BioDlink Drives Global Biologics Innovation with World’s First Approved EGFR-Targeted ADC

01 December 2025 | Monday | News


Global CMC platform enables seamless Europe–China tech transfer, accelerating biologics development and regulatory approval for recurrent/metastatic nasopharyngeal carcinoma.
Image Source : Public Domain

Image Source : Public Domain

  • Recognized as Biologics CDMO of the Year, BioDlink shares insights into the world's first approved EGFR-targeted ADC for recurrent/metastatic nasopharyngeal carcinoma
  • The company enables seamless Europe–China tech transfer and faster biologics development through an integrated, end-to-end CMC platform

BioDlink, a global leader in biologics contract development and manufacturing, took center stage at Biologics CDMO Europe 2025 to present its critical role in the regulatory approval and manufacturing support of the world's first approved EGFR-targeted antibody-drug conjugate (ADC) for the treatment of recurrent or metastatic nasopharyngeal carcinoma (R/M NPC).

 

During his keynote presentation, "Linking Europe and China —Mutual Success in Biologics CMC Development," Dr. Jian Zhang, Chief Operating Officer at BioDlink, discussed global and Chinese biologics market trends, pointing out that China contributed 54 percent of ADCs and 48 percent of bispecific and tri-specific antibodies in global Phase Ⅰ/Ⅱ trials as of 2025[1]. In Q1-Q3 2025, the country's license-out total deal value hit $920.3 billion, a 77 percent increase over 2024, including 16 deals valued over $1 billion each based on industry report[2].

Dr. Zhang also introduced BioDlink's cross-regional project execution capabilities, providing case studies on how its integrated one-base, end-to-end CMC (Chemistry, Manufacturing, and Controls) platform facilitated seamless technology transfer, agile regulatory alignment, and accelerated manufacturing timelines. The company recently manufactured a first-in-class Becotatug Vedotin injection, receiving marketing approval from China's National Medical Products Administration (NMPA), and is the first EGFR-targeted ADC ever approved globally, representing a significant R/M NPC therapeutic advancement.

Further reinforcing its industry leadership, BioDlink was named Biologics CDMO of the Year at the Biologics CDMO Excellence Europe 2025 awards, recognized for its overall excellence in biologics across core customer needs, including quality, speed, and cost.

BioDlink sponsored the "Tech-Transfer Simplified: Lessons across the Lifecycle" forum, with Dr. Zhang participating in a lively discussion with top biotech CEOs, MNC executives, research leaders, and investment leaders. Technology transfer should be treated not just as a technical hand‑off but as a strategic phase covering the transition from development to manufacturing, with implications for product quality, timelines, regulatory applications, and commercial outcomes. Seamless technology transfer is also essential to China's growth as a global innovation hub, enabling greater speed, broader modality expansion, and a shift to NewCo and out-licensing financing.

"We are empowering our global clients to innovate more fearlessly," said Dr. Zhang. "With world-class facilities anchored in Asia, strategic reach into Europe and tested quality systems, BioDlink is a strategic bridge from Europe to China's fast-growing drug discovery and CMC development ecosystem with significant speed and cost advantages. We are committed to serving as a strategic CDMO partner to global pharmaceutical companies advancing first-in-class and other advanced therapies."

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