As BioDlink, a leading global CDMO, affirms its commitment to strategic alliances to support biotech innovation worldwide as it marks 15 years of operations. Alliances are gaining momentum across the APAC region, where the first half of 2025 has seen a sharp rise in collaboration—24 new regional partnerships and counting—signaling a shift toward quality, speed, and cost efficiency.
Dr. Jun Liu, CEO and Executive Director of BioDlink, notes that biotech companies are increasingly joining trusted ecosystems like BioDlink’s to accelerate development and manufacturing to grow the market together in their globalization strategy. These companies demand not only high quality and fast delivery, but also a blend between quality, speed, and cost. Complex therapies such as antibody-drug conjugates (ADCs) demand meticulous fine-tuning to optimize combinations and targets, making reliable, agile partnerships essential.
For ADCs, we can complete the entire process from DNA synthesis to toxicology study material release in just 7 months, and the full IND application within 11 months. For monoclonal antibodies, the timelines are 6 months and 10 months, respectively.
In the face of global competition, it is more important to build a win-win global ecosystem than go for the lowest price. Driven by customer needs, we strive to balance quality, speed, and cost to maximize value.”
Dr. Jun Liu, CEO and Executive Director, BioDlink
BioDlink’s ongoing collaboration with GlycanLink exemplifies this approach, developing the GL-DisacLink® platform, an advanced site-specific conjugation (1-enzyme 1-step) technology that enhances ADC stability and efficacy beyond conventional linker methods. BDKcell®, BioDlink’s proprietary cell line construction platform, has a rapid development cycle of 14 weeks. These innovations offer significant process advantages, including high uniformity, simplified workflows, short reaction times, reduced off-target effects, and reduced overall production costs.
For global biotech companies seeking to develop new ADC targets, bispecific ADCs, dual-payload ADCs, PDCs, TCE-ADCs, non-internalizing ADCs and novel format ADCs, success also hinges on the ability to scale projects under stringent regulatory frameworks. Their evaluation includes whether alliance partners bring robust capabilities and a verifiable regulatory track record, including delivery reliability, process patents, and end-to-end chemistry, manufacturing, and control (CMC) systems.
Building on a strong foundation of 107 pre-clinical studies, 38 clinical studies and 8 pre-BLA studies (as of December 31, 2024), BioDlink’s global growth strategy is laser-focused on leveraging key areas such as ADCs, providing differentiated value to alliance partners, and unlocking ecosystem synergy, for instance, Kexing Biopharm covers global licensing, while BioDlink focuses on commercial supply.
Partnering with innovative biotechs like MediLink Therapeutics, Escugen, and Smart Nuclide, BioDlink has emerged as the go-to CDMO for ADC and RDC projects. Furthermore, BioDlink’s comprehensive CDMO platform for antibody drugs (mAbs/BsAbs), ADCs, fusion proteins, and other bioconjugates delivers:
- Production Capacity Flexibility: Operates four commercial production lines, with 20,000 L antibody drug substance capacity and annual output exceeding 150 batches. It also supports ADC payload production of 960 kg annually, across two independent production centers.
- Professional Team: A seasoned CMC team and customer-focused PM group bringing late-stage CMC project expertise, supporting eight pre-BLA projects and two commercial products, ensuring a smooth clinical-to-commercial transition.
- International Quality Management System and Good Audit Record: GMP-certified in multiple countries and regions, including the U.S., EU and China. Passed almost 100 official and client audits globally, including 4 FDA IND approvals without additional data requests and 5 successful EU-QP audits (including zero-defect) until now.
- Proven Commercialization Capabilities: The manufacturing facilities have passed GMP audits of NMPA and Brazil (PIC/S member country), Indonesia, Egypt, Colombia, Argentina, and Pakistan. BioDlink has obtained marketing authorization in China, Nigeria, and Pakistan, as well as PMDA certification in Japan. Biosimilars are produced and supplied to many countries around the world.
BioDlink’s competitive edge stems from its one-base, end-to-end streamlined platform for antibody drugs, ADCs, fusion proteins and other bioconjugates focused on three core customer needs: quality, speed, and cost-efficiency. Dr. Jun Liu also highlights: “Within China, we were among the first CDMOs to focus on antibodies and ADC-based antibodies and retain a first-mover advantage. We are going global with like-minded clients and alliance partners, with a commitment to sustainable success.”