Anyouping (finotonlimab) / Sinocelltech - LARVOL DELTA

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

Finotonlimab with chemotherapy in recurrent or metastatic head and neck cancer: a randomized phase 3 trial. (PubMed, Nat Med) - P3 | "Here a randomized, double-blind phase 3 trial evaluated the efficacy and safety of finotonlimab (SCT-I10A), a programmed cell death 1 (PD-1) monoclonal antibody, combined with cisplatin plus 5-fluorouracil (C5F) for the first-line treatment of R/M HNSCC. These results validate the efficacy and safety of the combination of finotonlimab and C5F in Asian patients with R/M HNSCC. ClinicalTrials.gov identifier: NCT04146402 ."

Clinical • Journal • Metastases • P3 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

SCT-I10A combined with a bevacizumab biosimilar (SCT510) versus sorafenib in the first-line treatment of advanced hepatocellular carcinoma: A randomized phase 3 trial. (ASCO 2024) - P2/3 | "The combination of SCT-I10A and SCT510 showed substantial clinical advantages and an acceptable safety profile in patients with advanced HCC, thereby supporting its suitability as a first-line treatment option for HCC."

Clinical • Metastases • P3 data • Cardiovascular • Cerebral Hemorrhage • Gastrointestinal Cancer • Gastrointestinal Disorder • Hematological Disorders • Hepatocellular Cancer • Hypertension • Oncology • Solid Tumor • AFP

SCT-I10A or Placebo Plus Docetaxel With Previously Treated Squamous Cell Non-small Cell Lung Cancer (clinicaltrials.gov) - P3 | N=188 | Terminated | Sponsor: Sinocelltech Ltd. | N=360 ➔ 188 | Active, not recruiting ➔ Terminated | Trial primary completion date: Oct 2022 ➔ Feb 2023; Strategy adjustments, independent of the safety and efficacy of the trial medication

Enrollment change • Metastases • Trial primary completion date • Trial termination • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

SCT-I10A Plus SCT510 Versus Sorafenib as First-Line Therapy for Advanced Hepatocellular Carcinoma (clinicaltrials.gov) - P2/3 | N=405 | Active, not recruiting | Sponsor: Sinocelltech Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

Phase Ib study of anti-EGFR antibody (SCT200) in combination with anti-PD-1 antibody (SCT-I10A) for patients with RAS/BRAF wild-type metastatic colorectal cancer. (PubMed, Cancer Biol Med) - P1 | "SCT200 combined with SCT-I10A demonstrated promising efficacy in previously treated RAS/BRAF wt mCRC patients with an acceptable safety profile. Further head-to-head studies with larger sample sizes are needed to validate whether the efficacy and safety of combined anti-EGFR and anti-PD-1 therapy are superior to anti-EGFR monotherapy in the third-line setting. (Registration No. NCT04229537)."

Combination therapy • Journal • Metastases • P1 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF • RAS

[PREPRINT] Preclinical Basis of the Efficacy and Pharmacodynamics of Finotonlimab, a Humanized Anti-PD-1 Monoclonal Antibody with Potent Implications for Clinical Benefit (bioRxiv) - “Our data showed Finotonlimab bind to human PD-1 with significantly high affinity and effectively inhibited its interaction with its ligands, PD-L1 and PD-L2, and thus could effectively stimulate the human T cell functions in vitro and exhibited significant antitumor efficacy in vivo. In addition, Finotonlimab showed minimal impact on Fc receptor dependent effector cell activation, which may contribute to the killing of PD-1+ T cells. In cynomolgus monkeys, Finotonlimab exhibited a non-linear pharmacokinetics (PK) profile in a dose-dependent manner, and approximately 90% of consistent receptor occupancy period was observed at 168 h after a single administration of 1 mg/kg. Following a 13-week successive administration of Finotonlimab, a pharmacodynamics study indicated a sustained mean receptor occupancy of ≥ 93% of PD-1 molecules on circulating T cells in cynomolgus monkeys up to 8 weeks even at 3 mg/kg.”

Preclinical • Preprint • Oncology

SCT200 in Combination With SCT-I10A/Paclitaxel/Docetaxel in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P1 | N=120 | Recruiting | Sponsor: Sinocelltech Ltd.

Combination therapy • IO biomarker • New P1 trial • Head and Neck Cancer • Immune Modulation • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

HCC: SCT-I10A Plus SCT510 Versus Sorafenib as First-Line Therapy for Advanced Hepatocellular Carcinoma (clinicaltrials.gov) - P2/3; N=621; Recruiting; Sponsor: Sinocelltech Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Combination therapy • Enrollment open • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Oncology • Solid Tumor

HCC: SCT-I10A Plus SCT510 Versus Sorafenib as First-Line Therapy for Advanced Hepatocellular Carcinoma (clinicaltrials.gov) - P2/3; N=621; Not yet recruiting; Sponsor: Sinocelltech Ltd.

Clinical • Combination therapy • New P2/3 trial • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Oncology • Solid Tumor

SCT-I10A Plus Standard Chemotherapy in First-line Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P3; N=330; Recruiting; Sponsor: Sinocelltech Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

Study of SCT-I10A Combined SCT200 or SCT-I10A Combined SCT200 Plus Chemotherapy in ESCC and CRC (clinicaltrials.gov) - P1; N=60; Not yet recruiting; Sponsor: Sinocelltech Ltd.; Trial completion date: Dec 2021 ➔ Dec 2022; Trial primary completion date: Aug 2021 ➔ Aug 2022

Clinical • Trial completion date • Trial primary completion date

SCT-I10A or Placebo Plus Docetaxel With Previously Treated Squamous Cell Non-small Cell Lung Cancer (clinicaltrials.gov) - P3; N=360; Active, not recruiting; Sponsor: Sinocelltech Ltd.

Clinical • IO Biomarker • New P3 trial

Study of SCT-I10A Combined SCT200 or SCT-I10A Combined SCT200 Plus Chemotherapy in ESCC and CRC (clinicaltrials.gov) - P1; N=60; Not yet recruiting; Sponsor: Sinocelltech Ltd.

Clinical • New P1 trial

Safety and Efficacy of SCT-I10A in Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P2; N=103; Recruiting; Sponsor: Sinocelltech Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • PD-L1

Newly added product (clinicaltrials.gov) - P3, NSCLC

Pipeline update