Waker BioScience advances global expansion with nearly 100M Series A funding to boost CGT CRO services

Shanghai Waker BioScience Co., Ltd. ("Waker BioScience") announced the completion of a nearly 100 million Series A financing round. This round was led by Shenzhen Capital Group (SCGC), with follow-on investment from Wuxi Capital Group. Fenghe Capital acted as the exclusive financial advisor.

The proceeds from this financing round will accelerate Waker BioScience's efforts to establish a cell and gene therapy (CGT) safety assessment testing laboratory in the United States and expand its overseas operations in CGT safety evaluation services, CGT clinical services, and biological breeding services.

Since the 21st century, genetic modification technology has been widely applied in fields such as biopharmaceuticals and synthetic biology, becoming a core driver of industrial transformation. However, the safety and efficacy of this technology heavily rely on the precise integration of exogenous genes into the genome of the modified cells—any errors in the integration site may lead to uncontrollable biological consequences, such as gene dysfunction and carcinogenicity. Therefore, site detection analysis serves as the scientific cornerstone and essential prerequisite for ensuring the safe translation of genetic modification technology.

The core team of Waker Bioscience originates from Heidelberg University and the German Cancer Research Center (DKFZ), with decades of deep expertise in CGT safety analysis and evaluation. Globally, the team has supported the development and marketing applications of several star cell and gene therapy products for multiple multinational corporations (MNCs), including the world's first gene therapy product, Glybera, and the first CAR-T product, Kymriah. They have also actively participated in the establishment of integration site-related regulations for CGT by the FDA and EMA, demonstrating solid global project experience.

As China's CGT field entered a phase of rapid development, regulatory requirements for safety and efficacy by the Center for Drug Evaluation (CDE) have become increasingly stringent. Against this backdrop, Waker Bioscience was formally established in March 2021. From the outset, the company has focused on providing one-stop safety evaluation solutions for CGT drugs and molecular breeding products. As Dr. Wu Ning, the founder, stated, "The growth journey of Waker Bioscience reflects not only the path of Chinese CGT companies from preclinical research to market approval but also the gradual maturation of China's regulatory system." In the Chinese market, Waker Bioscience has provided testing services for over 70 companies covering more than 100 pipelines, supporting the entire drug application lifecycle and assisting several companies in achieving simultaneous submissions in China and the United States. It is worth emphasizing that client projects supported by Waker Bioscience's safety evaluation data have successfully gained marketing approval.

Leveraging its leading expertise in integration site analysis and refined, customized project delivery capabilities, Waker Bioscience has expanded its services into broader safety evaluation areas, including viral vector genome characterization, gene editing off-target analysis, cell phenotype analysis, single-cell immune profiling, monoclonal cell identification, vector copy number (VCN) detection, replication-competent lentivirus (RCL) testing, and nucleic acid impurity analysis. Beyond safety assessment, Waker Bioscience also offers comprehensive CRO services covering the entire product development process—from early-stage clinical R&D and CMC development to late-stage IIT and registrational clinical trials, long-term follow-up, and market application—committed to providing clients with integrated products and solutions.

Beyond CGT applications, Waker Bioscience has achieved encouraging commercial progress in fields such as biological breeding, synthetic biology, and early screening and diagnosis. Taking the more advanced biological breeding segment as an example, Waker Bioscience's subsidiary established in Qingdao has served over hundreds of corporate and academic research clients.

From its inception, Waker Bioscience has embedded a global vision into its development DNA, committed to becoming an indispensable part of the global biopharmaceutical industry chain. Guided by the strategy of "not only serving Chinese pharmaceutical companies going global but also serving global CGT clients," the company is steadily advancing its international layout. A testing center in Boston, USA, compliant with local regulatory standards, is soon to be operational, enabling efficient service delivery for the European and American markets.

Supporting this global expansion is the team's profound overseas background and resource foundation. Dr. Wang Wei, co-founder and head of overseas business, previously served as BD lead for the CGT segment in Europe at several renowned international CROs and was an early co-founder and business lead of Germany's GeneWerk GmbH, possessing extensive international client networks and cross-cultural collaboration experience. According to information learned by VCBeat, Waker is already engaged in in-depth collaboration discussions with multiple overseas pharmaceutical companies, marking substantive progress in its global business operations.

Moving forward, Waker will continue to leverage its global foothold, rich international resources, and top-tier Chinese clinical assets to actively explore more cutting-edge business collaboration models, accelerating the two-way flow and value synergy of high-quality global medical resources.