As BioDlink, a starring world CDMO, affirms its committedness to strategical alliances to support biotech invention worldwide arsenic it marks 15 years of operations. Alliances are gaining momentum crossed nan APAC region, wherever nan first half of 2025 has seen a crisp emergence successful collaboration—24 caller location partnerships and counting—signaling a displacement toward quality, speed, and costs efficiency.
Dr. Jun Liu, CEO and Executive Director of BioDlink, notes that biotech companies are progressively joining trusted ecosystems for illustration BioDlink’s to accelerate improvement and manufacturing to turn nan marketplace together successful their globalization strategy. These companies request not only precocious value and accelerated delivery, but besides a blend betwixt quality, speed, and cost. Complex therapies specified arsenic antibody-drug conjugates (ADCs) request meticulous fine-tuning to optimize combinations and targets, making reliable, agile partnerships essential.
For ADCs, we tin complete nan full process from DNA synthesis to toxicology study worldly merchandise successful conscionable 7 months, and nan afloat IND exertion wrong 11 months. For monoclonal antibodies, nan timelines are 6 months and 10 months, respectively.
In nan look of world competition, it is much important to build a win-win world ecosystem than spell for nan lowest price. Driven by customer needs, we strive to equilibrium quality, speed, and costs to maximize value.”
Dr. Jun Liu, CEO and Executive Director, BioDlink
BioDlink’s ongoing collaboration pinch GlycanLink exemplifies this approach, processing nan GL-DisacLink® platform, an precocious site-specific conjugation (1-enzyme 1-step) exertion that enhances ADC stableness and efficacy beyond accepted linker methods. BDKcell®, BioDlink’s proprietary compartment statement building platform, has a accelerated improvement rhythm of 14 weeks. These innovations connection important process advantages, including precocious uniformity, simplified workflows, short guidance times, reduced off-target effects, and reduced wide accumulation costs.
For world biotech companies seeking to create caller ADC targets, bispecific ADCs, dual-payload ADCs, PDCs, TCE-ADCs, non-internalizing ADCs and caller format ADCs, occurrence besides hinges connected nan expertise to standard projects nether stringent regulatory frameworks. Their information includes whether confederation partners bring robust capabilities and a verifiable regulatory way record, including transportation reliability, process patents, and end-to-end chemistry, manufacturing, and power (CMC) systems.
Building connected a beardown instauration of 107 pre-clinical studies, 38 objective studies and 8 pre-BLA studies (as of December 31, 2024), BioDlink’s world maturation strategy is laser-focused connected leveraging cardinal areas specified arsenic ADCs, providing differentiated worth to confederation partners, and unlocking ecosystem synergy, for instance, Kexing Biopharm covers world licensing, while BioDlink focuses connected commercialized supply.
Partnering pinch innovative biotechs for illustration MediLink Therapeutics, Escugen, and Smart Nuclide, BioDlink has emerged arsenic nan go-to CDMO for ADC and RDC projects. Furthermore, BioDlink’s broad CDMO level for antibody narcotics (mAbs/BsAbs), ADCs, fusion proteins, and different bioconjugates delivers:
- Production capacity flexibility: Operates 4 commercialized accumulation lines, pinch 20,000 L antibody supplier constituent capacity and yearly output exceeding 150 batches. It besides supports ADC payload accumulation of 960 kg annually, crossed 2 independent accumulation centers.
- Professional team: A seasoned CMC squad and customer-focused PM group bringing late-stage CMC task expertise, supporting 8 pre-BLA projects and 2 commercialized products, ensuring a soft clinical-to-commercial transition.
- International value guidance strategy and bully audit record: GMP-certified successful aggregate countries and regions, including nan U.S., EU and China. Passed almost 100 charismatic and customer audits globally, including 4 FDA IND approvals without further information requests and 5 successful EU-QP audits (including zero-defect) until now.
- Proven commercialization capabilities: The manufacturing accommodation person passed GMP audits of NMPA and Brazil (PIC/S personnel country), Indonesia, Egypt, Colombia, Argentina, and Pakistan. BioDlink has obtained trading authorization successful China, Nigeria, and Pakistan, arsenic good arsenic PMDA certification successful Japan. Biosimilars are produced and supplied to galore countries astir nan world.
BioDlink’s competitory separator stems from its one-base, end-to-end streamlined level for antibody drugs, ADCs, fusion proteins and different bioconjugates focused connected 3 halfway customer needs: quality, speed, and cost-efficiency. Dr. Jun Liu also highlights: “Within China, we were among nan first CDMOs to attraction connected antibodies and ADC-based antibodies and clasp a first-mover advantage. We are going world pinch like-minded clients and confederation partners, pinch a committedness to sustainable success.”
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