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

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.

NCT06987734

/ RecruitingPhase 2IIT

Neoadjuvant Sugemalimab + Chemotherapy Followed by Adjuvant Sugemalimab for Patients With Resectable Stage II-IIIA Non-small-cell Lung Cancer Patients

This is a single arm, open-label exploratory study conducted in resectable stage II-IIIA NSCLC without EGFR/ALK mutations, aiming to investigate feasibility, safety and efficacy of Sugemalimab in perioperative contexts. Twenty-five resectable stage II-IIIA patients are planned to be enrolled. The proportion of patients with squamous cell carcinoma will not less than 40%.
Combined neoadjuvant chemotherapy and immunotherapy with fixed dose of Sugemalimab 1200 mg IV Q3W + Platinum-based chemo in resectable stage II-IIIA NSCLC adult patients followed by surgery. After completion of neoadjuvant therapy (3-4 cycles) and before surgery, a tumor assessment will be done. Patients have to leave the study if there is evidence of progression in neoadjuvant therapy. Pathological response is planned to assessed after surgery. Following surgery, the patients with complete resection will receive an additional 1 year of Sugemalimab q3w. Treatment will commence as soon as clinically feasible post-surgery.
Informed consent will be obtained prior to tissue collection and genome sequencing for each participant. Primary tumour tissue will be obtained at diagnosis by biopsy such as percutaneous lung puncture biopsy, bronchoscopic biopsy or endobronchial ultrasound (EBUS) (based on clinical practice). Fresh tumour tissue was collected after surgical resection. Tissues collected were subjected to medically necessary pathology for diagnosis. Specimens were processed for multiplex immunofluorescence, single-cell sequencing and spatial transcriptomics, bulk RNAseq and WES to explore the changes in the immune microenvironment before and after suglizumab administration.

Start Date19 Jun 2025

Sponsor / Collaborator

Shanghai Pulmonary Hospital

[+1]

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.

100 Clinical Results associated with Sugemalimab

100 Translational Medicine associated with Sugemalimab

100 Patents (Medical) associated with Sugemalimab

Literatures (Medical) associated with Sugemalimab

01 Jul 2025·LANCET ONCOLOGY

Sugemalimab versus placebo, in combination with platinum-based chemotherapy, as first-line treatment of metastatic non-small-cell lung cancer (GEMSTONE-302): 4-year outcomes from a double-blind, randomised, phase 3 trial

Article

Author: Dai, Hangjun ; Chen, Xueqin ; Li, Xingya ; Sun, Si ; Ma, Zhiyong ; Zhang, Xiaochun ; Cui, Jiuwei ; Wang, Ziping ; Yang, Jason ; Zhang, Yiping ; Ma, Rui ; Shu, Yongqian ; Zhao, Hui ; Wang, Bo ; Li, Lin ; Sun, Meili ; Shen, Hong ; Liu, Yunpeng ; Liang, Li ; Hu, Chunhong ; Yu, Yan ; Zhou, Caicun ; Wang, Mengzhao ; Zhuang, Wu ; Lu, You ; Sun, Ping ; Zhou, Jianying ; Chen, Jianhua ; Shi, Qingmei ; Cao, Lejie ; Liu, Jiwei ; Li, Jingzhang ; Li, Man ; Wang, Changli ; Wang, Qiang ; Yao, Wenxiu ; Wang, Jingru ; Yang, Hui ; Gu, Kangsheng ; Liu, Chunling ; Wu, Rong

BACKGROUND:

GEMSTONE-302 was a phase 3 trial in patients with treatment-naive metastatic squamous or non-squamous non-small-cell lung cancer (NSCLC), showed significant improvement in progression-free survival and overall survival with sugemalimab, a PD-L1 inhibitor, plus chemotherapy versus placebo plus chemotherapy. We report the 4-year outcomes from this study.

METHODS:

This randomised, double-blind, phase 3 trial was conducted across 35 hospitals and academic research centres in China. Eligible patients were aged 18-75 years; had treatment-naive, histologically or cytologically confirmed stage IV NSCLC, irrespective of PD-L1 expression levels; and had an Eastern Cooperative Oncology Group performance status of 0 or 1. Patients were randomised (2:1) by investigators using an interactive web response or voice response system via permuted blocks (block sizes of three or six, randomised within each stratum). Patients received histology-specific platinum-based chemotherapy combined with either sugemalimab (1200 mg; sugemalimab group) or placebo (placebo group) for up to four cycles, followed by for up to 35 cycles of maintenance therapy with sugemalimab alone for patients with squamous NSCLC and sugemalimab plus pemetrexed for patients with non-squamous NSCLC in the sugemalimab group, or placebo for patients with squamous NSCLC and placebo plus pemetrexed for patients with non-squamous NSCLC in the placebo group, administered intravenously. Treatment beyond 35 cycles was permitted at the investigator's discretion. The primary endpoint was investigator-assessed progression-free survival in the intention-to-treat population. Here, we report post-hoc 4-year efficacy and safety outcomes from GEMSTONE-302. This study is registered with ClinicalTrials.gov (NCT03789604) and concluded on May 15, 2023, with all patients discontinued.

FINDINGS:

Between December 13, 2018, and May 15, 2020, 846 patients were assessed for eligibility. 479 patients were randomly assigned into the sugemalimab group (n=320) and placebo group (n=159). 254 (79%) patients were men and 66 (21%) were women in the sugemalimab group and 129 (81%) were men and 30 (19%) were women in the placebo group. All patients were Asian. As of the data cutoff on May 15, 2023, median follow-up durations were 43·5 months (IQR 41·2-46·9) in the sugemalimab group and 43·0 months (40·7-44·8) in the placebo group; median treatment durations were 7·2 months (4·2-18·8) with sugemalimab and 4·6 months (2·8-6·9) with placebo. Median progression-free survival was 9·0 months (95% CI 7·4-10·9) in the sugemalimab group versus 4·9 months (4·8-5·2) in the placebo group (hazard ratio [HR] 0·49 [95% CI 0·39-0·60]). Median overall survival was 25·2 months (20·1-30·2) in the sugemalimab group versus 16·9 months (12·8-20·7) in the placebo group (HR 0·68 [0·54-0·85]). The 4-year overall survival rates were 32·1% (95% CI 26·7-37·6) in the sugemalimab group versus 17·3% (11·1-24·7) in the placebo group. The most common grade 3-4 treatment related adverse events were decreased neutrophil count (105 [33%] with sugemalimab vs 52 [33%] with placebo), decreased white blood cell count (48 [15%] vs 27 [17%]), anaemia (44 [14%] vs 18 [11%]), and decreased platelet count (35 [11%] vs 15 [9%]). Treatment-related serious adverse events occurred in 82 (26%) patients with sugemalimab and 31 (20%) with placebo. No additional treatment-related deaths occurred since the previous overall survival interim analysis. No new safety signals were identified.

INTERPRETATION:

Sugemalimab with chemotherapy showed a superior long-term overall survival benefit compared with placebo with chemotherapy, as a first-line treatment for patients with NSCLC with no known sensitising EGFR, ALK, ROS1, or RET genomic alterations. These results underscore the efficacy of sugemalimab plus platinum-based chemotherapy as a standard first-line treatment option for both squamous and non-squamous metastatic NSCLC while maintaining a manageable safety profile.

FUNDING:

CStone Pharmaceuticals.

TRANSLATION:

For the Chinese translation of the abstract see Supplementary Materials section.

15 Apr 2025·JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

First-Line Sugemalimab Plus Chemotherapy for Advanced Gastric Cancer

Article

Author: Shi, Qingmei ; Shen, Zhenwei ; Liang, Xinjun ; Liao, Wangjun ; Pan, Hongming ; Zhang, Tao ; Sun, Meili ; Shen, Lin ; Gao, Yanrong ; Hou, Anji ; Li, Qi ; Deng, Yanhong ; Zhao, Yunbo ; Xiao, Li ; Wang, Jufeng ; Wang, Qi ; Wan, Yiye ; Chen, Yanhua ; Xie, Zhong ; Liu, Yunpeng ; Luo, Zhanxiong ; Zhang, Li ; Xie, Yanru ; Wang, Gang ; Zhu, Dan ; Yang, Xinhui ; Lu, Chuangxin ; Yang, Jason ; Hu, Changlu ; Lin, Xiaoyan ; Lin, Yan ; Sun, Yinping ; Ji, Yanxia ; Luo, Jie ; Yan, Dong ; Wang, Junye ; Wang, Zishu ; Mou, Yiping ; Li, Hongxia ; Yao, Sheng ; Zhang, Xiaotian ; Zhang, Yanqiao ; Fan, Qingxia ; Zhang, Ruixing ; Shi, Yongquan ; Sun, Sanyuan ; Xiong, Jianping ; Li, Jiayi ; Shu, Yongqian ; Fu, Ting ; Chen, Ping ; Yao, Juntao

Importance:

Gastric cancer, including gastroesophageal junction cancer, is one of the most commonly diagnosed cancers worldwide, with high mortality. Sugemalimab is a fully human anti–programmed death-ligand 1 (PD-L1) antibody. The combination of sugemalimab and chemotherapy showed promising antitumor activity and safety in a phase 1b study among patients with treatment-naive, unresectable, locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma. This combination was further evaluated in the GEMSTONE-303 phase 3 trial.

Objective:

To evaluate the efficacy of sugemalimab in combination with capecitabine and oxaliplatin (CAPOX) compared with placebo plus CAPOX as first-line treatment for patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma with PD-L1 combined positive score (CPS) of 5 or greater.

Design, Setting, and Participants:

GEMSTONE 303 is a phase 3, randomized, double-blind, placebo-controlled study conducted at 54 sites in China that enrolled patients from April 9, 2019, through December 29, 2021, with follow-up to July 9, 2023. A total of 479 eligible patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma with PD-L1 CPS of 5 or greater who did not receive any prior systemic therapy were randomized.

Intervention:

Patients received sugemalimab (1200 mg intravenously) (n = 241) or placebo (n = 238) every 3 weeks for up to 24 months, plus CAPOX every 3 weeks for up to 6 cycles.

Main outcomes and Measures:

Primary outcomes were overall survival and investigator-assessed progression-free survival.

Results:

Baseline characteristics were well balanced between the 2 groups. Most patients were male (71.4% in sugemalimab group, 74.8% in placebo group). Median follow-up was 25.1 months in the sugemalimab group and 26.3 months in the placebo group. The sugemalimab group demonstrated significant improvements in overall survival (median, 15.6 months [95% CI, 13.3-17.8] vs 12.6 months [95% CI, 10.6-14.1]; hazard ratio, 0.75 [95% CI, 0.61-0.92]; P = .006) and progression-free survival (median, 7.6 months [95% CI, 6.4-7.9] vs 6.1 months [95% CI, 5.1-6.4]; hazard ratio, 0.66 [95% CI, 0.54-0.81]; P &lt; .001). Grade 3 or higher treatment-related adverse events occurred in 53.9% of patients in the sugemalimab group and 50.6% in the placebo group.

Conclusions and Relevance:

Sugemalimab plus chemotherapy significantly prolonged overall survival and progression-free survival with a manageable safety profile in previously untreated patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.

Trial Registration:

ClinicalTrials.gov Identifier: NCT03802591

01 Mar 2025·BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Comprehensive population pharmacokinetic modelling of sugemalimab, an anti‐programmed death‐ligand 1 (PD‐L1) human monoclonal antibody, in patients with solid tumours or lymphomas across multiple Phase I–III studies

Article

Author: Xu, Fengyan ; Wang, Kun ; Tse, Archie N. ; Sheng, Yucheng ; Pan, Chaohsuan

Aims:

The aim of this study was to develop a population pharmacokinetics model for sugemalimab, a monoclonal antibody that targets programmed death‐ligand 1 (PD‐L1), using data from Phase I–III trials and to assess clinical factors affecting sugemalimab exposure.

Methods:

A nonlinear mixed‐effect modelling approach was employed to analyse pooled data from nine studies involving 1628 subjects to characterize the PopPK of sugemalimab. This investigation examined the influence of various covariates on sugemalimab pharmacokinetics (PK), encompassing demographics, baseline hepatic and renal function‐related covariates, and others (including anti‐drug antibody [ADA], combination treatment, Eastern Cooperative Oncology Group [ECOG] performance score, tumour burden and tumour type). Estimation accuracy and predictive ability of the final model were evaluated using various methods. The influence of covariates on sugemalimab exposure was assessed by simulation from the final model.

Results:

A two‐compartment model with first‐order elimination and time‐varying clearance effectively described the PK of sugemalimab. Covariate analyses revealed significant relationships between sugemalimab clearance and body weight, albumin, gender, ADA, tumour burden and tumour type. The statistically significant covariates on central volume were body weight, albumin, gender and tumour type. No significant relationships were found in the final model for age, race, alanine aminotransferase, aspartate aminotransferase, creatinine, total bilirubin, alkaline phosphatase, combination treatment, creatinine clearance, ECOG, renal function or hepatic function. All significant covariates demonstrated less than a 20% effect on sugemalimab exposure.

Conclusions:

The PopPK model adequately described the pharmacokinetic profile of sugemalimab with no clinically meaningful impact observed on its exposure across all covariates. Dose adjustment does not appear to be necessary.

News (Medical) associated with Sugemalimab

20 May 2025

·firstwordpharma.com

Pfizer strikes $6B deal with China's 3SBio for cancer bispecific

Pfizer signed a mega licensing deal worth over $6 billion with Chinese firm 3SBio, securing ex-China rights to the latter’s PD-1/VEGF-targeting bispecific antibody SSGJ-707 in oncology indications. The news sent 3SBio’s stock surging over 30% at the Hong Kong exchange on Tuesday.The deal announced Monday, grants Pfizer exclusive global development, manufacturing and commercialisation rights for SSGJ-707, excluding China, with an option to acquire commercialisation rights within China at a later date. Under the agreed terms, Pfizer will make an upfront payment of $1.25 billion — a new record for licensing pacts with Chinese biotechs. Additionally, 3SBio will be eligible for potential milestone payments reaching $4.8 billion, alongside tiered double-digit sales royalties. SSGJ-707, which targets two critical cancer pathways simultaneously — immune checkpoint inhibition via PD-1 and anti-angiogenesis via VEGF — demonstrated encouraging efficacy and safety data in early trials and is being investigated across several solid tumours. 3SBio plans to kick off the first Phase III study for the bispecific in China later this year.Pfizer noted that upon closing of the transaction, which is anticipated in the third quarter subject to regulatory and shareholder approvals, it will make an additional $100-million equity investment in 3SBio. The US drugmaker will set up manufacturing operations for SSGJ-707 at its facilities in North Carolina and Kansas.The deal comes amid emerging competition in the PD-(L)1)/VEGF bispecific landscape, with Akeso and Summit Therapeutics’ ivonescimab and BioNTech’s BNT327 already battling it out to end the reign of Merck & Co.’s Keytruda (pembrolizumab), which the latter expects to offset by developing LaNova Medicines’ LM-299. Read more on this: Spotlight On: Biopharma's next immuno-oncology goldrush is already under way.With this agreement, Pfizer joins other major biopharmas that’ve had a flurry of China partnering deals in recent times. For more, see: Vital Signs: Who's taking the biggest risks (and rewards) with Chinese assets? In the past, Pfizer partnered with CStone Pharmaceuticals, gaining rights to CStone's experimental PD-L1 antibody sugemalimab in China.

License out/inImmunotherapyADC

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

100 Deals associated with Sugemalimab

R&D Status

Approved

10 top approved records.

to view more data

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	Cornerstone Pharmaceutical Co., Ltd	08 Dec 2023
Esophageal Squamous Cell Carcinoma	China	Pfizer Inc.	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.

to view more data

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	CStone Pharmaceuticals Co. Ltd.	19 Dec 2019
Unresectable Esophageal Squamous Cell Carcinoma	Phase 3	China	CStone Pharmaceuticals Co. Ltd.	19 Dec 2019
Locally Advanced Unresectable Gastric Adenocarcinoma	Phase 3	China	CStone Pharmaceuticals Co. Ltd.	28 Mar 2019
stomach adenocarcinoma	Phase 3	China	CStone Pharmaceuticals Co. Ltd.	28 Mar 2019
Advanced Lung Non-Small Cell Carcinoma	Phase 3	China	Cornerstone Pharmaceutical Co., Ltd	13 Dec 2018
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	China	CStone Pharmaceuticals Co. Ltd.	26 Oct 2018

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03802591 (GEMSTONE-303, Pubmed \| JAMA)	Phase 3	Advanced gastric carcinoma First line PD-L1 combined positive score (CPS) of 5 or greater	479	Sugemalimab + CAPOX	aaqeekzrre(nixubcaucm) = 53.9% of patients in the sugemalimab group and 50.6% in the placebo group hmthhoxszi (utagzeltks ) View more	Positive	15 Apr 2025
				Placebo + CAPOX
NCT03802591 (GEMSTONE-303, PRNewswire \| Pubmed) Manual	Phase 3	Stomach Cancer \| Gastroesophageal junction adenocarcinoma First line PD-L1 Positive	-	Sugemalimab + CAPOX	dwloktijdu(ivonscjauy) = usdwhfmqop sbavnrrffe (iaybxlpknw, 13.3 - 17.8) View more	Positive	24 Feb 2025
				Placebo + CAPOX	dwloktijdu(ivonscjauy) = lbinfmthkk sbavnrrffe (iaybxlpknw, 10.6 - 14.1) View more
NCT03789604 (GEMSTONE-302, ESMO2024 \| Pubmed) Manual	Phase 3	metastatic non-small cell lung cancer First line	479	Sugemalimab + Platinum-based chemotherapy	bihmknupjf(iwntgztwpg) = ipbnnlhzxh jqgjzzenxa (wrehrjugfz ) View more	Positive	14 Sep 2024
				Placebo + Platinum-based chemotherapy	bihmknupjf(iwntgztwpg) = tfhccggbxo jqgjzzenxa (wrehrjugfz ) View more
ASCO2024 Manual	Not Applicable	Non-Small Cell Lung Cancer Second line \| First line	-	Sugemalimab plus platinum-based chemo	exqwklyglq(iyrpheywnu) = umucntwjkj gqwrpfmobo (xtajyfcugb ) View more	Positive	24 May 2024
				Sugemalimaby (RT) plus Sugemalimab	xpkjtjvrnt(lavhqmprub) = ncufuroeup pdojjanxcp (zephncrwxl ) View more
NCT04187352 (Literature \| Pubmed \| Nat Med) Manual	Phase 3	Advanced Esophageal Squamous Cell Carcinoma First line	540	sugemalimab+chemotherapy	dnfivaslok(ddrekywrpi) = egxefxdyaa jcqtdlleed (hbqnnvpome ) View more	Positive	01 Feb 2024
				placebo+chemotherapy	dnfivaslok(ddrekywrpi) = tybhavhhvz jcqtdlleed (hbqnnvpome ) 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%)	ynggkijhtz(yxzkthkwva) = xiwwrrwiri jcqcfvxvwn (lbsobqvyfm, 13.27 - 17.81) View more	Positive	21 Oct 2023
				Placebo + CAPOX (PD-L1 Expression Level >=5%)	ynggkijhtz(yxzkthkwva) = wsqbmsmehy jcqcfvxvwn (lbsobqvyfm, 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	mekmjypsqt(lhnpneakbx) = wsmkldosgp rwauictmtg (kccrsaidsm ) View more	Positive	01 Jul 2023
				Placebo + FP	mekmjypsqt(lhnpneakbx) = jlyjnlpfeo rwauictmtg (kccrsaidsm ) View more
NCT03789604 (GEMSTONE-302, ASCO2023)	Not Applicable	Non-Small Cell Lung Cancer First line	-	Sugemalimab + chemotherapy	zbgkapeipt(armmkukaha) = lzwosuinmf zcyekojyvm (zogcdokntu )	Positive	31 May 2023
				Placebo + chemotherapy	zbgkapeipt(armmkukaha) = wlzfnoicet zcyekojyvm (zogcdokntu )
NCT03595657 (GEMSTONE-201, Pubmed)	Phase 2	Extranodal NK-T-Cell Lymphoma	80	Sugemalimab	imbxrnlzql(abxqlxudpd) = wsaoltqcly evknbogvdf (vuzdgbxwlc, 33.6 - 56.6) View more	Positive	30 Mar 2023
NCT03802591 (GEMSTONE-303, Corporate Publications) Manual	Phase 3	stomach adenocarcinoma \| Gastroesophageal junction adenocarcinoma First line PD-L1	-	Oxaliplatin+Capecitabine+Sugemalimab	wfhkrcaxtf(kwfcxxpzju) = cucznononp vtrzughasf (waczlzcygv ) View more	Positive	11 Nov 2022
				Oxaliplatin+Capecitabine+Placebo	wfhkrcaxtf(kwfcxxpzju) = ewfjfykmhp vtrzughasf (waczlzcygv ) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

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.

view full example data

Regulation

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

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

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

Start your data trial now!

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