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52 Diseases | | 196 Products |
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3529 Trials |  |
15381 News |  |
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- || HR091506 / Jiangsu Hengrui Pharma
New P1 trial: A Comparative Pharmacokinetic Study of Single-Dose Administration of HR091506 Tablets From Different Batches in Healthy Subjects (clinicaltrials.gov) - Jul 25, 2025
P1, N=18, Not yet recruiting, Sponsor: Jiangsu HengRui Medicine Co., Ltd.
- ||| SHR-A2102 / Jiangsu Hengrui Pharma
Enrollment open: SHR-A2102-I-102: Phase I Study of SHR-A2102 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - Jul 25, 2025
P1, N=395, Recruiting, Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
Active, not recruiting --> Recruiting
- | plinabulin (BPI 2358) / BeyondSpring
Journal: The Novel Diketopiperazine Derivative, Compound 5-3, Selectively Inhibited the Proliferation of FLT3-ITD Mutant Acute Myeloid Leukemia (AML) Cells. (Pubmed Central) - Jul 25, 2025
Plinabulin is a diketopiperazines derivative that exhibits extensive anti-cancer potency by targeting ?-tubulin...In conclusion, the study identified diketopiperazine derivative as a novel FLT3-ITD selective inhibitor. These results demonstrated that 5-3 might be a drug candidate for the treatment of FLT3-ITD-positive AML.
- | AiRuiKa (camrelizumab) / HLB Bio Group
Journal, PD(L)-1 Biomarker: Clinical evaluation of camrelizumab combined with transarterial chemoembolization in the interventional therapy of hepatocellular carcinoma with liver cirrhosis. (Pubmed Central) - Jul 25, 2025
One-year follow-up revealed prolonged overall survival rate and progression-free survival, along with better quality-of-life scores in the OG. These findings suggest that camrelizumab combined with TACE demonstrates definitive short-term efficacy, improved immune and liver function, better survival outcomes, and favorable safety in HCC patients with liver cirrhosis, supporting its clinical value.
- |||| SHR-2004 / Jiangsu Hengrui Pharma
Trial completion, Enrollment change, Trial completion date, Trial primary completion date: A Study to Evaluate the Efficacy and Safety of SHR-2004 Injection in Preventing Postoperative Venous Thromboembolism in Patients Undergoing Ovarian Cancer Surgery (clinicaltrials.gov) - Jul 25, 2025
P2, N=225, Completed, Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd
These findings suggest that camrelizumab combined with TACE demonstrates definitive short-term efficacy, improved immune and liver function, better survival outcomes, and favorable safety in HCC patients with liver cirrhosis, supporting its clinical value. Not yet recruiting --> Completed | N=350 --> 225 | Trial completion date: Jul 2025 --> Dec 2024 | Trial primary completion date: Jun 2025 --> Dec 2024
- ||| Ruiqin (henagliflozin) / Jiangsu Hengrui Pharma
Enrollment open, Trial initiation date: HOLIDYA: The Effects of Henagliflozin on Glucose Fluctuation and Immunosenescence in Type 2 Diabetes Patients on Insulin Therapy (clinicaltrials.gov) - Jul 25, 2025
P4, N=64, Recruiting, Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Not yet recruiting --> Completed | N=350 --> 225 | Trial completion date: Jul 2025 --> Dec 2024 | Trial primary completion date: Jun 2025 --> Dec 2024 Not yet recruiting --> Recruiting | Initiation date: Apr 2025 --> Jul 2025
- ||| HRS-9821 / Jiangsu Hengrui Pharma
Trial completion, Trial completion date: Study on Single and Multiple Atomization Inhalation of HRS-9821 Suspension for Inhalation in Healthy Subjects and COPD Patients (clinicaltrials.gov) - Jul 24, 2025
P1, N=106, Completed, Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd
Not yet recruiting --> Recruiting | Initiation date: Apr 2025 --> Jul 2025 Trial completion date: Sep 2025 --> Jun 2025 | Active, not recruiting --> Completed
- AiRuiLi (adebrelimab) / Jiangsu Hengrui Pharma
Phase Ib/II Clinical Study of Adebrelimab Combined with Decitabine, Nab-Paclitaxel, and Gemcitabine as First-Line (IL) Treatment for Metastatic Pancreatic Cancer (mPC) [WITHDRAWN] (Hall 25) - Jul 24, 2025 - Abstract #ESMO2025ESMO_4588;
- AiRuiKa (camrelizumab) / HLB Bio Group
Long-term neoadjuvant chemoradiotherapy (nCRT) combined with camrelizumab for locally advanced rectal cancer: A single-arm, prospective, phase II clinical study (Hall 25) - Jul 24, 2025 - Abstract #ESMO2025ESMO_4280;
P2
Legal entity responsible for the study The authors. Funding Has not received any funding.
- Efficacy and safety profiles of PARP inhibitors in Chinese patients with metastatic breast cancer: A multi-center real-world study (Hall 25) - Jul 24, 2025 - Abstract #ESMO2025ESMO_4244;
Conclusions PARPis showed promising PFS and tolerable toxicity in the real-word treatment of Chinese patients with metastatic breast cancer. Legal entity responsible for the study The authors.
- AiRuiKang (dalpiciclib) / Jiangsu Hengrui Pharma
Real-world study on the efficacy and safety of Dalpiciclib in elderly patients with HR-positive, HER2-negative advanced breast cancer in the Xinjiang region [WITHDRAWN] (Hall 25) - Jul 24, 2025 - Abstract #ESMO2025ESMO_4228;
- AiRuiKa (camrelizumab) / HLB Bio Group
Safety and Efficacy of camrelizumab Based Regimens in Triple Negative Breast Cancer : A Systematic Review and Meta Analysis [WITHDRAWN] (Hall 25) - Jul 24, 2025 - Abstract #ESMO2025ESMO_4203;
- AiTan (rivoceranib) / HLB Bio Group
Apatinib reverses tamoxifen resistance in ER+ breast cancer via the VEGFR2/ER?/PI3K/Akt pathway (Hall 25) - Jul 24, 2025 - Abstract #ESMO2025ESMO_4088;
By targeting VEGFR2, apatinib disrupts this signaling crosstalk, restores endocrine sensitivity, inhibits survival and migration pathways, and holds potential for clinical application in endocrine-resistant breast cancer. Legal entity responsible for the study The authors.
- ACR246 / Adcoris
ACR246, a novel 5T4 antibody-drug conjugate, showed promising anticancer efficacy in esophageal squamous cell carcinoma (Hall 25) - Jul 24, 2025 - Abstract #ESMO2025ESMO_4048;
Conclusions ACR246 exhibited potent anti-cancer efficacy across 5T4-high, moderate and low expression ESCC PDX and CIR-PDO models, supporting its clinical potential for ICI-refractory ESCC pts. Legal entity responsible for the study Hangzhou Adcoris Biopharma Co., Ltd.
- AiRuiLi (adebrelimab) / Jiangsu Hengrui Pharma, famitinib (SHR 1020) / Jiangsu Hengrui Pharma
Famitinib plus adebrelimab for advanced thyroid cancer after failed frontline treatment: A single-arm, open-label phase II trial (Hall 25) - Jul 24, 2025 - Abstract #ESMO2025ESMO_3951;
P2
Benefit was observed even in those with failed pretreatment. TLS enrichment and T-cell infiltration may predict response, warranting further validation.
- AiRuiLi (adebrelimab) / Jiangsu Hengrui Pharma, famitinib (SHR 1020) / Jiangsu Hengrui Pharma
Primary analysis of efficacy and safety of adebrelimab combined with famitinib and chemotherapy as first-line therapy for ES-SCLC: A multicenter, single-arm, phase II study (Hall 25) - Jul 24, 2025 - Abstract #ESMO2025ESMO_3810;
P2
Conclusions The combination therapy of adebrelimab, famitinib and chemotherapy showed an encouraging efficacy and acceptable safety profile as first-line treatment for ES-SCLC. This study is still ongoing.
- AiRuiLi (adebrelimab) / Jiangsu Hengrui Pharma
A prospective study of neoadjuvant adebrelimab combined with chemotherapy for limited-stage small-cell lung cancer (NIUS) (Hall 25) - Jul 24, 2025 - Abstract #ESMO2025ESMO_3804;
P4
This study is still ongoing. Methods 30 patients with stage I
- Xtandi (enzalutamide) / Pfizer, Astellas, Nubeqa (darolutamide) / Bayer, Orion Corp, AiRuiEn (rezvilutamide) / Jiangsu Hengrui Pharma
Evaluating treatment efficacy in metastatic hormone-sensitive prostate cancer with visceral disease: A systematic review and network meta-analysis (Hall 25) - Jul 24, 2025 - Abstract #ESMO2025ESMO_3648;
Conversely, ARPI-based doublets with Enzalutamide, Apalutamide, Darolutamide and Rezvilutamide showed modest efficacy...These findings provide crucial evidence to the current clinical decision-making and highlight the need for VD-specific clinical trials to further optimize treatment strategy. Legal entity responsible for the study The Authors.
- AiRuiLi (adebrelimab) / Jiangsu Hengrui Pharma
RAPID trial (NCT06251492): Radiation and adebrelimab in metastatic castration resistant prostate cancer with imaging-measurable disease (Hall 25) - Jul 24, 2025 - Abstract #ESMO2025ESMO_3606;
P2
Conclusions This novel iRT approach demonstrates remarkable efficacy in non-MMRd mCRPC patients with a manageable safety profile. Complete enrolment is expected by mid-2025, with comprehensive genomic analyses revealing potential precision biomarkers by year-end, potentially revolutionizing treatment of this aggressive disease.
- AiRuiEn (rezvilutamide) / Jiangsu Hengrui Pharma
Rezvilutamide (REZ) in combination with androgen-deprivation therapy (ADT) for prostate cancer patients with biochemical recurrence (BCR) post radical prostatectomy (RP): preliminary results from a phase II trial (Hall 25) - Jul 24, 2025 - Abstract #ESMO2025ESMO_3605;
P2
Conclusions The combination of REZ and ADT manifested the ability to achieve and sustain an undetectable PSA level over 12 months in the specific population of BCR. Ongoing follow-up is in progress to comprehensively assess the long-term efficacy and safety.
- AiRuiEn (rezvilutamide) / Jiangsu Hengrui Pharma
The efficacy of rezvilutamide (Rez) plus androgen-deprivation therapy (ADT) in patients (pts) with high-volume, nonvisceral metastatic hormone-sensitive prostate cancer (HSPC): A post hoc analysis of CHART study (Hall 25) - Jul 24, 2025 - Abstract #ESMO2025ESMO_3586;
P3
Compared with bicalutamide (Bic), Rez + ADT improved radiographic progression-free survival (rPFS) and overall survival (OS). Table: 2434P R group (mos) B group (mos) P value HR (95% CI) mrPFS ?10 NR NR 0.013 0.46 (0.25
- Teysuno (gimeracil/oteracil/tegafur) / Nordic Group, Otsuka, AiRuiLi (adebrelimab) / Jiangsu Hengrui Pharma
Neoadjuvant adebrelimab plus chemotherapy for locally advanced resectable gastric or gastroesophageal junction adenocarcinoma: A single-arm, open-label, phase II trial (Hall 25) - Jul 24, 2025 - Abstract #ESMO2025ESMO_3383;
P2
Based on the PRODIGY trial, docetaxel, oxaliplatin, and S-1 (DOS) is a neoadjuvant standard...ctDNA clearance may serve as a highly specific predictor of pathological response. Survival and biomarker (MRD) analyses ongoing.
- AiRuiKa (camrelizumab) / HLB Bio Group
Neoadjuvant camrelizumab plus chemotherapy versus chemotherapy alone for resectable esophageal squamous cell carcinoma: Primary efficacy/safety results and exploratory single-cell RNA sequencing correlates from a multicenter, prospective, randomized controlled study (Hall 25) - Jul 24, 2025 - Abstract #ESMO2025ESMO_3363;
P4
Pericytes show phenotype shifts related to immunosuppressive microenvironments and a weakened PD-1 response. These findings newly identify pericytes as a potential target to enhance immunotherapy efficacy.
- AiTan (rivoceranib) / HLB Bio Group, AiRuiLi (adebrelimab) / Jiangsu Hengrui Pharma
Adebrelimab plus apatinib in advanced esophageal squamous cell carcinoma following immune checkpoint inhibitors: Preliminary results from cohort 3 of CAP 02 study (Hall 25) - Jul 24, 2025 - Abstract #ESMO2025ESMO_3349;
P2
The most frequent TRAEs included decreased white blood cell count (36%), hypokalemia (20%), and abnormal liver function tests (20%). Conclusions The combination of adebrelimab and apatinib demonstrated promising efficacy with a manageable safety in patients with advanced ESCC following progression on or intolerance to ICIs, warranting further exploration.
- retlirafusp alfa (SHR-1701) / Jiangsu Hengrui Pharma
Health-related quality of life with first-line SHR-1701 versus placebo plus chemotherapy for HER2-negative gastric or gastroesophageal junction adenocarcinoma: Results from a randomized phase III trial (Hall 25) - Jul 24, 2025 - Abstract #ESMO2025ESMO_3326;
P3
Conclusions First-line SHR-1701 plus CAPOX maintained or improved HRQoL compared with placebo plus CAPOX and significantly reduced deterioration risk across key PRO items. Table: 2108P Time to deterioration Items Median (95% CI) HR (95% CI) SHR-1701 + CAPOX Placebo + CAPOX QLQ-C30 GHS/QoL 10.8 (5.7, NE) 5.7 (4.4, 7.1) 0.76 (0.61, 0.95) Nausea/vomiting 6.0 (3.4, NE) 3.0 (2.3, 4.7) 0.79 (0.64, 0.98) Pain 11.7 (10.4, NE) 6.8 (5.5, 9.7) 0.71 (0.56, 0.90) QLQ-STO22 Pain NR (NE, NE) 6.2 (4.6, 7.5) 0.59 (0.46, 0.76) Reflux 8.1 (5.5, NE) 4.8 (2.8, 6.6) 0.76 (0.61, 0.95)
- AiRuiKa (camrelizumab) / HLB Bio Group
First-line camrelizumab plus chemotherapy in patients with advanced non-squamous NSCLC and brain metastases: Effectiveness results from a nationwide retrospective study (Hall 25) - Jul 24, 2025 - Abstract #ESMO2025ESMO_3232;
Conclusions These long-term survival data in a large sample supported the application of camrelizumab plus chemotherapy as first-line treatment for patients with advanced non-squamous NSCLC and brain metastases in clinical practice, including elderly patients and those with poor physical status. Legal entity responsible for the study The authors.
- AiRuiLi (adebrelimab) / Jiangsu Hengrui Pharma
First-line adebrelimab plus anti-angiogenic therapy in PD-L1 ?50% NSCLC with brain metastases: Updated results from the BRAIN-AF01 study (Hall 25) - Jul 24, 2025 - Abstract #ESMO2025ESMO_3229;
P2
Conclusions Adebrelimab plus anti-angiogenic therapy demonstrated promising efficacy and durable intracranial control with manageable toxicity in PD-L1 high NSCLC with brain metastases. Pharmacokinetic and MRI findings support CNS activity, warranting further investigation.
- AiRuiKa (camrelizumab) / HLB Bio Group
First-line camrelizumab plus chemotherapy in 3187 patients with advanced non-squamous NSCLC: A nationwide retrospective study (Hall 25) - Jul 24, 2025 - Abstract #ESMO2025ESMO_3171;
The study is ongoing to enroll more patients and extend follow-up, and 3- to 5-year real-world OS rates will be reported in the future. Legal entity responsible for the study The authors.
- AiRuiKa (camrelizumab) / HLB Bio Group, famitinib (SHR 1020) / Jiangsu Hengrui Pharma
Phase II CAPSTONE trial of first-line camrelizumab plus famitinib for locally advanced or metastatic pulmonary sarcomatoid carcinomas (Hall 25) - Jul 24, 2025 - Abstract #ESMO2025ESMO_3156;
P2
Two pts experienced grade 5 AEs of unknown cause. Conclusions Camrelizumab plus famitinib as first-line treatment showed encouraging antitumor activity and manageable safety in pts with locally advanced or metastatic PSC, indicating a potential novel treatment option for this population.
- AiTan (rivoceranib) / HLB Bio Group, AiRuiKa (camrelizumab) / HLB Bio Group
Clinical benefit of camrelizumab (cam) + rivoceranib (rivo) in unresectable hepatocellular carcinoma (uHCC) patients with macrovascular invasion (MVI) and extrahepatic spread (EHS), CARES-310 (Hall 25) - Jul 24, 2025 - Abstract #ESMO2025ESMO_2929;
P3
Conclusions Cam + rivo showed a consistent, clinically meaningful benefit with manageable AEs in the first-line treatment of uHCC compared to sor, regardless of MVI or EHS status. Table: 1496P Cam + Rivo Sor Cam + Rivo Sor MVI+ MVI- EHS+ EHS- n 40 52 232 219 mOS, mo 17.6 (7.3, 29.2) 9.4 (6.3, 15.2) 23.9 (21.6, 30.0) 17.8 (13.7, 21.2) HR (CI) 0.7 (0.42, 1.16) 0.67 (0.53, 0.85) mPFS, mo 5.5 (3.6, 7.5) 3.0 (1.9, 3.8) 5.7 (5.5, 7.4) 3.7 (3.1, 3.7) HR (CI) 0.56 (0.34, 0.94) 0.54 (0.43, 0.67) n 175 180 97 91 mOS, mo 23.5 (18.8, 31.7) 13.0 (10.7, 15.4) 24.4 (18.7, 30.3) 21.4 (16.5, 28.3) HR (CI) 0.54 (0.42, 0.7) 0.92 (0.64, 1.33) mPFS, mo 5.6 (5.2, 7.4) 3.6 (2.7, 3.7) 5.7 (5.5, 7.5) 3.7 (1.9, 5.5) HR (CI) 0.47 (0.37, 0.61) 0.69 (0.48, 0.98)
- Pooled analysis in first-line HCC: Immune checkpoint inhibitor vs tyrosine kinase inhibitor regimens (Hall 25) - Jul 24, 2025 - Abstract #ESMO2025ESMO_2924;
By leveraging pseudo-IPD, we offer a methodologically innovative approach through pooled analysis, which can inform clinical practice in therapy selection. Legal entity responsible for the study The Larvol Group LLC, San Francisco, CA.
- AiTan (rivoceranib) / HLB Bio Group, AiRuiKa (camrelizumab) / HLB Bio Group
Effectiveness and safety of camrelizumab plus rivoceranib combined with TACE with or without HAIC in first-line treatment of unresectable hepatocellular carcinoma (Hall 25) - Jul 24, 2025 - Abstract #ESMO2025ESMO_2915;
P, P4
Legal entity responsible for the study The Larvol Group LLC, San Francisco, CA. Conclusions Camrelizumab plus rivoceranib combined with TACE
- AiTan (rivoceranib) / HLB Bio Group, AiRuiKa (camrelizumab) / HLB Bio Group
Neoadjuvant therapy of sequential transcatheter arterial chemoembolization, camrelizumab and apatinib for single large hepatocellular carcinoma (NEO-START): A randomized controlled trial (Hall 25) - Jul 24, 2025 - Abstract #ESMO2025ESMO_2913;
P3
Postoperative complication rates were similar between the two groups. Conclusions Neoadjuvant therapy of sequential TACE, camrelizumab and apatinib showed acceptable safety and significant antitumor activity in patients with single large HCC.
- AiRuiKa (camrelizumab) / HLB Bio Group, Lenvima (lenvatinib) / Eisai, Merck (MSD)
Neoadjuvant TACE plus lenvatinib and camrelizumab for borderline resectable hepatocellular carcinoma: Updated results of the BRHCC-I phase Ib/II trial (Hall 25) - Jul 24, 2025 - Abstract #ESMO2025ESMO_2911;
P1/2
Table: 1478P Efficacy of the phase Ib/II trial (BRHCC-I) Variable Phase Ib/II ( n = 59) Phase Ib-A ( n = 3) Phase Ib-B ( n = 3) Phase II ( n = 53) Phase Ib-B/II (n = 56) Surgery resectable rate 48 (81.4) 2 (66.7) 2 (66.7) 44 (83.0) 46 (82.1) # MPR (%) 31 (64.6) 2 (100.0) 2 (100.0) 27 (61.4) 29 (63.0) # pCR (%) 10 (20.8) 0 (0) 1 (50.0) 9 (20.5) 10 (21.7) ORR per mRECIST (%) 43 (72.9) 1 (33.3) 3 (100.0) 39 (73.6) 42 (75.0) DCR per mRECIST (%) 57 (96.6) 2 (66.7) 3 (100.0) 52 (98.1) 55 (98.2) CR (%) 5 (8.5) 0 (0) 1 (33.3) 4 (7.5) 5 (8.9) PR (%) 38 (64.4) 1 (33.3) 2 (66.7) 35 (66.0) 37 (66.1) SD (%) 14 (23.7) 1 (33.3) 0 (0) 13 (24.5) 13 (23.2) PD (%) 2 (3.4) 1 (33.3) 0 (0) 1 (1.9) 1 (1.8) # 2-year cumulative RFS% 48.8% 50.0% 50.0% 48.0% 52.6% Conclusions The updated BRHCC-I study data reinforce the efficacy and safety of neoadjuvant TACE combined with lenvatinib and camrelizumab in BRHCC. These findings provide compelling evidence supporting this triplet neoadjuvant approach in a forthcoming randomized multicenter phase III trial.
- AiRuiKa (camrelizumab) / HLB Bio Group
Neoadjuvant Camrelizumab with Chemotherapy in PD-L1-Negative Locally Advanced Cervical Cancer: An Open-Label, Multi-Center, Single-Arm, Phase 2 Trial [WITHDRAWN] (Hall 25) - Jul 24, 2025 - Abstract #ESMO2025ESMO_2724;
- AiRuiKa (camrelizumab) / HLB Bio Group
Three-Year Survival Outcomes and Correlative Analyses from the NACI Study: Neoadjuvant Chemotherapy Plus Camrelizumab for Locally Advanced Cervical Cancer [WITHDRAWN] (Hall 25) - Jul 24, 2025 - Abstract #ESMO2025ESMO_2709;
- AiRuiLi (adebrelimab) / Jiangsu Hengrui Pharma
Neoadjuvant adebrelimab plus chemotherapy for locally advanced cervical cancer: A prospective, single-arm, phase II trial (Hall 25) - Jul 24, 2025 - Abstract #ESMO2025ESMO_2664;
P4
In our exploratory analysis, we observed a significant increase in the number of T cells and myeloid cells in treatment-responsive patients. Conclusions The combination of adebrelimab and chemotherapy as a neoadjuvant treatment for LACC demonstrates favorable efficacy and manageable safety.
- Avastin (bevacizumab) / Roche, AiRuiYi (fluzoparib) / Jiangsu Hengrui Pharma
Efficacy and Safety of Fuzuloparib Combined with Bevacizumab as Maintenance Treatment in PARPi-Pretreated Platinum-Sensitive Recurrent Ovarian Cancer: A Phase II Study [WITHDRAWN] (Hall 25) - Jul 24, 2025 - Abstract #ESMO2025ESMO_2644;
- AiRuiLi (adebrelimab) / Jiangsu Hengrui Pharma
Preoperative short-course radiotherapy followed by chemotherapy and PD-L1 inhibitor for locally advanced rectal cancer: A prospective phase II study (Hall 25) - Jul 24, 2025 - Abstract #ESMO2025ESMO_2394;
This phase II study evaluated the efficacy and safety of preoperative short-course radiotherapy (SCRT) followed by chemotherapy and PD-L1 inhibitor (Adebrelimab) in LARC...Conclusions This novel SCRT-chemo-immunotherapy regimen achieved high cCR (73.7%) and sphincter preservation (92.8%) rates of cCR patients who opted for non-surgical management in LARC, with shortened treatment duration and manageable toxicity (45% grade?3 AEs). The favorable efficacy-safety profile warrants phase III validation.
- Xuan Yue Ning (bireociclib) / Sihuan Pharmaceutical
Matching-adjusted indirect comparison of bireociclib plus fulvestrant versus dalpiciclib Plus fulvestrant as second-line treatment of HR+/HER2- advanced breast cancer (ABC) (Hall 25) - Jul 24, 2025 - Abstract #ESMO2025ESMO_2272;
P3
Conclusions This MAIC analysis suggests comparable efficacy between bireociclib and dalpiciclib when combined with fulvestrant in HR+/HER2- ABC patients who progressed on or after prior endocrine therapy. The two agents display distinct safety profiles, with dalpiciclib showing more severe hematological toxicities and bireociclib exhibiting more gastrointestinal adverse events.
- AiRuiKang (dalpiciclib) / Jiangsu Hengrui Pharma
Efficacy and safety of dalpiciclib combined with endocrine therapy after progression on prior CDK4/6 inhibitors in HR+/HER2- advanced breast cancer (Hall 25) - Jul 24, 2025 - Abstract #ESMO2025ESMO_2271;
Subgroups including those without liver metastases, with secondary endocrine resistance, and receiving sequential CDK4/6i therapy appear to derive greater benefit. Legal entity responsible for the study The authors.
- AiTan (rivoceranib) / HLB Bio Group, AiRuiLi (adebrelimab) / Jiangsu Hengrui Pharma
Adebrelimab plus apatinib and etoposide in the treatment of HER2-negative breast cancer brain metastasis: A phase II study (Hall 25) - Jul 24, 2025 - Abstract #ESMO2025ESMO_2243;
P2
No grade 4 AEs were reported. Conclusions The combination of adebrelimab, apatinib and etoposide is well-tolerated and demonstrates initial anti-tumor efficacy, offering an alternative treatment strategy for HER2-negative BCBM.
- tizetatug rezetecan (SHR-A1921) / Jiangsu Hengrui Pharma
SHR-A1921, a novel trophoblast cell-surface antigen 2 targeted antibody-drug conjugate, with or without adebrelimab in advanced triple-negative breast cancer (TNBC): Data from two open-label, multicenter clinical trials (Hall 25) - Jul 24, 2025 - Abstract #ESMO2025ESMO_2231;
P1, P1/2
DCR, disease control rate; PFS, progression-free survival. Conclusions SHR-A1921 with or without adebrelimab showed favorable efficacy and safety profile in pts with advanced TNBC.
- trastuzumab rezetecan (SHR-A1811) / Jiangsu Hengrui Pharma, AiRuiLi (adebrelimab) / Jiangsu Hengrui Pharma
SHR-A1811 combined with adebrelimab in HR-/HR-low, HER2-low metastatic breast cancer: Preliminary results from an open-label, single-arm, phase II trial (Hall 25) - Jul 24, 2025 - Abstract #ESMO2025ESMO_2223;
P2
10 pts (41.67%) experienced grade ?3 TEAEs. Conclusions Preliminary results of SHR-A1811 combined with Adebrelimab in HR-negative/HR-low, HER2-low MBC pts yields promising antitumor efficacy with manageable toxicity.
- Irene (pyrotinib) / Jiangsu Hengrui Pharma, Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Efficacy and safety of pyrotinib-based therapy after prior trastuzumab and pertuzumab in HER2-positive metastatic breast cancer: A multicenter, retrospective, real-world study (Hall 25) - Jul 24, 2025 - Abstract #ESMO2025ESMO_2218;
Conclusions This study first retrospectively analyze the value of pyrotinib in the era of dual anti-HER2 therapy, preliminarily showing good efficacy and safety of pyrotinib in patients after prior trastuzumab and pertuzumab. Legal entity responsible for the study The Fifth Medical Center of Chinese PLA General Hospital.
- Irene (pyrotinib) / Jiangsu Hengrui Pharma, Cipterbin (inetetamab) / 3SBio
A retrospective multicenter cohort study on the efficacy and safety of inetetamab and pyrotinib combined with chemotherapy (IPyC) for HER2+ metastatic breast cancer (Hall 25) - Jul 24, 2025 - Abstract #ESMO2025ESMO_2217;
Funding Fujian Provincial Health Technology Project (grant number: 2022GGB012). Table: 545P Characteristics 1st L 2nd L Higher L Median age (range), years 47 (26-65) 49 (27-78) 47 (27-74) ER/PR Positive 51 48 47 Negative 45 50 60 HER2 status IHC 3+ 69 80 91 IHC 2+ & FISH + 27 18 16 Previous anti-HER2 therapy H or HP only 53 92 15 H or HP combined with TKI 0 5 81 Na
- TQB2102 / Sino Biopharm
Preliminary efficacy and safety of TQB2102 in patients with HER2 positive recurrent/metastatic breast cancer: Results from a phase Ib study (Hall 25) - Jul 24, 2025 - Abstract #ESMO2025ESMO_2210;
P1
The recommended dose of TQB2102 in HER2 positive r/m BC was 6.0 mg/kg Q3W. A phase III trial to evaluate the efficacy and safety of TQB2102 versus Trastuzumab Emtansine in HER2 positive r/m BC is currently ongoing.
- trastuzumab rezetecan (SHR-A1811) / Jiangsu Hengrui Pharma
SHR-A1811 plus pertuzumab in human epidermal growth factor receptor 2-positive (HER2+) unresectable/metastatic breast cancer: Results from a phase Ib/II study (Munich Auditorium - CityCube B) - Jul 24, 2025 - Abstract #ESMO2025ESMO_2208;
P2
The most common TRAE was decreased neutrophil count (86.7%, [54.7%, ?G3]), no deaths or interstitial lung disease were reported. Table: 536MO Efficacy summary Phase 2 SHR-A1811 + pertuzumab Total (phase 1b + phase 2 N=75) 3.2 mg/kg (N=11) 4.8 mg/kg (N=22) 6.4 mg/kg (N=32) ORR, n (%, 95% CI) 7 (63.6, 30.8-89.1) 19 (86.4, 65.1-97.1) 27 (84.4, 67.2-94.7) 58 (77.3, 66.2-86.2) median PFS, months (95% CI) 27.8 (16.6-NR) NR (22.3-NR) NR (NR-NR) NR (22.9-NR) 12-months PFS rate, % (95% CI) 100.0 (100.0-100.0) 90.5 (67.0-97.5) 96.4 (77.2-99.5) 91.0 (81.0-95.8) Conclusions SHR-A1811 plus pertuzumab demonstrated favorable efficacy and safety profile in pts with HER2+ unresectable/metastatic breast cancer.
- JS105 / Shanghai Junshi Biosci, Risen (Suzhou) Biosci
Efficacy and safety of JS105, a selective inhibitor of mutant PI3K?, in patients with advanced cancer (Hall 25) - Jul 24, 2025 - Abstract #ESMO2025ESMO_2144;
P1, P1/2
Among the 23 patients with PIK3CA mutations, the ORR and DCR were 39.1% and 87.0% (Table). Table: 466P The best overall response of two studies (Based on investigator assessment per RECIST 1.1) Monotherapy Study Combination Therapy Study Evaluable patients with PIK3CA mutation and measurable lesions, n 32 23 Best Overall Response, n (%) Complete Response (CR) 0 0 Partial Response (PR) 9 (28.1) 9 (39.1) Stable Disease (SD) 19 (59.4) 11 (47.8) Progressive Disease (PD) 4 (12.5) 3 (13.0) Objective Response Rate (ORR), %, (95% CI) 28.1 (13.7, 46.7) 39.1 (19.7, 61.5) Disease Control Rate (DCR), %, (95% CI) 87.5 (71.0, 96.5) 87.0 (66.4, 97.2) Conclusions JS105 monotherapy or combination therapy demonstrated a favorable safety profile and promising efficacy in patients with advanced cancer.
- Keytruda (pembrolizumab) / Merck (MSD), Opdivo (nivolumab) / Ono Pharma, BMS, AiRuiKa (camrelizumab) / HLB Bio Group
Evaluating the efficacy and safety of NEOadjuvant CHEmoimmunotherapy in early estrogen receptor low (1 (Hall 25) - Jul 24, 2025 - Abstract #ESMO2025ESMO_2035;
Table: 466P The best overall response of two studies (Based on investigator assessment per RECIST 1.1) Monotherapy Study Combination Therapy Study Evaluable patients with PIK3CA mutation and measurable lesions, n 32 23 Best Overall Response, n (%) Complete Response (CR) 0 0 Partial Response (PR) 9 (28.1) 9 (39.1) Stable Disease (SD) 19 (59.4) 11 (47.8) Progressive Disease (PD) 4 (12.5) 3 (13.0) Objective Response Rate (ORR), %, (95% CI) 28.1 (13.7, 46.7) 39.1 (19.7, 61.5) Disease Control Rate (DCR), %, (95% CI) 87.5 (71.0, 96.5) 87.0 (66.4, 97.2) Conclusions JS105 monotherapy or combination therapy demonstrated a favorable safety profile and promising efficacy in patients with advanced cancer. Table: 314P Study ER-low Patients, n Age (years), median (range) Type of ICI Type of taxane PROMENADE 2024 114 49 (26