First-in-Human Breakthroughs Surge: A Deep Dive into China’s Top 10 Innovative Drugs at AACR 2026
From April 17 to 22, 2026, one of the most influential global oncology conferences—the AACR 2026—was held in San Diego, USA.
At this year’s meeting, Chinese innovative pharmaceutical companies presented a series of first-in-human and early clinical data disclosures, spanning multiple key modalities including immunotherapy, antibody-drug conjugates (ADCs), bispecific antibodies, and small-molecule targeted therapies.
These developments highlight that China’s oncology innovation ecosystem is rapidly entering the core arena of global competition.
HongKong DengYueMed has curated 10 representative innovative drug candidates, providing a comprehensive overview of the latest clinical progress and technological advancements shaping China’s oncology landscape.
Adebrelimab (SHR-1316): Phase III Perioperative Therapy Reshaping Early-Stage NSCLC Treatment
Company: Jiangsu Hengrui Pharmaceuticals
This study presented the first Phase III results of adebrelimab in combination with platinum-based chemotherapy as perioperative treatment for resectable stage II–IIIB non-small cell lung cancer (NSCLC).
Study Design:
● 501 patients enrolled
● 1:1 randomization
● 3 cycles of neoadjuvant adebrelimab/placebo + chemotherapy
● Followed by surgery and 16 cycles of adjuvant therapy
Key Results:
● Median follow-up: 23.6 months
● Significant improvement in event-free survival (EFS)
● Improved major pathological response (MPR)
● Pathological complete response (pCR): 31.1% vs 7.6%
● R0 resection rate: 88.8% vs 83.2%
Safety: Grade ≥3 adverse events were comparable between groups (52.6% vs 53.6%), mainly hematologic.
Implication: Perioperative immunotherapy is further solidified, with Chinese regimens entering global standard-of-care competition.
Tislelizumab + SUR / LBL-007: No Added Benefit from Multi-Checkpoint Combination
Company: BeiGene
This Phase II study evaluated tislelizumab alone or in combination with anti-TIM-3 (surzebiclimab, SUR) and/or anti-LAG-3 (LBL-007) as first-line treatment for recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC).
Study Design:
● 160 patients
● Four arms: monotherapy / dual combinations / triple combination
Efficacy:
● ORR: 25.0%–27.5% across groups
● Complete responses: 3 in group C, 2 in group D
● Disease control rate (DCR): 55.0%–67.5%
Safety:
● Common AEs: anemia, hypothyroidism, AST elevation
● Immune-related AEs: 35.2%, mostly low grade
Conclusion: No additional benefit from adding TIM-3 or LAG-3 blockade.
Implication: Immunotherapy is shifting from “stacking checkpoints” to mechanism-driven optimization.
HS-10504: Fourth-Generation EGFR-TKI Targeting C797S Resistance
Company: Hansoh Pharma
A novel small-molecule EGFR inhibitor designed to target EGFR C797S resistance mutations.
Study Design:
● Phase I first-in-human study
● 82 patients enrolled
Key Data (400 mg QD):
● ORR: 47.1%
● DCR: 91.2%
● Partial response (PR): 50%
● Stable disease (SD): 41.2%
Patient Characteristics:
● All stage IV adenocarcinoma
● ≥71% received ≥2 prior lines
Safety:
● Grade ≥3 TEAEs: 74.3% (mainly lab abnormalities)
● No treatment-related deaths
Implication: Addresses a major unmet need after third-generation EGFR-TKI resistance.
Cadonilimab (AK104): Breakthrough in Pancreatic Cancer Immunotherapy
Company: Akeso Inc.
Cadonilimab (AK104), a PD-1/CTLA-4 bispecific antibody, is used in combination with chemotherapy as a first-line treatment for unresectable PDAC.
Study Design:
● Phase II COMPASSION-26
● 59 patients
Efficacy:
● Median OS: 13.8 months
● Locally advanced OS: 23.4 months
● ORR: 33.9%
● DCR: 96.4%
Safety: All patients experienced TRAEs, mainly hematologic, with no new safety signals.
Implication: One of the first meaningful immunotherapy signals in pancreatic cancer.
QLS5132: CLDN6 ADC Demonstrates High Activity in Ovarian Cancer
Company: Qilu Pharmaceutical
A CLDN6-targeting antibody-drug conjugate.
Study Design:
● Phase I (NCT06932094)
● 28 platinum-resistant patients
Efficacy:
● ORR: 50.0%
● DCR: 94.4%
● ≥3.2 mg/kg: ORR 52.9%, DCR 100%
Safety:
● Grade ≥3 AEs: 32.1%
● Common: nausea, anemia, fatigue
Implication: CLDN6 emerges as a next-generation ADC target.
HS-20093 + Adebrelimab: ADC-Immunotherapy Combination Shows Synergy
Company: Hansoh Pharma
B7-H3 ADC combined with PD-L1 inhibitor for pretreated NSCLC.
Study Design:
● Phase I ARTEMIS-101
● 40 patients
Efficacy:
● ORR: 47.1%
● DCR: 94.1%
● Median PFS: 14.0 months
Safety:
● Grade ≥3 TEAEs mainly hematologic
● No treatment-related deaths
Implication: ADC + immunotherapy is becoming a key combination strategy.
JS212: EGFR/HER3 Bispecific ADC Shows Strong Potential
Company: Junshi Biosciences
Study Design:
● Phase I/II first-in-human study
● 63 patients
Efficacy:
● ORR: up to 50%
● DCR: 100%
● HER2-negative breast cancer ORR: 50%
Safety:
● MTD not reached
● Well tolerated
Implication: Dual-target ADCs may enhance efficacy and delay resistance.
MK-2010 (LM-299): PD-1 × VEGF Tetravalent Bispecific Antibody
Company: Merck & Co. / China Biopharmaceutical
Study Design:
● First-in-human study
● 112 patients
Efficacy: ORR (treatment-naïve NSCLC): 44%–55%
Safety:
● Grade ≥3 TRAEs: 17%–27%
● No treatment-related deaths
Implication: Confirms global competitiveness of PD-1 + VEGF strategy.
HSK46575: Targeting CYP11A1 in Prostate Cancer
Company: Haisco Pharmaceutical
Study Design:
● Phase I
● 27 patients
Efficacy: PSA50 response rate: 30.8%
Safety:
● Grade ≥3 TRAEs: 7.4%
● No DLT observed
Implication: Targets steroidogenesis at the source.
JS207 (±JS007): Triple-Target Strategy for “Cold Tumors”
Company: Junshi Biosciences
(1) First-line HCC:
● ORR: 45.5%
● DCR: 86.4%
(2) First-line MSS/pMMR mCRC:
● ORR: 71.0%
● DCR: 96.8%
Implication: Demonstrates paradigm-shifting potential in immunologically “cold” tumors.
Four Key Trends from AACR 2026
1. Technological Evolution
ADC, bispecific antibodies, and multi-mechanism combinations are becoming dominant, reflecting a shift from single-target approaches to synergistic multi-pathway strategies.
2. Clinical Value Orientation
The focus is moving from ORR to long-term outcomes such as OS, PFS, and perioperative benefits, with surrogate endpoints like pCR and MPR gaining standardization.
3. Global Collaboration Acceleration
Chinese innovation is entering a “value export” phase, with early-stage assets attracting large-scale global partnerships and licensing deals.
4. Breakthroughs in Hard-to-Treat Tumors
Pancreatic cancer, MSS/pMMR colorectal cancer, and resistant NSCLC are showing promising signals, indicating a transition from “untreatable” to “strategically manageable.”
Conclusion
Insights from AACR 2026 highlight that China’s innovative drug development is rapidly advancing onto the global stage, driving both technological progress and clinical impact.
In this evolving landscape, efficient global distribution systems are equally critical. DengYueMed plays an important role in connecting global pharmaceutical resources and facilitating cross-border access to innovative therapies.
As innovation and distribution continue to evolve in tandem, China’s pharmaceutical industry is poised to achieve greater global influence in the years ahead.
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