Weke Bio Secures Tens of Millions in Angel Funding Led by BGI Capital to Advance Safety Evaluation Technologies for Cell and Gene Therapy

VCBeat has learned that in September 2022, Shanghai Weike Biotechnology Co., Ltd. (Wker Bioscience) completed an angel financing round worth tens of millions of RMB, with BGI Win-Win as the sole investor. This round of financing will help Wker Bioscience accelerate technological upgrades and team building, promote the expansion of testing services for safety assessments in the cell and gene therapy industry and the gene-edited breeding industry, and advance the automation of its laboratory platform.

Wker Bioscience, established in March 2021, is dedicated to providing safety assessments for vector insertion mutations in cell and gene therapy drugs. As an innovative enterprise, it conducts Integration Site Analysis (ISA) in compliance with regulatory requirements from the FDA, EMA, NMPA, and other authorities. Its technical team has performed ISA testing for marketing authorization applications of all overseas gene therapy products that have successfully reached the market, including the world’s first gene therapy product and the first CAR-T product, thereby establishing itself as a setter of industry standards. Wker Bioscience is currently seeking collaboration with institutions such as the National Institutes for Food and Drug Control (NIFDC) to participate in formulating domestic industry standards for cell and gene therapies, aiming to set industry benchmarks for gene therapy safety evaluation in China. Compared with technologies such as Whole Genome Sequencing (WGS) and Linear Amplification-Mediated PCR (LM-PCR), Wker Bioscience’s technical platform—based on LAM-PCR, LTA-PCR, and SEPTS/LM-PCR—offers advantages including high sensitivity, high specificity, and quantitative detection capabilities. It is the first ISA method validated under the FDA/EMA frameworks and is currently recognized as the global gold standard for ISA testing. This technical platform holds significant application potential in numerous fields, including safety evaluation of gene therapies, early cancer screening, and safety assessment of crop gene editing.

Wker Bioscience is located in the Lingang Life and Health City in Pujiang, Shanghai. It currently operates an 800-square-meter GLP-compliant cleanroom laboratory, with existing equipment assets exceeding RMB 8 million. Meanwhile, Wker Bioscience has established a comprehensive genomics and bioinformatics analysis platform, and has developed and validated NGS-based testing and analytical methods.

Wker Bioscience’s Qingdao team leverages the plant microbial safety evaluation technical system jointly established with the Chinese Academy of Sciences’ Qingdao Plant Molecular Breeding team, aiming to build a full-industry-chain platform for plant molecular breeding and to develop a professional team dedicated to supporting China’s utilization and innovation of germplasm resources.

Dr. Wu Ning, Founder of Wker Bioscience, stated“We are honored to have secured support from professional investment funds in this round. Although the gene therapy sector is booming and presents broad development prospects, safety concerns such as insertional mutagenesis persist and have consistently drawn attention both within and outside the biopharmaceutical industry. While lentiviral (LV) and adeno-associated viral (AAV) vectors are widely used in gene therapy and generally considered safe, the carcinogenic risk associated with insertional mutations remains a critical safety issue that cannot be overlooked for gene therapy products. What our company can do is to ensure timely detection of corresponding adverse events through long-term monitoring, thereby safeguarding the market approval of cell and gene therapy drugs. In the treatment of rare diseases, using stem cells for gene editing entails an even greater risk of tumorigenicity. Wker Bioscience currently provides comprehensive testing services, including viral vector integration site analysis, quantitative off-target detection for gene editing, vector copy number determination, and vector quality control. These capabilities enable early detection and intervention to reduce the risks of mutation and tumorigenesis. Currently, Wker is collaborating with renowned pharmaceutical companies and R&D institutions in China, with the aim of further benefiting a wide range of patients.”

Ji Changtao, Partner at BGI Win-Win Investment, stated“BGI WinWin adheres to a research-and-development-driven investment strategy, with a keen focus on industry development trends and underlying fundamentals. As technology, talent pools, and regulatory frameworks continue to mature, cell and gene therapy has emerged as one of the key directions for the future development of the biopharmaceutical industry. We maintain a strong bullish outlook on the application of cell and gene therapy in areas such as genetic diseases, rare diseases, oncology, neurology, and infectious diseases. Furthermore, we are actively positioning ourselves in upstream segments of the cell and gene therapy industry, including delivery systems, safety/toxicology studies, and equipment, consumables, and culture media.The core team of Wker Bioscience originates from GENEWERK, a company founded by Professor Manfred Schmidt in Germany, which has facilitated the FDA and EMA approval of multiple gene therapy drugs. Since its establishment, Wker Bioscience has rapidly built a comprehensive technical system for the safety evaluation of cell and gene therapies, which has been thoroughly validated and applied in fields such as cell and gene therapy and biological breeding. The company’s excellent and pragmatic team, solid technological accumulation, and forward-looking strategic layout have laid a strong foundation for its rapid future growth.”

BGI Win-Win, as a venture capital firm backed by the BGI Genomics industrial ecosystem, combines the dual advantages of Corporate Venture Capital (CVC) and traditional Venture Capital (VC) in terms of industrial resources and flexible decision-making mechanisms. Advocating the investment philosophy of "R&D-driven investment," it adheres to mapping out industry landscapes and proactively investing along the industrial chain. It focuses on comprehensive, stage-spanning investments in high-quality projects within the bio-economy sector, including gene technology, cutting-edge biopharmaceuticals, innovative medical devices, food nutrition, and biomaterials, striving to become a leading innovation investment management institution in the bio-economy. It aims to achieve resource sharing and win-win development among industrial partners, fund limited partners, and portfolio companies. Since its establishment five years ago, BGI Win-Win has launched eight funds, with assets under management exceeding RMB 2 billion, and has cumulatively invested in nearly 30 healthcare projects. The team’s historical cumulative investments cover nearly 80 projects, with approximately 20 IPOs, representing an IPO rate of nearly 25%. It has received honors for consecutive years from prestigious institutions such as Zero2IPO Group, China Venture, Financing China, the Fund of Funds Research Center, and VCBeat.