Anniko (penpulimab) / Akesobio, Sino Biopharm, Specialised Therap - LARVOL DELTA

Anlotinib plus penpulimab versus sorafenib in the first-line treatment of unresectable hepatocellular carcinoma (APOLLO): a randomised, controlled, phase 3 trial. (PubMed, Lancet Oncol) - P3 | "Anlotinib plus penpulimab significantly improved progression-free survival and overall survival versus sorafenib in unresectable HCC and might be a new first-line option. These findings require verification in other regions of the world."

Journal • P3 data • Cardiovascular • Hepatocellular Cancer • Hepatology • Hypertension • Liver Failure • Oncology • Solid Tumor • AFP

Integrated penpulimab (a PD-1 inhibitor), anlotinib (an antiangiogenic targeted drug), nab-paclitaxel and gemcitabine as first-line regimen for metastatic pancreatic cancer: A multi-centered, randomized controlled trial (RCT-PAAG). (ASCO-GI 2026) - P2 | "The integrated regimen involving Penpulimab, Anlotinib, Nab-Paclitaxel and Gemcitabine appears to be a more preferable choice than Gemcitabine-based chemotherapy alone for the first-line treatment of mPC on account of its improved efficacy and acceptable safety. Future follow-up is warranted in confirmation of its impact on OS."

Clinical • IO biomarker • Metastases • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Final Analysis of AK105-302: A Randomized, Double-blind, Placebo-Controlled, Phase III Trial of Penpulimab Plus Carboplatin and Paclitaxel as First-line Treatment for Advanced Squamous NSCLC (ESMO-IO 2022) - P3 | "Serious TRAEs occurred in 28.3% (P+C) vs. 26.9% (C). TRAEs led to treatment discontinuation were 5.2% in P+C and 3.4% in C. Conclusions These positive data will support penpulimab plus chemotherapy may be a promising and safe first-line treatment for locally advanced or metastatic squamous NSCLC."

Clinical • P3 data • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Primary results from the phase III ALTN-AK105-III-02 study: Anlotinib plus penpulimab versus sorafenib as first-line (1L) therapy for advanced hepatocellular carcinoma (aHCC) (ESMO 2024) - P3 | "The combination of anlotinib + penpulimab significantly prolonged PFS and OS vs sorafenib with no new safety signals observed, and presents as a new 1L treatment option for aHCC."

Clinical • Late-breaking abstract • Metastases • P3 data • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • AFP • FGFR • KIT

A prospective phase 2 study on efficacy and safety of AK105, anlotinib combined with nab-paclitaxel (nab-P) as a first-line therapy in patients(pts) with advanced triple-negative breast cancer (TNBC). (SABCS 2024) - P2 | "The combination of AK105, anlotinib and nab-P showed better treatment response and tolerable toxicity in the treatment of first-line patients with TNBC. Further studies enrolling more patients are still needed."

Clinical • Metastases • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PD-L2 • PGR

Penpulimab versus placebo in combination with chemotherapy as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma: A global, multicenter, randomized, double-blind, phase 3 trial (AK105-304) (AACR 2025) - P3 | "Penpulimab combined with gemcitabine and cisplatin or carboplatin demonstrated statistically significant and clinically meaningful benefit with a manageable safety profile, and provides a new beneficial treatment option in the first-line treatment for R/M NPC patients globally."

Clinical • Combination therapy • Metastases • P3 data • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

Updated results of anlotinib combined with penpulimab and nab-paclitaxel as first-line treatment for advanced esophageal squamous cell carcinoma (ESCC): A single-arm, open-label phase II clinical trial. (ASCO-GI 2026) - P=N/A | "The combination of anlotinib plus penpulimab and nab-paclitaxel as first-line therapy demonstrated promising efficacy and manageable safety profile in patients with advanced ESCC. These findings warrant confirmation in large randomized trials."

Clinical • Metastases • P2 data • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Oncology • FLT1

Efficacy and safety of immune checkpoint inhibitors for advanced squamous non-small cell lung cancer: a systematic review and network meta-analysis. (PubMed, Front Immunol) - "Compared with chemotherapy, except for ipilimumab+chemo [HR = 0.92,95%CI: (0.59-1.40)], atezolizumab+chemo [HR = 0.88, 95%CI: (0.56-1.40)], and durvalumab+chemo [HR = 0.84, 95% CI: (0.52-1.40)], durvalumab+ tremelimumab+chemo [HR = 0...Cemiplimab [HR = 0.48, 95% CI: (0.34-0.67)] showed the best OS benefit...Sugemalimab+chemo provided the best survival benefit [HR = 0.34, 95% CI: (0.24-0.48)]. 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."

Checkpoint inhibition • Clinical • IO biomarker • Journal • Retrospective data • Review • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Clinical Studies for the Treatment of Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=194 | Recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. | N=134 ➔ 194

Enrollment change • Solid Tumor

A pathomics model for predicting response to chemo-immunotherapy in lung squamous cell carcinoma: A multicenter study. (PubMed, Lung Cancer) - "We developed a GEP-based pathomics model that provides a practical, cost-effective strategy to identify patients most likely to derive superior survival benefit from first-line CIT over chemotherapy alone."

Clinical • IO biomarker • Journal • Non Small Cell Lung Cancer • Oncology • Squamous Cell Carcinoma

3D-Ultrastructural Organization of the Macula Utricle Supporting Cell Cytoplasmic Granules (ARO 2026) - "Previous scanning electron microscopy studies had revealed secretory granules in the cytoplasm of vestibular SCs (Takumida and Anniko, Acta Otol 114:2,150-155,1994)... This study reveals, for the first time, the 3D ultrastructural organization of secretory granules in mouse utricular SCs, and their presence in the human macula utricle. Otopetrin-2 may be among the proteins present in the SCs granules. Insights into SC organization may inform future strategies for hair cell regeneration and cell survival after ototoxic damage or aging."

GFAP

Exploration of the mechanism of anlotinib in reversing PD-1 immunotherapy resistance: Insights from single-cell sequencing (ESMO-IO 2025) - "This study explores how anlotinib reverses penpulimab (PD-1 inhibitor) resistance via single-cell sequencing.Methods A penpulimab-resistant model (PD-R) was established by inoculating Lewis lung cancer cells into humanized PD-1 mice with repeated penpulimab dosing. Apoe+ M2, Srgn+ M1 macrophages, and Cxcl2+ T cells are key targets. Findings highlight anti-angiogenic-immunotherapeutic combination potential in resistant tumors."

IO biomarker • Lung Cancer • Oncology • Solid Tumor • APOE • TNFA

An Exploratory Clinical Study for Neoadjuvant Treatment of HER2-low Expressing, Stage II-III Breast Cancer with Vedolizumab in Combination with Pembrolizumab (SABCS 2025) - "Background: HER2-low expressing breast cancer is a heterogenous subtype with limited targeted therapeutic options. Although the clinical benefit may be limited, the combination of Disitamab Vedotin and Penpulimab as neoadjuvant treatment for HER2-low expressing, stage II-III breast cancer shows manageable safety and potential for further refinement, warranting additional investigation to optimize treatment strategies. Pretreatment CD4+ TIL density and total immune infiltration may serve as predictive markers for neoadjuvant response."

Clinical • Combination therapy • IO biomarker • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • CD4 • CD8 • HER-2 • PD-L1

Penpulimab combined with anlotinib as first-line chemotherapy-free regimen in elderly patients with advanced NSCLC: A phase II single-center study (ESMO Asia 2025) - P=N/A | "This chemotherapy-free combination shows promising efficacy and manageable toxicity in elderly advanced NSCLC, supporting its potential as a tailored strategy for this vulnerable population."

Clinical • IO biomarker • Metastases • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A cost-effectiveness analysis of a new and more effective treatment for unresectable hepatocellular carcinoma-from a Chinese perspective. (PubMed, Ann Med) - "In 99.9% of the simulations, the incremental cost of each QALY gained by the anlotinib plus penpulimab group was less than $37,944.50. Under the threshold of three times China's per capita GDP, anlotinib plus penpulimab is more cost-effective compared with sorafenib."

HEOR • Journal • Hepatocellular Cancer • Oncology • Solid Tumor

Penpulimab: All 4 Approved Indications Now Covered by NRDL (PRNewswire) - "Penpulimab, a differentiated PD-1 monoclonal antibody, participated in the national reimbursement negotiation for the first time in 2025....During this negotiation, penpulimab successfully secured NRDL inclusion for all four of its approved indications: first-line treatment of squamous NSCLC, first-line treatment of NPC, ≥3L treatment of NPC, and ≥3L treatment of relapsed/refractory classical Hodgkin lymphoma (R/R cHL)."

Reimbursement • Hodgkin Lymphoma • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer

A Prospective, Open-Label, Multicenter, Randomized Controlled Study Comparing the Efficacy and Safety of Polatuzumab Vedotin, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone Combined with Orelabrutinib/Chidamide/Venetoclax/Lenalidomide/Penpulimab (Pola-RCHP-X) Versus RCHOP-X and Pola-Rchp in Previously Untreated Patients with Diffuse Large B-Cell Lymphoma (ASH 2024) - P2 | "The primary endpoint of the study is progression-free survival at 24 months (PFS24) as assessed by the investigators. Secondary endpoints include investigator-assessed complete response (CR) rate, overall response rate (ORR), event-free survival (EFS), overall survival (OS), and safety."

Clinical • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20 • TP53

Cost-effectiveness analysis of anlotinib plus penpulimab versus sorafenib in the treatment of unresectable hepatocellular carcinoma. (PubMed, Hum Vaccin Immunother) - "Scenario analysis results showed that the Patient Assistance Program of penpulimab could help the regimen achieve favorable cost-effectiveness. Compared with sorafenib, anlotinib plus penpulimab for unresectable HCC patients was unlikely cost-effective under the perspective of the Chinese healthcare system."

HEOR • Journal • Hepatocellular Cancer • Oncology • Solid Tumor

Toripalimab and Penpulimab: Targeting PD-1 in Recurrent or Metastatic Nasopharyngeal Carcinoma. (PubMed, Ann Pharmacother) - "Toripalimab and penpulimab significantly improve outcomes in RM-NPC. Their use is anticipated to expand into additional settings and malignancies as research matures."

Journal • Review • Endocrine Disorders • Nasopharyngeal Carcinoma • Oncology • Solid Tumor • PD-1

TQB2223-AK105-Ib-01: Clinical Study of TQB2223 Injection Combined With AK105 Injection in the Treatment of Advanced Hepatocellular Carcinoma. (clinicaltrials.gov) - P1 | N=22 | Terminated | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | N=34 ➔ 22 | Recruiting ➔ Terminated | Trial primary completion date: Feb 2025 ➔ Nov 2025; This study was closed due to business reasons. Closure was not prompted by any safety or efficacy concerns.

Enrollment change • Trial primary completion date • Trial termination • Hepatocellular Cancer • Oncology • Solid Tumor

Molecular and immune correlates of response to first-line de-escalated chemotherapy plus penpulimab and anlotinib in advanced cervical cancer. (PubMed, Cancer Discov) - "Patients with a high TLS-to-tumor area ratio exhibited better survival. Our findings lay the groundwork for the feasibility of first-line de-escalated chemotherapy plus anlotinib and penpulimab in metastatic, persistent, or recurrent cervical cancer patients."

Journal • Cervical Cancer • Oncology • Solid Tumor • PD-L1

TQB2223 in Combination with Penpulimab in Patients with Relapsed or Refractory Lymphoma: Primary Analysis of an Open-Label Phase I Study (ASH 2024) - P1 | "Among 14 HL patients, 12 were previously treated with anti-PD-1/L1 and 7 were previously treated with Brentuximab vedotin. Conclusions : TQB2223 in combination with penpulimab was generally safe, well-tolerated and demonstrated encouraging efficacy in patients with lymphoma, especially in patients with Hodgkin lymphoma who has received extensive prior treatments including anti-PD-1/L1. A complex of TQB2223 and penpulimab was prepared and more clinical studies were planned."

Clinical • Combination therapy • P1 data • Atopic Dermatitis • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Dermatology • Diffuse Large B Cell Lymphoma • Dyslipidemia • Endocrine Disorders • Hematological Malignancies • Hodgkin Lymphoma • Hypertriglyceridemia • Immunology • Infectious Disease • Large B Cell Lymphoma • Lymphoma • Melanoma • Metabolic Disorders • Natural Killer/T-cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Pneumonia • Primary Mediastinal Large B-Cell Lymphoma • Respiratory Diseases • Solid Tumor • T Cell Non-Hodgkin Lymphoma • LAG3

Immune checkpoint blockers plus chemotherapy as the first-line treatment for advanced or metastatic squamous non-small-cell lung carcinoma: a network meta-analysis and economic evaluation. (PubMed, Front Pharmacol) - "The camrelizumab plus chemotherapy and penpulimab plus chemotherapy regimens showed the greatest OS benefit, while camrelizumab plus chemotherapy provided the best PFS benefit. However, with a threshold of $13,445/QALY or $40,334/QALY, camrelizumab plus chemotherapy provided greater QALY benefits than tislelizumab plus chemotherapy. Thus, camrelizumab plus chemotherapy is recommended as the preferred first-line treatment for advanced squamous non-small-cell lung cancer in this context."

Checkpoint inhibition • HEOR • Journal • Retrospective data • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A prospective, randomized, open-label, controlled clinical study comparing ivosimod combined with chemotherapy versus pamiparib combined with chemotherapy as neoadjuvant therapy for NSCLC (ChiCTR) - P2 | N=168 | Recruiting | Sponsor: Peking University People's Hospital; Peking University People's Hospital

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Efficacy and safety of adjuvant penpulimab in very high-risk clear cell renal cell carcinoma: A prospective, controlled, phase II study (ESMO 2025) - P2 | "Background The KEYNOTE-564 trial showed adjuvant pembrolizumab improved disease-free survival (DFS) in high-risk clear cell renal cell carcinoma (ccRCC), though subgroup heterogeneity existed. No treatment-related death was observed. Conclusions Adjuvant penpulimab demonstrated promising antitumor activity and manageable safety profile in ccRCC with a very high-risk of recurrence."

Clinical • P2 data • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Sarcoma • Solid Tumor