Chinese New Drugs Set ESMO Record with 29 LBAs, Accounting for One-Third of Total

MADRID — When the full program for this year's European Society for Medical Oncology congress was released on Sept. 22, it confirmed a shift that has been building for years: Chinese pharmaceutical companies are no longer supporting players on the global oncology stage. They are headliners.

A record 29 Chinese drug studies earned Late-Breaking Abstract (LBA) slots at the 2026 ESMO Annual Congress, set for Oct. 23–27 in Spain — roughly one-third of the 12 studies selected for the congress's most prestigious venue, the Presidential Symposium. Five Chinese programs will be presented in that top-tier session, with another 24 appearing in the Proffered Paper and Rapid Oral tracks.

The numbers mark a new high for Chinese oncology drug development at ESMO, both in absolute count and share of the total. More importantly, the sheer volume of Phase III readouts signals that a new generation of Chinese-developed therapies — led by antibody-drug conjugates and bispecific antibodies — are ready to reshape global cancer treatment standards for the next decade.

Blockbuster Phase III Data Arrive

At the Presidential Symposium, Chinese innovators are moving from being multinationals' "inventory fillers" to their marquee assets, armed with pivotal clinical evidence that now shapes international treatment guidelines.

Three of China's most prominent overseas drug programs each secured a Phase III slot in the Presidential Symposium: Akeso's PD-1/VEGF bispecific antibody ivonescimab, Hansoh Pharmaceutical's B7-H3 ADC rekinvofutabart vetalogin, and Kelun-Biotech's Trop2 ADC sacituzumab govitecan (sac-TMT).

Ivonescimab earned its spot through the Phase III HARMONi-GI1 trial, a randomized, controlled, double-blind study comparing ivonescimab plus chemotherapy versus durvalumab plus chemotherapy as first-line treatment for advanced biliary tract cancer. It marks yet another head-to-head victory over the global standard of care for the bispecific antibody — and one of the most significant clinical breakthroughs in biliary cancer in a decade.

The result also underscores ivonescimab's dual-front strategy: after surpassing PD-1 inhibitors in PD-1-positive NSCLC — a classic "hot tumor" — the drug is now penetrating harder-to-treat "cold tumors" in the gastrointestinal tract. HARMONi-GI1 is the first Phase III study to deliver positive results in gastrointestinal cancers, firing a critical opening shot for PD-1/VEGF dual-target synergy in reshaping the immune microenvironment.

Rekinvofutabart vetalogin (Hansoh Pharma) and sacituzumab govitecan (Kelun-Biotech) each delivered their own breakthroughs. Both are the first ADC drugs to achieve positive Phase III results in historically difficult-to-treat indications, opening new treatment pathways for tumors with limited late-line options.

Rekinvofutabart vetalogin's Phase III ARTEMIS-011 trial — presented after the drug earned the highest honor in lung cancer treatment at WCLC — evaluates the B7-H3 ADC as monotherapy versus gemcitabine plus docetaxel in heavily pretreated relapsed/refractory osteosarcoma. Two successful Phase III trials make rekinvofutabart vetalogin the first B7-H3 ADC to achieve positive results in two distinct solid tumor types, validating the target's therapeutic potential across refractory solid tumors.

Sacituzumab govitecan's Phase III TroFuse-005 study is equally landmark: evaluating the ADC as monotherapy in advanced or recurrent endometrial cancer, it is the first — and currently only — Phase III ADC study in this population to achieve statistically significant improvements in both overall survival and progression-free survival versus chemotherapy.

MNCs Double Down on Chinese Partnerships

Merck emerged as one of ESMO's biggest winners, with three related studies selected. Its Phase III KEYNOTE-C93 trial — evaluating pembrolizumab versus carboplatin plus paclitaxel as first-line treatment for mismatch repair-deficient advanced or recurrent endometrial cancer — also earned a Presidential Symposium slot. The success could accelerate the shift toward chemotherapy-free regimens in this disease.

Also from Merck, the Phase III INTerpath-001 study for its mRNA cancer vaccine intismeran autogene will open the first Presidential Symposium session. The company is expected to present complete data from a preplanned interim analysis — the first global Phase III confirmatory data for the vaccine, validating the Phase II signal in a larger population and potentially supporting a marketing application.

The three Merck studies reveal its next-generation oncology playbook: leveraging pembrolizumab as the immunotherapy cornerstone, the company is betting on ADCs and mRNA cancer vaccines through partnerships and in-licensing to attack recurrent and refractory tumors.

AstraZeneca is running a parallel strategy, also with three related studies at ESMO. Building on its PD-1 inhibitor and third-generation EGFR-TKI franchises, the company is expanding into next-generation small-molecule targeted therapies and ADCs — into perioperative adjuvant treatment, late-line therapy, and hard-to-treat high-incidence tumors. Chinese innovators have become its strongest ally.

In the ADC space, the Phase III CLARITY-Gastric 01 trial for sonesitatug vedotin (Sone-Ve), an anti-CLDN18.2 ADC developed by Lepu Bio and CanSino Biologics with AstraZeneca holding global rights, earned a Presidential Symposium slot. Evaluating Sone-Ve in second-line and beyond CLDN18.2-positive advanced or metastatic gastroesophageal cancer, the trial met its dual primary endpoints for overall survival in third-line and beyond populations when positive results were announced in July.

The result could see AstraZeneca replicate in gastric cancer what it achieved when its HER2 ADC rewrote breast cancer treatment standards. The trial is the first to demonstrate that an anti-CLDN18.2 ADC delivers an OS benefit in this setting — and could expand the CLDN18.2-positive definition to expression levels ≥25%, covering roughly 60% of such patients.

In lung cancer small-molecule targeting, the Phase III SAFFRON study also earned a Presidential Symposium slot. The trial evaluates osimertinib plus savolitinib versus platinum-pemetrexed in advanced NSCLC with EGFR mutations and MET overexpression and/or amplification that progressed on osimertinib. Savolitinib, China's first approved MET-TKI developed by Hutchmed, is being co-developed globally by AstraZeneca and Hutchmed. The study provides a template for combination development targeting other bypass pathways (HER2, RET, etc.) after EGFR resistance, and completes the evidence chain for osimertinib plus savolitinib from first-line to late-line treatment.

AstraZeneca's Phase III VOLGA study also made the cut, evaluating perioperative durvalumab with or without tremelimumab plus neoadjuvant enfortumab vedotin for muscle-invasive bladder cancer. Combined with the earlier NIAGARA and POTOMAC studies, VOLGA's success gives AstraZeneca a pipeline spanning the full treatment landscape of early-stage bladder cancer — across non-muscle-invasive and muscle-invasive disease, and in both cisplatin-eligible and cisplatin-ineligible populations.

Rounding out the Presidential Symposium, Amgen's Phase III DeLLphi-305 and Roche's Phase III Krascendo-1 represent the latest breakthroughs in bispecific antibodies and KRAS inhibitors, respectively.

DeLLphi-305 evaluates the DLL3/CD3 bispecific tarlatamab plus durvalumab versus durvalumab alone as first-line maintenance treatment for extensive-stage small-cell lung cancer. Earlier this month, Amgen announced the study met its primary OS endpoint at a preplanned interim analysis, with significant benefits in PFS and ORR.

Krascendo-1 evaluates the next-generation KRAS G12C inhibitor divarasib versus sotorasib or adagrasib in previously treated KRAS G12C-mutant advanced or metastatic NSCLC. In July, Roche announced divarasib defeated the earlier-generation KRAS G12C inhibitors, with significant extensions in both primary endpoint PFS and key secondary endpoint OS.

Concentration by Indication and Technology — Who Breaks Through First?

Beyond the Presidential Symposium, the oral presentation sessions are among ESMO's most closely watched. According to PharmCube data, 12 Chinese pharma LBAs appeared in oral sessions, from nine companies, spanning breast cancer, NSCLC, nasopharyngeal cancer, melanoma, and extrapulmonary neuroendocrine carcinoma.

ADCs and bispecific ADCs are the dominant technology, with the remainder covering bispecific antibodies, small-molecule targeted inhibitors, PD-1 immunotherapy, and cell therapy — essentially representing the mainstream of China's oncology R&D. The vast majority are registration-intent trials, with study designs geared toward new drug approvals.

Hengrui Medicine brought two LBAs to oral sessions. Its HER2 ADC rekinstuzumab (SHR-A1811) earned a Phase III slot through the HORIZON-Breast06 trial in HER2-low advanced breast cancer. SHR-A1811 has already been approved in China for multiple indications, including locally advanced or metastatic NSCLC, locally advanced or metastatic HER2-positive breast cancer, and HER2-positive colorectal cancer.

Hengrui's second LBA is the Phase III HERON-Lung01 mid-analysis, evaluating the HER3-targeting ADC ruzaltatug rezetecan versus platinum-based chemotherapy in EGFR-mutant advanced NSCLC that progressed on EGFR-TKI therapy.

Baili Tianheng also had two Phase III results selected as LBAs, presented as preferred oral reports. An independent data monitoring committee determined both studies met their primary PFS endpoints at preplanned interim analyses. The trials evaluate iza-bren (BL-B01D1) in previously treated unresectable locally advanced or metastatic HR+/HER2- breast cancer, and in EGFR-mutant non-squamous NSCLC that progressed after third-generation EGFR TKI therapy.

Kelun-Biotech's self-developed TROP2 ADC sacituzumab govitecan (sac-TMT) also had two Phase III studies selected as LBAs for oral presentation: OptiTROP-Lung04, evaluating sac-TMT versus platinum chemotherapy in EGFR-mutant NSCLC post-EGFR-TKI with final OS analysis; and OptiTROP-Lung06, evaluating sac-TMT plus pembrolizumab versus chemotherapy plus pembrolizumab as first-line treatment for PD-L1-negative advanced non-squamous NSCLC.

In breast cancer, beyond Hengrui's rekinstuzumab and Baili Tianheng's iza-bren, CanSino Biologics and CSPC Pharmaceutical's jointly developed anitrolimab (KN026) also earned an oral LBA slot for its Phase III trial combining the drug with albumin-bound docetaxel in HER2-positive advanced breast cancer.

In lung cancer, Hutchmed's Phase III SANOVO study — exploring savolitinib or placebo plus osimertinib in treatment-naïve EGFR-mutant, MET-overexpressing advanced NSCLC — drew significant attention. Junshi Bio's toripalimab plus chemotherapy for resectable Stage II/III NSCLC perioperative treatment also made the cut, with the Phase III Neotorch final analysis presented in the oral session.

Beyond breast and lung cancer, three remaining Chinese LBAs in oral sessions represent differentiated plays, with some already commanding major overseas licensing deals.

Yilian Bio's TAISHAN-301 trial — a Phase III study of its self-developed B7-H3 ADC tam-pelitcan versus chemotherapy in heavily pretreated relapsed/metastatic nasopharyngeal carcinoma — earned an LBA slot. Yilian Bio previously partnered with Roche, granting exclusive global rights outside Greater China for tam-pelitcan development, manufacturing, and commercialization, with upfront and near-term milestone payments reaching $570 million USD — a benchmark deal for Chinese ADC technology going global.

Junsei Bio's extended follow-up data from a pivotal Phase II study of its autologous natural tumor-infiltrating lymphocyte therapy nolgileucel (GC101) in advanced melanoma also made the LBA list, with the latest results to be presented orally.

Weilizhibo's PD-L1/4-1BB bispecific weilixin (LBL-024) monotherapy study in advanced extrapulmonary neuroendocrine carcinoma — a pivotal registrational Phase IIb trial evaluating the drug in patients who received at least two prior lines of systemic therapy — also earned a slot, with data supporting the company's new drug application filing.

From Exploration to Registration

These studies — representing the cutting edge of Chinese oncology innovation — reveal an industry that has moved well beyond small-sample Phase I/II exploration. A large number of self-developed molecules have entered randomized, controlled registration trials, with a clear industrial cluster advantage in ADCs.

But a standout performance at an academic conference is only a waypoint in the oncology drug marathon. Clinical endpoint results, post-approval commercialization, and global market validation remain the ultimate measures of a pharmaceutical company's asset value.