Solutions-Based Thinking: BioDlink’s Model for Successful CDMO Partnerships

In an era where speed-to-clinic can mean the difference between a first-in-class breakthrough and a me-too follower, European biotech companies face mounting pressure. Capital constraints, intensifying global competition, and compressed development timelines are forcing innovative drug developers to rethink their development and manufacturing strategies. For many, the solution lies not just in finding a Contract Development and Manufacturing Organization (CDMO), but in securing a true strategic partner.

Dr. Jian Zhang, Acting CEO of BioDlink, brings a unique perspective to this challenge. Educated in both China and the U.S., Dr. Zhang has over 10 years of international experience including positions at Fortune 500 companies Thermo-Fisher and Bristol-Myers Squibb. In China, Dr. Zhang spent nearly a decade at Wuxi Biologics where he helped scale operations from 500 to 10,000 employees. His transpacific experience allows Dr. Zhang to understand the technical complexities of biologics development, the operational excellence required to deliver good results at speed and the cultural nuances important to partnering with western companies.

“We treat every client project not as just a one-time project, but as an asset we’re developing ourselves,” Dr. Zhang explains. Having transitioned from a biotech firm into a CDMO, BioDlink exemplifies the pharmaceutical sector values of quality and innovation in everything from its corporate culture to drug development and GPM manufacturing.

“I want my team to view every project working with a client just like they’re developing our own products,” he said.

The Competitive Landscape Has Changed

The urgency facing European biotech has intensified dramatically. According to recent data from the consultancy McKinsey & Company more than 30% of innovative drug modalities now originate from China, with Chinese biotech companies completing over $130 billion in out-licensing deals in 2025 alone. That’s more than double the previous year’s volume.

“Whatever innovations U.S. and European companies develop, multiple Chinese companies are likely to pursue drugs against the same targets or similar modalities. In this competitive landscape, speed has become more critical than ever,” Dr. Zhang notes.

For European companies developing antibody-drug conjugates (ADCs), one of the fastest-growing therapeutic modalities, the competitive pressure is particularly acute. China now accounts for 54% of ADCs in phase 1 and 2 development globally, according to McKinsey & Company. This dominance isn’t just about volume; it’s about the ecosystem that has emerged to support rapid development.

Beyond Transactional: A Partnership Model

What distinguishes BioDlink’s approach is its evolution from a product company to a CDMO. In 2020, the company made a strategic pivot from developing biosimilars to becoming a service provider focused on next-generation modalities, particularly ADCs. This heritage shapes how the company engages with clients today.

“A good CDMO, the best CDMO, is whoever can best help the client solve the problem,” Dr. Zhang emphasizes. “Not only to make a manufacturer batch or do a test, but to provide a comprehensive solution and solve critical problems encountered during the CMC development.”

This philosophy translates into tangible benefits for early-stage biotech companies that may lack deep CMC development experience. Rather than simply executing on client specifications, BioDlink’s team leverages its drug development background to anticipate challenges, recommend solutions, and share insights that can accelerate timelines.

“We have the accountability and ownership to solve challenges—not only to solve the challenges, but also to foresee the challenges and solve any problem the client may encounter,” Dr. Zhang explains.

The Speed Advantage

McKinsey & Company confirms what many European biotechs are discovering: developing a drug candidate from preclinical stage to IND in China takes one-third to one-half the time compared to the U.S. or Europe, at one-third to one-half the cost.

These advantages stem from multiple factors, including regulatory reforms that have transformed China’s biotech landscape over the past decade. IND approval timelines have compressed from over two years to less than two months. China’s 2017 entry into the International Council for Harmonisation (ICH) has aligned regulatory requirements with U.S. and European standards. And regulatory changes now permit contract manufacturing, previously prohibited, creating a robust CDMO ecosystem.

For BioDlink’s clients, these systemic advantages combine well with the company’s specialized capabilities. With nearly 80% of projects focused on ADCs, BioDlink has developed deep expertise in this complex modality, working with nearly every biotech company developing ADCs in China.

This specialization has produced results. BioDlink clients have successfully out-licensed assets to major European pharmaceutical companies, including multiple deals with BioNTech and Roche. One notable example: Profound Bio, founded by a BioDlink client in 2021, was acquired by Danish biotech company Genmab for €1.8 billion after just three years. Several of Profound Bio’s ADC molecules were developed in partnership with BioDlink.

Innovation as Competitive Advantage

While speed and cost matter, BioDlink is investing in proprietary technologies that provide additional differentiation. The company’s co-developed conjugation technology platform, in collaboration with GL-DisacLink^®, streamlines the ADC manufacturing process with one enzyme-based conjugation strategy vs two enzymes-based Synaffix (acquired by Lonza).

“The process is much faster and more cost-effective,” Dr. Zhang said, explaining how BioDlink helped engineer and scale the enzyme technology for GMP production.

The company has also developed its own CHO-K1 cell line, branded as BDKcell^®, which consistently achieves 8-10 grams per liter titer using traditional fed-batch processes without requiring intensified processes or perfusion technology. This high-performing cell line has been used to develop more than 30 molecules across various formats, including monoclonal antibodies, bispecific antibodies, fusion protein and nanobody.

Perhaps most innovative is BioDlink’s mathematical modeling approach to lyophilization process development –BDKLyo, a digital-intelligent Lyo Process Calculation Platform. Designed to optimize both development and manufacturing, it ensures product quality and appearance while significantly shortening the timeline. By analyzing data from over 50 different ADC drug products, the company has created predictive models that significantly reduce the wet lab testing typically required to optimize lyophilization conditions for these inherently unstable molecules.

“We can now predict the optimized conditions with a mathematical model, which will significantly reduce the timeline for drug product process development, reducing the cost of the development,” Dr. Zhang explains.

Aligned Values: The ESG Imperative

For European companies where environmental, social, and governance (ESG) commitments are non-negotiable, BioDlink offers reassurance through both certification and performance.

The company holds ISO 45001 certification for occupational health and safety. This is particularly critical given the highly potent, toxic materials involved in ADC manufacturing. It’s also certified for ISO 50001 (energy management), ISO 14001 (environmental management) and ISO 9001 (quality management）.

More impressively, BioDlink has achieved a long-term and marked downward trend in energy consumption, reducing it by approximately 33% over the past two years through operational improvements like optimized building management systems that adjust clean room temperatures based on occupancy and activity levels.

“I believe ESG and company goals can be very well aligned,” Dr. Zhang states. “For example, reducing energy consumption also reduces costs for the company and improves profitability.”

This performance has earned recognition: BioDlink has been listed among the top 10 ESG competitiveness rankings for public pharmaceutical companies in China for three consecutive years and received a double-A rating from Wind ESG, placing it in the top 10% of Chinese biotech companies for ESG performance.

A Strong Audit Track Record in Quality & Compliance

BioDlink operates international quality management systems aligned with regulatory requirements in the U.S., the EU, and China, supported by 90+ audits, date inspections over the past three years. The company has successfully passed EU QP inspections six times in the past four years, a rare feat that underscores operational excellence. Its manufacturing facility is GMP-certified across multiple regions, including China, Brazil, Egypt, Indonesia, Colombia, Argentina, Pakistan, and Thailand, and is also recognized by Japan’s PMDA. And also successfully go-live of Veeva QMS, marking a key milestone in its digital transformation and strengthening its GMP quality management capabilities.

Looking Ahead: Gateway to Asia

While BioDlink currently focuses on supplying clinical samples for trials outside China, Dr. Zhang sees long-term opportunities as regulatory pathways evolve. Recent changes now permit segmented production which allows drug substance manufactured outside China to be formulated into drug product within China. This opens new possibilities for European companies seeking Asian market access.

That opportunity is becoming more tangible as China’s regulatory environment continues to advance, BioDlink is demonstrating how strong execution and integrated capabilities can accelerate innovative ADC programs from development to commercialization. In October 2025, BioDlink congratulated partner Lepu Biopharma on receiving NMPA conditional marketing approval for MEIYOUHENG (Becotatug Vedotin injection), described as the world’s first approved non-photoimmunological EGFR-targeted ADC for recurrent or metastatic nasopharyngeal carcinoma (R/M NPC). BioDlink positioned the program as its first commercial ADC manufacturing initiative globally—an example of how fast, tightly coordinated tech transfer and GMP delivery.

The company also received formal recognition from Chengdu Kanghong Pharmaceutical Group for advancing KH815, the world’s first dual-payload ADC, achieving IND approval 1.5 months ahead of schedule, demonstrating strong execution of complex first-in-class programs.

The Chinese market opportunity is substantial: with 1.4 billion people and rapidly aging demographics, China is already the world’s second-largest pharmaceutical market and poised for faster growth than Western markets over the next decade.

For now, however, BioDlink’s value proposition centers on helping European biotechs maintain their competitive position in global markets through faster, more cost-effective CMC development.

“If they are looking for a reliable partner who offers top-tier quality, reliability and speed, BioDlink is here for them to consider,” Dr. Zhang concludes.

In a landscape where first-in-class status can determine a company’s fate, that combination of partnership mindset, specialized expertise, and operational excellence may be exactly what European biotech needs.