Jul. 25, 2016

Wuxi Fuent Biotechnology Co., Ltd. was established as a manufacturing center, wholly owned by Fuent (Shanghai).

• On July 25, 2016, Wuxi Qurgen Biotechnology Co., Ltd. completed official industrial and commercial registration and commenced full-scale operation. As a core pillar within the Group’s industrialization strategic layout, Wuxi Qurgen is wholly owned and fully controlled by Shanghai Qurgen Biotechnology Co., Ltd. Positioned exclusively as the Group’s specialized production center for stem cell therapeutics, it serves to solidify a robust foundation for the industrial translation and large-scale manufacturing of innovative biopharmaceutical R&D achievements. 
• Leveraging the strong core R&D expertise, comprehensive scientific innovation system, and years of expertise in novel stem cell drug development accumulated by the Shanghai headquarters, the establishment of this wholly-owned production subsidiary in Wuxi marks a pivotal strategic initiative. It aligns with the overall development trend of the biopharmaceutical industry, advances forward-looking deployment in the transcription factor protein therapeutics sector, and completes the full industrial chain loop of R&D – Manufacturing – Clinical Application for innovative stem cell drugs. For years, the Group has focused on breakthrough research in the clinical application of embryonic stem cells. It has successfully overcome the long-standing industrial bottleneck of in vivo tumorigenicity, achieving a landmark breakthrough in the in vivo safety profile of stem cell medicines. The enterprise remains at the forefront of original research and development for serial transcription factor new drugs. The launch of this professional, standardized production base delivers critical manufacturing capacity to accelerate the translation of laboratory research into high-quality, clinically accessible therapeutics. 
• In accordance with corporate strategic positioning, Wuxi Qurgen does not engage in early-stage drug research or clinical operation. It focuses entirely on large-scale manufacturing of innovative stem cell drugs, standardized process optimization, quality control for commercial production, compliant supply chain management, and industrial operation support. The company strictly adheres to GMP guidelines for biopharmaceutical production and benchmarks against leading global pharmaceutical manufacturing standards. It has built a fully controllable, traceable, and fully compliant modern production line tailored for the mass manufacturing of core original transcription factor protein drugs, including SON‑DP, GHMT‑DP and PMPN‑DP. All production processes adopt fully human-derived protein raw materials, with strict elimination of viral vectors, non-human nucleic acids, exogenous proteins and other high-risk materials, securing drug safety from the manufacturing source. 
• Within the biopharmaceutical industry, industrialization represents the ultimate realization of scientific innovation, and high-standard manufacturing is essential to bringing new therapies to patients. According to senior management at Shanghai Qurgen, the launch of the Wuxi production center establishes a dual-core collaborative model: R&D and innovation led by the Shanghai headquarters, and specialized large-scale production supported by the Wuxi base. This creates a well-structured, highly efficient and mutually supportive operational system with clear division between research and industrial manufacturing. Moving forward, Wuxi Qurgen will continue to strengthen manufacturing capabilities, refine production processes, enforce rigorous quality control, and expand mass production capacity. It will ensure stable supply for clinical trials and future commercial launch of the proprietary transcription factor drug portfolio, steadily advance the industrial realization of the era of in vivo artificial gene expression, and accelerate the delivery of cutting-edge stem cell biopharmaceutical innovations to benefit patients worldwide.