— The phase III TAISHAN-302 trial found that tambotatug pelitecan (Tam-Peli, YL201), a novel anti-B7-H3 antibody-drug conjugate developed by MediLink Therapeutics, significantly improved overall survival, progression-free survival and objective response rate compared with topotecan in patients with relapsed small-cell lung cancer (SCLC). The findings were presented at the IASLC 2026 World Conference on Lung Cancer presidential symposium.
Relapsed SCLC remains a highly aggressive disease with limited effective treatment options following first-line immunotherapy and platinum-based chemotherapy. Topotecan has long been the standard second-line treatment, but its survival benefit remains modest and its toxicity profile presents significant clinical burdens.
The randomized, open-label study enrolled 451 patients who had relapsed SCLC after first-line therapy. Patients were Patients were randomized 1:1 to receive Tam-Peli (2.0 mg/kg intravenously on day 1 of each 3-week cycle, with a maximum dose of 200 mg) or topotecan (per label) until disease progression or unacceptable toxicity.
After a median follow-up of approximately nine months, median overall survival was 13.3 months with Tam-Peli compared with 9.4 months with topotecan, with a hazard ratio (HR) of 0.46 (95% CI: 0.35–0.62; p<0.0001) — a 54% reduction in the risk of death. The survival benefit was consistent across all major subgroups, including patients with brain metastases, liver metastases and those with a chemotherapy-free interval of less than 90 days.
Tam-Peli also demonstrated a 71% reduction in the risk of disease progression or death, with median progression-free survival of 7.4 months versus 2.8 months for topotecan (HR 0.29; 95% CI: 0.23–0.37; p<0.0001). The objective response rate was 59.1% with Tam-Peli, compared with 9.7% for topotecan (p<0.0001).
The safety profile was manageable and consistent with prior studies. Grade 3 or higher treatment-related adverse events occurred in 46.4% of patients receiving Tam-Peli, versus 74.7% in the topotecan group. There were no treatment-related deaths in the Tam-Peli arm. Interstitial lung disease — a known concern for B7-H3 ADCs — was reported in 4.9% of Tam-Peli patients, with only 0.9% experiencing Grade 3 events and no Grade 4 or 5 cases.
A long-elusive target, now clinically validated
B7-H3 has drawn intense industry interest for its broad expression across multiple solid tumors, including SCLC, esophageal squamous cell carcinoma, and nasopharyngeal carcinoma, while showing limited presence in normal tissues. Yet the target has proven notoriously difficult to drug.
TMALIN® (Tumor Microenvironment Activable LINker-payload) is MediLink’s proprietary ADC platform, which has a unique dual-cleavage mechanism releasing payload both extracellularly in the tumor microenvironment and intracellularly in lysosomes. A proprietary tripeptide linker confers high stability in circulation. More than 8,000 patients have been treated with TMALIN®-based ADCs in global trials, generating a robust safety dataset that supports the platform’s clinical viability.
“In TAISHAN-302, Tam-Peli demonstrates statistically significant and clinically meaningful improvements in overall survival, progression-free survival and response rate compared with topotecan in relapsed SCLC,” said Professor Li Zhang from Sun Yat-sen University Cancer Center. “These results support Tam-Peli as a potential new standard of care for second-line SCLC.”
Global partnerships and regulatory momentum
Founded in 2020, MediLink has advanced a novel ADC platform from discovery to positive registrational readout in under six years. In January 2026, the company entered into a global exclusive licensing agreement with Roche for Tam-Peli, with an upfront and near-term milestone payment of $570 million — a record for a single-target ADC out-licensed by a Chinese biotech. Total out-licensing partnerships across MediLink’s pipeline have exceeded $10 billion in aggregate value.
The drug has received five Breakthrough Therapy Designations from China’s CDE for indications including SCLC, nasopharyngeal carcinoma, esophageal squamous cell carcinoma, and pancreatic ductal adenocarcinoma, as well as an FDA Breakthrough Therapy Designation for SCLC. In July 2026, MediLink submitted its first new drug application to China’s CDE for nasopharyngeal carcinoma, which was accepted and granted priority review. The second NDA, for relapsed SCLC, was accepted by the CDE in September 2026 — marking the first time any ADC has received an NDA acceptance in SCLC based on Phase III data.
A new competitive dynamic
Globally, more than 20 B7-H3 ADC candidates are in clinical development, with Chinese biotechs accounting for nearly 80% of the pipeline. Among the five ADCs currently in Phase III stage, four are Chinese-developed.
For MediLink, near-term priorities include maturing long-term follow-up data, exploring frontline combinations with PD-1 inhibitors, and advancing regulatory submissions outside China. The Roche partnership is expected to accelerate global development.
“SCLC has been a graveyard for drug development for decades,” said Tony Xue, CEO of MediLink. “Based on these results, we believe this drug could become the genuinely new standard of care for relapsed SCLC in a generation. And for the field, it finally proves that B7-H3 is a druggable target — that changes the calculus for a whole class of tumors.”
About MediLink Therapeutics
Founded in 2020, MediLink Therapeutics is a biotechnology company focused on innovative conjugated drugs, with its headquarters in Suzhou and R&D centers in Shanghai, Boston, and Singapore. Through proactive and visionary planning, the company has strategically established a full-chain ADC capability. Anchored on the core concept of “tumor microenvironment + lysosomal dual-cleavage mechanism”, MediLink has developed proprietary Tumor Microenvironment Activable LINker (TMALIN) platform and other next-generation technology platforms. The safety and efficacy profiles are being consistently validated in multiple clinical studies across the world. To date, MediLink has advanced 15 ADC assets into clinical development, addressing large unmet medical needs. Guided by an entrepreneurial spirit, the company drives integrated innovation across concept, technology, pipeline, clinical studies, global partnerships, and intelligent manufacturing, staying true to its mission of “Innovative Medicines for Global Patients,” and striving to bring better treatment options to patients around the world.
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Organization: MediLink Therapeutics (Suzhou) Co., Ltd.
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