- |||||||||| Irene (pyrotinib) / Jiangsu Hengrui Pharma, Herceptin (trastuzumab) / Roche, Perjeta (pertuzumab) / Roche
Pertuzumab versus pyrotinib in combination with trastuzumab and taxanes for first-line (1L) treatment of patients with HER2 (Exhibition (Poster area)) - Oct 3, 2025 - Abstract #ESMOAsia2025ESMO_Asia_293; Compared with the THP ,THPy significantly improved PFS in patients with untreated HER2+MBC. Notably, THPy demonstrated superior survival benefits specifically in subgroups with:premenopausal status, ECOG PS 0, de novo stage IV disease, previous untreated trastuzumab, Ki-67 ?20%, and liver metastases.
- |||||||||| AiRuiKang (dalpiciclib) / Jiangsu Hengrui Pharma, HHPG-19K (mecapegfilgrastim) / Jiangsu Hengrui Pharma
Efficacy and safety of mecapegfilgrastim for prophylaxis of dalpiciclib-induced neutropenia in patients with advanced HR+/HER2- breast cancer: A multicenter, open-label, randomized controlled phase II trial (Exhibition (Poster area)) - Oct 3, 2025 - Abstract #ESMOAsia2025ESMO_Asia_291; P2 Notably, THPy demonstrated superior survival benefits specifically in subgroups with:premenopausal status, ECOG PS 0, de novo stage IV disease, previous untreated trastuzumab, Ki-67 ?20%, and liver metastases. Mecapegfilgrastim reduced the incidence of grade ?3 dalpiciclib- induced neutropenia in the first cycle, thereby decreasing the rates of dalpiciclib interruption, dose reduction and discontinuation.
- |||||||||| plinabulin (BPI 2358) / BeyondSpring
Immune Activation with Plinabulin Promotes Monocyte-Macrophage Responses Combining Radiation with Immune Checkpoint Blockade (ICB) in ICB-Relapsed/Refractory Tumors (Poster Hall (Exhibit Halls AB); Virtual) - Oct 3, 2025 - Abstract #SITC2025SITC_993; P1/2 There was no baseline difference in TIIC-associated GEF-H1 immune scores between PR+SD and PD groups, whereas total MoMac-associated GEF-H1 immune score was higher in PD group when compared to PR+SD group. Further subgroup analysis of MoMac I-IV suggests that AGR1+ MoMac-III may represent the dominating pro-tumor M2 phenotype and that plinabulin combined with RT+ICB drives differential monocyte-macrophage responses in responders.Conclusions In addition to maturation of DCs to generate a systemic immune response, plinabulin combined with radiation and ICB promotes proinflammatory monocytes and M1 polarization via a GEF-H1-dependent mechanism with the potential of overcoming acquired ICB resistance from pro-tumor macrophages.Ethics Approval Among the 19 patients evaluable for safety, 1 male (Hispanic or Latino) patient entered 'other' ethnics and should be added to the 18 patients under 'Racial Categories'.
- |||||||||| AiRuiKa (camrelizumab) / HLB Bio Group, Lenvima (lenvatinib) / Eisai, Merck (MSD)
Journal, Checkpoint inhibition: Overlapping Syndrome of Myocarditis, Myositis, Transaminitis, and Myasthenia Gravis in a Patient with Hepatocellular Carcinoma after Treatment with Immune Checkpoint Inhibitors: A Case Report and Literature Review. (Pubmed Central) - Oct 3, 2025 IrAEs are common after ICI treatment. After ICI treatment initiation, close monitoring, early detection, and treatment of irAEs is required to improve clinical outcomes.
- |||||||||| HR091506 / Jiangsu Hengrui Pharma
Trial completion, Trial completion date, Trial primary completion date: Clinical Study of HR091506 Tablets in Treatment of Gout With Hyperuricemia in Adults (clinicaltrials.gov) - Oct 2, 2025 P3, N=765, Completed, After ICI treatment initiation, close monitoring, early detection, and treatment of irAEs is required to improve clinical outcomes. Not yet recruiting --> Completed | Trial completion date: Jun 2025 --> Sep 2025 | Trial primary completion date: Nov 2024 --> Aug 2025
- |||||||||| AiSuDa (ivarmacitinib) / Jiangsu Hengrui Pharma, Arcutis
Clinical, P1 data, PK/PD data, Journal: Pharmacokinetics, Relative Bioavailability, and Safety of the SHR0302 Oral Solution and Tablets: A Single-Center, Randomized, Open-Label, Crossover (Two-Formulation, Two-Period) Phase I Trial in Healthy Chinese Volunteers. (Pubmed Central) - Oct 2, 2025 In healthy Chinese male volunteers, the bioavailability of the SHR0302 oral solution was comparable to that of the SHR0302 tablet. The drug was safe and well tolerated following a single dose.
- |||||||||| Clinical, Retrospective data, Review, Journal, Checkpoint inhibition, PD(L)-1 Biomarker, IO biomarker: Efficacy and safety of immune checkpoint inhibitors for advanced squamous non-small cell lung cancer: a systematic review and network meta-analysis. (Pubmed Central) - Oct 2, 2025
For PD-L1?50% tumors, penpulimab showed excellent OS and PFS; for PD-L1 1-49% tumors, pembrolizumab+chemo and camrelizumab+chemo achieved the best OS and PFS, respectively; for PD-L1?1% tumors, the tislelizumab+chemo and camrelizumab+chemo showed the best OS and PFS results, while for tumors with PD-L1 <1%, both nivolumab and serplulimab+chemo provided significant survival benefit...Ipilimumab+chemo had the highest incidence of adverse events (AEs) [OR = 2.0, 95% CI:(1.5-2.7)]. https://www.crd.york.ac.uk/prospero/, identifier CRD420251027447.
- |||||||||| ByFavo (remimazolam) / PAION, Cosmo Pharma, Mundipharma, Pharmascience, Eagle Pharma, remimazolam tosylate (HR-7056) / Jiangsu Hengrui Pharma
Journal, Intubation: Comparison of remimazolam tosylate and sevoflurane for anesthesia induction with preserved spontaneous respiration during tracheal intubation: a prospective, single-center, randomized controlled trial. (Pubmed Central) - Oct 2, 2025 https://www.crd.york.ac.uk/prospero/, identifier CRD420251027447. Compared with sevoflurane, remimazolam can be safely and effectively used for intubation while preserving spontaneous breathing, with a shorter time to achieve conditions for topical anesthesia and intubation.
- |||||||||| AnDaJing (vunakizumab) / Jiangsu Hengrui Pharma
Clinical, P3 data, Retrospective data, Journal: Efficacy and safety of vunakizumab in patients with moderate-to-severe plaque psoriasis across different regions of China: a post-hoc exploratory analysis of a phase III, randomized controlled trial. (Pubmed Central) - Sep 29, 2025 P3 The incidence of adverse events was 80.5%, 90.1%, and 90.1% in the North, Central, and South China groups, respectively. The efficacy and safety of vunakizumab are not affected by different regions of China in patients with moderate-to-severe plaque psoriasis.
- |||||||||| AnDaJing (vunakizumab) / Jiangsu Hengrui Pharma
Journal: Vunakizumab for Treatment of Acrodermatitis Continua of Hallopeau: A Case Report and Literature Review. (Pubmed Central) - Sep 29, 2025 Emerging evidence indicates that elevated IL-17 levels modulate keratinocyte proliferation and immune cell infiltration, contributing to ACH pathogenesis and representing a promising therapeutic target. Herein, we presented a case of ACH successfully treated with vunakizumab, China's first self-developed anti-IL-17A monoclonal antibody, and reviewed publications reporting IL-17 targeted therapies for ACH, highlighting the potential benefit of IL-17 targeted therapy in ACH management.
- |||||||||| leucovorin calcium / Generic mfg., AiRuiYi (fluzoparib) / Jiangsu Hengrui Pharma, Lynparza (olaparib) / Merck (MSD), AstraZeneca
Journal, BRCA Biomarker, PARP Biomarker: Continuous response to maintenance fuzuloparib for germline BRCA2- mutated metastatic pancreatic adenocarcinoma: a case report and literature review. (Pubmed Central) - Sep 25, 2025 Despite showing improved efficacy and a more favorable safety profile compared to olaparib in preclinical studies, clinical evidence for its application in pancreatic adenocarcinoma harboring gBRCAm remains limited...This case underscores the important role of biomarker-directed therapy in pancreatic adenocarcinoma and fuzuloparib may represent a potential PARP inhibitor option for maintenance treatment in pancreatic adenocarcinoma with gBRCAm. However, large-scale randomized controlled trials are needed to validate these results.
- |||||||||| colchicine / Generic mfg., plinabulin (BPI 2358) / BeyondSpring
Review, Journal: Dynamic Microtubules as Sensors in Animal Cells. (Pubmed Central) - Sep 25, 2025 In tissue cells with stable morphologies, the sensory functions of microtubules may be as or more important than their architectural functions. This re-framing of microtubule biology suggests new directions for mechanistic inquiry and drug discovery.
- |||||||||| rivocibart (SHR-1918) / Jiangsu Hengrui Pharma
Enrollment closed, Trial primary completion date: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of SHR-1918 in Patients With Homozygous Familial Hypercholesterolemia (clinicaltrials.gov) - Sep 24, 2025 P3, N=55, Active, not recruiting, This re-framing of microtubule biology suggests new directions for mechanistic inquiry and drug discovery. Recruiting --> Active, not recruiting | Trial primary completion date: May 2025 --> Aug 2025
- |||||||||| AiRuiKang (dalpiciclib) / Jiangsu Hengrui Pharma, letrozole / Generic mfg.
Journal: Case Report: Synchronous cervical, gastric and rectal metastases in occult breast cancer. (Pubmed Central) - Sep 24, 2025 Following six months of treatment with letrozole (1mg/day) in combination with dalpiciclib the patient demonstrated significant symptomatic relief, with remarkable reduction in the lesions located in the cervix, stomach, and rectum. This case represents the first documented instance of occult primary breast cancer with simultaneous metastases to the cervix, stomach, and rectum.
- |||||||||| AiRuiKa (camrelizumab) / Elevar Therapeutics, famitinib (SHR 1020) / Jiangsu Hengrui Pharma
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: A Study to Evaluate SHR-1210 in Combination With Famitinib Plus Chemotherapy in Subjects With NSCLC. (clinicaltrials.gov) - Sep 23, 2025 P3, N=48, Terminated, Despite advancements in anti-HER2 therapies, further research is required to address remaining challenges in this specific clinical scenario. N=560 --> 48 | Trial completion date: Oct 2023 --> Aug 2025 | Recruiting --> Terminated | Trial primary completion date: Dec 2022 --> Aug 2025; Terminated by Sponsor
- |||||||||| HR19042 / Jiangsu Hengrui Pharma
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date: A Study to Evaluate the Efficacy and Safety of HR19042 Capsules in the Treatment of Primary IgA Nephropathy. (clinicaltrials.gov) - Sep 23, 2025 P2, N=316, Active, not recruiting, N=560 --> 48 | Trial completion date: Oct 2023 --> Aug 2025 | Recruiting --> Terminated | Trial primary completion date: Dec 2022 --> Aug 2025; Terminated by Sponsor Recruiting --> Active, not recruiting | N=210 --> 316 | Trial completion date: May 2024 --> Nov 2025 | Trial primary completion date: Feb 2024 --> Nov 2025
- |||||||||| AnDaJing (vunakizumab) / Jiangsu Hengrui Pharma
PK/PD data, Journal: Safety, pharmacokinetics, and bioequivalence of vunakizumab injection, a specific dermatitis drug, in healthy Chinese volunteers: an open-label, randomized, two-stage, two-sequence cross-over study. (Pubmed Central) - Sep 23, 2025 P1 Both injection devices were well-tolerated in terms of safety. Participants preferred a single 2?mL subcutaneous injection over two 1?mL subcutaneous injections.Clinical Trial Registration www.clinicaltrials.gov, identifier: NCT06182384.
- |||||||||| AiRuiKa (camrelizumab) / HLB Bio Group
Biomarker, Journal, PD(L)-1 Biomarker, IO biomarker: Predicting Postoperative Pneumonia in ESCC After Neoadjuvant Chemo-Immunotherapy: Combined Use of ARISCAT Score and Inflammatory Biomarkers. (Pubmed Central) - Sep 22, 2025 We retrospectively analyzed 312 patients with resectable ESCC who underwent two cycles of platinum-based chemotherapy plus camrelizumab followed by McKeown esophagectomy between 2018 and 2023...Integrating ARISCAT with inflammatory biomarkers enhances predictive performance, enabling refined preoperative risk stratification and potentially guiding targeted preventive strategies. Prospective multicenter validation is warranted.
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