Tee Labs Incubated: Fusion Bioscience’s Tumor Microenvironment-Targeting Bispecific Antibody Fusion Protein FS-8002 Gains Clinical Approval
July 25, 2024 – China’s Center for Drug Evaluation (CDE) announced that FS-8002, a bispecific antibody fusion protein targeting the tumor microenvironment independently developed by Fusion Bioscience (Shanghai) Biotechnology Co., Ltd. (a wholly-owned subsidiary of Huapu Biotechnology), has received clinical trial authorization for advanced solid tumors. Notably, the investigational new drug (IND) application for FS-8002 was approved by the U.S. FDA on March 27, 2024. This product represents one of China’s few bispecific therapeutics targeting the tumor microenvironment for cancer treatment.
“Drug development must be science-driven, data-anchored, and ultimately dedicated to empowering human health.”
About FS-8002
Over the past decade, cancer immunotherapies exemplified by CTLA-4 and PD-1 immune checkpoint inhibitors have achieved remarkable success. However, the immunosuppressive nature of the tumor microenvironment (TME) has been increasingly recognized as a key factor limiting therapeutic efficacy, with only 20-30% of patients responding to current immunotherapies. Cancer is not merely a disease but a complex ecosystem involving diverse non-cancerous cells and intricate interactions within tumors. The TME comprises immune cells, cancer-associated fibroblasts, endothelial cells, pericytes, and tissue-resident cells—once considered bystanders but now known to play pivotal roles in tumorigenesis. Targeting the TME has emerged as a strategic frontier in oncology drug development.
FS-8002 is a bifunctional protein independently developed by Fushengkang Biotechnology, used for the treatment of advanced solid tumors. Preclinical in vivo and in vitro studies have confirmed that FS-8002 can effectively improve the tumor microenvironment, inhibit tumor angiogenesis, promote the normalization of tumor blood vessels, enhance the activity of tumor infiltrating immune cells, and inhibit tumor cell immune evasion. More importantly, FS-8002 can potentially enhance the sensitivity of immune checkpoint inhibitors and expand the application scope of immunotherapy by promoting the transition from “cold” tumors to “hot” tumors.
About Huapu-Fusion Bioscience
Huapu Biotechnology, founded in 2001, has pioneered globally patented vaccine adjuvants and oncology therapeutics centered on its TLR9 agonist CpG platform. As a biopharmaceutical innovator with core CpG patents and iterative development capabilities, the company has established process scale-up and commercial manufacturing infrastructure, positioning itself as a leading global developer and producer of CpG adjuvants.
Fusion Bioscience was established in late 2020 as an early-stage drug discovery company specializing in developing therapeutics that improve the tumor microenvironment. Our mission is to overcome drug resistance to anti-cancer agents (including tumor immunotherapies), enhance patient response rates, and extend survival. To date, leveraging our robust fusion protein technology platform, Fusion Bioscience has developed two novel large molecule drugs: FS-8002 and FS-0918.
In April 2023, Fusion Bioscience merged with Huapu Biotechnology (Hebei) Co., Ltd., becoming Huapu’s Shanghai R&D center. In September 2023, Huapu-Fusion Bioscience submitted the IND for HP007 in China（see related：AACR 2024：ORR 达84.6%，华普生物的HP007联合免疫治疗在晚期及转移性前列腺癌患者中展现良好前景）。
About Tee Labs
Tee Labs is an international community and startup incubator co-founded by entrepreneurs and venture capitalists, dedicated to advancing medical frontiers including AI-driven drug discovery, diagnostics, and personalized medicine through digital solutions. We provide comprehensive support encompassing R&D facilities, corporate services, integrated supply chains, and funding—deeply empowering startup teams to accelerate development cycles. Our laboratory features core equipment and shared instrument platforms, significantly reducing preparatory phases for workspace and device setup, allowing companies to focus on critical R&D. Currently operating 2,600 sqm of incubation space—including 1,500 sqm of specialized labs—Tee Labs houses chemistry, molecular biology, cell culture, bacteriology, and biosafety level 2 (BSL-2) facilities. This multi-domain infrastructure enables diverse research initiatives and offers early-stage companies the flexibility for multifunctional teams to collaborate within integrated workspaces.