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Jiangsu Alphamab Passed On-site Inspection of EU Qualified Person

February 08, 2020 12:00 Eastern Daylight Time

Suzhou, February 7, 2020 –Alphamab Oncology (Stock code: 9966.HK) announced that Jiangsu Alphamab Biopharmaceuticals Co., Ltd. (“Jiangsu Alphamab”), a wholly-owned subsidiary of the Company, has passed the on-site inspection of an European Union qualified person on February 3, 2020.


The inspection is for the preparation of the reliable supply for global clinical trials and subsequent manufacturing for the  commercialization of KN035 (an anti-PD-L1 recombinant humanized single domain antibody invented by the Group). The  EU Qualified Person conducted a comprehensive, strict and systematic inspection mainly on the quality control system and facilities in the biopharmaceutical production base of Jiangsu Alphamab located at Suzhou Industrial Park, Suzhou Area of Jiangsu Pilot Free Trade Zone, China. The scope of the inspection covers production workshops, warehouses and related support systems in the BioBay in Suzhou Industrial Park, as well as the new warehouse and the quality control laboratory located at No. 175, Fangzhou Road, Suzhou Industrial Park.


Previously the Production Base has successfully passed the on-site inspection of the Jiangsu Drug Administration of the People’s Republic of China and was granted the Pharmaceutical Production License. Having successfully passed the on-site inspection of the EU Qualified Person marked that the production, warehousing and related support system and quality control system of Jiangsu Alphamab have been further improved and its production capacity has been further expanded, laying a solid foundation for reliable supply for global clinical trials and subsequent manufacturing for the commercialization.


Bring health to patients and happiness to families. Jiangsu Alphamab will continue to improve the management and operation of the production quality system and provide high quality biotherapy to global cancer patients.


About KN035

Invented by Alphamab, KN035 is a Fc fusion protein with PD-L1 domain antibody with. Based on its unique feature for subcutaneous administration, KN035 has advantages in safety, convenience, compliance and, lower medical costs over conventional PD-(L)1 antibody. It can also be used for patients who are not suitable for intravenous infusion. Currently, KN035 is undergoing clinical trials in China, the United States, and Japan for multiple cancer indications, and it has entered phase III clinical trials for some cancer indications.


About Alphamab Oncology

Alphamab Oncology is a biopharmaceutical company focusing on the research and development, manufacturing and commercialization of biologics for oncology. In December 12, 2019, the Company was listed in the mainboard of Hong Kong Stock Exchange with stock code 9966.


Alphamab has fully integrated proprietary biologics platform in bi-specifics and protein engineering. Its highly differentiated in-house pipeline consists of eight anti-cancer drug candidates, four of which have advanced into Phase I – III clinical development phases in China, US and Japan.  


The Company also has proprietary CRIB and CRAM platforms for bi-specifics and antibody mixtures, and state-of-the-art manufacturing capability designed and built to meet NMPA and EU/FDA’s cGMP standards.


With multiple in-house proprietary platforms for innovative biopharmaceuticals, Alphamab Oncology has built a robust pipeline in oncology/immunology to benefit cancer patients around the world.

Visit http://www.alphamabonc.com for more information.