The global oncology community will once again turn its eyes to Chicago on the shores of Lake Michigan. But this time, Chinese innovative drugs are standing in the spotlight.

 

On May 29, the world's largest and most academically influential oncology conference – the American Society of Clinical Oncology (ASCO) Annual Meeting – will open as scheduled. According to statistics, 63 Late-Breaking Abstracts (LBAs) have been selected for this year's ASCO, of which 13 studies come from 12 Chinese companies. Additionally, 94 Chinese studies have been selected for oral presentations. Both figures set new records.

 

These numbers are not just a "quantitative" breakthrough; they mark that Chinese innovative drugs have earned broad recognition from international peers on a "qualitative" level.

 

TONACEA 01: Star Drugs Deliver Their Results

 

A Donghai Securities report notes that Chinese clinical research has entered the global top tier. Within this, the two hot tracks of bispecific antibodies and ADCs continue to lead, establishing China's global leadership in the "IO 2.0" and "ADC 2.0" eras.

 

Among all Chinese projects selected for LBAs, none draws more attention than Akeso's ivonescimab (PD-1/VEGF bispecific antibody). At this ASCO, Akeso will present over 40 studies. The centerpiece is undoubtedly the overall survival (OS) data from the Phase III HARMONi-6 study of ivonescimab plus chemotherapy as first-line treatment for advanced squamous non-small cell lung cancer (sq-NSCLC).

 

This study has been successfully selected as an LBA in the Plenary Session. The Plenary Session is the most prestigious and influential segment of the ASCO Annual Meeting, typically reserved for findings deemed to have a transformative impact on oncology research and clinical practice. HARMONi-6 is the only Chinese project selected for this session this year.

 

HARMONi-6 is a randomized, double-blind, parallel-controlled Phase III trial comparing ivonescimab head-to-head against tislelizumab for first-line treatment of advanced sq-NSCLC.

 

Interim results were previously reported at the ESMO 2025 Presidential Symposium. The study enrolled a total of 532 patients. Results showed a median progression-free survival (PFS) of 11.1 months in the ivonescimab-plus-chemotherapy group, significantly superior to the 6.9 months in the control group. OS data were not yet mature at that time.

 

Jockeying for position alongside ivonescimab is Kelun-Biotech/Merck & Co.'s sacituzumab tirumotecan (sac-TMT, a TROP2 ADC). The Phase III OptiTROP-Lung05 study evaluating sac-TMT plus Keytruda (pembrolizumab) versus Keytruda alone as first-line treatment for PD-L1-positive advanced NSCLC has been selected for an oral presentation at this ASCO.

 

The OptiTROP-Lung05 study is the world's first Phase III clinical trial demonstrating a significant benefit of combining a TROP2 ADC with immunotherapy as first-line treatment for PD-L1-positive, driver-gene-negative advanced NSCLC. The study enrolled 413 patients. Results of a pre-specified interim PFS analysis, with a median follow-up of 10.5 months, showed a statistically significant and clinically meaningful improvement in median PFS, along with a favorable trend in OS.

 

By BICR assessment, the ORR in the combination group exceeded 70.2%, compared to 42.0% in the monotherapy group. While median PFS in the combination group has not yet been reached, the current data suggest that median PFS is expected to surpass that of first-line immunotherapy plus chemotherapy (KEYNOTE-189 and KEYNOTE-407 studies reported median PFS of 10.9 and 8.3 months, respectively, for PD-L1 ≥1% subgroups).

 

Another heavy-hitting ADC selected for an LBA is Baili Tianheng's iza-bren (EGFR×HER3 bispecific ADC). The Phase III study comparing iza-bren versus chemotherapy for the treatment of advanced triple-negative breast cancer (TNBC) will be disclosed on the evening of June 2 (Beijing time). This is a registrational Phase III trial targeting TNBC patients who have received 1-2 prior lines of chemotherapy (including taxanes). Results showed that compared to investigator's choice of chemotherapy, iza-bren significantly improved both PFS and OS, meeting both primary endpoints.

 

Treatment options for advanced TNBC are scarce, and long-term survival rates are low, representing a huge unmet clinical need. This breakthrough is iza-bren's first positive Phase III result in breast cancer, potentially offering patients a new standard-of-care and further broadening iza-bren's oncology indication footprint.

 

TONACEA 02: Where Are the Next BD Opportunities Hiding?

 

Both ivonescimab and iza-bren are familiar faces on the Chinese innovative drug BD stage. But beyond the spotlight, many more pipelines are waiting for their moment to be seen, and ASCO serves as a critical showcase window. The ability to attract potential buyers often hinges on one condition: whether the new drug can address a genuine, significant unmet clinical need.

 

From a deal-making perspective, several types of pipelines are particularly noteworthy.

 

The first category: breakthroughs in "untreatable" difficult indications – exemplified by GenFleet's GFH375.

 

Data from a study of GFH375 monotherapy for KRAS G12D-mutant cholangiocarcinoma and colorectal cancer have been selected for an oral presentation at this ASCO. This represents the first dedicated clinical data release for a RAS inhibitor in cholangiocarcinoma.

 

GFH375 received clinical trial approval in June 2024, entering a domestic single-agent clinical trial for KRAS G12D-mutant solid tumors. Preliminary data from this trial were presented as a rapid oral abstract at last year's ASCO. This year's oral presentation will showcase preliminary efficacy and safety data for GFH375 in cholangiocarcinoma and colorectal cancer.

 

Cholangiocarcinoma patients have low overall survival rates and poor prognoses. Most are diagnosed with inoperable disease, with a 5-year survival rate below 20%. KRAS G12D is one of the most prevalent KRAS mutations, widely present in pancreatic, colorectal, and biliary tract cancers, representing a huge patient population. To date, no drug targeting KRAS G12D has been approved globally. If GFH375 is successful in subsequent clinical development, it could fundamentally alter the treatment landscape for these two indications.

 

A similar logic applies to Zelgen Biopharmaceuticals' ZG006, a novel DLL3-targeting trispecific T-cell engager (TCE). Zelgen will present results from a Phase II dose-expansion study of ZG006 monotherapy for advanced neuroendocrine carcinoma as an oral presentation.

 

Neuroendocrine carcinoma is a relatively rare malignancy, with certain subtypes (e.g., small cell and large cell neuroendocrine carcinoma) having extremely poor prognoses and lacking established standard-of-care.

 

Previously disclosed data show that as of April 25, 2025, the ORR was 22.7% in the 10 mg dose group and 40.9% in the 30 mg dose group. For these heavily pretreated, refractory patients, this is undoubtedly a breakthrough. Traditional chemotherapy typically achieves efficacy rates of only 5-6% in this population. In 2025, ZG006 received Orphan Drug Designation from the FDA for the treatment of neuroendocrine carcinoma.

 

The second category: pipelines with clear differentiation, unique designs, and scarcity – exemplified by CStone Pharmaceuticals' CS2009 (PD-1/VEGF/CTLA-4 trispecific antibody).

 

CS2009 features a "2+1+1" asymmetric structure design, achieving precise tumor microenvironment enrichment through its VEGF arm and reduced peripheral immune toxicity through monovalent, low-affinity CTLA-4 binding. CS2009 has entered Phase II, with global multi-center Phase III expected to initiate by the end of 2026, making it one of the fastest-progressing in its class.

 

Previously reported data show that in first-line NSCLC patients with high PD-L1 expression (TPS ≥50%), CS2009 achieved an ORR of 90% and a DCR of 100%. In immunotherapy-pretreated, actionable gene alteration (AGA)-negative second-line and later NSCLC patients, the ORR was 25%.

 

More notably, CS2009 also demonstrated potent anti-tumor activity in "cold tumors," with an ORR of 40% in non-clear cell renal cell carcinoma (nccRCC) patients and 33.3% in soft tissue sarcoma (STS) patients. This data quickly positioned CS2009 as the next potential Chinese trispecific antibody BD deal. At ASCO, CStone will present Phase I/II clinical data for CS2009 in NSCLC and Phase I data in advanced solid tumors.

 

Innovent Biologics' IBI363 also falls into this category. As a PD-1/IL-2α-bias bispecific antibody fusion protein, it has demonstrated a differentiated mechanism in IO-resistant NSCLC. The IO-resistant patient population is large, with no current standard-of-care. IBI363 blocks the PD-1/PD-L1 pathway and activates the IL-2 pathway. Its IL-2 arm has been engineered to retain affinity for IL-2Rα while weakening binding to IL-2Rβ and IL-2Rγ, thereby reducing toxicity. The PD-1 binding arm simultaneously enables PD-1 blockade and selective IL-2 delivery.

 

This ASCO will feature preliminary results from a Phase I proof-of-concept (PoC) study of IBI363 as first-line treatment for advanced NSCLC.

 

A third category: pipelines with "head-to-head" positive data in major cancer types, directly challenging the current standard-of-care.

 

At this ASCO, data from the Phase III study of Jiangsu Alphamab's KN026 (HER2 bispecific antibody) plus chemotherapy versus trastuzumab and pertuzumab plus chemotherapy for neoadjuvant treatment of HER2-positive early or locally advanced breast cancer have been selected as an LBA – a signal warranting close attention.

 

HER2-positive breast cancer is a well-developed market. The dual HER2 blockade of trastuzumab plus pertuzumab has been the standard-of-care for many years. As a HER2 bispecific antibody, KN026 theoretically has the potential to achieve superior efficacy to the "pertuzumab+trastuzumab" combination through its "dual-epitope binding" mechanism. If successfully commercialized, KN026 would directly address a multi-billion-dollar annual market, with obvious BD implications.

 

TONACEA 03: Why Does ASCO Always Generate Big Deals?

 

Showcasing findings at top-tier international conferences like ASCO and ESMO often catalyzes a wave of new BD opportunities. Looking at high-value deals over the years, many were finalized within months of these conferences.

 

Legend Biotech's BCMA CAR-T therapy, Carvykti (ciltacabtagene autoleucel), is a classic example. At the 2017 ASCO Annual Meeting, Legend Biotech presented its initial clinical data: among 35 patients with relapsed or refractory multiple myeloma, the study achieved a 100% ORR. This striking data immediately caught Johnson & Johnson's attention.

 

In December of that year, J&J announced a global collaboration and licensing agreement with Legend Biotech to jointly develop and commercialize Carvykti, sharing costs and profits according to an agreed ratio. J&J paid Legend Biotech a US$350 million upfront payment plus subsequent milestones – at that time, the record for the largest upfront payment in a Chinese out-licensing deal, and one of the most favorable collaboration terms.

 

Carvykti received FDA approval in 2022. By 2025, it had become the world's best-selling CAR-T therapy.

 

Akeso also reaped significant rewards at ASCO. At the 2022 ASCO Annual Meeting, Akeso presented Phase II clinical data for ivonescimab plus chemotherapy in advanced NSCLC. The data showed that ivonescimab plus chemotherapy had a superior safety and tolerability profile compared to PD-1/PD-L1 inhibitors plus chemotherapy ± anti-angiogenic agents, along with promising anti-tumor efficacy. The presentation garnered widespread attention, leading to numerous collaboration inquiries.

 

About half a year later (December 2022), Akeso announced that it had entered into an ivonescimab licensing agreement with Summit Therapeutics. Summit was granted exclusive rights to develop and commercialize ivonescimab in the US, Canada, Europe, and Japan. Akeso received a US500millionupfrontpayment,withtotaldealvaluepotentiallyreachingUS500millionupfrontpayment,withtotaldealvaluepotentiallyreachingUS5 billion – setting a new record for Chinese innovative drug out-licensing deals at the time.

 

Baili Tianheng's iza-bren also made its mark at ASCO. During the 2023 ASCO Annual Meeting, Baili Tianheng first reported clinical data for iza-bren in patients with EGFR-mutant NSCLC. The overall ORR across 139 patients was 45.3%. In the subgroup of 38 patients with EGFR-mutant NSCLC, the ORR was even higher, reaching 63.2%.

 

These strong data led BMS to secure an exclusive license to iza-bren in December 2023, paying an US800millionupfrontpaymentaspartofatotaldealvalueofUS800millionupfrontpaymentaspartofatotaldealvalueofUS8.4 billion – once again shattering the record for Chinese innovative drug out-licensing deal value.

 

ASCO brings together BD teams from virtually every top-tier pharmaceutical company worldwide, along with investors and academic leaders. The release of compelling data can instantly reverberate across the entire industry. More importantly, ASCO provides a fair and transparent "data arena." Regardless of company size, strong data earn equivalent visibility.

 

For Chinese innovative drug companies that have not yet established global brand awareness, international conferences like ASCO are the most efficient vehicles for "credibility endorsement" and "value amplification." Historically, from Legend Biotech, to Akeso, to Baili Tianheng – each used an ASCO "data explosion" as a catalyst, quickly followed by major deals.

 

In Chicago this year, this "academic-commercial" acceleration mechanism is operating with unprecedented intensity. Because Chinese new drugs taking the international stage have now formed a full product pipeline – from large Phase III drugs already licensed out, to early-stage high-potential candidates not yet partnered – spanning the hottest tracks: ADCs, bispecifics, trispecifics, and more. With MNC patent cliff anxiety colliding head-on with maturing Chinese innovative drug data within the same timeframe, accelerated deal-making is almost inevitable.

 

The Chicago spotlight has yet to be fully lit, but the BD window for Chinese innovative drugs is already open.

 

And after ASCO, another, even broader door will open in Shanghai.

 

The first "China Pharmaceutical Innovation Conference" (CPIC), hosted by TONACEA, will be held on July 22–24, 2026, at the National Exhibition and Convention Center (Shanghai). Benchmarking the J.P. Morgan Healthcare Conference, CPIC aims to establish a model of "Chinese Innovation – Global Translation – Shanghai Transaction," highlighting China's status as a major power in innovative drugs and driving Chinese innovation to lead the global health industry.

 

The conference brings together multinational pharmaceutical companies, top investment institutions, regulatory experts, and research pioneers, featuring over 300 thematic sessions covering the full chain of R&D, clinical development, BD, investment and financing, and globalization. It includes a 1v1 appointment system to help participants efficiently connect with global partners, and a 10,000 m² dedicated exhibition area linking upstream and downstream resources. Thousands of industry leaders will gather, making CPIC a one-stop platform for networking and opportunity discovery.

 

Curious about how Chinese innovative drugs go global, or how the next billion-dollar deal will emerge? CPIC is the next most worthwhile destination after ASCO.