Innovative drugs continue to be strong! Have you jumped on this wave?
Oncology Annual Meeting Approaches: ADC Pipeline Sees Intense Catalysts—What’s the Outlook for Innovative Drugs?
Author: Sun Bihan BWS708 | 2026-05-22
The most important upcoming window is ASCO (American Society of Clinical Oncology Annual Meeting), held annually from late May to early June—this year falling exactly on these dates. It is the biggest oncology catalyst of the year, $BEONE MEDICINES (06160.HK)$ 、 $INNOVENT BIO (01801.HK)$ 、 $JUNSHI BIO (01877.HK)$ with data readouts expected from Hong Kong-listed biotech companies such asHong Kong-listed innovative drug stocks typically show pronounced market reactions around ASCO.。
I. 📅 Key ASCO Data Calendar
🔬 $SKB BIO (06990.HK)$ : May 29 – sac-TMT + Keytruda, Phase 3 in 1L NSCLC (#8506); Lunbotinib RET Phase 2 (#8505)
🔬 $AKESO (09926.HK)$ : May 31 – Ivonescimab (PD-1/VEGF bispecific antibody) will present primary endpoint OS data from its Phase 3 trial in 1L squamous NSCLC during the Plenary Session. PFS HR is known to be approximately 0.60; a statistically significant OS benefit would representa practice-changing result in the U.S.。
II. 🧬 Summary of Key ADC Data Highlights
Other notable areas to watch:ADC pipeline— The pace of domestic ADC out-licensing deals continues, with the second half of 2026 marking a period of intensive data readouts.
Project ① BL-B8101(EGFRxHER3 bispecific ADC, Sichuan Biotel BioPharma / BioNTech)
⭐️ Most-watched Chinese ADC, backed by BioNTech with over $500 million
Indications:NSCLC, BC – multiple tumor types
Beneficiaries:$Sichuan Biokin Pharmaceutical (688506.SH)$ ； $WUXI BIO (02269.HK)$ ; Revaluation of the entire Chinese ADC sector’s BD prospects → $SKB BIO (06990.HK)$ 、 $DUALITYBIO-B (09606.HK)$ , sentiment spillover to Yilian Biosciences
Project ② TroFuse-005 (sac-TMT)(TROP2, Kelun-Biotech / Merck & Co)
⭐️ Domestic NDA filing by Kelun-Biotech; milestone triggered for Merck & Co
Indication:Second-line+ esophageal cancer, interim OS data
Project ③ SHR-A1811(HER2 ADC, Hengrui)
⭐️ Can domestic HER2 ADC match the data quality of T-DXd?
Indication:HER2+ breast cancer / gastric cancer
Beneficiaries: $HENGRUI PHARMA (01276.HK)$ ; if data meet targets, supports valuation for out-licensing BD
Project ④: RC48 + Keytruda(HER2, RemeGen)
⭐️ RC48 already approved in China; international validation milestone
Tumor types:Urothelial carcinoma / gastric cancer
Beneficiaries: $REMEGEN (09995.HK)$ (direct); if gastric cancer data are strong, out-licensing restarts
III. 🏢 Individual Stock View: Kelun-Biotech (6990.HK)
Company Fundamentals
$SKB BIO (06990.HK)$ Founded in 2016, the company is a domestic leader in the research and development of antibody-drug conjugates (ADCs). It currently has one ADC drug, SKB264 (datopotamab deruxtecan), approved for marketing in China, with another eight ADC candidates in clinical stages and three non-ADC oncology new drugs for which New Drug Applications (NDAs) have been submitted in China and are under regulatory review.
The company leverages its proprietary, advanced OptiDC next-generation ADC drug development platform,which significantly accelerates the design and development of next-generation ADCs, demonstrating a clear R&D efficiency advantage. Its world-class ADC capabilities have earned strong recognition from Merck & Co.,which licensed exclusive rights to SKB264 outside of Chinaand has initiated 14 global Phase III clinical trials for this product, covering a broader range of indications than competing products Dato-DXd and sacituzumab govitecan (Trodelvy).
We believe SKB264 has the potential to become the global best-in-class (BIC) TROP2-targeting ADC drug. Our estimates suggest that the drug’s peak sales in China could exceed RMB 9 billion, with peak international sales reaching US$6 billion。
📌 Near-term catalysts
① Positive readout from TroFuse-005 — sac-TMT becomes the first and only ADC in the late-line endometrial cancer setting to demonstrate concurrent improvement in both OS and PFS
On May 18, 2026, Merck & Co announced that sac-TMT (lurbinectedin sacituzumab), the TROP2 ADC co-developed with its partner, met both primary endpoints of overall survival (OS) and progression-free survival (PFS) in the global Phase III TroFuse-005 trial.
The TroFuse-005 trial is a randomized, open-label global Phase III study that enrolled a total of 776 patients Patients with advanced or recurrent endometrial cancer who had previously progressed after platinum-based chemotherapy and anti-PD-(L)1 immunotherapy were randomized 1:1 to receive sac-TMT (4 mg/kg every two weeks) or investigator-chosen chemotherapy.
In the pre-specified interim analysis, sac-TMT demonstrated statistically significant and clinically meaningful improvements over chemotherapy in both overall survival (OS) and progression-free survival (PFS). The key secondary endpoint of objective response rate (ORR) was also met, and the safety profile remained consistent with prior observations, with no new safety signals identified. This isworld's firstthe first Phase III clinical trial in this indication to demonstrate dual improvement in both OS and PFS, andthe first and onlyantibody-drug conjugate (ADC) to show positive results in this treatment setting. sac-TMT has the potential to become a cornerstone therapy for patients who have failed platinum-based and immunotherapy regimens. Relevant data will be disclosed at an upcoming medical conference and submitted to global regulatory authorities, with a BLA expected by the end of 2026。
② Merck & Co.-led 17 Phase III trials of sac-TMT are poised to read out results, with data from multiple later-line indications expected over the next 1–2 years.
In addition to TroFuse-005, Merck & Co. is currently leading 16 items Phase III clinical trials of sac-TMT globally (a total of 17 studies under the TroFuse program), covering breast cancer (triple-negative and HR+/HER2-negative), non-small cell lung cancer (squamous/non-squamous, EGFR-mutant/wild-type), gastroesophageal adenocarcinoma, urothelial carcinoma, ovarian cancer, cervical cancer, and other nine major tumor types。
According to the Insight database from Dingxiang Garden, upcoming global Phase III trials expected to report data include:
– TroFuse-015(third-line or later gastric or gastroesophageal junction adenocarcinoma, with primary endpoint completion expected in January 2027)
– TroFuse-004(non-squamous non-small cell lung cancer with prior treatment failure and EGFR mutations or other actionable genomic alterations, expected in May 2027)
– TroFuse-010(in combination with Keytruda for HR+/HER2- breast cancer previously treated with CDK4/6 inhibitors plus endocrine therapy, expected in July 2027)
– TroFuse-007(non-small cell lung cancer with PD-L1 TPS ≥50%, comparing combination with Keytruda versus Keytruda monotherapy, expected in January 2028)
– TroFuse-020(Second-line monotherapy for cervical cancer previously treated with platinum-based therapy plus PD-(L)1 inhibitors; expected in June 2028)
– TroFuse-009(For EGFR-mutated non-squamous non-small cell lung cancer previously failed on EGFR-TKI therapy; expected in August 2028)
The success of TroFuse-005 has set a positive precedent for multiple subsequent Phase III clinical trials,the commercial value of sac-TMT is expected to be progressively realized as it advances across multiple indications, and as the originator of this asset, the company will continue to benefit.
③ SKB264 has already entered its commercial ramp-up phase in China (with an estimated peak sales potential of RMB 7 billion)
We expect the company’s SKB264 commercial revenue in 2026 to achieve over 100% year-over-year growth, considering:
a) Two key indications—TNBC3L (third-line treatment for triple-negative breast cancer) and EGFRmtNSCLC3L (third-line treatment for EGFR-mutated non-small cell lung cancer)—have been included in the national reimbursement drug list (NRDL). Additionally, EGFRmtNSCLC2L (second-line) and HR+/HER2-BC2L (second-line) are expected to be renegotiated for NRDL inclusion.
b) The company’s commercial team now exceeds 600 personnel, with dedicated teams established for gynecological oncology, lung cancer, and other tumor types. Furthermore, for indications not yet covered by the NRDL, the company is actively advancing local惠民保 (government-backed supplementary health insurance) initiatives across regions.
We are optimistic that the company’s robust commercial infrastructure will continue to drive the domestic commercial ramp-up of SKB264.
④ Upcoming data readouts
1L NSCLC (PD-L1 TPS ≥1%): First-line non-small cell lung cancer with PD-L1 expression, expected ASCO disclosed interim analysis data for PFS and OS events
First-line NSCLC (PD-L1 TPS <1%)andFirst-line TNBC are also expected to be disclosed at ESMO for data disclosure
💊 Other pipeline candidates
SKB571: Viewed as a potential next blockbuster; the OptiDC platform may yield multiple successes. This candidate balances potent tumor-killing efficacy with low systemic toxicity, and its potential for first-line combination therapies is promising,entered Phase II clinical trials in China in November 2025
Other potential FIC programs: SKB518 (Phase II) / SKB535 (Phase I) / SKB445 (Phase I) / SKB107 (RDC, bone metastasis, Phase I)
ADC + next-generation IO strategy: The PD-1/VEGF bispecific antibody is expected to subsequently enable combination regimens with the company's differentiated ADC assets
IV. ⚠️ Key Risks
① Policy risk: The House Appropriations Committee’s FY2027 FDA appropriations bill report language proposes prohibiting the FDA from accepting, reviewing, or considering clinical trial data originating fromChina, Russia, Iran, and North Koreafor supporting IND applications.
This is currently report language (non-binding), but if ultimately codified into law: the primary impact would be a severe disruption to U.S. large-cap pharmaceutical companies’ license-in pipelines that rely heavily on clinical data generated in China; Chinese biotechs’ overseas expansion strategies would face fundamental restructuring pressure—requiring supplementary clinical data from the U.S. or Europe.
② Data risk: Disappointing data releases at ASCO and in the second half of the year falling short of expectations.
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