Recent Milestones in Oncology Targeted Therapy Approvals and Clinical Trials (Part XII) | Highlights (86)
CStone Pharmaceuticals
Innovative Oncology Immunotherapy and Precision Medicine Drug Developer
Qilu Pharmaceutical
Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer
AstraZeneca
Biopharmaceutical Manufacturer
Introduction | INTRODUCTION
This issue's highlights continue to compile the significant approval events of targeted drugs in the solid tumor field over the past month.
EMA | CStone Pharmaceuticals' PD-L1 Monoclonal Antibody Sugemalimab Approved for Marketing, for Non-Small Cell Lung Cancer
On July 26, CStone Pharmaceuticals' Zejula® (Sugemalimab) was approved by the European Commission for use in combination with platinum-based chemotherapy in patients withoutEGFRSensitive mutation, or noneALK、ROS1、RETFirst-line treatment for adult patients with metastatic non-small cell lung cancer (NSCLC) harboring genomic tumor mutations. Sugemalimab is the world’s first PD-L1 monoclonal antibody approved in Europe for first-line treatment in combination with chemotherapy for both squamous and non-squamous NSCLC. CStone Pharmaceuticals is also the first innovative biopharmaceutical company to bring a China-produced PD-L1 monoclonal antibody to the international market. Sugemalimab was approved for marketing in China in 2021. Currently, it has been approved in China for use in non-small cell lung cancer, esophageal squamous cell carcinoma, and extranodal NK/T-cell lymphoma.
NMPA | Qilu Pharmaceutical's HER2 Antibody Trastuzumab Biosimilar Approved for Marketing in China, for HER2-Positive Breast Cancer/Gastric Cancer
On July 5, Qilu Pharmaceutical's independently developed biosimilar Trastuzumab Monoclonal Antibody Injection (brand name: Antruto) was approved for marketing by the NMPA, indicated for HER2-positive metastatic breast cancer and HER2-positive metastatic gastric cancer patients. So far, five companies in China have received approval for their Trastuzumab biosimilars. The availability of multiple biosimilars provides Chinese patients with cost-effective and reliable treatment options, benefiting numerous breast cancer and gastric cancer patients.
EMA | Bio-Thera Solutions' VEGF Antibody Bevacizumab Biosimilar Approved for Marketing, for Multiple Solid Tumors
On July 31, Bevacizumab biosimilar Avzivi (BAT1706) developed by Bio-Thera Solutions was approved for marketing by the EMA, indicated for metastatic colorectal cancer, metastatic breast cancer, non-small cell lung cancer, renal cell carcinoma, epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer, and cervical cancer. The drug was previously approved for marketing in China in November 2021 and in the United States in December 2023.
MHRA | AstraZeneca's AKT Inhibitor Capivasertib Approved for HR+/HER2- Breast Cancer
On July 17, the UK Medicines and Healthcare products Regulatory Agency (MHRA) approved the listing of AstraZeneca's AKT inhibitor Capivasertib for advanced HR-positive, HER2-negative patients who do not respond to other anti-hormonal therapies.PIK3CA、AKT1、PTENBreast cancer patients with one or more mutations. Capivasertib has been approved in the United States, the European Union, and Japan. In October 2023, the CDE website showed that the marketing application for Capivasertib has been accepted, hoping that Chinese breast cancer patients will also benefit from it in the near future.
EMA/PHAC | AstraZeneca's Third-Generation EGFR-TKI Osimertinib Approved for Marketing in Combination with Chemotherapy for Non-Small Cell Lung Cancer
In July, AstraZeneca announced that the European Medicines Agency (EMA) and Health Canada (PHAC) approved the third-generation EGFR-TKI inhibitor osimertinib in combination with pemetrexed and platinum for the treatment of patients withEGFRAdult patients with advanced non-small cell lung cancer harboring mutations. This therapy has been approved in countries such as the United States, China, and Japan.
PHAC | GSK's PD-1 Antibody Dostarlimab Approved for Marketing, for Endometrial Cancer
In July, Health Canada fully approved PD-1 antibody Dostarlimab for advanced or recurrent dMMR/MSI-H endometrial cancer. Dostarlimab has been approved in the United States and the European Union for endometrial cancer but has not yet been marketed in China.
Breakthrough Therapies and Priority Review Drugs in China
Hansoh Pharma/Hansen Biologics' Third-Generation EGFR InhibitorAlmonertinib Mesylate TabletsProposed for inclusion in the breakthrough therapy designation, for the treatment of patients with unresectable locally advanced non-small cell lung cancer harboring EGFR exon 19 deletion (19del) or exon 21 substitution mutation (L858R), who have not experienced disease progression after platinum-based radical chemoradiotherapy.
Recombinant Humanized PDL1 Single-Domain Antibody Fc Fusion Protein Injection submitted by Alphamab Oncology/3D MedicinesEnvonli Monoclonal AntibodyProposed inclusion in the breakthrough therapy category for unresectable or metastatic solid tumors with high tumor mutational burden (TMB-H) that have failed prior standard treatments and lack satisfactory alternative therapies.
Nectin-4-targeted antibody conjugate independently developed by Mabwell9MW2821Proposed inclusion in the breakthrough therapy category for the treatment of locally advanced or metastatic urothelial carcinoma that has failed prior platinum-based chemotherapy and PD-(L)1 inhibitor therapy.
Boehringer IngelheimBI 1810631Included in the breakthrough therapy category for the treatment of patients with human epidermal growth factor receptor-2 (HER2) Adult patients with advanced, unresectable, or metastatic non-small cell lung cancer who have previously received systemic therapy.
Su Zhong Pharmaceutical/Maidu PharmaceuticalsSutent Maleate CapsulesIncluded in the breakthrough therapy category for locally advanced or metastatic non-small cell lung cancer (limited to non-resistant rare types).EGFRMutations, including L861Q, G719X and/or S768I).
Kangfang SainuoIvonescimab InjectionNew indications for marketing application are proposed to be included in the priority review, for use in patients assessed as PD-L1 positive [Tumor Proportion Score (TPS) ≥1%] by a detection method approved by the National Medical Products Administration.EGFRNegative gene mutation and anaplastic lymphoma kinase (ALK) Negative locally advanced or metastatic non-small cell lung cancer (NSCLC) first-line treatment.
Drugs applied for marketing in China
CTTQCDK 2/4/6InhibitorCumo XiliThe first new drug marketing application has been accepted for the treatment of patients with locally advanced or metastatic breast cancer who are positive for hormone receptors (HR), negative for human epidermal growth factor receptor 2 (HER2), and have previously undergone endocrine therapy.
Roche PD-L1 InhibitorAtezolizumab Injection (Subcutaneous Injection)The listing application has been accepted. Subcutaneous injection only takes about 7 minutes, greatly facilitating patient medication.
CStone Pharmaceuticals' anti-PD-L1 antibody submissionSocazolimabNew Indication Marketing Application Accepted for Small Cell Lung Cancer Treatment.
