Antibody-drug conjugates (ADCs) are often called "biological missiles" โ€“ they combine the targeting precision of monoclonal antibodies with the cancer-killing potency of cytotoxic drugs, delivering chemotherapy directly to tumor cells while sparing healthy tissue. This mechanism has made ADCs one of the hottest areas in global oncology R&D.

China has emerged as a global leader in this field. Chinese companies now contribute nearly 40% of the world's ADC R&D pipeline, and more than half of global next-generation ADC assets originate from China. Industry analysts project the global ADC market will reach $16.4 billion in 2026 and exceed $122.7 billion by 2035.

This article explores China's ADC breakthroughs โ€“ from the world's first approved bispecific ADC to next-generation dual-payload technologies and blockbuster out-licensing deals that are reshaping global oncology.

I. A Global First: The World's First Bispecific ADC

On June 22, 2026, China's National Medical Products Administration (NMPA) approved Lunkan Yilongtuo Monoclonal Antibody (Izalontamab Brengitecan, brand name: Yizekangยฎ) โ€“ a first-in-class EGFRร—HER3 bispecific ADC developed by Sichuan-based SystImmune.

This approval marked a historic milestone: the world's first approved bispecific ADC.

Aspect Details
Drug Name Lunkan Yilongtuo Monoclonal Antibody (BL-B01D1 / Iza-bren)
Brand Name Yizekangยฎ (ๅฎœๆณฝๅบท)
Developer SystImmune (Sichuan Baili Tianheng)
Type EGFRร—HER3 bispecific ADC
Approval Date June 22, 2026
Indication Recurrent/metastatic nasopharyngeal carcinoma after โ‰ฅ2 lines of systemic chemotherapy and PD-1/PD-L1 inhibitor therapy
Global Significance World's first approved bispecific ADC; first-in-class, new-concept drug

The approval was supported by the PANKU-NPC 01 study โ€“ the world's first confirmatory Phase III clinical trial for post-line nasopharyngeal carcinoma treatment. The results were selected for the LBA (Late Breaking Abstract) session at ESMO 2025 and simultaneously published in The Lancet.

Professor Ma Jun, Academician of the Chinese Academy of Sciences and Executive Vice President of Sun Yat-sen University Cancer Center, commented: "The approval of Lunkan Yilongtuo Monoclonal Antibody marks the beginning of a new era of bispecific ADC therapy for recurrent and metastatic nasopharyngeal carcinoma. Patients who previously had no options after multiple lines of treatment now have a breakthrough therapy that has doubled survival benefits. The drug has been listed as a preferred option by both NCCN and CSCO guidelines."
๐Ÿ’ก What this means for international patients: The world's first bispecific ADC is available in China. For patients with nasopharyngeal carcinoma, lung cancer, esophageal squamous cell carcinoma, and triple-negative breast cancer โ€“ all indications currently in clinical development โ€“ China offers access to a therapy that doesn't exist anywhere else in the world.

Global Reach: In December 2023, SystImmune licensed the global rights for this drug to Bristol-Myers Squibb (BMS) for $800 million upfront, with a total deal value of $8.4 billion โ€“ a record for ADC out-licensing. As of June 2026, the drug has initiated over 40 cross-tumor clinical trials in China and the U.S., and has received 7 Breakthrough Therapy Designations, including one from the U.S. FDA.

II. Clinical Breakthroughs: From "Follower" to "Leader"

TQB2102: The World's First Successful HER2 Bispecific ADC Phase III

On September 2, 2026, Sino Biopharmaceutical's subsidiary Chia Tai Tianqing announced that its HER2 bispecific ADC TQB2102 (Rolditamig Deuderuxtecan) had successfully completed a pre-specified interim analysis in a Phase III study for HER2-low relapsed/metastatic breast cancer.

This is the world's first successful Phase III study of a HER2 bispecific ADC in HER2-low breast cancer.

  • TQB2102 significantly reduced the risk of disease progression or death compared to investigator-selected chemotherapy
  • Both statistically significant and clinically meaningful improvements in progression-free survival (PFS) were achieved
  • The study met both primary and key secondary endpoints

TQB2102 is a next-generation HER2 bispecific ADC that simultaneously targets both the ECD II and ECD IV domains of HER2, enhancing receptor cross-linking and internalization efficiency.

๐Ÿ’ก What this means for international patients: HER2-low breast cancer patients โ€“ who previously had limited targeted therapy options โ€“ now have a new precision treatment. China is leading the way in this therapeutic area.

Other Key Clinical Milestones in 2026

Company Drug Milestone
Hansoh Pharmaceutical HS-20110 (CDH17-targeting ADC) NDA accepted by CDE โ€“ potential first-in-class
Huadong Medicine HDM2005 IND approved for combination with PD-1 inhibitor in Hodgkin lymphoma
Sino Biopharmaceutical LM-302 (CLDN18.2-targeting ADC) NDA submitted for gastric cancer
CStone Pharmaceuticals CS5007 (EGFR/HER3 bispecific ADC) IND approved by NMPA; Phase I initiated in Australia
Asieris Pharmaceuticals APL-2501 (CLDN6/9-ADC) IND approved by both NMPA and FDA
Simcere SIM0613 (LRRC15-targeting ADC) IND approved for advanced solid tumors

Breakthrough Therapy Designations

  • YL202 (HER3 ADC): China's CDE is considering the first-ever Breakthrough Therapy Designation for a HER3 ADC in melanoma. No HER3 ADC has been approved anywhere in the world to date, and China alone has 23 HER3 ADC programs in active development.
  • TQB2102: Has received three Breakthrough Therapy Designations from CDE.
  • Elfetabart (B7-H3 ADC): Developed by Duality Biologics in collaboration with BioNTech, received Breakthrough Therapy Designation from CDE in July 2026.

III. Next-Generation Technologies: Beyond Traditional ADCs

Dual-Payload ADCs: The Next Frontier

On July 27, 2026, Kelun-Biotech announced that CDE had approved the IND application for SKB565 โ€“ the company's first dual-payload ADC.

Unlike traditional ADCs that deliver only a single cytotoxic payload, SKB565 incorporates a unique dual-payload design that combines both:

  • Cytotoxic agents (tumor-killing)
  • Immunomodulators (immune system activation)

This innovative approach enables both direct tumor cell destruction and activation of the immune system within the tumor microenvironment. It is designed to overcome limitations associated with conventional single-payload ADCs by delivering stronger, longer-lasting anti-tumor responses.

๐Ÿ’ก What this means for international patients: Dual-payload ADCs represent the next generation of cancer therapy. China is at the forefront of this innovation, with clinical trials now underway.

New Targets and Expanding Horizons

Chinese companies are exploring novel ADC targets beyond the traditional HER2, EGFR, and TROP2:

Target Company Indication Status
GPC3 Chia Tai Tianqing (TQB6426) Hepatocellular carcinoma FDA IND approved Sep 2026
CDH17 Hansoh (HS-20110) Solid tumors NDA accepted
CLDN18.2 Sino Biopharm (LM-302) Gastric cancer NDA submitted
Nectin-4 Hengrui (SHR-A2102) Urothelial cancer Phase III
B7-H3 Duality/BioNTech (Elfetabart) Solid tumors Breakthrough Therapy Designation
LRRC15 Simcere (SIM0613) Solid tumors IND approved

GPC3 is particularly noteworthy: it is highly expressed in 70โ€“80% of hepatocellular carcinoma cases, a cancer where China accounts for 42.4% of global cases and where approximately 64% of patients are diagnosed at an advanced stage. No GPC3-targeting ADC has been approved globally to date, making TQB6426 a potential breakthrough for liver cancer patients.

IV. Global Reach: The "China Speed" of ADC Out-Licensing

Chinese ADCs are attracting unprecedented global attention. As of June 30, 2026, China had completed 81 out-licensing deals with a total value of approximately $110 billion โ€“ already reaching 80% of the full-year 2025 total. ADCs are among the most frequent and highest-value categories in these deals.

Representative ADC Out-Licensing Deals in 2026

Deal Partners Value Details
TQB2102 Chia Tai Tianqing ร— Cipla $123 million HER2 bispecific ADC; covers India, South Africa, and 5 other emerging markets
TQB2102 First regional deal (2025) ~$30M upfront Previous regional authorization

Major Deals Entering the "Payoff Phase" in 2026

Deal Partners Value 2026 Milestone
BL-B01D1 SystImmune ร— BMS $8.4B total ($800M upfront) Approved in China as world's first bispecific ADC
Sac-TMT (SKB264) Kelun-Biotech ร— Merck (MSD) $11.8B+ cumulative (7 ADCs) Global Phase III TroFuse studies ongoing
YL202 (BNT326) MediLink ร— BioNTech $1B+ potential ($70M upfront) Phase III; CDE considering Breakthrough Therapy Designation

TQB2102's Emerging Market Deal: On August 31, 2026, Chia Tai Tianqing signed an exclusive licensing agreement with Cipla, India's third-largest pharmaceutical company, covering India, South Africa, and five other emerging markets. The deal is valued at up to $123 million, plus double-digit royalties. This is TQB2102's second regional authorization, bringing cumulative upfront and milestone payments to approximately $30 million.

The agreement reflects a "Chinese R&D + Local Commercialization" collaboration model โ€“ China retains core technology control while leveraging established local channels to accelerate market access.

๐Ÿ’ก What this means for international patients: Chinese ADC drugs are being licensed to global pharmaceutical giants and regional leaders. This means the innovative therapies developed in China are becoming accessible worldwide โ€“ and the fact that companies like BMS, Merck, and BioNTech are investing billions speaks to the quality of Chinese ADC innovation.

V. The Bigger Picture: China's ADC Ecosystem

China's ADC leadership is not accidental. It is built on:

  • Platform Technologies
    Companies like Kelun-Biotech (OptiDCโ„ข platform), MediLink (TMALIN platform), and others have developed proprietary ADC platforms that enable rapid, differentiated drug development.
  • Regulatory Acceleration
    China's regulatory reforms โ€“ including conditional approval pathways, IND 60-day silent approval, and priority review โ€“ have dramatically accelerated ADC development and approval timelines.
  • Clinical Trial Infrastructure
    With 2,997 new drug clinical trials registered in 2025 and a vast patient population, China offers an efficient environment for ADC clinical development.
  • Manufacturing Capability
    NMPA has recognized the complexity of ADC manufacturing, implementing policies to support segmented production and quality assurance.

Conclusion

China's ADC sector has undergone a remarkable transformation. In the words of one industry observer, the sector has moved from "selling molecules" to "selling systems" โ€“ from simply licensing out early-stage candidates to building comprehensive platforms capable of global innovation and commercialization.

Key milestones in 2026 alone:

โœ… World's first bispecific ADC approved
โœ… World's first successful HER2 bispecific ADC Phase III
โœ… First dual-payload ADC enters clinical trials
โœ… $110 billion in out-licensing deals (H1 2026)
โœ… FDA IND approvals for multiple novel-target ADCs

For international patients, this means:

  • โœ… Access to world-first therapies not available elsewhere
  • โœ… Cutting-edge clinical trials for difficult-to-treat cancers
  • โœ… World-class innovation at competitive costs
  • โœ… Global-standard quality โ€“ validated by partnerships with BMS, Merck, and BioNTech

China is no longer following the global ADC race โ€“ it is leading it.

๐Ÿ“Œ Data sources: National Medical Products Administration (NMPA), Center for Drug Evaluation (CDE), public company announcements, industry reports (2025โ€“2026).