Akeso, Inc | Affiliates Akeso Pharma

Akeso Pharma Co., Ltd

Founded on August 10th, 2017, Akeso Pharma Co., Ltd (Akeso Pharma) is a subsidiary of Akeso, Inc. (9926.HK), a pioneer in biologics innovation in China. Focusing on clinical needs worldwide, Akeso Pharma is committed to the innovative development and production of first-in-class bi-specific antibody drugs for tumor immuno-therapy. On June 29th, 2022, the world’s first dual immune checkpoint inhibitor bi-specific antibody drug in-house developed by the Company, 开坦尼® (PD-1/CTLA-4 Bi-specific Antibody, Cadonilimab Injection), was approved for marketing by the National Medical Products Administration (NMPA).

As a key project in Guangzhou, Akeso Pharma has built an biological antibody industrialization base according to GMP requirements of the U.S., Europe and China at China-Singapore Guangzhou Knowledge City. According to the international first-class design concept, it is planned to be built into a demonstration base for China’s biopharmaceutical innovation enterprises, with a total investment of nearly RMB 2 billion and a planned production capacity of 60,000L.

The production system of the base is composed of internationally advanced production equipment. The drug substance is produced by Cytiva's cGMP integrated Flexfactory Antibody Manufacturing Platform with centralized automation, Pall single-use depth filtration and virus filtration system, Merck ultrafiltration system and other equipment. The preparation workshop adopts BOSCH Filling and Sealing Machine for Vials equipment,Steris Sterilization cabinet and washing machines, etc. The quality management system mainly uses Waters ultra-performance liquid chromatograph and SCIEX PA 800 Plus capillary electrophoresis apperatus, GE Sievers M9 Portable TOC Analyzer,Agilent Gas chromatography, PerkinElmer LAMBDA 365 UV-Vis Spectrometer and other imported precision detection and analysis equipment.

The first phase of the base was officially put into production in March 2021 with a production capacity of 20,000L, and is mainly used for the large-scale production of self-developed new biologics including开坦尼^®.

GE Xcellerex XDR-2000 Single Use Bioreactor

QC Laboratory

Merck TFF System- 5m²

SCIEX PA 800 Plus capillary electrophoresis

BOSCH Filling and Sealing Machine for Vials

Waters ACQUITY UPLC H-Class PLUS Chromatography System

Merck TFF System- 30m²

PerkinElmer LAMBDA 365 UV-Vis Spectrometer

BOSCH Sterilization and Depyrogenation Tunnel

Agilent Gas chromatography

BOSCH Automatic Washing Machine

METTLER TOLEDO Precision Balances

GE AxiChrom 1000 chromatography column & BioProcess chromatography System

GE-Sievers M9 Portable TOC Analyzer

开坦尼^® (Cadonilimab Injection)

Globally first dual immune checkpoint inhibitor bi-specific antibody approved for marketing

开坦尼^® (Cadonilimab injection) is a novel, first-in-class PD-1/CTLA-4 bi-specific immuno-therapy drug in-house developed by the Company, which is mainly used in the treatment of cervical cancer, lung cancer, liver cancer, gastric cancer, renal cancer, esophageal squamous cell cancer, and other malignant tumors. The research data show that, as compared with the combination therapy of PD-1 and CTLA-4, Cadonilimab demonstrates promising safety profile and efficacy.

On June 29th, 2022, 开坦尼^® has been granted marketing approval by the NMPA of China for the treatment of recurrent/metastatic cervical cancer (R/M CC) patients that who has progressed on or after platinum-based chemotherapy. Currently, a global phase III trial of Cadonilimab combined with platinum-based chemotherapy +/- bevacizumab for the first-line treatment of recurrent/metastatic cervical cancer has completed patients enrollment, and a Phase III pivotal registry clinical trial of Cadonilimab plus concurrent chemoradiotherapy (CCRT) for locally advanced cervical cancer (LACC) is ongoing. In addition, two phase III trials of Cadonilimab to treat early-stage hepatocellular carcinoma (HCC) and gastric (G) or gastroesophageal junction (GEJ) cancer are also ongoing.

The project of Cadonilimab development has been included among National Major Scientific and Technological Special Project for “Significant New Drugs Development” , and supported by “Guangdong Pearl River Talent Program (introduction of innovation and entrepreneurship teams)” as well. Cadonilimab was awarded “China’s Top Ten Breakthroughs in Medical Biotechnology in 2017”. Based on its excellent clinical data, Cadonilimab has been granted Fast Track Designation (FTD) and Orphan Drug Designation (ODD) by the United States Food and Drug Administration (FDA) and has been granted “Breakthrough Therapy Designation（BTD）” by the NMPA.