Anyouping (finotonlimab) / Sinocelltech - LARVOL DELTA

A Prospective, Single-Arm, Phase II Clinical Study of Finotonlimab Combined with Carboplatin and Nab-Paclitaxel in the Treatment of Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma (ChiCTR) - P2 | N=35 | Not yet recruiting | Sponsor: SUN YAT-SEN MEMORIAL HOSPITAL; SUN YAT-SEN MEMORIAL HOSPITAL

New P2 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A prospective, multicenter, randomized, controlled, open-label trial to evaluate the efficacy and safety of Finotonlimab in locally advanced head and neck squamous cell carcinoma (ChiCTR) - P4 | N=292 | Not yet recruiting | Sponsor: Fudan University Shanghai Cancer Center; Fudan University Shanghai Cancer Center

New P4 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Anti-PD-1 antibody (SCT-I10A) plus anti-EGFR antibody (SCT200) in patients with advanced esophageal squamous cell carcinoma: A multicenter, open-label, phase 1b clinical trial. (PubMed, Cancer) - P1 | "SCT-I10A plus SCT200 demonstrated durable antitumor activity with a manageable safety profile in previously treated patients with advanced ESCC, even in patients who had previously failed anti-PD-(L)1 therapy."

Journal • P1 data • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

Neoadjuvant Chemotherapy Combined With Finotonlimab in the Treatment of Locally Advanced Hypopharyngeal Carcinoma (clinicaltrials.gov) - P2 | N=116 | Recruiting | Sponsor: Eye & ENT Hospital of Fudan University | Not yet recruiting ➔ Recruiting

Enrollment open • Head and Neck Cancer • Hypopharyngeal Cancer • Oncology • Solid Tumor

Neoadjuvant Chemotherapy Combined With Finotonlimab in the Treatment of Locally Advanced Hypopharyngeal Carcinoma (clinicaltrials.gov) - P2 | N=116 | Not yet recruiting | Sponsor: Eye & ENT Hospital of Fudan University

New P2 trial • Head and Neck Cancer • Hypopharyngeal Cancer • Oncology • Solid Tumor

Cost-effectiveness of finotonlimab plus chemotherapy versus chemotherapy alone for recurrent or metastatic head and neck cancer in China. (PubMed, Sci Rep) - "Although finotonlimab combined with chemotherapy provides clinical benefits for patients with R/M HNSCC, it is not cost-effective at current pricing in China. Substantial price reductions, biomarker-guided patient selection, and inclusion in national reimbursement programs may improve its economic viability."

HEOR • IO biomarker • Journal • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Induction chemotherapy combined with Finotonlimab ± high and low-dose radiotherapy in Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma: a Multi-center, Open-label,Randomized Controlled Phase II Clinical Trial (ChiCTR) - P2 | N=84 | Not yet recruiting | Sponsor: Jiangxi cancer hospital; Jiangxi cancer hospital

New P2 trial • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Cost-effectiveness analysis of first-line treatments for recurrent or metastatic head and neck cancer in China: an economic evaluation based on network meta-analysis. (PubMed, Front Pharmacol) - P3 | "From the perspective of the Chinese population, finotonlimab-chemotherapy is the most cost-effective first-line treatment for R/M HNSCC, followed by cetuximab-chemotherapy. Pembrolizumab, whether as monotherapy or in combination, does not offer economic benefits."

HEOR • Journal • Retrospective data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Cost-effectiveness analysis of first-line treatments for recurrent or metastatic head and neck cancer in China: an economic evaluation based on network meta-analysis (Front Pharmacol) - "In the overall population, compared to cetuximab-chemotherapy, pembrolizumab monotherapy (ICER: 85,131.70/QALY) and pembrolizumab-chemotherapy (ICER: 203,545.22/QALY) were less cost-effective, while finotonlimab-chemotherapy (ICER: 161.13/QALY) was significantly more favorable."

HEOR

First-line immune checkpoint inhibitors plus targeted therapy versus sorafenib or lenvatinib monotherapy for unresectable or advanced hepatocellular carcinoma: a meta-analysis of phase 3 trials. (PubMed, Front Immunol) - "Eight phase 3 trials (IMbrave150, ORIENT-32, COSMIC-312, CARES-310, LEAP-002, SCT-I10A-C301, HEPATORCH, APOLLO) involving 4,379 patients were included. These findings support ICI-TT as a preferred first-line strategy for eligible patients, although individualized risk-benefit assessment remains crucial. https://www.crd.york.ac.uk/prospero/, identifier CRD420251053588."

Checkpoint inhibition • Clinical • Journal • Monotherapy • P3 data • Retrospective data • Review • Hepatocellular Cancer • Oncology • Solid Tumor

An anti-PD-1 antibody (SCT-I10A) plus anti-EGFR antibody (SCT200) and chemotherapy for RAS/BRAF wild-type metastatic colorectal cancer: A phase Ib study. (PubMed, Cancer Lett) - "Immunotherapy has demonstrated limited efficacy against microsatellite-stable (MSS) metastatic colorectal cancer (mCRC). Oxaliplatin may induce greater immune activation, with GZMA and CXCL13 serving as potential prognostic biomarkers. Thus, combining immunotherapy, EGFR inhibitors, and XELOX represents an optimal therapeutic strategy for mCRC."

IO biomarker • Journal • P1 data • Colorectal Cancer • Oncology • Solid Tumor • BRAF • CXCL13 • GZMA

HPV-positive HNSCC and Fc-silent PD-1 blockade: a clinical discrepancy that raises next immunological questions. (PubMed, J Immunother Cancer) - "The recent phase 3 trial of the Fc-silent anti-programmed cell death protein-1 (PD-1) antibody finotonlimab demonstrated promising clinical activity in recurrent/metastatic head and neck squamous cell carcinoma (HNSCC)...These considerations prompt further evaluation of how Fc engineering may interact with tumor immune contexture, particularly in virally associated cancers. We suggest experimental validation and stratified analysis in future studies to clarify these context-specific effects."

Journal • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Finotonlimab Combined With Stapokibart in the Treatment of Recurrent/ Metastatic HNSCC ( LONG'E ) (ChiCTR) - P1 | N=10 | Not yet recruiting | Sponsor: Bejing Tongren Hospital, Capital Medical Uniersity; Bejing Tongren Hospital, Capital Medical Uniersity

New P1 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Finotonlimab (PD-1 inhibitor) plus bevacizumab (bevacizumab biosimilar) as first-tier therapy for late-stage hepatocellular carcinoma: a randomized phase 2/3 trial. (PubMed, Signal Transduct Target Ther) - P2/3 | "We aimed to assess the tolerability and efficacy of finotonlimab (an anti-programmed cell death protein-1 antibody) in combination with SCT510, a bevacizumab biosimilar, versus sorafenib in unresectable advanced HCC. Median OS was also significantly longer in patients receiving finotonlimab plus SCT510 (22.1 months [18.6, not available]) than in those receiving sorafenib (14.2 months [95% CI: 10.2, 15.8]; HR: 0.60 [95% CI: 0.44, 0.81], p < 0.0008). Finotonlimab in combination with bevacizumab demonstrated favorable efficacy, in comparison to sorafenib, as a first-line treatment for unresectable HCC, with a manageable safety profile."

Clinical • Journal • P2/3 data • Hepatocellular Cancer • Oncology • Solid Tumor

Finotonlimab (PD-1 inhibitor) plus bevacizumab (bevacizumab biosimilar) as first-tier therapy for late-stage hepatocellular carcinoma: a randomized phase 2/3 trial (Nature) - P2/3 | N=405 | NCT04560894 | Sponsor: Sinocelltech Ltd. | "We aimed to assess the tolerability and efficacy of finotonlimab (an anti-programmed cell death protein-1 antibody) in combination with SCT510, a bevacizumab biosimilar, versus sorafenib in unresectable advanced HCC...The median follow-up time for the dual-agent therapy and sorafenib groups was 19.9 and 19.0 months, respectively. Median PFS, assessed by BICR according to RECIST 1.1, was significantly longer in the dual-agent group (7.1 months [95% confidence intervals {CI}: 6.1, 8.4]) than in the sorafenib group (2.9 months [95% CI: 2.8, 4.1]; stratified hazard ratio [HR]: 0.5, 95% CI: 0.38, 0.65, p < 0.0001). Median OS was also significantly longer in patients receiving finotonlimab plus SCT510 (22.1 months [18.6, not available]) than in those receiving sorafenib (14.2 months [95% CI: 10.2, 15.8]; HR: 0.60 [95% CI: 0.44, 0.81], p < 0.0008)."

P2/3 data • Hepatocellular Cancer

LONG'E: Finotonlimab Combined With Stapokibart in the Treatment of Recurrent/Metastatic HNSCC (clinicaltrials.gov) - P1 | N=10 | Not yet recruiting | Sponsor: Beijing Tongren Hospital

New P1 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Finotonlimab with taxane/platinum chemotherapy or cetuximab as first-line therapy for recurrent or metastatic head and neck squamous cell carcinoma: a real-world study (ChiCTR) - P4 | N=300 | Not yet recruiting | Sponsor: Shanghai East Hospital; Shanghai East Hospital

New P4 trial • Real-world evidence • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A Multicenter, Prospective Study of Perioperative Finotonlimab Combined With Bevacizumab in Resectable Hepatocellular Carcinoma Patients With High-Risk Factors for Recurrence (clinicaltrials.gov) - P=N/A | N=130 | Active, not recruiting | Sponsor: Tongji Hospital

New trial • Hepatocellular Cancer • Oncology • Solid Tumor

Efficacy and safety of finotonlimab plus docetaxel vs. docetaxel in previously treated advanced squamous cell non-small-cell lung cancer: a randomized, double-blinded, phase III trial. (PubMed, Transl Lung Cancer Res) - P3 | "SCT-I10A combined with docetaxel significantly prolonged OS and improved clinical outcomes in patients with treated advanced sqNSCLC compared to docetaxel, without increasing safety risk. NCT04171284, ClinicalTrials.gov."

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

Preclinical Characterization of Efficacy and Pharmacodynamic Properties of Finotonlimab, a Humanized Anti-PD-1 Monoclonal Antibody. (PubMed, Pharmaceuticals (Basel)) - "Following a 13-week successive administration of finotonlimab, a pharmacodynamic analysis revealed that a sustained mean receptor occupancy of PD-1 molecules on circulating T cells remained at or above 93% for up to 8 weeks, even at a dose of 3 mg/kg, and that there were higher antibody accumulations in different dose groups. Taken together, the preclinical findings are promising and provide the groundwork for evaluating the efficacy and pharmacodynamic characteristics of finotonlimab in clinical trials."

Journal • PK/PD data • Preclinical • Oncology • Solid Tumor

Just now! Sinocell's new anti-PD-1 monoclonal antibody cancer drug was approved for marketing [Google translation] (163.com) - "...The official website of the China National Medical Products Administration (NMPA) announced that the marketing application for the Class 1 new drug finotonlimab injection submitted by Sinocell has been approved. This is a recombinant humanized anti-PD-1 IgG4 monoclonal antibody injection independently developed by Sinocell, and its approved indication is for the first-line treatment of recurrent and/or metastatic head and neck squamous cell carcinoma in combination with platinum-containing chemotherapy."

China approval • Squamous Cell Carcinoma of Head and Neck

Neoadjuvant CAPOX plus SCT510 (bevacizumab biosimilar) and finotonlimab in high-risk resectable colorectal liver metastases (CRLM): A multicenter, phase II study (ESMO Asia 2024) - P4 | "Pts will receive 3 cycles of CAPOX (130 mg/m 2 oxaliplatin, day [D] 1 + 1000 mg/m 2 capecitabine, D1-14, bid), SCT510 (7.5 mg/kg, D1) and finotonlimab (200 mg, D1), followed by 1 cycle of CAPOX plus finotonlimab in 21-day cycle. The primary endpoint is pathologic complete response. Secondary endpoints include 1-year progression-free survival rate, major pathological response, R0 resection, R1 resection, and safety."

Clinical • P2 data • Oncology • Solid Tumor

Sinocell's revenue increased by 60% in the first half of the year, with a net profit of 126 million yuan [Google translation] (Sina Corp) - "Sinocell's R&D expenses in the first half of the year were 476 million yuan, a slight decrease from the same period last year. The R&D direction is more focused on accelerating the commercialization of existing products and the echelon R&D construction of high-quality and high-potential innovative drugs. During the reporting period, R&D investment was mainly used for mid- and late-stage clinical research of products such as SCT1000, SCT-I10A, and SCTV01, early clinical investment in newly approved clinical research products, and preclinical development of many products...in terms of products under development, SCT1000....has completed the third dose of Phase III clinical trials and is currently in the follow-up stage with smooth progress..."

Commercial • Trial status • Infectious Disease • Oncology • Solid Tumor

Shenzhou Cell (688520): Eight factor dosage turned a loss into a profit in 24Q1 (FUTU) - "Pipeline developments in 2023 include: SCT-I10A (PD-1 monoclonal antibody) NDA for the two indications of the single drug 1L head and neck squamous cell carcinoma and bevacizumab 1L hepatocellular carcinoma were accepted in November 2023 and January 2024"

Filing • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Sinocell received a buy rating from Guojin Securities, and its new vaccine was approved, further proving its strength (jrj.com) - "...PD-1 Finolimab for the treatment of head and neck squamous cell carcinoma (HNSCC) was accepted for new drug application (NDA), which will be the first domestically produced PD-1 for this indication."

China filing • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck