CStone Pharmaceuticals (HKG: 2616) has decided to suspend manufacturing operations at its Suzhou industrialization plant, according to a recent statement. The decision was made due to the lack of a clear plan for mass production at present and to reduce enterprise operating costs. According to Healthcare Executive, the Chinese firm has emphasized that the shutdown is temporary and does not indicate a permanent closure of the facility. Core staff members will be retained, and CStone will actively seek collaboration opportunities to prepare for a future relaunch.
Suzhou Plant Profile
The plant in question is located at the China-Singapore Suzhou Industrial Park and serves as the manufacturing base for CStone, where its research and development (R&D) and translational medicine center are also situated. The 100,000 square meter facility has a manufacturing capacity of 26,000L for macromolecular biological drugs and 1 billion small molecule chemical tablets and capsules. CStone’s 2022 interim report indicated that the plant had started pilot operations alongside the technology transfer of Ayvakit (avapritinib), a tyrosine kinase inhibitor used to treat gastrointestinal stromal tumors (GIST). While more technology transfers were expected within the next 12 months, these programs have been delayed for various reasons, and the plant underwent trial operations until the end of 2021.
Commercialized Products
CStone has commercialized four products in China, including the PD-L1 inhibitor sugemalimab, which received its first approval in December 2021. Sugemalimab has since gained approvals for use in the first-line treatment of epidermal growth factor receptor (EGFR) gene mutation-negative and anaplastic lymphoma kinase (ALK)-negative metastatic non-squamous non-small cell lung cancer (NSCLC) in combination with pemetrexed and carboplatin; in combination with pemetrexed and carboplatin for first-line treatment of metastatic squamous NSCLC; and for unresectable stage III NSCLC without disease progression after platinum-based chemotherapy and radiotherapy. Other products include the RET inhibitor Gavreto (pralsetinib), licensed from US-based biotech Blueprint Medicines in June 2018; avapritinib; and Ivosidenib, an IDH1 inhibitor licensed from Agios Pharmaceuticals Inc., now owned by France-based Servier, which acquired Agios’s oncology business for USD 2 billion in April 2021.-Fineline Info & Tech
