Key takeaway

The company has 5 products with a total of 7 studies selectedfor the ASCO conference, including 4 oral presentations and 1LBA, indicating intensive delivery of its innovative pipeline.

Among them, EGFR/HER3 ADC Iza-Bren disclosed phase IIIclinical data in TNBC and ESCC at the conference: in 2L+ TNBC,mOS reached 15.9m and mPFS reached 8.5m, demonstratingstrong competitiveness in the later-line ADC landscape; in thepopulation with progression after first-line PD-(L)1 + platinumcontainingchemotherapy for ESCC, mOS reached 9.8m andmPFS reached 4.2m, showing significant benefit compared withexisting therapies and expected to become a new standard forlater-line treatment. Looking ahead to 2026, the company’s corepipeline phase III clinical trials are expected to continuedelivering readouts, and overseas phase III clinical trials will alsogradually commence under the organization of the company’soverseas team. Collaboration with BMS continues to advance,and the clinical study of Iza-Bren combined with PD-L1/VEGFbispecific antibody is also expected to enter phase III, furtherenhancing the value of the pipeline.

Event

ASCO 2026: intensive pipeline data readoutsFive molecules of the company (iza-bren, T-Bren, BL-M05D1,BL-M14D1, SI-B001) with a total of 7 studies were selected forpresentation at the 2026 ASCO annual meeting, including 4 oralpresentations, 1 LBA presentation, and 2 posters.

Quick Take

Outstanding phase III clinical data for iza-bren, multi-tumorpotential gradually realized

At ASCO 2026, seven studies on the company’s five molecules— iza-bren, T-Bren, BL-M05D1, BL-M14D1, and SI-B001 —　　were selected and presented, including four oral presentations, one LBA presentation, and two posters. Amongthem, Iza-Bren disclosed two key phase III datasets: the phase III PANKU-Breast02 study in 2L+ triple-negativebreast cancer (TNBC) was presented as an LBA Oral. PANKU-Breast02 is a randomized, multicenter, open-labelphase III study that enrolled 406 patients with unresectable locally advanced or metastatic TNBC who hadpreviously progressed after receiving 1–2 lines of chemotherapy (including taxanes). Patients were randomlyassigned in a 1:1 ratio to the iza-bren group (2.5 mg/kg, D1D8 Q3W) or the investigator’s choice chemotherapygroup (eribulin, capecitabine, gemcitabine, etc.). The dual primary endpoints were PFS assessed by BICR and OS.

As of Jan 13, 2026, median progression-free survival (mPFS) reached 8.5m (vs 3.1m in the chemotherapy group,HR 0.29), and mOS significantly extended to 15.9m (vs 12.5m in the chemotherapy group, HR 0.60), withsignificant benefits in both PFS and OS. The benefit trend was consistent across different subgroups. In theHER2-low population, mPFS was 9.7 months vs. 4.1 months (HR=0.32); in the HER2 IHC 0 population receivingsecond-line treatment, mPFS was 8.3 months vs. 2.6 months (HR=0.28). In patients with baseline livermetastases, the benefit trend was more pronounced, with mPFS of 9.9 months vs. 2.6 months (HR=0.25). Thesubsequent treatment rate in the chemotherapy group (63.4%, of which 42.0% were ADC) was much higher thanthat in the iza-bren group (38.6%, of which only 16.4% were ADC). Iza-bren still significantly improved overallsurvival, providing a solid basis for the second-line use of iza-bren.

In terms of safety, the incidence of ≥grade 3 TEAE was 88.9% vs 62.9%. The main ≥grade 3 safety events werehematologic toxicities, with extensive clinical management experience. The discontinuation rate due to TRAE was1.9%. The incidence of ILD was low (1.4%), with no ≥grade 3 events.

The Phase III PANKU-Esophagus01 study in 2L ESCC enrolled a total of 493 patients, of whom 249 received iza -bren 2.5mg/kg D1D8 Q3W, and 244 received investigator’s choice chemotherapy(irinotecan/docetaxel/paclitaxel Q3W). As of Oct 17, 2025, median progression-free survival (mPFS) reached4.17m (vs 1.97m in the chemotherapy group, HR=0.50, P<0.0001), and median overall survival (mOS)significantly extended to 9.79m (vs 7.20m in the chemotherapy group, HR=0.64, P=0.0004). The objectiveresponse rate (ORR) reached 35.3% (vs 13.1% in the chemotherapy group), and the disease control rate (DCR)was as high as 74.3% (vs 45.5% in the chemotherapy group).

Safety was manageable and tolerability was good. Given that drug exposure duration in the iza -bren group wassignificantly longer than in the chemotherapy group (median 3.5m vs 1.6m), the incidence of ≥Grade 3 TRAEwas 85.1% vs 60.2%, mainly manifested as hematologic abnormalities. With routine dose adjustments (such asdelay or dose reduction), rapid recovery can be achieved. The treatment discontinuation rate and fatality ratedue to TRAE were 2.0% and 1.2%, respectively (vs 3.3% and 1.6% in the chemotherapy group); the incidence of ILDwas 1.6%.

Among patients who previously failed PD-(L)1 plus platinum-containing therapy, OS and PFS were furtherimproved compared with standard chemotherapy. The ESCC indication in China has been accepted by the CDE　　and included in the priority review pathway, and Iza-Bren’s multi-cancer potential continues to be realized.

Data readouts from the innovative pipeline continue to be delivered intensively, and platform valuecontinues to be validated

The company’s other innovative pipelines are also continuously delivering: 1) Izalontamab combined withpaclitaxel achieved an ORR of 52.9% and a DCR of 73.5% in later-line HNSCC, with mPFS and mOS of 5.4 monthsand 11.2 months respectively, and the benefit trend was further amplified in 2-3L patients; 2) T-Bren showedBIC treatment potential in platinum resistant ovarian cancer, with ORR of 55%, cORR of 52.5%, DCR of 87.5%,and a target lesion shrinkage rate of 83.7% in the 3.8mg/kg group; mPFS was not reached, the 9 month PFSrate reached 54.7%, and the 9 month OS rate was 74%. At present, a phase III study for platinum resistantovarian cancer is underway (NCT07545460); 3) T-Bren as monotherapy/combined with pertuzumab in first-lineHER2+ breast cancer achieved ORR of 93.0%/87.5% and 12 month PFS rates of 79.1%/90.8%, with overall goodsafety; 4) BL-M05D1 (CLDN18.2 ADC) determined a phase I RP2D of 4.0 mg/kg Q3W, with 2L ORR of50.0%/44.8%/45.0% in pancreatic cancer/gastric cancer/cholangiocarcinoma respectively; 5) BL-M14D1 showedexcellent efficacy in later-line SCLC and NEC, with the SCLC (4.0mg/kg) group achieving a cORR of 61.8%, DCRof 97.1%, and mPFS of 7.1 months, while among second-line patients cORR reached 71.4%, DCR reached 100%,and mPFS extended to 8.1 months. NEC (4.5mg/kg): ORR was 58.1%, cORR was 38.7%, DCR was 93.5%, and the 6 month PFS rate was 67.1%. Based on outstanding later-line data in SCLC and good safety, the companyregistered a phase III clinical study on ClinicalTrails on June 5 combining atezolizumab for first-line extensivestageSCLC patients, accelerating the realization of the global value of DLL3 ADC.

Global phase III clinical launch plan clear, dense catalysts in 26H2-27H1Looking ahead to 26H2-27H1, the company expects Iza-Bren to initiate three global phase III clinical trials,including first-line EGFR-mutant NSCLC combined with osimertinib and first-line ESCC combination regimens.

At ESMO in October, a phase II clinical data update for first-line combination with osimertinib in EGFR mutantNSCLC patients is expected to be read out, with mPFS expected to reach 3 years; together with BMS, thecompany is currently accelerating the world’s first clinical program combining a bispecific ADC with a PDL1/VEGF bispecific antibody, and the first global phase III combination study is expected to start by the end of2026. The global phase III study of DLL3 ADC in first-line treatment has already been registered on clinical trailand is expected to start soon; the HER2 ADC BL-M07D1 has already demonstrated BIC potential, and the firstnon head to head global phase III trial in a large indication is expected to start by the end of 2026.

Profit forecast and investment recommendationsThe company has established R&D platforms for ADC, multispecific antibodies, specificity enhanced bispecificantibodies, and ARC radiopharmaceuticals, and the two positive phase III data results of Iza -Bren together withmultiple global phase III pipeline plans verify the platform based development capability. We expect thecompany to achieve operating revenue of RMB2.207bn, RMB2.754bn, and RMB3.441bn in 2026–2028, YoY -12.41%, +24.76%, and +24.95%; and net profit attributable to shareholders of the parent company of -RMB1.462bn, -RMB1.639bn, and -RMB1.675bn. We are optimistic about platform validation and valuerealization driven by the continued global advancement of the company’s pipeline, and maintain a “Buy” rating.

Risks:

Industry policy risk: Changes in policies such as innovative drug review and approval, medical insurance access,payment policies, or centralized procurement may affect the approval timeline, pricing system, andcommercialization ramp-up of Iza-Bren.

R&D below-expectation risk: There is uncertainty in the mature follow-up of OS/PFS for Iza-Bren, enrollmentand readout of other indications, and the advancement of overseas phase II/III trials. Clinical efficacy and safetyresults may fall short of expectations.

Approval below-expectation risk: During the submission and review process for indications such as TNBC andESCC, approval timelines may be extended due to supplementary data requests, changes in review procedures,or label scope limitations.

Sales below-expectation risk: Newly launched ADC drugs face factors such as market access, physicianprescribing habits, competitive landscape, and medical insurance negotiation pricing, which may lead tocommercialization sales falling short of expectations.

Safety and competition risk: ADCs require strict management of adverse events such as hematologic toxicity andILD. If subsequent real-world safety data, competing clinical data, or pricing strategies change, the clinical useand peak sales of Iza-Bren may be affected.