Science&Manufacturing
Innovation Capacity
Since RemeGen's inception, we have been committed to the development of biologics with novel targets, innovative designs and transformative capability with the mission of fulfilling global unmet clinical needs for patients worldwide. After more than a decade of hard work, we have built a fully integrated, end-to-end drug discovery and development platform that covers all key biologics development functions, including discovery, preclinical pharmacology, process and quality development, clinical development, and GMP-compliant manufacturing.
Technology Platform
Our biopharmaceutical research and development capabilities consist of three specialized platforms, targeting multiple areas of biotherapy. These include the antibody and fusion protein platform, the antibody-drug conjugate (ADC) platform, and the multi-specific antibody platform. Our platforms are capable of discovering, screening, and developing new molecules, creating proprietary technologies, and efficiently optimizing production processes, thereby ensuring end-to-end integration of drugs from research and development to commercialization in the pipeline.
- Antibody and Fusion Protein Platform
- Antibody-Drug Conjugate (ADC) Platform
- Multispecific Antibody Platform
Our capabilities in the discovery and development of antibodies and fusion proteins are driven by innovative technologies and our expertise in bioinformatics-assisted protein design and protein engineering. Our antibody and fusion protein platform has been well established, encompassing key functions including antibody/fusion protein screening and protein engineering; cell line/process development; and GMP production of drug substances (DS) and drug products (DP). Through this platform, we have developed a few innovative biologics, including telitacicept (RC18) and RC28.
We are one of the few leading biopharmaceutical companies with a fully integrated ADC platform, with in-house capabilities covering the entire process of ADC development and production. Our ADC platform has the following key features: development of innovative linkers, payloads, and conjugation processes; a screening platform for optimizing ADC payload and linker combinations; a proprietary Thiel-bridge coupling technology; GMP production of drug linkers. GMP production of ADC drug substance (DS) and drug product (DP). Through this platform, we have developed a few innovative biopharmaceuticals, including RC48 (disitamab vedotin ) and RC88 (an ADC targeting mesothelin MSLN).
Our multispecific antibody platform focuses on the development of next-generation biotherapeutic molecules, which facilitates the implementation of innovative therapeutic approaches. The multispecific platform is designed to accommodate a variety of molecular formats, enabling tailored therapeutic solutions that provides the potential to increase the efficacy and specificity of antibody-based therapies. Through this platform, we have developed a number of innovative biologics such as the bispecific antibody RC148.
Manufacturing
We possess a total cultivation capacity of 70,000 liters of antibody and ADC production facilities that comply with international GMP standards, meeting the production needs of our product pipeline for both clinical and commercial stages. With advanced single-use technologies, top brand process equipment, analytical instruments, and high standard utility facilities, we have established competitive capabilities for large-scale production of various innovative biologics. In line with the rapid commercialization of our products, new production facilities featuring automation, digitalization, and informatization technologies are currently under construction.
Quality System
As an innovative biotech company RemeGen conducts its quality activities based on the core principles of “integrity, science, continuous improvement and pursuit of excellence”. RemeGen has developed important processes for producing high-quality biotech products (monoclonal/bispecific antibodies, fusion proteins and antibody-drug conjugates) in compliance with international regulatory requirements (NMPA, FDA, EMA). With adoption of the Quality by Design (QbD) principles, RemeGen builds in quality, beginning with the design of molecules, all the way through to their development, manufacturing, and distribution to patients. To ensure our unwavering commitment to delivering high-quality products to patients, RemeGen has built an experienced and engaged quality workforce equipped with advanced quality management system (QMS).
Talent Team
RemeGen is led by a visionary management team with an average of more than 20 years of industry experience, possessing a successful track record in innovative drug R&D, clinical development, and commercialization.
We have constituted a workforce of more than three thousand employees, gathering a team of skilled professionals.
Dr. Fang Jianmin possesses rich experience in developing innovative biopharmaceuticals at well-known research institutions and biopharmaceutical companies. Under his leadership, we have established a strong R&D team that encompasses all major functions involved in biopharmaceutical development.
Our clinical development department implements the global clinical development plan in line with rigorous study design and standard clinical practice. What sets us apart is the clinical development team is committed to discovering and exploring unexpected clinical opportunities, which drives the growth and expansion of our clinical development plan.
No. 58 Beijing Middle Road, Yantai Development Zone, Shandong, China.
（+86）535-3573511
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