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

/ CompletedPhase 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 Date03 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)

460

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)

22 Dec 2025

·www.globenewswire.com

Ipsen expands early development pipeline with Simcere Zaiming’s innovative antibody drug conjugate

Ipsen gains exclusive global rights, outside of Greater China, for development, manufacturing and commercialization of SIM0613, a LRRC15-targeting antibody-drug conjugateSIM0613 is optimally designed for superior tumor penetration with robust preclinical efficacy dataProgram expected to enter Phase I clinical development in H2 2026Simcere Zaiming is eligible to receive up to $1.06B in total payments PARIS, FRANCE; 22 DECEMBER 2025 - Ipsen (Euronext: IPN; ADR: IPSEY) announced today an exclusive licensing agreement for global rights outside of Greater China, for SIM0613, an antibody-drug conjugate (ADC) with best-in-class potential. Targeting the LRRC15 protein, SIM0613 is designed for enhanced tumor penetration and differentiated anti-tumor activity in solid tumors with the highest unmet needs. “Today’s announcement underscores our bold vision to lead innovation and shape the future of oncology,” said Christelle Huguet, PhD EVP and Head of Research & Development, Ipsen. “By advancing first- and best-in-class therapies early, we maximize the potential to transform patient outcomes globally. The addition of the SIM0613 ADC is testament to this ambition—pioneering science that opens new possibilities for those who need it most and builds on Ipsen’s rapidly evolving research and early development portfolio, with over 20 programs added since 2020." "SIM0613 is developed via Simcere Zaiming's proprietary antibody-drug conjugate platform," said Renhong Tang, PhD, CEO of Simcere Zaiming. "We are excited to partner with Ipsen on this novel drug candidate and look forward to working together to advance the clinical development of SIM0613. " Under the terms of the agreement, Simcere Zaiming is eligible to receive up to $1.06B comprising upfront, development, regulatory and commercial milestone payments, and tiered royalties on sales, contingent upon successful development and regulatory approvals. Ipsen will have manufacturing rights, following the tech transfer process and will assume responsibility for all activities outside Greater China including Phase I preparation activities and submission of the Investigational New Drug and Clinical Trial applications. About SIM0613SIM0613 targets the leucine-rich repeat-containing 15 (LRRC15), a protein highly expressed on varies tumor types and cancer-associated fibroblasts but with limited expression on normal cells. Upon binding to the LRRC15 protein, SIM0613 is internalized where the cytotoxic payload is released, killing the cancer cell and therefore sparing healthy cells. SIM0613 is specifically engineered for deep tumor and cancer-associated fibroblast penetration, resulting in robust tumor regressions in multiple in vivo preclinical models. About IpsenWe are a global biopharmaceutical company with a focus on bringing transformative medicines to patients in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Our pipeline is fueled by internal and external innovation and supported by nearly 100 years of development experience and global hubs in the U.S., France and the U.K. Our teams in more than 40 countries and our partnerships around the world enable us to bring medicines to patients in more than 100 countries. Ipsen is listed in Paris (Euronext: IPN) and in the U.S. through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information, visit ipsen.com. About Simcere ZaimingSimcere Zaiming is an oncology-focused bipharmaceutical company and a subsidiary of Simcere Pharmaceutical Group Limited (HKEX: 2096, “Simcere”). Founded in 2023, Simcere Zaiming dedicated to developing ground breaking 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 Enzeshu®, 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. About antibody-drug-conjugatesAntibody-Drug Conjugates are comprised of three main components: the antibody, a payload and a linker. The antibody selectively targets an identified tumor antigen. Payloads are the pharmaceutically active component to treat the cancer, attached to the antibody via a chemical linker. The linker connects the antibody and the payload and reduces the amount of payload that reaches non-tumor tissue. Ipsen ContactsInvestorsHenry Wheeler henry.wheeler@ipsen.com +33 7766471149Khalid Deojee khalid.deojee@ipsen.com +33 666019526 MediaSally Bain sally.bain@ipsen.com +1 8573200517Anne Liontas anne.liontas.ext@ipsen.com +33 0767347296 Disclaimers and/or forward-looking statements The forward-looking statements, objectives and targets contained herein are based on Ipsen’s management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. All of the above risks could affect Ipsen’s future ability to achieve its financial targets, which were set assuming reasonable macroeconomic conditions based on the information available today. Use of the words ‘believes’, ‘anticipates’ and ‘expects’ and similar expressions are intended to identify forward-looking statements, including Ipsen’s expectations regarding future events, including regulatory filings and determinations. Moreover, the targets described in this document were prepared without taking into account external-growth assumptions and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by Ipsen. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties, notably the fact that a promising medicine in early development phase or clinical trial may end up never being launched on the market or reaching its commercial targets, notably for regulatory or competition reasons. Ipsen must face or might face competition from generic medicine that might translate into a loss of market share. Furthermore, the research and development process involves several stages each of which involves the substantial risk that Ipsen may fail to achieve its objectives and be forced to abandon its efforts with regards to a medicine in which it has invested significant sums. Therefore, Ipsen cannot be certain that favorable results obtained during preclinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the medicine concerned. There can be no guarantees a medicine will receive the necessary regulatory approvals or that the medicine will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Other risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and healthcare legislation; global trends toward healthcare cost containment; technological advances, new medicine and patents attained by competitors; challenges inherent in new-medicine development, including obtaining regulatory approval; Ipsen’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Ipsen’s patents and other protections for innovative medicines; and the exposure to litigation, including patent litigation, and/or regulatory actions. Ipsen also depends on third parties to develop and market some of its medicines which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to Ipsen’s activities and financial results. Ipsen cannot be certain that its partners will fulfil their obligations. It might be unable to obtain any benefit from those agreements. A default by any of Ipsen’s partners could generate lower revenues than expected. Such situations could have a negative impact on Ipsen’s business, financial position or performance. Ipsen expressly disclaims any obligation or undertaking to update or revise any forward looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. Ipsen’s business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés Financiers. The risks and uncertainties set out are not exhaustive and the reader is advised to refer to Ipsen’s latest Universal Registration Document, available on ipsen.com. Attachment Ipsen PR_Simcere Zaiming_22122025

License out/inADC

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

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	China	Shandong Simcere Biopharmaceutical Co. Ltd.	12 Sep 2005

Developing

10 top R&D records.

to view more data

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

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03796364 (Pubmed \| Oncologist)	Phase 4	Non-Small Cell Lung Cancer	40	Rh-endostatin + glucocorticoid	ahzedbaorr(pkxeyzcllf) = ozmjcxvyzm pzljzgyyut (lkwwvemimv ) View more	Positive	11 Nov 2025
				glucocorticoid only	ahzedbaorr(pkxeyzcllf) = fczzeuhpfc pzljzgyyut (lkwwvemimv ) View more
ESMO_IO2025	Not Applicable	Non-Small Cell Lung Cancer	22	Chemotherapy + Endostar	xpliyamvsd(nrqbluzucx) = angzoifotm psqhauqfga (roanvdzgie ) View more	Positive	12 Oct 2025
				Chemotherapy + Endostar + IO	xpliyamvsd(nrqbluzucx) = atcxohbijv psqhauqfga (roanvdzgie ) View more
NCT03086681 (Pubmed \| Ther Adv Med Oncol)	Phase 2	Locally Advanced Cervical Carcinoma	120	Endostarcisplatin + Endostarcisplatin	numgpzxxgj(irjlqopzns) = xeidxomwep yzcorsngus (njkikazwts ) View more	Positive	01 Sep 2025
				cisplatin	numgpzxxgj(irjlqopzns) = jphnbiagda yzcorsngus (njkikazwts ) View more
WCLC2024 Manual	Phase 2	Non-Small Cell Lung Cancer First line driver gene-negative	29	EnvafolimabRh-endostatin	ozriblxtaj(kwfmpanysi) = immxbkrfyf cbwsewltsn (ptoaxjwoyh, 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	zyftxenepq(advxrxnzzr) = ooszlmoktr dnwhzgbybz (aznojjelbu, 3.8 - 9.1) View more	Positive	01 Jun 2024
				rh-endostatin + platinum with paclitaxel	zyftxenepq(advxrxnzzr) = egyymsnbxh dnwhzgbybz (aznojjelbu, 3.8 - 9.1) View more
NCT02907710 (phase III, ASCO2024) Manual	Phase 3	Advanced Nasopharyngeal Carcinoma	300	Endostar plus CCRT	koyhhyjznq(oiptwxfwwj) = caqfighxpe aajwlbrnnz (ijbixkywzu ) View more	Positive	24 May 2024
				CCRT alone	koyhhyjznq(oiptwxfwwj) = yknjcllfdu aajwlbrnnz (ijbixkywzu ) View more
ESMO_ASIA2023	Phase 2	Locally Advanced Esophageal Squamous Cell Carcinoma	90	Endostar plus concurrent chemoradiotherapy (CCRT)	hszziugqsf(bnilleyfes) = gcuilijxda pyuwyfhhbd (xvyburadqo ) View more	Positive	02 Dec 2023
				Concurrent chemoradiotherapy (CCRT)	dkozzdzedw(joargiaucp) = jevvshklsx kbfingcbdg (ypwsjxonvz ) View more
ESMO 12023 \| ESMO 22023 Manual	Phase 2	Locally Advanced Esophageal Squamous Cell Carcinoma	92	Endostar+concurrent chemoradiotherapy	hdxhwldrpd(cctulorgvz) = bkipvkqjzk xieknroncd (eabkoqloch ) View more	Positive	23 Oct 2023
				Concurrent chemoradiotherapy	hdxhwldrpd(cctulorgvz) = lbzdpcglkm xieknroncd (eabkoqloch ) 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	lcobltcedj(cwcqhvpekg) = 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 hoajvzfyji (dthwdspkkr ) 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	qexbijwrup(ohdvodsscg) = fjxlfsbhsl rskihglbnf (ssmadmlije, 3.19 - 5.49) View more	Positive	05 Apr 2022

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