【Pharmaceutical Network Industry News】In the development of China's innovative pharmaceutical sector, out-licensing overseas is a crucial component, with Chinese Antibody-Drug Conjugate (ADC) therapeutics emerging as highly sought-after targets for out-licensing partnerships with multinational pharmaceutical companies, and numerous blockbuster deals also taking place in the ADC field.
Among them, DualityBio stands out as a major player in the global out-licensing of ADCs. Currently, 6 of the company's 13 ADC pipeline programs are out-licensed partnerships. Multinational pharmaceutical companies such as BioNTech, GSK, and BMS are among its partners. Notably, the total potential deal value for the three ADCs licensed to BioNTech is expected to reach $6 billion.
For example, BioNTech will acquire DualityBio's candidate drug DB-1303, an antibody-drug conjugate (ADC) based on a topoisomerase I inhibitor targeting human epidermal growth factor receptor 2 (HER2). Overexpression of this target in various cancers drives the aggressive growth and spread of cancer cells. HER2-targeted antibody therapies have proven to be an effective treatment strategy for HER2-expressing cancers. The DB-1303 program has received Fast Track designation from the U.S. Food and Drug Administration ("FDA") and is currently in a Phase II clinical trial (NCT05150691) for various HER2-expressing advanced solid tumors. BioNTech will also acquire DB-1311, another topoisomerase I inhibitor-based ADC candidate. This third-generation ADC product is based on DualityBio's DITAC technology platform. It has demonstrated potent antitumor activity across a range of tumor models representing multiple cancer types, and has exhibited favorable tolerability and pharmacokinetic profiles in preclinical safety assessments.
The licensing agreement between DualityBio and GSK for DB-1324 also reached $1 billion. DB-1324 is a next-generation antibody-drug conjugate (ADC) developed based on DualityBio's DITAC platform. In October 2025, DB-1324 received approval from the Australian Human Research Ethics Committee (HREC) and obtained Clinical Trial Notification (CTN) authorization from the Therapeutic Goods Administration (TGA) of Australia. In December 2025, the Investigational New Drug (IND) application for DB-1324 was approved by the U.S. Food and Drug Administration (FDA). The global clinical development of this product is progressing steadily and is expected to provide a new treatment option for patients with advanced/metastatic gastrointestinal tumors.
MediLink’s strength in the ADC sector is also not to be underestimated. Leveraging its proprietary ADC (antibody-drug conjugate) technology platform, the company boasts prominent differentiated advantages. In January 2024, MediLink announced a global collaboration and licensing agreement with Roche to jointly develop YL211, a next-generation ADC candidate targeting the mesenchymal-epithelial transition factor (c-MET) for the treatment of solid tumors. In January 2026, Roche entered into a new exclusive licensing agreement with MediLink for YL201, an ADC targeting B7-H3. Under the agreement, MediLink received a one-time upfront and near-term milestone payment of $570 million, and will subsequently be eligible for multiple milestone payments across the R&D, clinical, and commercialization stages, as well as royalties calculated on actual net sales post-launch. Industry observers note that Roche’s additional endorsement not only underscores the enhanced bargaining power of Chinese biopharmaceutical companies, but also signals that top-tier multinationals are systematically placing strategic bets on China’s ADC innovation pipeline. For MediLink, establishing stable and robust partnerships with MNCs represents a pivotal milestone on its journey toward globalization.
As one of the earliest Chinese companies to license out ADCs overseas, RemeGen’s disitamab vedotin is China’s first domestically developed ADC drug and has already been out-licensed internationally. Early in 2026, the company introduced its next-generation Claudin 18.2-targeting ADC. Backed by outstanding clinical data in gastric and pancreatic cancers, the asset secured a $4.8 billion record-breaking licensing deal with AstraZeneca, with an upfront payment reaching $720 million.
Meanwhile, Hengrui Medicine's TROP2 ADC achieved objective response rates (ORR) of 62.3% and 58.7%, respectively, in global multi-center clinical trials for advanced non-small cell lung cancer and triple-negative breast cancer. Outperforming globally marketed comparable products, it demonstrated particularly robust efficacy in patients with brain metastases, ultimately attracting competitive bids from three pharmaceutical companies, including Merck and Pfizer, and culminating in a partnership deal valued at $5.6 billion.
Across the industry, the overseas expansion of China’s ADC (antibody-drug conjugate) therapeutics has evolved from isolated breakthroughs to a sector-wide surge. As overseas clinical trials continue to advance, the domestic ADC “going-global” cohort will enter a harvest phase, emerging as a major force in China’s innovative pharmaceutical landscape.
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