Chime Biologics Enters into a Collaboration with HanxBio to Accelerate the Development and Marketing of HX009
- Chime Biologics entered into a collaboration with Hanx Biopharmaceutical Co., Ltd. (hereinafter referred to as “HanxBio”) regarding HanxBio Class I biologic anti-CD47/PD-1 bispecific antibody HX009, accelerating the development and marketing of this innovative drug.
- Having completed more than 60 commercial batches of cGMP 2000L drug substance under the international quality standards (FDA, EMA and NMPA), Chime Biologics has extensive experience in biologics drug manufacturing and regulatory application with many domestic and international licenses and certifications.
Wuhan, China, March 13, 2023 – Chime Biologics signed a strategic collaboration agreement with HanxBio, an innovative biopharmaceutical company, regarding HanxBio Class I biologic anti-CD47/PD-1 bispecific antibody HX009.
The two powerful local enterprises in Wuhan joined hands this time to create more value for the industry. This strategic cooperation will utilize Chime Biologics’ rich experience in technology transfer, process scale-up, process characterization, GMP manufacturing to BLA, so as to rapidly characterize and manufacture this novel drug and bring it to the market as soon as possible for the benefit of more patients.
HX009 is an innovative anti-PD-1/CD47 bispecific immunotherapy independently developed by HanxBio to treat cancer. It enhances the phagocytosis of macrophages and activates the immune response of CD8+ T cells through the interaction of ligand protein SIRPα of CD47 with CD47 on tumor cells and effector T cells, thus boosting the innate and cellular immune responses in multiple steps. Currently, the Phase I clinical trials of HX009 have been completed in Australia and China, and its Phase II clinical trials are initiating in both China and US.
Through this strategic collaboration, Chime Biologics will provide support to HanxBio in technology transfer, process scale-up, process characterization, process validation, GMP manufacturing and BLA, up to the commercial manufacturing of the bispecific antibody HX009. As the world’s first modular plant applying disposable bio-manufacturing technology, Chime Biologics has completed more than 60 commercial batches of cGMP 2000L drug substances under international quality standards (FDA, EMA, NMPA, etc.), with rich experience in drug application.
Dr. Henry Li, President of HanxBio stated that “For HX009, a novel bispecific antibody drug in the clinical-stage developed independently by HanxBio, we are very pleased to make a strategic collaboration with Chime Biologics. With its advanced technology, robust quality system, extensive experience in drug application and excellent services, Chime Biologics will help to ensure an efficient and sustainable manufacturing process for HX009. We also look forward to future collaborations to bring more innovative biologics to patients worldwide.”
James Huang, Chairman of Chime Biologics, said, “We are pleased to establish a strong partnership with HanxBio, and through which, both of us will try every effort to promote the commercialization of HX009 and ensure its smooth marketing. This is one of the multiple bispecific antibody projects enabled by Chime Biologics in the China market. Currently, Chime Biologics has completed more than 60 commercial batches of cGMP 2000L drug substance and has also started the commercial manufacturing of drugs already in the market. We are proud to be able to empower our global partners to bring more drugs to market faster for the benefit of patients.
Established in 2016, Hanx Biopharmaceutical Co., Ltd. is a global biopharmaceutical company that develops innovative immune-oncology therapeutics. HanxBio brings together well-known experts in the biopharmaceutical industry advance the development of novel cancer medicines from early discovery, translational research, process development, cGMP manufacturing, business development, to clinical research. We leverage our expertise to develop patented high-affinity long half-life antibody screening, rationally designed multi-functional molecule and novel tumor-targeting antibody technology platforms (GPSmAb). We develop innovative treatments to address significant unmet medical needs and help patients around the world. We aim to accomplish our goal through in-house research development as well as global collaborations.
About Chime Biologics
Chime Biologics is a leading CDMO that has introduced the first modular biopharmaceutical plant KUBio in the world to empower its partners’ success in biologics in the whole process from cell line development to commercial manufacturing. Relying on cell line development and advanced technology development from our Shanghai Innovation Center and proven success in IND-enabling through BLA filing at its Wuhan plant, Chime Biologics is providing a one-stop CMC solution for biopharmaceutical customers around the world. We share a common goal to make cutting-edge biomedicines affordable and accessible to all patients globally, fulfilling its commitment to human health.