On April 11, 2023, Shanghai Porton Nova Biologics, Ltd., a wholly-owned subsidiary of Porton Pharma Solutions Ltd., officially launched the construction of its biologics R&D and manufacturing site in the Waigaoqiao Free Trade Zone of Pudong New Area, Shanghai, China. As an important link in Porton’s strategic new capability building, the site will provide one-stop CDMO services for early clinical stage process development and pilot scale production of antibodies and antibody-drug conjugates (ADCs) for global biopharmaceutical companies and new drug R&D institutions after being put into use.

Mr. Oliver Ju, Chairman and CEO of Porton, Dr. Bo Qiu, Chief Technology Officer of Shanghai Porton Nova Biologics, Ltd. and other company management representatives as well as core members of the biological macromolecule segment attended the ceremony for the start of construction. Mr. Haixia Wu, CEO of Simbay Park, Simbay Group and Mr. Bin Ni, Assistant President of the Fourth Construction Co., Ltd. of China Electronic System Engineering (project owner) and General Manager of the Biomedical Business Group were invited to attend the ceremony and delivered speeches to jointly witness the beginning of construction of Porton’s first macromolecule R&D and manufacturing site.

The facility is located in the PhaseII of Simbay Park in the Waigaoqiao Free Trade Zone, Shanghai, with a total area of nearly 7,000 m2. The site will be constructed based on guidelines from NMPA, FDA, EMA, ICH and has capacity of process development and GMP production for antibodies and antibody-drug conjugates (ADCs), which can provide global customers with one-stop services from cell line construction, upstream and downstream process development, conjugation process development, formulation process development, analytical method development, technology transfer to GMP DS manufacturing, GMP filling, finish, release tests, stability study and regulatory filing support.

The process development platform and manufacturing facility in the site are expected to be successively put into use from the third quarter to the fourth quarter of 2023, and will closely cooperate with the chemical synthesis service of Payload and Linker of Porton Small Molecule Business Segment, give full play to the technical and production capacity advantages of Porton chemical and biologics capacity, and build a one-stop service platform for antibodies and ADCs with differentiation advantages.

We look forward to the smooth completion of the construction and early launch of the site, which will serve the CDMO needs of more biomedical enterprises so that enabling the public’s early access to good medicines.