RegulationOrphan Drug (United States), Priority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China), Special Review Project (China), Innovative Licensing and Access Pathway (United Kingdom), Breakthrough Therapy (United States)

Structure/Sequence

Sequence Code 616714836H

Source: *****

Sequence Code 616714851L

Source: *****

Clinical Trials associated with Sugemalimab

NCT05700448

/ Not yet recruitingPhase 3

A Phase III, Randomized, Double-Blind, Multicenter Study of Sugemalimab (CS1001) Plus PGemOx Regimen Versus Placebo Plus PGemOx for Subjects With Relapsed or Refractory Extranodal NK/T-Cell Lymphoma (R/R ENKTL)

The purpose of this study is to evaluate the efficacy and safety of sugemalimab (CS1001) in combination with PGemOx regimen (pegaspargase, gemcitabine, oxaliplatin) in treatment of adult patients with Extranodal NK/T-Cell Lymphoma (ENKTL) who have relapsed or become refractory to asparaginase-based regimens.

Start Date01 Jun 2025

Sponsor / Collaborator

CStone Pharmaceuticals Co. Ltd.

CTR20233170

/ RecruitingPhase 1

活菌MNC-168肠溶胶囊分别联用帕博利珠单抗、舒格利单抗在晚期恶性实体瘤受试者中的安全性、耐受性、药代动力学特征及初步有效性的I期临床研究

[Translation] Phase I clinical study on the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of live bacteria MNC-168 enteric-coated capsules combined with pembrolizumab and sugemalimab in subjects with advanced malignant solid tumors

主要目的：评价MNC-168分别联用帕博利珠单抗、舒格利单抗在晚期恶性实体瘤受试者中的安全性和耐受性，确定其最大耐受剂量（MTD）和/或推荐的II期剂量(RP2D)。次要目的： 1) 评价MNC-168分别联用帕博利珠单抗、舒格利单抗在晚期恶性实体瘤受试者中的药代动力学特征； 2) 评估MNC-168分别联用帕博利珠单抗、舒格利单抗的初步抗肿瘤疗效，为后续临床研究推荐合适的用药剂量。

[Translation]

Primary objective: To evaluate the safety and tolerability of MNC-168 in combination with pembrolizumab and sugemalimab in subjects with advanced malignant solid tumors, and to determine its maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D). Secondary objectives: 1) To evaluate the pharmacokinetic characteristics of MNC-168 in combination with pembrolizumab and sugemalimab in subjects with advanced malignant solid tumors; 2) To evaluate the preliminary anti-tumor efficacy of MNC-168 in combination with pembrolizumab and sugemalimab, and to recommend appropriate dosages for subsequent clinical studies.

Start Date24 Sep 2024

Sponsor / Collaborator

Guangzhou Colony Biotechnology Co., Ltd.

NCT06217757

/ RecruitingPhase 1/2IIT

Phase I Study of Low-Dose Radiotherapy Plus Chemotherapy and Sugemalimab and Olaparib for First-Line Treatment of SLFN-11 Positive Extensive Stage Small Cell Lung Cancer

The purpose of this study was to evaluate the safety and efficacy of low-dose radiotherapy (LDRT) combined with sugemalimab, olaparib, chemotherapy in the first-line treatment of SLFN-11 positive extensive stage small cell lung cancer.

Start Date18 Apr 2024

Sponsor / Collaborator

Sichuan University

100 Clinical Results associated with Sugemalimab

100 Translational Medicine associated with Sugemalimab

100 Patents (Medical) associated with Sugemalimab

Literatures (Medical) associated with Sugemalimab

01 Feb 2025·Translational Lung Cancer Research

Comparative outcomes of first-line PD-1/PD-L1 inhibitors plus chemotherapy for advanced squamous non-small cell lung cancer: a systematic review and network meta-analysis of randomized clinical trials

Article

Author: Liu, Zhefeng ; Patel, Akshay J ; Wang, Zhikuan ; Hu, Yi ; Han, Lu ; Zhu, Jun ; Tao, Haitao ; Huang, Ziwei

Background:

Head-to-head comparisons between the available first-line regimens with programmed cell death-1/programmed death-ligand 1 (PD-1/PD-L1) inhibitors and chemotherapy for advanced squamous non-small cell lung cancer (NSCLC) are lacking. Therefore, we conducted a systematic review and network meta-analysis to identify the optimal first-line regimen with PD-1/PD-L1 inhibitors plus chemotherapy for advanced squamous NSCLC.

Methods:

A systematic review and network meta-analysis of randomized clinical trials (RCTs) were performed. PubMed, Embase, Web of Science, and the ClinicalTrials.gov databases and major annual conferences were searched. RCTs that compared PD-1/PD-L1 inhibitors plus chemotherapy with chemotherapy alone in patients with advanced squamous NSCLC were eligible for inclusion. Risk of bias was assessed using the Cochrane Risk of Bias Tool (version 2.0), and a funnel plot was used to assess the publication bias.

Results:

A total of nine RCTs comprising 3,210 patients were included. When combined with chemotherapy, PD-1 inhibitors were superior to PD-L1 inhibitors in terms of overall survival (OS) [PD-1: hazard ratio (HR) 0.70, 95% credible interval (CrI): 0.62 to 0.79; PD-L1: HR 0.82, 95% CrI: 0.71 to 0.94] and progression-free survival (PFS) (PD-1: HR 0.50, 95% CrI: 0.45 to 0.55; PD-L1: HR 0.63, 95% CrI: 0.55 to 0.72). Moreover, the PD-1 inhibitor camrelizumab was the most effective agent in combined therapy for prolonging OS (HR 0.56, 95% CrI: 0.44 to 0.71) and PFS (HR 0.32, 95% CrI: 0.25 to 0.42), followed by the PD-L1 inhibitor sugemalimab (OS: HR 0.61, 95% CrI: 0.43 to 0.86; PFS: HR 0.37, 95% CrI: 0.26 to 0.52). Moreover, the addition of camrelizumab or tislelizumab to chemotherapy was associated with the improved objective response rate (ORR) and a longer duration of response (DoR). Regarding safety, pembrolizumab and camrelizumab were associated with the lowest risk of developing grade 3-5 treatment-related adverse events (TRAEs). Most of the trials were at low risk for bias, and no obvious publication bias was observed in the outcomes.

Conclusions:

When combined with first-line chemotherapy, camrelizumab has the potential to be a preferred option in patients with advanced squamous NSCLC. This finding might serve as a guideline to aid in the selection of first-line immunotherapy plus chemotherapy strategies for advanced squamous NSCLC.

02 Jan 2025·EXPERT OPINION ON BIOLOGICAL THERAPY

An evaluation of sugemalimab for the treatment of relapsed or refractory extranodal natural killer T-cell lymphoma

Review

Author: Yu, Jingwei ; Li, Lanfang ; Zhang, Huilai ; Qian, Zhengzi ; Qiu, Lihua ; Liu, Xia ; Wang, Xianhuo ; Zhou, Shiyong ; Feng, Yingfang ; Song, Zheng

INTRODUCTION:

Relapsed or refractory extranodal natural killer/T-cell lymphoma (R/R ENKTL) is a rare and aggressive subtype arising from natural killer or cytotoxic T-cells, predominantly affecting the nasal cavity and paranasal sinuses, lacking a standardized therapeutic approach. Sugemalimab, a fully human, full-length anti-PD-L1 immunoglobulin G4 (IgG4) monoclonal antibody (mAb), has been investigated in a Single-Arm, Multicenter, Phase II Study (GEMSTONE-201). The results demonstrated significant efficacy, favorable tolerability, and manageable adverse reactions of sugemalimab in R/R ENKTL. This study summarizes and compares the efficacy and safety profile of sugemalimab with several other PD-1/PD-L1 inhibitors in R/R ENKTL patients.

AREA COVERED:

We included a Phase II study (GEMSTONE-201) of sugemalimab in R/R ENKTL.

EXPERT OPINION:

The clinical trials have demonstrated superior efficacy of sugemalimab, evidenced by a complete response rate (CRR) of 35.9% and an overall response rate (ORR) of 44.9%. In comparison with other immune checkpoint inhibitors (ICIs), sugemalimab shows a notably higher CRR. Additionally, sugemalimab exhibits a manageable safety profile. Further evaluation of sugemalimab is required based on its efficacy and safety in real-world patient populations. Should sugemalimab be included in medical insurance in the future, it could potentially benefit a larger number of patients with R/R ENKTL.

16 Nov 2024·Journal of chemotherapy (Florence, Italy)

Clinical benefit of anti-PD-1/PD-L1 plus chemotherapy in first-line treatment for patients over the age of 65 or 75 with metastatic non-small cell lung cancer (NSCLC)

Review

Author: Sadaoui, Nassyma ; Chouaïd, Christos ; Bouharati, Djamila ; Landre, Thierry ; Taleb, Chérifa

Anti-PD-1/PD-L1 plus chemotherapy (CT) is considered the standard of care in first line treatment of metastatic NSCLC. However, the clinical benefit of this combination in older patients is controversial. We performed a meta-analysis of phase III randomized trials that compared PD-1/PD-L1 inhibitor plus CT with CT alone in first line of treatment for older patients with advanced NSCLC. Subgroups of patients over 65 and over 75 were analyzed. The outcomes included overall survival (OS) and progression-free survival (PFS). A fixedeffect model was used. We analyzed ten trials with an anti-PD-1 (camrelizumab, cemiplimab, nivolumab, pembrolizumab, tislelizumab or toripalimab) and six trials with an anti-PD-L1 (atezolizumab, durvalumab or sugemalimab), including 3666 patients over the age of 65 (41%) and 282 patients over the age of 75 (<10%). For patients over 65 years of age, anti-PD- 1/PD-L1 + CT was significantly associated (hazard ratio [95% confidence interval]) with prolonged OS (0.79 [0.72-0.86]; p < 0.00001) and P FS (0.63 [0.58-0.68]; p < 0.00001) compared to CT alone. Survival benefits occurred in both anti-PD-1 and anti-PD-L1 trials. For patients over 75 years of age, OS benefit was not statistically significant (0.88 [0.67-1.16]; p = 0.37). For patients over the age of 65 with untreated NSCLC, the anti-PD-1/PD-L1 combination with CT, compared with CT alone, is associated with significantly improved OS and PFS. Due to the low number of patients, it is difficult to conclude for those over 75.

News (Medical) associated with Sugemalimab

27 Mar 2025

·www.prnewswire.com

CStone Pharmaceuticals Announces 2024 Annual Results and Recent Business Progress

Financial Performance: Strong Year-over-Year Improvemen t - Total Revenue: RMB 407.2 million, including RMB 232.1 million in licensing and royalty income. - Net Loss Reduction: 71.5% year-over-year improvement. Key Product Advancements - Sugemalimab (Anti-PD-L1 mAb) - Regulatory Milestones: - China: Approved for first-line treatment of gastric/gastroesophageal junction adenocarcinoma (GC/GEJC). - EU & UK: Approved for first-line treatment of stage IV non-small cell lung cancer (NSCLC); stage III NSCLC new indication application submitted to EMA. - Global Partnerships: Three strategic partnerships across 40+ countries, to accelerate global commercialization. - Avapritinib (AYVAKIT® ) - Localized Production: Approved for localized manufacturing in China, enhancing cost efficiency. - Commercial Collaboration: Partnered with Hengrui to expand market access in China. Clinical Pipeline Progress - CS5001 (ROR1 ADC): - Leading Position: Top 2 globally in clinical development for ROR1-targeted ADCs. - Phase I Clinical Data: Demonstrated encouraging monotherapy efficacy in aggressive/indolent lymphomas with a manageable safety profile; positioned for accelerated registration. - Phase Ib Expansion: Evaluating first-line/frontline, monotherapy/combination therapies in lymphomas and solid tumors across the U.S., Australia, and China. - CS2009 (PD-1/VEGF/CTLA-4 Trispecific Antibody): - First-in-Human Trial: Global Phase I study initiated in Australia; first patient dosed. - Preclinical Differentiation: Superior tumor suppression vs. benchmarked competitors; potential first-in-class/best-in-class IO backbone therapy. Pipeline 2.0: Fueling Long-Term Innovation - More than 9 Differentiated Candidates: Focus on first-in-class/best-in-class assets, including multispecific antibodies and ADCs, with global rights and broad therapeutic potential. - Proprietary ADC Platform: Enables rapid development of high-value candidates, reinforcing leadership in next-generation oncology. SUZHOU, China, March 27, 2025 /PRNewswire/ -- CStone Pharmaceuticals ("CStone", HKEX: 2616), a biopharmaceutical company dedicated to developing innovative cancer therapies, today reported 2024 annual results and recent business updates. Business Highlights For the year ended December 31, 2024 and up until the date of this results announcement, key milestones have been achieved across regulatory approvals, clinical advancements, and strategic collaborations, reinforcing our position as a leader in innovative therapeutics. A shortlist of our achievements over this period includes: Commercial Products • CEJEMLY® (sugemalimab), anti-PD-L1 antibody – Global expansion and regulatory approvals Sugemalimab secured three new drug application approvals in 2024, including its fifth indication in mainland China for first-line treatment of gastric/gastroesophageal junction adenocarcinoma (GC/GEJC). Sugemalimab also gained approvals in the EU and UK for first-line treatment of stage IV NSCLC, marking its entry into major international markets. We have recently completed the regulatory submission to the European Medicines Agency (EMA) for the new indication application of sugemalimab in the treatment of Stage III NSCLC. – Strategic alliances drive global commercialization Partnered with Ewopharma AG in May 2024 for commercialization in Central and Eastern Europe (CEE) and Switzerland. Collaborated with Pharmalink Store – L.L.C – O.P.C in November 2024 to expand access across the Middle East, North Africa (MENA) Region and South Africa. Entered an agreement with SteinCares in January 2025 for Latin America (LATAM). Additional partnerships in Western Europe, Southeast Asia, and Canada are anticipated in 2025. – Robust clinical data reinforce efficacy GEMSTONE-304 Study: Final progression-free survival (PFS) and interim overall survival (OS) data for the first-line esophageal squamous cell carcinoma (ESCC) published in Nature Medicine (February 2024). GEMSTONE-302 Study: Four-year OS data for stage IV NSCLC presented at the 2024 Congress of European Society for Medical Oncology (ESMO), confirming sustained survival benefits. GEMSTONE-303 Study: Final PFS and OS analysis for GC/GEJC with combined positive score (CPS) ≥5 published in the top-tier medical journal-Journal of the American Medical Association (JAMA) (February 2025). ESMO Guideline Recognition: CEJEMLY® recommended as first-line NSCLC therapy in ESMO's 2025 Non-Oncogene-Addicted Metastatic NSCLC Living Guidelines, covering both squamous and non-squamous NSCLC (February 2025). • AYVAKIT ® (avapritinib), KIT/PDGFRA inhibitor – Localized manufacturing in China The National Medical Products Administration of China (NMPA) approved domestic production of AYVAKIT ® tablets (300 mg and 100 mg) in June and August 2024 respectively. Full transition to localized supply is expected in 2025, improving cost efficiency. – NRDL inclusion enhances accessibility AYVAKIT® (avapritinib) has been included to China's National Reimbursement Drug List (NRDL), effective January 1, 2024 for unresectable or metastatic gastrointestinal stromal tumor (GIST), harboring the PDGFRA exon 18-mutated, including PDGFRA D842V mutations. This significantly improves AYVAKIT ®'s affordability for eligible patients. – Commercial partnership with Hengrui In July 2024, we forged a new partnership with Jiangsu Hengrui Pharmaceuticals Co., Ltd., granting them the exclusive promotion rights in mainland China to amplify commercial reach and profitability. • GAVRETO ® (pralsetinib), RET inhibitor – Progress towards localized manufacturing The NMPA's Center for Drug Evaluation (CDE) accepted the manufacturing localization and bioequivalence (BE) study application in April 2024, and regulatory review is ongoing. – Sustained collaboration with Allist Commercial operations has been transferred to Shanghai Allist Pharmaceuticals Co., Ltd in the first half of 2024 under an exclusive agreement signed in November 2023. Collaboration remains strong to maximize market penetration. Clinical Stage Core Assets • CS5001 (ROR1 ADC) – Phase Ib clinical trial with registration potential A global multicenter clinical trial of CS5001 is actively enrolling patients across the United States of America (U.S.), Australia and China. Recruitment is ongoing for monotherapy cohorts targeting aggressive and indolent advanced lymphomas with potential to be expanded into a Phase II single-arm registrational study. Additional cohorts, including CS5001 in combination with R-CHOP (Rituximab + Cyclophosphamide + Hydroxydaunorubicin + Vincristine + Prednisone) for the first-line diffuse large B-cell lymphoma (DLBCL), and CS5001 in combination with standard of cares (SOC) for front-line DLBCL will be initiated to expand the therapeutic potential of CS5001 across all DLBCL stages. CS5001 is also being studied as both a monotherapy and in combination with a PD-L1 inhibitor for advanced solid tumors, underscoring its versatility across oncology indications. – Compelling clinical data at ASCO & ASH 2024 Phase Ia data for CS5001 presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and the 66th American Society of Hematology (ASH) Annual Meeting demonstrated that CS5001 is so far the first receptor tyrosine kinase-like orphan receptor 1 (ROR1) antibody-drug conjugate (ADC) known to demonstrate clinical anti-tumor activity in both solid tumors and lymphomas. Clinical data of CS5001 revealed superior efficacy and favorable safety profile as a monotherapy for both aggressive and indolent advanced lymphomas. At the tentative recommended Phase II dose (RP2D) (125 μg/kg), CS5001 achieved an objective response rate (ORR) of 70% in non-Hodgkin lymphoma (NHL) and 100% in Hodgkin lymphoma (HL). These results support its potential as a faster-to-market candidate and a frontline combination therapy backbone. • CS2009 (PD-1/VEGF/CTLA-4 trispecific antibody) – Global Phase I clinical trial initiated A global multicenter first-in-human (FIH) trial among solid tumors has been launched in Australia in December 2024, with subsequent expansion to China and the U.S.. The first patient was dosed in March 2025. – Potential FIC/BIC next-generation I/O backbone Preclinical data presented at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) highlighted its first-in-class (FIC) or best-in-class (BIC) potential with superior antitumor activity compared to potential competitors benchmarks, including PD-1/CTLA-4 or PD-1/VEGF bispecific antibody and PD-1/ CTLA-4 combination therapies. Unique trispecific mechanism positions CS2009 as a next-generation immuno-oncology backbone with broad applicability. Preclinical/IND-enabling Stage Programs and ADC Platform CStone's preclinical pipeline includes more than nine promising candidates, each with global rights and focusing on FIC/BIC profiles with broad indications. These candidates include multispecific antibodies, ADCs and radionuclide drug conjugates (RDC) covering various therapeutic fields such as oncology, autoimmune diseases, and metabolic disorders. The Company is dedicated to delivering clinical value through the development of these Pipeline 2.0 candidates, which will undergo international, multi-center clinical trials to maximize their global potential. CStone has also developed an in-house ADC technology platform featuring proprietary linkers, optimized for diverse targets and payloads. This platform supports multiple upcoming ADC projects in Pipeline 2.0, including CS5007 (dual targeting epidermal growth factor receptor (EGFR) & human epidermal growth factor receptor 3 (HER3)), CS5005 (targeting somatostatin receptor 2 (SSTR2)), CS5008 (dual targeting delta-like ligand 3 (DLL3) & SSTR2) and CS5006 (targeting ITGB4). Future and Outlook As we look to the future, we reaffirm our commitment to advancing a robust and differentiated pipeline by prioritizing internal discovery capabilities and sustained R&D investments. Concurrently, we aim to maximize the global commercial potential of our approved therapies through strategic collaborations and localized manufacturing enhancements. Key growth drivers in 2025 include: • Clinical milestones – Progress CS5001 (ROR1 ADC) and CS2009 (PD-1/VEGF/CTLA-4 trispecific) towards pivotal trials and in parallel pursue global partnerships to expedite development. – Advance early-stage candidates (e.g., CS2011, CS5007, CS5005, CS5008, CS5006) into clinical stages within the next two years. • Commercial excellence – Maximize the value of approved products through strategic collaborations and manufacturing localization (e.g., AYVAKIT®, GAVRETO®) to enhance profitability and market reach. – Accelerate ex-China commercialization of CEJEMLY® (sugemalimab) via regional partnerships. • Innovation and technology – Strengthen proprietary platforms (e.g., ADC technology) to sustain pipeline growth. – Present key clinical data at major conferences (e.g., AACR, ESMO, ASH) Financial Highlights International Financial Reporting Standards (IFRS) Measures: • Revenue was RMB407.2 million for the year ended December 31, 2024, composed of RMB175.1 million in sales of pharmaceutical products (avapritinib and pralsetinib), RMB204.0 million in license fee income and RMB28.1 million in royalty income of sugemalimab, representing a year-on-year increase of RMB108.3 million, or 113.1%, in license fee which was largely offset by a decrease in revenue from sales of pharmaceutical products, such that total revenue decreased by RMB56.6 million, or 12.2%, year on year. • Research and development expenses were RMB134.7 million for the year ended December 31, 2024, representing a decrease of RMB393.1 million from RMB527.8 million for the year ended December 31, 2023, primarily due to the decrease in milestone fee and third-party contracting costs. • Administrative expenses were RMB77.8 million for the year ended December 31, 2024, representing a decrease of RMB104.9 million from RMB182.7 million for the year ended December 31, 2023, primarily due to the decrease in employee costs. • Selling and marketing expenses were RMB133.8 million for the year ended December 31, 2024, representing a decrease of RMB65.5 million from RMB199.3 million for the year ended December 31, 2023, primarily attributable to the decrease in employee costs and others which was partially offset by an increase in channel service fee. • Loss for the year was RMB91.2 million for the year ended December 31, 2024, representing a decrease of RMB276.0 million, or 75.2%, from RMB367.2 million for the year ended December 31, 2023, primarily attributable to a substantial decrease in operating expenses. • Cash and cash equivalents and time deposits were RMB672.9 million as of December 31, 2024. Non-International Financial Reporting Standards (Non-IFRS) Measures: • Research and development expenses excluding the share-based payment expenses were RMB124.7 million for the year ended December 31, 2024, representing a decrease of RMB410.0 million from RMB534.7 million for the year ended December 31, 2023, primarily due to the decrease in milestone fee and third party contracting costs. • Administrative and selling and marketing expenses excluding the share-based payment expenses were RMB224.4 million for the year ended December 31, 2024, representing a decrease of RMB113.8 million from RMB338.2 million for the year ended December 31, 2023, primarily attributable to the decrease in employee costs. • Loss for the year excluding the share-based payment expenses was RMB94.0 million for the year ended December 31, 2024, representing a decrease of RMB236.2 million, or 71.5%, from RMB330.2 million for the year ended December 31, 2023, primarily attributable to a substantial decrease in operating expenses. 2024 Annual Results Conference Call The Company will host a 2024 annual results conference call at 10:00 a.m. (Beijing Time) on Friday March 28, 2025. Please attend the conference call through the link: (Password:067784). About CStone CStone Pharmaceuticals (HKEX: 2616), founded in late 2015, is an innovation-driven biopharmaceutical company focused on advancing cutting-edge oncology therapies. Committed to addressing unmet medical needs globally, the company has achieved remarkable milestones since its inception, including the successful launch of four novel therapeutics and securing 16 regulatory approvals across nine indications. CStone's robust pipeline features 16 high-potential candidates, including first-in-class and best-in-class assets such as antibody-drug conjugates (ADCs), multispecific antibodies, immunotherapies, and precision medicines. The company further distinguishes itself through a seasoned leadership team with comprehensive expertise in drug development—from preclinical research and clinical trials to manufacturing, business development, and commercialization. For more information about CStone, please visit . Forward-looking statements The forward-looking statements made in this article only relate to events or information as of the date when the statements are made in this article. Except as required by law, we undertake no obligation to update or publicly revise any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. All statements in this article are made on the date of publication of this article and may change due to future developments. Disclaimer: only for communication and scientific use by medical and health professionals, it is not intended for promotional purposes. SOURCE CStone Pharmaceuticals WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 1Drug ApprovalLicense out/inClinical ResultASH

24 Mar 2025

·www.prnewswire.com

CStone Submits Application to the European Medicines Agency for New Indication of Sugemalimab in Stage III Non-Small Cell Lung Cancer

SUZHOU, China, March 23, 2025 /PRNewswire/ -- CStone Pharmaceuticals ("CStone", HKEX: 2616), a biopharmaceutical company dedicated to developing innovative cancer therapies, today announced the submission of a Type II variation application to the European Medicines Agency (EMA) for sugemalimab. The application seeks approval for the treatment of patients with unresectable stage III non-small cell lung cancer (NSCLC) who have not progressed following concurrent or sequential platinum-based chemoradiotherapy (CRT). This marks CStone's second regulatory submission for sugemalimab to the EMA, following its initial approval in Europe for metastatic squamous and non-squamous NSCLC in 2024. If this new indication is approved, sugemalimab would address a critical unmet need in stage III NSCLC, where only one PD-L1 antibody is currently approved in Europe. The drug's dual utility in stage III and IV NSCLC could solidify its role as a cornerstone immunotherapy in lung cancer. The submission is supported by data from the GEMSTONE-301 Phase III trial, a multicenter, randomized, double-blind study evaluating sugemalimab as consolidation therapy in patients with unresectable stage III NSCLC post-CRT. Results published in The Lancet Oncology demonstrated: 36% reduction in risk of disease progression or death, significantly improved progression-free survival (PFS). 56% reduction in risk of death, with a strong positive trend toward overall survival (OS) benefit. Consistent clinical benefits across subgroups, regardless of prior CRT modality (concurrent or sequential). Favorable safety profile, no new safety signals identified. Dr. Jason Yang, CEO, President of R&D, and Executive Director at CStone, commented: "Following sugemalimab's approval in Europe for stage IV NSCLC, we are working closely with EMA to expand its indications in earlier stage lung cancer and other malignancies. With its demonstrated outstanding efficacy and safety profile, sugemalimab is poised to address critical unmet needs for stage III NSCLC patients. We remain steadfast in expanding global access through strategic partnerships and collaborations with regulatory authorities, ensuring this innovative therapy reaches patients worldwide." About Sugemalimab The anti-PD-L1 monoclonal antibody sugemalimab was developed by CStone using OmniRat® transgenic animal platform, which allows creation of fully human antibodies in one step. Sugemalimab is a fully human, full-length anti-PD-L1 immunoglobulin G4 (IgG4) monoclonal antibody, which may reduce the risk of immunogenicity and toxicity for patients, a unique advantage over similar drugs. The European Commission (EC) and the Medicines and Healthcare products Regulatory Agency (MHRA) have approved sugemalimab in combination with platinum-based chemotherapy for the first-line treatment of patients with metastatic NSCLC with no sensitizing EGFR mutations, or ALK, ROS1 or RET genomic tumor aberrations. The National Medical Products Administration (NMPA) of China has approved sugemalimab for five indications: In combination with chemotherapy as first-line treatment of patients with metastatic squamous and non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations and metastatic squamous NSCLC; For the treatment of patients with unresectable Stage III NSCLC whose disease has not progressed following concurrent or sequential platinum-based chemoradiotherapy; For the treatment of patients with relapsed or refractory extranodal NK/T-cell lymphoma; In combination with fluorouracil and platinum-based chemotherapy as first-line treatment of patients with unresectable locally advanced, recurrent or metastatic ESCC; and In combination with fluoropyrimidine- and platinum-containing chemotherapy as first-line treatment for unresectable locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma with a PD-L1 expression CPS ≥5. About CStone CStone Pharmaceuticals (HKEX: 2616), founded in late 2015, is an innovation-driven biopharmaceutical company focused on advancing cutting-edge oncology therapies. Committed to addressing unmet medical needs globally, the company has achieved remarkable milestones since its inception, including the successful launch of four novel therapeutics and securing 16 regulatory approvals across nine indications. CStone's robust pipeline features 16 high-potential candidates, including first-in-class and best-in-class assets such as antibody-drug conjugates (ADCs), multispecific antibodies, immunotherapies, and precision medicines. The company further distinguishes itself through a seasoned leadership team with comprehensive expertise in drug development—from preclinical research and clinical trials to manufacturing, business development, and commercialization. For more information about CStone, please visit . IR contact: [email protected] PR contact: [email protected] Forward-looking statements The forward-looking statements made in this article only relate to events or information as of the date when the statements are made in this article. Except as required by law, we undertake no obligation to update or publicly revise any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. All statements in this article are made on the date of publication of this article and may change due to future developments. Disclaimer: only for communication and scientific use by medical and health professionals, it is not intended for promotional purposes. SOURCE CStone Pharmaceuticals WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Drug ApprovalImmunotherapyClinical ResultADC

06 Mar 2025

·www.prnewswire.com

CStone Submits Clinical Trial Application in Australia for CS5001 (ROR1 ADC) in Combination with First-Line Standard-of-Care for DLBCL

Phase Ib trial to evaluate CS5001 in combination with R-CHOP as a first-line treatment for diffuse large B-cell lymphoma (DLBCL), aiming to reshape the standard-of-care landscape. CS5001 is also being investigated globally in a multi-center Phase Ib clinical trial for multiple solid tumor types. SUZHOU, China, March 5, 2025 /PRNewswire/ -- CStone Pharmaceuticals ("CStone", HKEX: 2616), a biopharmaceutical company dedicated to developing innovative cancer therapies, today announced the submission of a Phase Ib clinical trial application in Australia for CS5001, its ROR1-targeting antibody-drug conjugate (ADC), in combination with first-line standard-of-care (SoC) for DLBCL. CS5001 is also being evaluated as both a monotherapy and in combination with a PD-L1 inhibitor for advanced solid tumors in an ongoing global multi-center clinical trial. Building on promising data from CS5001 monotherapy in later-line aggressive and indolent lymphomas, this Phase Ib trial aims to expand the therapeutic potential of CS5001 across all DLBCL stages and solid tumors. The study will explore: CS5001 + R-CHOP: First-line treatment for DLBCL patients who have not received prior systemic therapy. CS5001 + SoC: For patients with relapsed or refractory DLBCL. CS5001 Monotherapy: Targeting ROR1-expressing solid tumors. CS5001 + Sugemalimab: Combination therapy for advanced solid tumors. Dr. Jason Yang, CEO, President of R&D, and Executive Director at CStone, stated: "We are thrilled to reach another key clinical milestone for CS5001. The existing data underscore its broad potential in both lymphomas and solid tumors. Notably, a ROR1 ADC combined with R-CHP has demonstrated an impressive complete response (CR) rate in a Phase II trial for first-line DLBCL. As we advance from late-line monotherapy to frontline combination therapy, we are optimistic that CS5001 will provide significant clinical benefits to DLBCL patients and establish itself as a first-line treatment option. Meanwhile, we continue to explore CS5001's potential in solid tumors and eagerly anticipate further positive outcomes." The global multi-center Phase Ib trial for CS5001 is actively enrolling patients across the United States, Australia, and China. Recruitment is ongoing for monotherapy cohorts targeting aggressive and indolent advanced lymphomas, which could potentially expand into a Phase II single-arm registrational study. Additional cohorts, including the first-line DLBCL combination therapy and solid tumor monotherapy and combination therapy arms, will be initiated soon. About CS5001 (ROR1 ADC) CS5001 is a clinical-stage antibody-drug conjugate ("ADC") targeting ROR1 (receptor tyrosine kinase-like orphan receptor 1). CS5001 has been uniquely designed with proprietary tumor-cleavable linker and pyrrolobenzodiazepine ("PBD") prodrug. Only after reaching the tumor, the linker and prodrug are cleaved to release the PBD toxin, resulting in lethal DNA cross-links in cancer cells. The use of the linker plus PBD prodrug effectively helps address the toxicity associated with traditional PBD payloads, leading to a better safety profile. CS5001 has demonstrated complete tumor suppression in several preclinical cancer models and demonstrated favorable serum half-life and pharmacokinetic characteristics. CS5001 is a promising candidate drug with precision treatment potential in both hematologic tumors and malignant solid tumors. Additionally, CS5001 utilizes site-specific conjugation for a precise drug antibody ratio of which enables homogeneous production and large-scale manufacturing. In October 2020, CStone signed a licensing agreement with LigaChem Biosciences, Inc. (LCB) for the development and commercialization of CS5001 which was originally generated by collaboration of LCB and ABL Bio, both South Korea-based leading biotech companies. Under the agreement, CStone obtains the exclusive global right to develop and commercialize CS5001 outside the Republic of Korea. The first-in-human data for CS5001 in patients with advanced solid tumors and lymphomas was presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. Additionally, the latest clinical data on CS5001 as a monotherapy in patients with advanced lymphomas has recently been presented at the 66th American Society of Hematology (ASH) Annual Meeting. CS5001 has demonstrated encouraging safety and robust anti-tumor activity in the Phase 1a dose escalation trials across 10 dose levels. At the tentative recommended Phase 2 dose (RP2D) of DL8 (125 μg/kg), CS5001 achieved objective response rates (ORRs) of 70% in advanced B-cell lymphoma and 100% in Hodgkin lymphoma. Encouraging efficacy signals were also observed in advanced solid tumors, including non-small cell lung cancer and pancreatic cancer. CS5001 was well tolerated in heavily pre-treated patients with advanced B-cell lymphomas and solid tumors. About CStone CStone (HKEX: 2616), established in late 2015, is an innovation-driven biopharmaceutical company focused on the research and development of anti-cancer therapies. Dedicated to addressing patients' unmet medical needs in China and globally, the Company has made significant strides since its inception. To date, the Company has successfully launched 4 innovative drugs and secured approvals for 16 new drug applications (NDAs) covering 9 indications. The company's pipeline is balanced by 16 promising candidates, featuring potentially first-in-class or best-in-class antibody-drug conjugates (ADCs), multispecific antibodies, immunotherapies and precision medicines. CStone also prides itself on a management team with comprehensive experiences and capabilities that span the entire drug development spectrum, from preclinical and translational research to clinical development, drug manufacturing, business development, and commercialization. For more information about CStone, please visit . Forward-looking statements The forward-looking statements made in this article only relate to events or information as of the date when the statements are made in this article. Except as required by law, we undertake no obligation to update or publicly revise any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. All statements in this article are made on the date of publication of this article and may change due to future developments. Disclaimer: only for communication and scientific use by medical and health professionals, it is not intended for promotional purposes. SOURCE CStone Pharmaceuticals WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 1License out/inASCOClinical Result

100 Deals associated with Sugemalimab

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
metastatic non-small cell lung cancer	European Union	-	24 Jul 2024
metastatic non-small cell lung cancer	Iceland	-	24 Jul 2024
metastatic non-small cell lung cancer	Liechtenstein	-	24 Jul 2024
metastatic non-small cell lung cancer	Norway	-	24 Jul 2024
Gastroesophageal junction adenocarcinoma	China	Cornerstone Pharmaceutical Co., Ltd	12 Mar 2024
Stomach Cancer	China	Cornerstone Pharmaceutical Co., Ltd	12 Mar 2024
Esophageal Squamous Cell Carcinoma	China	Pfizer Inc.	08 Dec 2023
Esophageal Squamous Cell Carcinoma	China	Cornerstone Pharmaceutical Co., Ltd	08 Dec 2023
Extranodal NK-T-Cell Lymphoma	China	Cornerstone Pharmaceutical Co., Ltd	27 Oct 2023
Extranodal NK-T-Cell Lymphoma	China	Pfizer Investment Co. Ltd.	27 Oct 2023
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	China	Pfizer Investment Co. Ltd.	20 Dec 2021
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	China	Cornerstone Pharmaceutical Co., Ltd	20 Dec 2021
Non-squamous non-small cell lung cancer	China	Pfizer Investment Co. Ltd.	20 Dec 2021
Squamous non-small cell lung cancer	China	Cornerstone Pharmaceutical Co., Ltd	20 Dec 2021
Squamous non-small cell lung cancer	China	Pfizer Investment Co. Ltd.	20 Dec 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Unresectable Lung Non-Small Cell Carcinoma	NDA/BLA	European Union	CStone Pharmaceuticals Co. Ltd.	24 Mar 2025
Locally Advanced Gastroesophageal Junction Adenocarcinoma	NDA/BLA	China	Pfizer Investment Co. Ltd.	28 Feb 2023
Non-Small Cell Lung Cancer	NDA/BLA	China	Wuxi Biologics (Cayman), Inc.	13 Nov 2020
Non-Small Cell Lung Cancer	NDA/BLA	China	Cornerstone Pharmaceutical Co., Ltd	13 Nov 2020
Locally Advanced Esophageal Squamous Cell Carcinoma	Phase 3	China	Cornerstone Pharmaceutical Co., Ltd	19 Dec 2019
Unresectable Esophageal Squamous Cell Carcinoma	Phase 3	China	Cornerstone Pharmaceutical Co., Ltd	19 Dec 2019
Locally Advanced Unresectable Gastric Adenocarcinoma	Phase 3	China	Cornerstone Pharmaceutical Co., Ltd	28 Mar 2019
stomach adenocarcinoma	Phase 3	China	Cornerstone Pharmaceutical Co., Ltd	22 Jan 2019
Advanced Lung Non-Small Cell Carcinoma	Phase 3	China	Cornerstone Pharmaceutical Co., Ltd	13 Dec 2018
Non-small cell lung cancer stage III	Phase 3	China	Cornerstone Pharmaceutical Co., Ltd	26 Oct 2018

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03802591 (GEMSTONE-303, PRNewswire \| Pubmed) Manual	Phase 3	Stomach Cancer \| Gastroesophageal junction adenocarcinoma First line PD-L1 Positive	-	Sugemalimab + CAPOX	svytoiuane(dkuklrxwpm) = hjrmhigxvo hciagoonqu (rfnwqneasy, 13.3 - 17.8) View more	Positive	24 Feb 2025
				Placebo + CAPOX	svytoiuane(dkuklrxwpm) = kcozimivio hciagoonqu (rfnwqneasy, 10.6 - 14.1) View more
NCT03789604 (GEMSTONE-302, ESMO2024) Manual	Phase 3	metastatic non-small cell lung cancer First line	479	Sugemalimab + Platinum-based chemotherapy	tjfkgtjjzp(rrsxxqljyv) = aejbbnynnr idiyltbnqk (lomdjatqgq ) View more	Positive	14 Sep 2024
				Placebo + Platinum-based chemotherapy	tjfkgtjjzp(rrsxxqljyv) = mhcftmgfeb idiyltbnqk (lomdjatqgq ) View more
NCT03595657 (GEMSTONE-201, CTgov)	Phase 2	Extranodal NK-T-Cell Lymphoma	80	sugemalimab (CS1001)	qphhaquudz = wnzvpmzbbf xsevhcjvcw (pydrtlfnla, wrkxisxjbk - sxtjnryixh) View more	-	18 Jun 2024
ASCO2024 Manual	Not Applicable	Non-Small Cell Lung Cancer Second line \| First line	-	Sugemalimab plus platinum-based chemo	fuxvnmalab(guzdnfnbno) = mjjqmmojdm llfnmiejzp (ukjigfmhmr ) View more	Positive	24 May 2024
				Sugemalimaby (RT) plus Sugemalimab	johjghuwak(rrenxhvevm) = ijbqvkkcfb vspbyopknx (fhczxluvgo ) View more
NCT04187352 (Literature \| Pubmed \| Nat Med) Manual	Phase 3	Advanced Esophageal Squamous Cell Carcinoma First line	540	sugemalimab+chemotherapy	flimhahcbq(gwyrujmhfv) = uijnlxccad oqepglhiey (nhuapxclcq ) View more	Positive	01 Feb 2024
				placebo+chemotherapy	flimhahcbq(gwyrujmhfv) = mmdbvcossu oqepglhiey (nhuapxclcq ) View more
NCT03802591 (GEMSTONE-303, ESMO 12023 \| ESMO 22023) Manual	Phase 3	stomach adenocarcinoma \| Gastroesophageal junction adenocarcinoma First line PD-L1 expression	479	Sugemalimab + CAPOX (PD-L1 Expression Level >=5%)	cmqasblxyp(vrjkvinhwq) = tdqxbdrstq jfwvksncrb (orbetbzxsd, 13.27 - 17.81) View more	Positive	21 Oct 2023
				Placebo + CAPOX (PD-L1 Expression Level >=5%)	cmqasblxyp(vrjkvinhwq) = dmnbdgzuwd jfwvksncrb (orbetbzxsd, 10.64 - 14.06) View more
NCT04187352 (GEMSTONE-304, ESMO_GI2023)	Phase 3	Unresectable Esophageal Squamous Cell Carcinoma First line PD-L1	540	Sugemalimab + FP	wscmikstwi(jdhudydoxh) = kygelzhfum qngkxvvngg (owhphwthqo ) View more	Positive	01 Jul 2023
				Placebo + FP	wscmikstwi(jdhudydoxh) = mtiywclonq qngkxvvngg (owhphwthqo ) View more
NCT03789604 (GEMSTONE-302, ASCO2023)	Not Applicable	Non-Small Cell Lung Cancer First line	-	Sugemalimab + chemotherapy	hpytguxxyo(oykiqmuctj) = bfgivhyjqg aobvpuvitv (mpqiksrhqw )	Positive	31 May 2023
				Placebo + chemotherapy	hpytguxxyo(oykiqmuctj) = kwpaodmuwt aobvpuvitv (mpqiksrhqw )
NCT03802591 (GEMSTONE-303, Corporate Publications) Manual	Phase 3	stomach adenocarcinoma \| Gastroesophageal junction adenocarcinoma First line PD-L1	-	Oxaliplatin+Capecitabine+Sugemalimab	tctloxygze(izjhpluall) = vlkkyilugh lyhjprzgrm (vbjbczsbrz ) View more	Positive	11 Nov 2022
				Oxaliplatin+Capecitabine+Placebo	tctloxygze(izjhpluall) = couinrmopa lyhjprzgrm (vbjbczsbrz ) View more
NCT03595657 (GEMSTONE-201, ASCO2022) Manual	Phase 2	Lymphoma	80	sugemalimab	kcdhockvyb(ktttcsrnan) = suewqegtzc ydlmrhbsfh (alrkimaxrj, 34.8 - 57.8) View more	Positive	02 Jun 2022

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