies such as targeted protein degradation, mutant fusion proteins, bispecific T engager and others. Oral Presentations: Title: Identification of a high selective SMARCA2 degrader which effectively suppresses the SMARCA4-deficient tumors M vitro and in Wvo Session Type: Minisymposium Session Category: Experimental and Molecular Therapeutics Session Title: Innovative Therapeutic Approaches Session Date/Time: Sunday Apr 16, 2023 3:00 PM - 5:00 PM Location: Room W331 Abstract Presentation Number: 1137 Presenter: Dr. Zhengtao Li, Vice President, Simcere Zaiming Targeting the "synthetic lethal" partner proteins SMARCA2/4 (human chromatin SWI/SNF- Related, Matrix-Associated, actin-dependent regulatory factor subfamily A member 2 and 4), SCR-9140 selectively degrades SMARCA2 to precisely kill SMARCA4-deficient tumors in preclinical studies while preventing damage to normal cells, thus exhibiting strong antitumor efficacy and favorable safety profile. Title: Identification of the selective CBL-b inhibitors which effectively prevent T cells from exhaustion and demonstrate synergistic anti-tumor activity in combination with an anti-PD1 antibody Session Title: Immune Checkpoints at Tumor Beds Session Date/Time: Monday Apr 17, 2023 2:30 PM - 4:30 PM Abstract Presentation Number: 3474 Presenter: Dr. Tamas Oravecz, Senior Vice President, Chief Scientific Officer, Simcere Zaiming The E3 ubiquitin ligase CBL-b (Casitas B-cell lymphoma protein b) negatively regulates immune function and is considered a potential novel intracellular immune checkpoint. In preclinical studies, a group of Cbl-b inhibitor candidate drugs developed by Simcere Zaiming have demonstrated strong immune activation capabilities and synergistic effects with PD-1 inhibitors, suggesting strong potential for clinical application. Poster Presentations: Title: Identification of SS008871, a novel Polθ inhibitor that effectively inhibits tumors with homologous recombination deficiency in vitro and in vivo Session Title: Experimental and Molecular Therapeutics, Novel Antitumor Agents 2 Session Date and Time: Sunday Apr 16, 1:30 PM – 5:00 PM Location: Poster Section 18 Poster Board Number: 12 Abstract Number: 512 DNA polymerase θ (Polθ) is a key enzyme for DNA double-strand break repair and cell survival in homologous recombination-deficient tumors, and it is also a potential synthetic lethal new therapeutic target. The small molecule inhibitor of Pol θ, SS008871, has shown significant anti-tumor effect and good safety in various preclinical models. Title: SCR-8388, a potent and selective SOS1::KRAS inhibitor, is effective in KRAS-addicted cancers Session Title: Oncogenes and Tumor Suppressor, Genes as Targets for Therapy 2 Session Date and Time: Monday, Apr 17, 9 AM – 12:30 PM Location: Poster Section 20 Poster Board Number: 21 Abstract Number: 1724 The most common oncogene, KRAS, was once regarded as the most difficult drug target, and there was a large unmet clinical need. SCR-8388 is a selective SOS 1 protein inhibitor that acts on the upstream pathway of KRAS and prevents KRAS activation. Preclinical studies have shown that SCR-8388 can significantly inhibit the growth of KRAS mutant tumors in both in vitro and in vivo models, and has a synergistic effect with EGFR antagonists. Title: SCR-9171, a MUC17-targeted bispecific T cell engager molecule for gastrointestinal cancer Session Title: Immunology, Therapeutic Antibodies 1 Session Date and Time: Monday Apr 17, 9:00 AM - 12:30 PM Location: Poster Section 25 Poster Board Number: 21 Abstract Number: 1882 MUC17 is a transmembrane mucin that is often overexpressed in gastric cancer tissues and is also a potential target for gastric cancer therapy. SCR-9171 is a MUC17/CD3 bispecific T cell engager that precisely inhibits MUC17 expressing tumors with optimal CD3 affinity. In preclinical studies, SCR-9171 induces T cell activation, thereby potently killing MUC17-positive tumors, while releasing low level of cytokines that can lead to better treatment tolerability. Title: A novel T cell engager targeting BCMA and GPRC5D showed promising preclinical activity with low toxic risk for multiple myeloma treatment Session Title: Immunology, Therapeutic Antibodies 1 Session Date and Time: Monday Apr 17, 9:00 AM - 12:30 PM Location: Poster Section 25 Poster Board Number: 22 Abstract Number: 1883 SCR-8572, a T-cell engager developed against two specific targets in multiple myeloma, BCMA and GPRC5D, demonstrated potent tumor-killing effects in preclinical in vitro and in vivo models, with preliminary good safety results. It is expected to become a candidate drug for clinical development. Title: Identification of SP-002, a highly selective USP1 inhibitor effectively inhibits HRD tumor growth and displays low hematotoxicity risk Session Title: Experimental and Molecular Therapeutics, DNA Repair / Molecular Classification of Tumors for Diagnostics, Prognostics, and Therapeutic Outcomes / Others Session Date and Time: Wednesday Apr 19, 9:00 AM - 12:30 PM Location: Poster Section 18 Poster Board Number: 3 Abstract Number: 6201 USP1 (ubiquitin-specific peptidase 1) is a synthetic lethal protein of HRD (homologous recombination deficient) tumors. As a highly selective USP1 inhibitor, SP-002 has significant anticancer activity against HRD tumors as a single drug or in combination with PARP inhibitors in preclinical in vitro studies. Furthermore, no significant hematological toxicity was observed. Title: Generation of a mutant SIRPa fusion protein with highly-improved affinity and favorable safety profile Session Title: Immunology, Immune Checkpoints Session Date and Time: Wednesday Apr 19, 9:00 AM - 12:30 PM Location: Poster Section 23 Poster Board Number: 1 Abstract Number: 6357 Interaction of the transmembrane glycoprotein CD47 with signal regulatory protein alpha (SIRPα) triggers "don't eat me" signaling to the macrophage, thereby serving as a key immune checkpoint in a variety of hematological malignancies. SCR9168 is a SIRPα mutant protein fused with Fc, which has significantly improved CD47 affinity, and has good safety in various animal models including cynomolgus monkeys and has best-in-class potential of SIRPα mutant protein in the treatment of hematological tumors. About Simcere Zaiming Simcere Zaiming is a pharmaceutical company specializing in oncology, and a subsidiary of Simcere Pharmaceutical Group Limited, that focuses on the R&D, production and commercialization of innovative cancer therapeutics. The company was formed in 2023 and is committed to solving unmet clinical needs for cancer patients in China and around the world by developing breakthrough treatments. Simcere Zaiming has an innovative R&D pipeline with differentiated clinical value, among which 15 assets are currently in clinical trials. In addition to the company's R&D portfolio, Simcere Zaiming is marketing three innovative drugs, COSELA®, Endostar®, and Envafolimab®. By collaborating with partners globally, Simcere Zaiming strives to bring potentially new innovative therapeutics to cancer patients worldwide. Media Contact: [email protected] About Simcere Pharmaceutical Group Simcere Pharmaceutical Group Limited (2096.HK) is an innovation and R&D-driven pharmaceutical company. The Company focuses on three therapeutic areas, oncology, central nervous system and autoimmune diseases, with a forward-looking vision toward disease areas that may have significant clinical needs in the future, aiming to achieve the mission of "providing today's patients with medicines of the future." Leveraging its R&D capability and commercialization excellence, Simcere has built a market-leading product portfolio in China. Its vigorous in-house R&D efforts and extensive R&D and commercial stage collaborations have made it a strategic alliance partner with world-leading innovative companies and research institutes. For more information, please visit: Media Contact: [email protected] Tyler Gagnon Simcere Pharmaceutical Group Limited Director, Corporate Communications & Public Affairs [email protected] SOURCE Simcere Zaiming

AACRImmunotherapy

14 Mar 2023

·www.prnewswire.com

Simcere Zaiming Announces Clinical Collaboration to Evaluate SIM0235, a TNFR2 Monoclonal Antibody, in Combination with KEYTRUDA® (pembrolizumab) in a Phase 1 Trial in Advanced Solid Tumors and Cutaneous T-cell Lymphoma

NANJING, China, March 14, 2023 /PRNewswire/ -- Simcere Pharmaceutical Group Limited (2096.HK) (Simcere), an innovative global biopharmaceutical company, announced today that Simcere Zaiming, an innovative oncology pharmaceutical company of Simcere has entered into a clinical collaboration agreement with MSD (Merck & Co., Inc., Rahway, NJ, USA) to evaluate the combination of SIM0235, a potential first-in-class humanized anti-tumor necrosis factor receptor 2 (TNFR2) monoclonal antibody, and MSD's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with advanced solid tumors and cutaneous T-cell lymphoma (CTCL). This is a Phase 1 trial（SIM1811-03-TNFR2-102） to evaluate the safety, efficacy, pharmacokinetic/pharmacodynamic characteristics and immunogenicity of SIM0235 monotherapy and SIM0235 in combination with KEYTRUDA in patients with advanced solid tumors and CTCL. Tumor necrosis factor receptor 2 (TNFR2) is a member of the tumor necrosis factor receptor superfamily and is primarily expressed on the surface of tumor cells and immune suppressive cells in the tumor microenvironment, leading to immune escape and tumor proliferation. "Data generated from preclinical models demonstrate the capability of our potential first-in-class monoclonal antibody, SIM0235, in combination with KEYTRUDA, to clinically benefit patients with these cancers," said Dr. Bijoyesh Mookerjee, M.D., Chief Medical Officer, Oncology, Simcere Pharmaceutical Group. Under the terms of the agreement, MSD will supply KEYTRUDA and collaborate with Simcere Zaiming on this study. Simcere Zaiming retains all worldwide commercial rights to SIM0235. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. About SIM0235 SIM0235 (SIM1811-03 injection) is an investigational humanized immunoglobulin G1 (IgG1) monoclonal antibody that targets TNFR2 and blocks its activation by endogenous tumor necrosis factor (TNF), inhibiting the immunosuppressive function and proliferation mediated by TNFR2, to enhance the anti-tumor immune response. Additionally, the antibody has shown cytotoxic effect on TNFR2-expressing immune suppressive cells including regulatory T cells (Tregs) and bone marrow-derived suppressor cells via antibody-dependent cell cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). SIM0235 is currently being studied in patients with advanced solid tumors or cutaneous T-cell lymphoma (CTCL) in Phase 1 trials in China (SIM1811-03-TNFR2-101) and the US (SIM1811-03-TNFR2-102). About Simcere Zaiming Simcere Zaiming is an oncology biopharmaceutical company, and a subsidiary of Simcere Pharmaceutical Group Limited, that focuses on the R&D, production and commercialization of innovative cancer therapeutics. The company was formed in 2023 and is committed to solving unmet clinical needs for cancer patients in China and around the world by developing breakthrough treatments. Simcere Zaiming has built an innovative R&D pipeline with differentiated clinical value. In addition to the company's R&D portfolio, Simcere Zaiming has three innovative drugs, COSELA®, Endostar®, and Envafolimab®. By collaborating with partners globally, Simcere Zaiming strives to bring potentially new innovative therapeutics to cancer patients worldwide. About Simcere Pharmaceutical Group Simcere Pharmaceutical Group Limited (2096.HK) is an innovation and R&D-driven pharmaceutical company. The Company focuses on three therapeutic areas, oncology, central nervous system and autoimmune diseases, with a forward-looking vision toward disease areas that may have significant clinical needs in the future, aiming to achieve the mission of "providing today's patients with medicines of the future." Leveraging its R&D capability and commercialization excellence, Simcere has built a market-leading product portfolio in China. Its vigorous in-house R&D efforts and extensive R&D and commercial stage collaborations have made it a strategic alliance partner with world leading innovative companies and research institutes. For more information, please visit: SOURCE Simcere Pharmaceutical Group Limited

Phase 1ImmunotherapyLicense out/in

100 Deals associated with Recombinant Human Endostatin (Simcere)

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L01	DB06423

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Non-Small Cell Lung Cancer	CN	Shandong Simcere Biopharmaceutical Co. Ltd.	12 Sep 2005

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Malignant ascites	Phase 3	CN	Shandong Simcere Biopharmaceutical Co. Ltd.	21 Jul 2021
Malignant Pleural Effusion	Phase 3	CN	Shandong Simcere Biopharmaceutical Co. Ltd.	21 Jul 2021
Advanced Lung Non-Small Cell Carcinoma	Phase 3	CN	Jiangsu Simcere Pharmaceutical Co., Ltd.	01 Aug 2018
Advanced Colorectal Adenocarcinoma	Phase 3	CN	Jiangsu Simcere Pharmaceutical Co., Ltd.	01 Jul 2018
Lung Cancer	Phase 3	CN	Peking University Third Hospital	01 Jan 2014
Advanced Lung Adenocarcinoma	Phase 2	CN	Jiangsu Simcere Pharmaceutical Co., Ltd.	01 Mar 2012
Brain metastases	Phase 2	CN	Jiangsu Simcere Pharmaceutical Co., Ltd.	01 Jun 2011
Esophageal Carcinoma	Phase 2	CN	Jiangsu Simcere Pharmaceutical Co., Ltd.	01 May 2011
Melanoma	Phase 2	CN	Jiangsu Simcere Pharmaceutical Co., Ltd.	01 Aug 2008

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02907710 (phase III, ASCO2024) Manual	Phase 3	Advanced Nasopharyngeal Carcinoma	300	Endostar plus CCRT	lkbgiktypb(wbzfemzuje) = jtjvldctms hqnfsvxfpl (crsepekclm ) View more	Positive	24 May 2024
				CCRT alone	lkbgiktypb(wbzfemzuje) = qvlgfmyhvz hqnfsvxfpl (crsepekclm ) View more
ESMO_ASIA2023	Phase 2	Locally Advanced Esophageal Squamous Cell Carcinoma	90	Endostar plus concurrent chemoradiotherapy (CCRT)	hhsgaoebzc(yxfhdckkjk) = dvmdtfiiag ofgmutjyrr (ifihagmnqx ) View more	Positive	02 Dec 2023
				Concurrent chemoradiotherapy (CCRT)	sexqpiktac(nkanqysrgf) = bnpqwuonqe taikjcxgqd (spalqplrnm ) View more
ESMO2023 Manual	Phase 2	Locally Advanced Esophageal Squamous Cell Carcinoma	92	Endostar+concurrent chemoradiotherapy	gpypwytlwp(hczgpidcrs) = bqnlxkmrtn tsamwraqqz (vwhxcokunl ) View more	Positive	23 Oct 2023
				Concurrent chemoradiotherapy	gpypwytlwp(hczgpidcrs) = rzchajwije tsamwraqqz (vwhxcokunl ) View more
ESMO_GCC2023	Not Applicable	Locally Advanced Cervical Carcinoma	41	Endostar combined with chemoradiotherapy	qbieeqbqri(dzxzdxjmdt) = fkfjedxzjt pmdpgtxpny (ionzxvemoa ) View more	-	23 Feb 2023
				Chemoradiotherapy	qbieeqbqri(dzxzdxjmdt) = adkjrlmqju pmdpgtxpny (ionzxvemoa ) View more
CSCO2022	Not Applicable	Advanced Lung Squamous Cell Carcinoma	19	重组人血管内皮抑制素联合阿法替尼及替吉奥	bxmtpcnelc(pzjwqkjddr) = 没有与治疗相关的死亡报告 lnxjdzvvpm (dgbkimlvbf ) View more	-	21 Sep 2022
CSCO2022	Not Applicable	-	815	对照治疗组	uyqghxulja(djnyuiwiuz) = lnvabrxhss zmrfqbqvvn (nmaisoswzp ) View more	Positive	21 Sep 2022
				恩度治疗组	uyqghxulja(djnyuiwiuz) = tleneusjyi zmrfqbqvvn (nmaisoswzp ) View more
CSCO2022	Not Applicable	Lung Cancer \| Malignant Pleural Effusion	78	顺铂	crxfrgkxpx(eeriuyneud) = vjppjwaxbc alfpeadlaz (ecfwsisvuq ) View more	-	21 Sep 2022
WCLC2022	Not Applicable	Advanced Lung Non-Small Cell Carcinoma	27	Endostar + Camrelizumab + Chemotherapy	fsqlmxotkp(qthrfmniog) = bkdjigqxwk kznkjhkbor (xlkssykkun ) View more	-	06 Aug 2022
NCT04063449 (ENPOWER, ASCO2022)	Phase 2	Advanced Lung Non-Small Cell Squamous Carcinoma \| Non-squamous non-small cell lung cancer First line	43	rh-Endostatin plus PD-1 antibody plus standard chemotherapy	gfphkvftob(tjwvuhhrmy) = Adverse events of any grade that occurred in at least 10% of patients were AST/ALT abnormal (33%) in the cohort 1 and AST/ALT abnormal (21%) in the cohort 2 zbwkvcndsz (mswkfycsiq ) View more	-	02 Jun 2022
				rh-Endostatin plus standard chemotherapy
NCT03797625 (Pubmed \| Oncologist) Manual	Phase 2	Advanced Esophageal Squamous Cell Carcinoma Second line	50	Irinotecan+Cisplatin+Rh-Endostatin	rytbhyfhek(vxkfbigcle) = dznkmyiwir neaunhilqr (bsyvdtrjmz, 3.19 - 5.49) View more	Positive	05 Apr 2022

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