Porton Bio Obtains Drug Manufacturing License (C), Extending CGT CDMO into the Commercial Stage

Suzhou Porton Bio received the license from the Jiangsu MPDA, qualifying it for commercial CGT contract manufacturing. H1 CGT new orders grew ~75% YoY; lentiviral platform material localization exceeds 96%.

Porton Pharma (300363.SZ) announced that its subsidiary Suzhou Porton Biopharma has obtained the Drug Manufacturing License (No. Su 20260010, classification code Cs, valid to July 26, 2031) from the Jiangsu Provincial Medical Products Administration. This is Porton Bio's first such license, qualifying it for commercial-stage contract manufacturing of cell and gene therapy (CGT) products — extending its CGT CDMO services from process development and clinical production into commercialization.

The milestone follows rapid business growth: H1 2026 CGT new orders reached ~RMB 91.9M, up ~75% YoY, with overseas clients accounting for 38%. During the period, Porton Bio completed its first cell-therapy process validation project, supported a client's oncolytic-bacteria US-China dual IND filing, and helped a client win China's first lentiviral in vivo CAR-T IND approval.

On supply chain, Porton Bio has achieved multi-source localization: cell-therapy platform materials are 80% domestic, the lentiviral platform over 96%, and the plasmid platform over 98%, materially improving resilience. On August 6, Porton Bio also formed a strategic partnership with Yeasen Biotechnology covering custom transfection reagent development and joint QC product validation — connecting core raw materials with CDMO services.

Porton Pharma cautioned that commercial manufacturing will proceed according to client timelines, and the license is not expected to materially affect 2026 results. But as the CGT industry enters its commercialization phase, the CDMOs that secured their commercial "ticket" early are positioned to lead the next competitive round.