Suzhou Suncadia Biopharmaceuticals Co Ltd, a company in SIP’s Jinji Lake CBD, recently received the approval from the National Medical Products Administration for piloting segmented production of its trastuzumab rezetecan (SHR-A1811), an HER2 targeted antibody-drug conjugate. It is the first pilot site for segmented production of biologics in East China’s Jiangsu province.

Suzhou Suncadia Biopharmaceuticals is a wholly-owned subsidiary of Chinese pharmaceutical conglomerate Hengrui Pharmaceuticals. It is engaged in developing products for treatment of cancers and autoimmune diseases, currently with five products available in market.

The SHR-A1811 represents a breakthrough in targeted cancer therapy. It is expected to be approved for marketing in the first half of this year for treatment of non-small cell lung cancer.

Segmented production of biologics is a manufacturing approach where the production process of biologics is divided into several stages, with each stage potentially being outsourced to a different contract manufacturing organization. It marks significant progress in optimizing resource allocation, reducing production cost, and improving production efficiency.

April 22, 2025