Waker Bio Secures Tens of Millions in Pre-A Financing to Advance Safety Evaluation Platforms for Cell and Gene Therapies and Expand Global Operations

VCBeat has learned that Shanghai Weike Biotechnology Co., Ltd. (Wker Bioscience) recently completed a Pre-A financing round worth tens of millions of RMB, led by BMC and followed by investors including HTI. The funds will accelerate Wker Bioscience’s development and upgrading of its safety assessment technology platform for cell and gene therapies, its biological breeding detection technology platform, and its overseas business expansion.

Wker Bioscience, established in March 2021, has a core team primarily hailing from Heidelberg University, the German Cancer Research Center (DKFZ), and GeneWerk GmbH. With over two decades of expertise in integration site analysis (ISA) and safety assessment, the company has participated in more than 80 non-clinical and clinical studies for gene therapy products worldwide. It has assisted in the marketing authorization applications for numerous blockbuster products, including Glybera (the world’s first approved gene therapy), Kymriah (the world’s first CAR-T product), and CARVYKTI (the first Chinese-developed CAR-T therapy approved by the FDA), covering over 80% of FDA-approved products. Wker Bioscience’s core technological platforms—LAM-PCR, S-EPTS/LM-PCR, and TES—demonstrate significant application potential across various fields, including the safety evaluation of cell and gene therapies and biological breeding.

Wker Bioscience is dedicated to providing safety assessment solutions for cell and gene therapy drugs as well as molecular breeding products. As an innovative technology enterprise, it conducts integration site analysis and off-target detection services in compliance with regulatory requirements from the FDA, EMA, and CDE. The company currently operates a 1,000-square-meter Grade 10,000 clean laboratory compliant with Good Laboratory Practice (GLP) standards and a 600-square-meter crop genetic breeding laboratory. It has established a comprehensive genomics and bioinformatics analysis platform with independent intellectual property rights, along with detection and analytical methods based on Next-Generation Sequencing (NGS) and Nanopore sequencing. Wker Bioscience holds various compliance certifications, including ISO 9001:2015 and BSL-2. In the fields of Integration Site Analysis (ISA) and Targeted Integration Site Analysis (TISA), Wker’s LAM-PCR and S-EPTS/LM-PCR methodologies constitute the only methodological system validated and officially recommended by the FDA, as well as the only one recognized by the National Institutes for Food and Drug Control (NIFDC) in China.

As the official testing platform of the National Institutes for Food and Drug Control (NIFDC), Wker Bioscience provides quantitative assessment of integrated cell clones and high-fidelity detection of vector integration distribution profiles, and participates in the formulation of industry standards for safety evaluation of integration sites in cell and gene therapy drugs. Through de novo validation, Wker Bioscience has established a comprehensive technical platform covering the entire process from “transformation system establishment–genome editing vector optimization–genome editing material creation–safety testing of gene-edited plants.” Leveraging its core safety testing technologies, the company fills the market gap for high-throughput, low-cost safety evaluation services in the field of precision design breeding for gene-edited plants, and further provides comprehensive commercial services for plant molecular breeding.

BMC was established in 2010 as a professional venture capital firm that has long adhered to the philosophy of value investing, focusing on “technology + entrepreneurship” enterprises. It currently serves as a vice-president unit of the Shanghai Venture Capital Industry Association. Since its inception, BMC has remained dedicated to key technologies and scientific innovations in three major sectors: integrated circuits and next-generation electronic information, innovative medical biotechnology, and new materials and new energy. Upholding the spirit of “long-termism” and the principles of value discovery and value creation, we are committed to growing alongside China’s most promising sci-tech innovators and entrepreneurs, jointly advancing their scientific and technological ventures.

Shenzhen HTI, established in 1994, is a specialized financial services institution founded by the Shenzhen Municipal Party Committee and Municipal Government to address financing difficulties faced by small and medium-sized technology enterprises. The Group’s business portfolio encompasses bank loan guarantees, engineering guarantees, bond credit enhancement, venture capital, fund management, micro-lending and pawnbroking, and commercial factoring, providing comprehensive investment and financing services to enterprises from their start-up phase through to maturity.

In recent years, Shenzhen HTI has deepened its expertise in the investment sector, focusing intensively on strategic emerging industries such as high-end equipment manufacturing, electronic information, new materials and new energy, and biopharmaceuticals. As of July 2024, Shenzhen HTI had cumulatively invested in 458 companies, with a total investment amounting to RMB 7.5 billion. By the second quarter of 2024, more than 30 of its portfolio companies had successfully been listed on stock exchanges.

Currently, HTI has gradually established a collaborative “fund cluster” community, with local governments at various levels as the supporting entities, various financial institutions as partners, and listed companies and collective enterprises as enabling forces, managing a total fund scale of over RMB 15 billion.