Efficacy and Safety of Perioperative Toripalimab Combined With Recombinant Human Endostatin as Postoperative Adjuvant Therapy for Clinical Stage II Malignant Melanoma: A Multicenter, Single-Arm, Phase II Clinical Study

This is a Phase II clinical trial to evaluate the efficacy and safety of perioperative toripalimab (anti-PD-1) combined with recombinant human endostatin (Endostar) as postoperative adjuvant therapy in patients with clinical stage II cutaneous or acral malignant melanoma. The study aims to answer:
1. Does this combination improve the 2-year recurrence-free survival (2y-RFS) compared to historical data?
2. Is the treatment safe and tolerable for patients?
Participants will:
1. Receive 2 cycles of toripalimab before surgery (neoadjuvant therapy).
2. Undergo surgical removal of the tumor.
3. Post surgery, receive toripalimab every 2 weeks + Endostar (72-hour continuous infusion every 4 weeks) for up to 6 cycles (Endostar) or 11 cycles (toripalimab).
4. Be monitored for tumor recurrence, side effects, and survival for up to 2 years after treatment.
This is a single-arm, multicenter study involving 58 patients across several hospitals in China. Results will help determine if this combination could become a new standard adjuvant therapy for stage II melanoma.

Start Date01 Jan 2025

Sponsor / Collaborator

Fudan University

NCT06562673

/ RecruitingPhase 1/2IIT

Efficacy and Safety of Intra-arterial Cisplatin Plus Anti-angiogenesis Inhibitor Rh-endostatin (Endostar) Combined With Systematic Chemotherapy in Osteosarcoma

The goal of this clinical trial is to learn the efficacy and safety of intra-arterial cisplatin plus anti-angiogenesis inhibitor rh-endostatin (Endostar) combined with systematic chemotherapy in osteosarcoma. The main questions it aims to answer are:
* Is it safe when rh-endostatin and cisplatin are administered intra-arterially?
* Does intra-arterial cisplatin plus rh-endostatin increase the rate of tumor necrosis compared with traditional treatment?
Researchers will treat newly diagnosed osteosarcoma patients with systematic treatment and local treatment.
For systematic treatment, regular high-dose methotrexate and adriamycin will be administered intravenously.
For local treatment, rh-endostatin was administered intra-arterially with dosage of 150 mg for a 6-h continuous infusion; then cisplatin was administered intra-arterially at 120 mg/m2 as a 6-h continuous infusion.
Local treatment is conducted by insertion of a catheter percutaneously using the Seldinger technique through the brachial or femoral artery under local anesthesia.
Participants will:
• Receive local combined with systematic treatment once every 2-3 weeks for 2-4 cycles before surgery.

Start Date01 Dec 2024

Sponsor / Collaborator-

NCT06618391

/ Not yet recruitingPhase 2IIT

Envafolimab and Recombinant Human Endostatin and Recombinant Human Adenovirus Type 5 Intratumor Local Injection Combined With Systemic Therapy in Patients With Advanced NSCLC :a Prospective, Exploratory Phase II Clinical Study Tudy

This study is a prospective, exploratory Phase II clinical study aimed at evaluating the safety and efficacy of Envafolimab and recombinant human endostatin and Recombinant Human Adenovirus Type 5 Intratumor local injection combined with systemic therapy in patients with locally advanced or advanced non-small cell lung cancer(NSCLC).

Start Date08 Oct 2024

Sponsor / Collaborator

Henan Cancer 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)

466

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

31 Dec 2025·CANCER BIOLOGY & THERAPY

Inhibitory effect of Endostar on HIF-1 with upregulation of MHC-I in lung cancer cells

Article

Author: Wang, Hai-Jing ; Wang, Jing-Na ; Zhao, Zhi-Wei ; Zhang, Yan-Min ; Zheng, Hong-Fei ; Zhao, Ming-Zhen

Endostar is a human recombinant endostatin which is an attractive anti-angiogenesis protein. Because inefficient antigen presenting MHC class I expression (which can be downregulated by HIF-1) is an important strategy for cancer immune evasion, besides its anti-angiogenesis effect, it remains unclear whether Endostar has an inhibitory effect on HIF-1 expression by upregulating MHC class I expression in cancer cells to facilitate immunotherapies, including PD-1/PD-L1 inhibitors. In this study, A549 and NCI-H1299 lung cancer cells were treated with Endostar (6.25 μg/ml, 12.5 μg/ml, and 25 μg/ml, respectively). HIF-1 expression was detected by Immunocytochemistry and Western blot. Proteins of the MHC class I α-heavy chain and β2 m light chain, STAT3 and pSTAT3 were detected by Western blot. The mRNAs of MHC class I α-heavy chain and β2 m light chain were detected by RT-qPCR. It was shown that decreased expression of HIF-1 and promotion of β2-microglobulin were observed after Endostar treatment. In addition, elevated levels of MHC class I α-heavy chain mRNA and protein, as well as downregulation of STAT3 and pSTAT3, were also observed following Endostar treatment. Endostar inhibited HIF-1 expression in A549 and NCI-H1299 lung cancer cells, upregulated expression of MHC class I α-heavy chain and β2 m light chain, with the upregulation of STAT3 and pSTAT3, suggesting involvement of STAT3 pathway. It is important because only in combination with MHC class I on target cells can tumor antigenic peptides be recognized by CD8+ CTLs which destroy target cells. However, MHC class I is frequently deficient in cancer cells.

01 Sep 2025·Therapeutic Advances in Medical Oncology

Efficacy of Endostar plus concurrent chemoradiotherapy in locally advanced cervical cancer: a multicenter, phase II randomized trial

Article

Author: Tang, Xiaobi ; Liao, Sihui ; Wang, Hongqian ; Liu, Meilian ; Jiang, Li ; Huang, Haixing ; Liu, Wenqi ; Ma, Shanshan ; Wu, Fang ; Zhang, Yong ; Luo, Zhanxiong

Background::

Cervical cancer remains the fourth most common malignant cancer in females and the fourth most common cause of mortality in women worldwide. Approximately 70% of new cases are diagnosed as locoregionally advanced cervical cancer (LACC), posing a significant threat to women’s health. Concurrent chemoradiotherapy (CCRT) is the established standard treatment for LACC. However, more than 30% of patients still experience local recurrence and distant metastasis. Improving treatment outcomes for LACC is a critical global objective.

Objective::

To investigate the safety and efficacy of adding Endostar to CCRT in patients with LACC.

Design::

This is a multicenter, open-label, randomized, controlled, phase II trial.

Methods::

A total of 120 patients were randomly allocated (1:1) to receive either CCRT alone (definitive radiotherapy plus cisplatin 40 mg/m 2 every week for 4–5 cycles) or CCRT plus Endostar, Endostar at a dose of 7.5 mg/m 2 /day, from 5 days before CCRT for 10 consecutive days every 15 days for four cycles).

Results::

The CCRT + E arm demonstrated a significantly higher complete response rate (CRR) compared to the CCRT arm (68.3% vs 35.0%, p = 0.001), while the overall response rate (ORR) was similarly in both arms (98.3% vs 100%, p = 1.000). The CCRT + E arm showed significantly improved distant metastasis-free survival (DMFS) (1-year: 91.6% vs 94.8%, 2-year: 82.3% vs 91.6%, 5-year: 67.0% vs 88.0% p = 0.029). No significant differences were found in overall survival (OS), progression-free survival (PFS), or locoregional recurrence-free survival (LRFS) ( p > 0.05). Multivariable analysis identified maximum tumor diameter >4 cm and failure to achieve CR as predictive factors of poor PFS, and maximum tumor diameter >4 cm and stage IIIA–IVA disease as poor prognostic factors for OS. According to the subgroup analysis, Endostar significantly improved the DMFS in cohorts of patients with squamous cell carcinoma ( p = 0.005), a maximum tumor diameter > 4 cm ( p = 0.011), and stage IB2 or IIA2–IIB disease ( p = 0.005). The rates of acute and late adverse reactions were similar in both arms ( p > 0.05), with no cardiac toxicity, hypertension, or grade 5 toxicity reported.

Conclusion::

The addition of Endostar to CCRT significantly enhanced tumor response (CRR) and reduced distant metastasis (DMFS) in LACC patients without increasing treatment toxicity, offering a promising therapeutic enhancement. Clinically, patients with squamous cell carcinoma, maximum tumor diameter > 4 cm, and International Federation of Gynecology and Obstetrics stage IB2 or IIA2–IIB disease derived particularly robust DMFS benefits from the combination regimen, suggesting they should be prioritized for this approach. Although the 5-year DMFS results are encouraging, validation in a larger phase III study and longer follow-up are warranted before considering this regimen as a new standard treatment modality for LACC.

Trial registration::

This trial was registered at ClinicalTrials.gov (NCT 03086681, registered 22 March 2017, https://clinicaltrials.gov/study/NCT03086681 .

01 Jul 2025·Journal of Thoracic Disease

Combining recombinant human endostatin with third-generation EGFR-TKIs in advanced EGFR-sensitive mutant non-small cell lung cancer

Article

Author: Peng, Sujuan ; Wang, Fen ; Tan, Aaron C ; Huang, Hongxiang ; Chen, Li ; Kong, Ping ; Lu, Zhihui ; Ding, Xinjing ; Song, Tiantian ; Chen, Jinhong ; Zhong, Peiyuan ; Zhu, Xie ; Xiao, Fang

Background:

Third-generation epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) are standard first-line options in advanced or metastatic EGFR mutant non-small cell lung cancer (NSCLC). This study aimed to compare the efficacy and safety of third generation EGFR-TKIs combined with recombinant human endostatin (Endostar) versus EGFR-TKIs alone in previously untreated advanced epidermal growth factor receptor (EGFR) mutant NSCLC patients.

Methods:

A total of 118 untreated advanced EGFR-sensitive-mutant NSCLC patients from a single center were retrospectively included in the study. Of the patients, 71 received third-generation EGFR-TKIs (the T group) and 47 received combination of Endostar and third-generation EGFR-TKIs therapy (the E + T group). Progression-free survival (PFS), overall survival (OS), the objective response rate (ORR), the disease control rate (DCR), and adverse events (AEs) were evaluated.

Results:

Compared to the T group, the E + T group had a significantly higher ORR (91.5% vs. 77.5%; P=0.047), and improved PFS (20.2 vs. 17.6 months; P=0.002) and OS (41.5 vs. 33.8 months; P=0.04). However, there was no significant difference in the DCR between the two groups (97.9% vs. 97.2%; P>0.99). Multivariate analysis identified the Eastern Cooperative Oncology Group performance status (ECOG-PS) score, brain metastasis, EGFR co-mutation, and treatment regimen as independent prognostic factors. Subgroup analysis showed that the E + T group had greater clinical benefits for patients with ≥2 distant metastatic organs (P=0.01) and EGFR/TP53 co-mutations (P=0.01). The incidence of AEs of any level was higher in the E + T group than the T group (53.2% vs. 45.1%, P=0.39).

Conclusions:

In this real-world study, the combination of recombinant human endostatin and third-generation EGFR-TKIs significantly improved the ORR, PFS, and OS in previously untreated advanced EGFR-mutant NSCLC patients and thus represents a promising treatment option that requires further prospective evaluation.

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

16 Oct 2025

·ir.nextcure.com

NextCure and Simcere Zaiming Announce Expansion of Ongoing Phase 1 Trial of SIM0505 (CDH6 ADC) into the United States

First U.S. patient dosed at a mid-tier dose level where multiple responses have been observed Multi-regional trial to accelerate time to proof-of-concept data in 1H 2026 BELTSVILLE, Md. and SHANGHAI, Oct. 16, 2025 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to developing novel therapies to treat cancer, and Simcere Zaiming, an oncology-focused biopharmaceutical company and a subsidiary of Simcere Pharmaceutical Group Ltd (HKEX: 2096), today announced that the first patient in the U.S. has been dosed with SIM0505 in the ongoing Phase 1 trial (NCT06792552), which is evaluating safety, tolerability, pharmacokinetics and efficacy in patients with advanced solid tumors. SIM0505 is a novel antibody drug conjugate directed to cadherin-6 (CDH6 ADC), featuring a proprietary topoisomerase 1 inhibitor (TOPOi) payload, designed for broad anti-tumor activity, high systemic clearance and an improved potential therapeutic window. NextCure has now expanded the ongoing Phase 1 dose escalation study, which was initiated in China, by enrolling patient(s) in the U.S. into a mid-tier dose level while dose escalation is currently advancing in China. NextCure acquired an exclusive global license, excluding Greater China, for SIM0505 from Simcere Zaiming. “We are pleased by the significant progress achieved by our partner, which has enabled us to start U.S. enrollment at doses within a therapeutic range where clinical responses have already been observed. Based on current data, SIM0505 has been well tolerated with a favorable safety profile,” said Udayan Guha, M.D., Ph.D., NextCure’s chief medical officer. “We believe that SIM0505 has the potential to become a leading ADC targeting CDH6. We look forward to accelerating the ongoing trial and presenting proof-of-concept clinical data in the first half of 2026.” “Enrollment of the first patient in the U.S. marks a significant milestone in global clinical development of SIM0505. This achievement reflects our ongoing commitment to advancing innovative oncology treatments for patients in China and worldwide,” said Yongyu Wang, M.D., Chief Medical Officer, Simcere Zaiming.” About NextCure, Inc. NextCure is a clinical-stage biopharmaceutical company that is focused on advancing innovative medicines that treat cancer patients that do not respond to, or have disease progression on, current therapies, through the use of differentiated mechanisms of actions including antibody-drug conjugates. We focus on advancing therapies that leverage our core strengths in understanding biological pathways and biomarkers, the interactions of cells, including in the tumor microenvironment, and the role each interaction plays in a biologic response. http://www.nextcure.com About Simcere Zaiming Simcere Zaiming is an oncology-focused biopharmaceutical company and a subsidiary of Simcere Pharmaceutical Group Limited (HKEX: 2096, "Simcere"). Founded in 2023, Simcere Zaiming dedicated to developing groundbreaking therapies to meet 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 innovative products in China, including COSELA®, Enweida®, Endostar®, and Enlituo®. 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. NextCure’s Cautionary Statement Regarding Forward-Looking Statements Some of the statements contained in this press release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including with respect to funding for our operations, objectives and expectations for our business, operations and financial performance and condition, including the progress and results of clinical trials, development plans and upcoming milestones regarding our therapies. Any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “continue,” “could,” “should,” “due,” “estimate,” “expect,” “intend,” “hope,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “target,” “towards,” “forward,” “later,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or similar language. Forward-looking statements involve substantial risks and uncertainties that could cause actual results to differ materially from those projected in any forward-looking statement. Such risks and uncertainties include, among others: positive results in preclinical studies may not be predictive of the results of clinical trials; NextCure’s limited operating history and not having any products approved for commercial sale; NextCure’s history of significant losses; NextCure’s need and ability to obtain additional financing on acceptable terms or at all; risks related to clinical development, marketing approval and commercialization; NextCure’s ability to maintain listing of its common stock on the Nasdaq Global Select Market; and NextCure’s dependence on key personnel. More detailed information on these and additional factors that could affect NextCure’s actual results are described under the heading “Risk Factors” in NextCure’s most recent Annual Report on Form 10-K and in NextCure’s other filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. Forward-looking statements speak only as of the date of this press release, and NextCure assumes no obligation to update any forward-looking statements, even if expectations change. NextCure Investor Inquiries Timothy Mayer, Ph.D. NextCure, Inc. Chief Operating Officer (240) 762-6486 IR@nextcure.com Simcere Zaiming Contacts PR contacts: pr@zaiming.com IR contacts: ir@zaiming.com Source: NextCure

Phase 1License out/inADCIND

19 Jun 2025

·www.prnewswire.com

Simcere Zaiming Announces First Patient Dosed in the US in a Phase 1 Trial of Trispecific Antibody SIM0500 in Patients with Relapsed/Refractory Multiple Myeloma

SHANGHAI, June 18, 2025 /PRNewswire/ -- Simcere Zaiming, an innovative oncology-focused subsidiary of Simcere Pharmaceutical Group (2096.HK) today announced the first US patient has started treatment in the ongoing Phase 1 trial (SIM0500-101, NCT06375044) at The Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai, evaluating safety, tolerability, pharmacokinetics and preliminary efficacy of SIM0500 in patients with relapsed/refractory multiple myeloma (RRMM). SIM0500 (formerly SCR-8572) is a humanized trispecific antibody targeting GPRC5D, BCMA and CD3, developed using Simcere Zaiming's proprietary T-cell engager polyspecific antibody platform. [1] "In the last few years, BCMA and GPRC5D-targeted therapies have demonstrated significant promise in treating RRMM and have been anticipated as the cornerstones of the next chapter in the pursuit of curing myeloma. SIM0500 is the natural evolution of combining these targets with the aim to optimize outcomes in the RRMM," said Dr. Joshua Richter, M.D., Associate Professor of Medicine at the Icahn School of Medicine at Mount Sinai, Director of Multiple Myeloma at the Blavatnik Family Chelsea Medical Center at Mount Sinai, and Principal Investigator. "SIM0500 is designed to bind to two tumor antigens, GPRC5D and BCMA. It has shown strong T-cell cytotoxicity against multiple myeloma cells in preclinical studies," said Prof. Shaji Kumar, M.D. "I look forward to participating in the Phase 1 study of SIM0500 to evaluate the safety and efficacy of this potentially transformative therapy in patients with RRMM." "We are quite pleased with the safety and encouraging efficacy results generated to-date in the ongoing dose escalation and look forward to the extension of the SIM0500 Phase 1 trial to the US. This marks an important step forward in Simcere Zaiming's continued commitment to advance new oncology treatments and elevate the standard of care for patients with RRMM," said Yongyu Wang, M.D., Chief Medical Officer, Simcere Zaiming. SIM0500 is being developed in partnership with AbbVie. About SIM0500 SIM0500 stands as a potentially best-in-class candidate, poised to offer novel therapeutic options for solving drug resistance encountered in existing multiple myeloma treatments. In April 2024, the FDA awarded SIM0500 a Fast Track designation. In January 2025, Simcere Zaiming entered into an agreement with AbbVie granting AbbVie an option to license SIM0500. SIM0500 is an investigational agent that has not been approved by the FDA or any other regulatory authority. About SIM0500-101 Phase 1 study SIM0500 is currently being investigated in a phase 1 clinical trial both in US and in China. Preliminary data suggested a good safety profile, desired pharmacokinetic profile of SIM0500 with encouraging efficacy. About Simcere Zaiming Simcere Zaiming is an oncology-focused biopharmaceutical company and a subsidiary of Simcere Pharmaceutical Group Limited (HKEX: 2096, "Simcere"). Founded in 2023, Simcere Zaiming dedicated to developing groundbreaking therapies to meet 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 innovative products in China, including COSELA®, Enweida®, Endostar®, and Enlituo®. 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. This press release contains forward-looking statements within the meaning of applicable securities laws. These statements involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Factors that could cause such differences include, but are not limited to, the inherent uncertainties in clinical development, regulatory approval processes, competitive developments, and other risks detailed in our filings with the Hong Kong Stock Exchange. [1]. FU Y, You S, Wei M, et al.: A novel T cell engager targeting BCMA and GPRC5D showed promising preclinical activity with low toxic risk for multiple myeloma treatment. Cancer Res (2024) 83 (7_Supplement): 1883 Contacts: Simcere Zaiming PR contacts: [email protected] IR contacts: [email protected] SOURCE Simcere Zaiming WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 1Fast Track

16 Jun 2025

·pipelinereview.com

NextCure and Simcere Zaiming Announce Strategic Partnership for a Novel Antibody-Drug Conjugate Targeting CDH6

BELTSVILLE, MD, USA and SHANGHAI, China I June 16, 2025 I NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class and best-in-class therapies to treat cancer, and Simcere Zaiming, an oncology-focused biopharmaceutical company and a subsidiary of Simcere Pharmaceutical Group Ltd (HKEX: 2096), today announced a strategic partnership to develop SIM0505, a novel antibody-drug conjugate (ADC) targeting CDH6 (cadherin-6 or K-cadherin) for the treatment of solid tumors. SIM0505 is currently in Phase 1 clinical testing in China; NextCure expects to begin clinical testing in the U.S. in the third quarter of 2025. SIM0505 is a novel ADC developed by Simcere Zaiming. It is directed to CDH6, a promising anti-tumor target, using a unique binding epitope with increased tumor binding compared to competing candidates. It also features Simcere Zaiming’s proprietary topoisomerase 1 inhibitor (TOPOi) payload, designed for broad anti-tumor activity while offering high systemic clearance to enlarge the therapeutic window. Preclinical studies have demonstrated robust anti-tumor activity across multiple solid tumor models and a promising safety profile in toxicology models. SIM0505 is currently in Phase 1 dose escalation studies in China. A global dose expansion study is expected following the dose escalation portion of the study to include multiple tumor types. An Investigational New Drug application has been cleared by the U.S. Food and Drug Administration. The partnership also includes a license for NextCure to access Simcere Zaiming’s proprietary linker and TOPOi payload for a preclinical-stage novel target ADC developed by NextCure. Simcere Zaiming will have Greater China rights to this additional novel target ADC. “We believe SIM0505 has the potential to be an important new therapy for cancer patients. Partnering with Simcere Zaiming, a leader in antibody-drug conjugates, provides us with an opportunity to advance a class-leading ADC directed to CDH6. Their proprietary payload is a potent cytotoxin with a potentially improved safety and efficacy profile compared to other topoisomerase inhibitors,” said Michael Richman, NextCure’s president and CEO. “We look forward to initiating clinical development of SIM0505 in the United States.” “We are very pleased to collaborate with NextCure on the global development of SIM0505,” said Renhong Tang, PhD, CEO of Simcere Zaiming. “SIM0505 is a significantly differentiated CDH6 targeting ADC candidate independently developed by Simcere Zaiming. Our alliance reflects NextCure’s recognition of our proprietary ADC platform, and together, we aim to accelerate drug development to benefit more cancer patients worldwide.” Simcere Zaiming is eligible to receive payments throughout the potential development phases, including upfront payment, development, regulatory and sales milestones up to $745M, as well as tiered royalties up to double digits on net sales outside of the Greater China territory. About NextCure, Inc. NextCure is a clinical-stage biopharmaceutical company that is focused on advancing innovative medicines that treat cancer patients that do not respond to, or have disease progression on, current therapies, through the use of differentiated mechanisms of actions including antibody-drug conjugates. We focus on advancing therapies that leverage our core strengths in understanding biological pathways and biomarkers, the interactions of cells, including in the tumor microenvironment, and the role each interaction plays in a biologic response. http://www.nextcure.com About Simcere Zaiming Simcere Zaiming is an oncology-focused biopharmaceutical company and a subsidiary of Simcere Pharmaceutical Group Limited (HKEX: 2096, “Simcere”). Founded in 2023, Simcere Zaiming dedicated to developing groundbreaking therapies to meet 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 innovative products in China, including COSELA ® , Enweida ® , Endostar ® , and Enlituo ® . 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. SOURCE: NextCure

ADCPhase 1License out/in

100 Deals associated with Recombinant Human Endostatin (Simcere)

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-	-	L01	DB06423

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Non-Small Cell Lung Cancer	China	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	China	Shandong Simcere Biopharmaceutical Co. Ltd.	21 Jul 2021
Malignant Pleural Effusion	Phase 3	China	Shandong Simcere Biopharmaceutical Co. Ltd.	21 Jul 2021
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	China	Jiangsu Simcere Pharmaceutical Co., Ltd.	01 Aug 2018
Advanced Colorectal Adenocarcinoma	Phase 3	China	Jiangsu Simcere Pharmaceutical Co., Ltd.	01 Jul 2018
Advanced Lung Adenocarcinoma	Phase 2	China	Jiangsu Simcere Pharmaceutical Co., Ltd.	01 Mar 2012
Brain metastases	Phase 2	China	Jiangsu Simcere Pharmaceutical Co., Ltd.	01 Jun 2011
T-Cell Lymphoma	Phase 2	China	Jiangsu Simcere Pharmaceutical Co., Ltd.	01 Jun 2011
Esophageal Carcinoma	Phase 2	China	Jiangsu Simcere Pharmaceutical Co., Ltd.	01 May 2011
Locally Advanced Melanoma	Phase 2	China	Jiangsu Simcere Pharmaceutical Co., Ltd.	01 Aug 2008
Metastatic melanoma	Phase 2	China	Jiangsu Simcere Pharmaceutical Co., Ltd.	01 Aug 2008

Clinical Result

Indication

Phase

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03086681 (Pubmed \| Ther Adv Med Oncol)	Phase 2	Locally Advanced Cervical Carcinoma	120	Endostarcisplatin + Endostarcisplatin	jcoiteadak(qlqgihedlc) = okdxatzows qzudnjlgaz (tyabbrhvle ) View more	Positive	01 Sep 2025
				cisplatin	jcoiteadak(qlqgihedlc) = skwsflschi qzudnjlgaz (tyabbrhvle ) View more
WCLC2024 Manual	Phase 2	Non-Small Cell Lung Cancer First line driver gene-negative	29	EnvafolimabRh-endostatin	ufnhauzkzq(zcxdawkpjr) = qqpxrqpmhu coagzjljla (eprvyrbdhn, 76.8 - 109.4) View more	Positive	09 Sep 2024
NCT05574998 (Pubmed)	Phase 2	Advanced Lung Non-Small Cell Carcinoma serum carcinoembryonic antigen (CEA)	48	rh-endostatin + platinum with pemetrexed	przlukuvyc(yotlgflsor) = ilrnauxbjh livpykkvyq (xvzqsyuxjx, 3.8 - 9.1) View more	Positive	01 Jun 2024
				rh-endostatin + platinum with paclitaxel	przlukuvyc(yotlgflsor) = mjikueagig livpykkvyq (xvzqsyuxjx, 3.8 - 9.1) View more
NCT02907710 (phase III, ASCO2024) Manual	Phase 3	Advanced Nasopharyngeal Carcinoma	300	Endostar plus CCRT	iztzjeeegg(bcfdcjfdzq) = qdodgtbcdc qrrpmqqtwa (khnqcajmrj ) View more	Positive	24 May 2024
				CCRT alone	iztzjeeegg(bcfdcjfdzq) = ymgdbngpnl qrrpmqqtwa (khnqcajmrj ) View more
ESMO_ASIA2023	Phase 2	Locally Advanced Esophageal Squamous Cell Carcinoma	90	Endostar plus concurrent chemoradiotherapy (CCRT)	tgqtnlhiwr(bhmgpxjczr) = dmpvdwpwwe ekwsqatewe (cakjwaxeyh ) View more	Positive	02 Dec 2023
				Concurrent chemoradiotherapy (CCRT)	ksgwazkfoj(jlaekqcaaa) = eyrccowjjz gkfmafvhkj (bbjnvszlqc ) View more
ESMO 12023 \| ESMO 22023 Manual	Phase 2	Locally Advanced Esophageal Squamous Cell Carcinoma	92	Endostar+concurrent chemoradiotherapy	bpauinrqab(helwqysrfm) = axpjkrwbmh rtifbmzxjs (eeseatlfvc ) View more	Positive	23 Oct 2023
				Concurrent chemoradiotherapy	bpauinrqab(helwqysrfm) = xacbkfunfv rtifbmzxjs (eeseatlfvc ) View more
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	yqblfrzybm(wlnjudobjb) = 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 mulggnlmey (qyvtcgxuib ) 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	yngtemdrxg(uxzwkyacnp) = zzyahfyplx pjvocokjmv (bhhchqdtrq, 3.19 - 5.49) View more	Positive	05 Apr 2022
ASTRO2021	Not Applicable	Non-Small Cell Lung Cancer	1,036	Endostar combined with concurrent chemoradiotherapy (CCRT)	vvpmuszwwi(omphkfayks): RR = 1.113 (95% CI, 1.006 - 1.231), P-Value = 0.038 View more	Positive	01 Nov 2021
				Concurrent chemoradiotherapy (CCRT)
CSCO2021	Not Applicable	Advanced Lung Squamous Cell Carcinoma	328	endostar (Continuous intravenous pumping (CIV))	wsokqxlmfn(nfwqveblmx) = fitqxbomhg ppmwolfetp (ztauekrsoz ) View more	-	25 Sep 2021
				endostar (Intravenous injection (IV))	wsokqxlmfn(nfwqveblmx) = ndtscpgfhf ppmwolfetp (ztauekrsoz ) View more

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Clinical Trial

Identify the latest clinical trials across global registries.

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Approval

Accelerate your research with the latest regulatory approval information.

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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Regulation

Understand key drug designations in just a few clicks with Synapse.

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AI Agents Built for Biopharma Breakthroughs

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Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

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Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis