Ankeda (bevacizumab biosimilar) / Qilu Pharma - LARVOL DELTA

A Study to Compare the Pharmacokinetics and Safety of QL1101 and EU-Avastin® in Healthy Volunteers (clinicaltrials.gov) - P1 | N=84 | Completed | Sponsor: Qilu Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Completed | Initiation date: Mar 2024 ➔ Jun 2024

Trial completion • Trial initiation date • Oncology

A Study to Compare the Pharmacokinetics and Safety of QL1101 and EU-Avastin® in Healthy Volunteers (clinicaltrials.gov) - P1 | N=84 | Not yet recruiting | Sponsor: Qilu Pharmaceutical Co., Ltd.

New P1 trial • Oncology

A Study of Fluzoparib Combined With QL1101 Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy (clinicaltrials.gov) - P2 | N=25 | Recruiting | Sponsor: Yongpeng Wang | Not yet recruiting ➔ Recruiting | Initiation date: Oct 2022 ➔ Jul 2023

Enrollment open • Metastases • Trial initiation date • Endometrial Cancer • Oncology • Ovarian Cancer • Solid Tumor • BRCA1 • BRCA2

A multi-center, randomized, double-blind, parallel, two-group phase III clinical study on the efficacy and safety of QL1101 or bevacizumab in combination with paclitaxel and carboplatin in the first-line treatment of non-squamous non-small cell lung cancer (ELCC 2019) - P3; "QL1101 and Avastin are equivalent in clinical efficacy in non-squamous cell non-small cell lung cancer patients, and the safety profile (including immunogenicity) is similar. There are no unexpected serious adverse reactions found."

Clinical • Combination therapy • P3 data

A Study of Fluzoparib Combined With QL1101 Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy (clinicaltrials.gov) - P2 | N=25 | Not yet recruiting | Sponsor: Yongpeng Wang

New P2 trial • Endometrial Cancer • Oncology • Ovarian Cancer • Solid Tumor • BRCA1 • BRCA2

Updates in Treatment and Management of Chemotherapy-induced Myelosuppression - Episode 6 Unmet Needs and Future Directions in the Management of CIM (OncLive) - "Edgardo Santos, MD, FACP: Dr Dietrich, it's always a pleasure to share this forum with you. I'm looking forward to seeing you another time. It's important what we are doing. We are providing our cancer patients with new hope so they know there is something more to deliver than just therapy. We are also watching them, to protect them from side effects of therapy. I think it is very important what we are doing. Thank you once again for having us."

Video

"ANKADA #ankara #kizilay #cankaya #esc2022 💋💋" (@HANDEm006)

Cardiovascular

Equivalent efficacy assessment of QL1101 and bevacizumab in nonsquamous non-small cell lung cancer patients: A two-year follow-up data update. (PubMed, Chin J Cancer Res) - "For patients who received QL1101 maintenance therapy, similar results were shown between the QL1101 group (n=157) and the bevacizumab group (n=148) (PFS: 253 d vs. 272 d, log-rank P=0.387; OS: 673 d vs. 790 d, log-rank P=0.101; mean tumor shrinkage rate: 26.6% vs. 27.5%). This study reported that QL1101 had similar efficacy in treating nonsquamous NSCLC in terms of ORR, PFS and OS based on two-year updated data, providing a basis for the clinical application of QL1101."

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

A multi-center, randomized, double-blind, parallel, two-group Phase III trial on the efficacy and safety of QL1101 or bevacizumab in combination with paclitaxel and carboplatin in first-line treatment of non-squamous non-small cell lung cancer (ESMO Asia 2018) - P3; "QL1101 and Avastin are equivalent in clinical efficacy in non-squamous cell non-small cell lung cancer patients, and the safety profile (including immunogenicity) is similar. There are no unexpected serious adverse reactions."

Clinical • Combination therapy • P3 data • Non Small Cell Lung Cancer

A multi-center, randomized, double-blind, parallel, two-group phase III clinical study on the efficacy and safety of QL1101 or bevacizumab in combination with paclitaxel and carboplatin in the first-line treatment of non-squamous non-small cell lung cancer (ELCC 2019) - P3; "QL1101 and Avastin are equivalent in clinical efficacy in non-squamous cell non-small cell lung cancer patients, and the safety profile (including immunogenicity) is similar. There are no unexpected serious adverse reactions found."

Clinical • Combination therapy • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer

Efficacy and Safety of Biosimilar QL1101 Compared with Avastin in Patients with Non-Squamous Non-Small Cell Lung Cancer (IASLC-WCLC 2019) - P3; "The patients were divided into QL1101 (test group) or Avastin® (control group) at 1:1 ratio in combination respectively with paclitaxel/carboplatin (paclitaxel 175mg/m2, carboplatin AUC=5). QL1101 and Avastin are equivalent in clinical efficacy, and the safety profile (including immunogenicity) is quite similar in patients with non-squamous cell non-small cell lung cancer. There are no unexpected serious adverse reactions were found during the study."

Clinical

Equivalent efficacy study of QL1101 and bevacizumab on untreated advanced non-squamous non-small cell lung cancer patients: a phase 3 randomized, double-blind clinical trial. (PubMed, Cancer Biol Med) - "QL1101 showed similar efficacy and safety profiles as compared to bevacizumab among Chinese patients with untreated locally advanced non-squamous NSCLC."

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

Nab-paclitaxel Combined With Bevacizumab in the Treatment of Metastatic Neuroendocrine Carcinoma (clinicaltrials.gov) - P2; N=100; Recruiting; Sponsor: Peking University

Clinical • New P2 trial • Neuroendocrine Tumor • Oncology • Solid Tumor

A randomized, double-blind, single-dose study to evaluate the biosimilarity of QL1101 with bevacizumab in healthy male subjects. (PubMed, Cancer Chemother Pharmacol) - "The study demonstrated the pharmacokinetic equivalence of QL1101 to Avastin. QL1101 (3 mg/kg, iv) is safe and tolerable in healthy Chinese subjects. These data support the further clinical evaluation of QL1101 as a bevacizumab biosimilar."

Clinical • Journal

BEST-CP: Bevacizumab in Severe or Critical Patients With COVID-19 Pneumonia (clinicaltrials.gov) - P2; N=27; Completed; Sponsor: Qilu Hospital of Shandong University; Recruiting ➔ Completed; Phase classification: P2/3 ➔ P2; N=20 ➔ 27

Clinical • Enrollment change • Phase classification • Trial completion • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

BEVTOR: QL1101 in Combination With JS001 in Patients With pMMR/MSS Refractory Metastatic Colorectal Cancer (clinicaltrials.gov) - P2; N=50; Not yet recruiting; Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

New P2 trial • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • MSI • PD-L1

Bevacizumab in Severe or Critically Severe Patients With COVID-19 Pneumonia-RCT (clinicaltrials.gov) - P=N/A; N=118; Recruiting; Sponsor: Qilu Hospital of Shandong University; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

Bevacizumab in Severe or Critical Patients With COVID-19 Pneumonia-RCT (clinicaltrials.gov) - P=N/A; N=118; Not yet recruiting; Sponsor: Qilu Hospital of Shandong University

Clinical • New trial

Early-stage study details similarity of bevacizumab biosimilar to Avastin (Center for Biosimilars) - P1, N=82; "The incidence of adverse events was 90.5% and 95.0% in the QL 1101 and Avastin groups, respectively. Mean serum concentration-time profiles, secondary pharmacokinetic parameters, and safety and immunogenicity profiles were comparable between the 2 cohorts. Investigators concluded QL 1101 demonstrated pharmacokinetic equivalence to Avastin, as well as safety and tolerability."

P1 data

A multi-center, randomized, double-blind, parallel, two-group phase III clinical study on the efficacy and safety of QL1101 or bevacizumab in combination with paclitaxel and carboplatin in the first-line treatment of non-squamous non-small cell lung cancer. (PubMed, Ann Oncol) - No abstract available

Clinical • Combination therapy • Journal • P3 data

BEST-CP: Bevacizumab in Severe or Critical Patients With COVID-19 Pneumonia (clinicaltrials.gov) - P2/3; N=20; Recruiting; Sponsor: Qilu Hospital of Shandong University

Clinical • New P2/3 trial

Qilu’s biosimilar Ankada needs strong commercialization strategy in China, says analyst (The Pharma Letter) - "Being the first approved Avastin biosimilar in China, Ankada will have the first-mover advantage, however its success will depend on a strong commercialization strategy..."

Commercial

Qilu's bevacizumab biosimilar priced at USD 181 in Shandong (GBI Health) - "The price point for China-based Qilu Pharmaceutical Co., Ltd's biosimilar version of Roche's Avastin (bevacizumab) has been revealed by Shandong's provincial centralized drug procurement platform. The drug, which Qilu will market under the trade name Ankada, is to be made available for RMB 1,266 (USD 180.70) per 4ml:100mg injection. Ankada was awarded market approval last week, given the nod for Avatin’s existing indications as a treatment for advanced, metastatic or recurrent non-small cell lung cancer (NSCLC) and metastatic colorectal cancer (mCRC)."

Pricing

Qilu Pharma wins approval for China’s first bevacizumab biosimilar (GBI Health) - "The National Medical Products Administration (NMPA) revealed that a market approval award has been issued to Qilu Pharmaceutical Co., Ltd, for its biosimilar version of bevacizumab (trade name: Ankada). Qilu is therefore the first firm to win a market nod for a version of Roche’s Avastin, which was first approved in China in February 2010, and has accrued indication approvals in advanced, metastatic or recurrent non-small cell lung cancer (NSCLC) and metastatic colorectal cancer (mCRC)."

Non-US regulatory