Thousand Oaks Biologics supports Kexing Biopharm in officially launching the R&D and industrialization project of KXBS001
Kexing Biopharm
Developer, Manufacturer, and Marketer of Recombinant Protein Drugs and Microecological Preparations
Thousand Oaks
Biopharmaceutical R&D and Production Service Provider
Shanghai Thousand Oaks Biologics, a wholly-owned subsidiary of Thousand Oaks Biologics and Kexing Biopharm have established a strategic partnership to advance the research, development, and industrialization of the biosimilar KXBS001. Both parties held a signing ceremony in Shenzhen. This milestone collaboration marks Kexing's entry into the European and American biosimilar markets.
In today's global biopharmaceutical field, drug development has become an important force in promoting medical progress and human health. With the expiration of patents for multiple biologics, In recent years, high-end biosimilars have also entered a "golden period of development."
On April 1 this year, the European Medicines Agency (EMA) released a draft Reflection Paper on Tailored Clinical Approaches in Biosimilar Development for public consultation from April 1 to September 30, aiming to streamline the review of biosimilars. For biosimilars that can demonstrate comparable clinical efficacy and safety pharmacology through sufficiently rigorous analytical comparability assessments, in vitro pharmacology, and comparative clinical pharmacokinetic (PK) trials, there will be no need to conduct comparative efficacy phase III clinical trials.
If this draft is successfully implemented, it could open a new fast track for Chinese pharmaceutical companies to enter the EU pharmaceutical market. According to an IQVIA research report, the EU remains the mainstream market for biosimilars globally, accounting for approximately 40% of market value. Moreover, between 2024 and 2030, about 71% of patented biologic drugs in the EU that are nearing expiration do not currently have corresponding biosimilar candidates in the development pipeline. This supply-demand gap also indicates significant room for growth for biosimilars in the EU in the future.
Kexing Biopharm insists the strategy of "innovation + internationalization". In recent years, the company has consistently laid out its R&D pipeline with an international perspective, focusing on the development of antibody technology platforms. This has formed a full-chain innovation capability ranging from target discovery, molecular design to process optimization. Centering on antiviral, oncology, and autoimmune fields, the company has built a "high-value R&D pipeline matrix," with more than ten new drugs in the layout, including monoclonal antibodies, bispecific antibodies, and multi-target antibody fusion proteins, creating systematic and tiered pipeline arrangements across all fields.
At the signing ceremony, Deng Xueqin, Chairman of Kexing Biopharm, stated that the Thousand Oaks Biologics' team has extensive experience in CMC development, commercial production, and regulatory submissions for large molecules such as monoclonal antibodies, multi-specific antibodies, and ADCs. In the future, both parties will collaborate closely to develop high-quality biosimilars that meet the regulatory standards of China, the U.S., and Europe, enriching the company’s product pipeline in Europe and the U.S. and seizing market opportunities.
Chairman of Thousand Oaks Biologics, Luo Shun expressed anticipation for the cooperation with Kexing Biopharm, noting that the company has made rapid progress on its path to internationalization in recent years. Thousand Oaks will leverage its own strengths, applying a global perspective and cutting-edge technology to accelerate the development of the collaborative projects.
As a strategic partner, Thousand Oaks will leverage its comprehensive commercial CRDMO capabilities to support Kexing in entering the global multiple disease areas. The company has successful experience with multiple listed projects and a mature process development system, covering the entire process from cell line construction, process development to the release of formulation products for marketing; flexible production lines significantly improve the conversion efficiency from R&D to commercial production. In addition, Thousand Oaks' Shanghai Lingang production base complies with European and American regulatory requirements, providing a solid guarantee for the smooth progress of the project.
This collaboration not only reflects Kexing Bioharma's strategic ambition in the global biosimilar market but also demonstrates Thousand Oaks Biologics' comprehensive strength in the CRDMO field. Through this powerful partnership, both parties aim to jointly promote high-quality biologics to the international market, further enhancing their competitiveness and influence in the global biopharmaceutical market.
Source: Thousand Oaks Biologics