• Tambotatug Pelitecan (Tam-Peli, R&D code: YL201) demonstrated statistically significant and clinically meaningful efficacy over topotecan in a Phase III regulatory study (Protocol No. TAISHAN-302), reducing the risk of death by 54% and disease progression by 71%, while achieving an objective response rate of 59.1% vs 9.7%.^1,2

• Tam-Peli is an anti-B7-H3 ADC built on MediLink’s proprietary TMALIN® (Tumor Microenvironment-Activatable Linker) platform with a      camptothecin payload. Anchored on the core concept of "tumor microenvironment + lysosomal dual-cleavage mechanism”, TMALIN^® platform was designed to maximise antitumour activity while minimising off-target toxicity.^3,4

• In January 2026, MediLink entered a strategic collaboration with Roche to advance Tam-Peli globally. The partnership combines complementary capabilities to expedite clinical development, regulatory submissions, and market access across multiple solid tumor indications.

• Interim results of TAISHAN-302 were selected for a Presidential Presentation and congress briefing at the International Association for the Study of Lung Cancer (ISALC) 2026 World Conference on Lung Cancer (WCLC).¹ These results have been accepted for publication by the New England Journal of Medicine (NEJM) and will appear online at NEJM.org.²

• NDA acceptance by China NMPA under priority.

SUZHOU, China – [September 13^th], 2026 – MediLink Therapeutics (Suzhou) Co., Ltd. today announced interim results from the regulatory Phase III TAISHAN-302 evaluating Tambotatug Pelitecan (Tam-Peli, R&D code: YL201) versus topotecan in relapsed small cell lung cancer (SCLC) who progressed after prior platinum-based chemotherapy with or without PD-(L)1 inhibitor. ^1,2 The trial met its primary endpoint of overall survival (OS) with Tam-Peli demonstrating a statistically significant and clinically meaningful OS benefit, reducing the risk of death by 54% (median OS 13.3 vs. 9.4 months; stratified HR=0.46; p<0.0001). Tam-Peli also showed robust efficacy across secondary endpoints, significantly extending progression-free survival (PFS) (median PFS 7.4 vs. 2.8 months) and response rates (59.1% vs. 9.7%) compared to standard-of-care topotecan. ^1,2

The trial results are presented by Professor Li Zhang from Sun Yat-sen University Cancer Center as a Late-Breaking Abstract during a Presidential Presentation at the International Association for the Study of Lung Cancer (ISALC) 2026 World Conference on Lung Cancer (WCLC) in Seoul and featured in the congress briefing.¹ These results have been accepted for publication by the New England Journal of Medicine (NEJM) and will appear online at NEJM.org.²

Key efficacy results from the phase III TAISHAN-302 trial

Consistent OS and PFS improvements were observed across prespecified subgroups, including age, chemotherapy-free interval (<90 vs. ≥90 days), and baseline liver or brain metastatic status. In patients with baseline brain metastases, Tam-Peli extended median intracranial PFS (6.1 months vs. 4.2 months; unstratified HR=0.43; 95% CI: 0.27–0.68) and achieved a higher intracranial response rate (32.4% vs. 2.9%).^1,2

Tam-Peli showed a favorable and manageable safety profile, demonstrating lower rates of Grade ≥3 treatment-related adverse events (TRAEs) compared with topotecan (46.4% vs. 74.7%). Serious TRAEs occurred in 25.9% of patients receiving Tam-Peli versus 36.4% with topotecan. Treatment-emergent interstitial lung disease (ILD / pneumonitis) across all grades occurred in 4.9% of Tam-Peli patients versus 1.4 % with topotecan; grade 3 ILD/pneumonitis events were low in both groups (0.9% each), with no Grade 4 or 5 events reported.^1,2

Tam-Peli is designed to target B7-H3, a protein broadly expressed in solid tumours but minimally in normal tissue, allowing it to target cancer cells with high selectivity. Built on MediLink's TMALIN^® platform, its stable linker and dual-release mechanism is designed to maximise therapeutic efficacy while limiting off-target toxicity.^3,4

Following the positive phase III TAISHAN-301 trial (NCT06629597) in nasopharyngeal carcinoma, TAISHAN-302 represents the second positive phase III readout for Tam-Peli. Based on the interim results of TAISHAN-302, MediLink has submitted an NDA to the Center for Drug Evaluation (CDE) in China, which was accepted on September 2, 2026 (Acceptance No. CXSS2600135), with priority review subsequently granted.

About the TAISHAN-302 study

TAISHAN-302 (NCT06612151) is a randomised, open-label phase III study evaluating the efficacy and safety of Tam-Peli (2.0 mg/kg intravenously on day 1 of each 21-day cycle, maximum dose 200 mg) compared with topotecan in patients with small-cell lung cancer (SCLC) who have progressed after one prior line of platinum-based chemotherapy with or without a PD-(L)1 inhibitor. The trial enrolled 451 patients across 85 study sites in China. The primary endpoint of the trial is overall survival (OS). Key secondary endpoints include investigator-assessed progression-free survival (PFS) and objective response rate (ORR), alongside disease control rate (DCR), duration of response (DoR), time to response (TTR), safety, pharmacokinetics, and immunogenicity. ^1,2

About Tam-Peli (R&D Code: YL201)

Tam-Peli is an anti-B7-H3 ADC built on MediLink Therapeutics’ proprietary TMALIN^® (Tumor Microenvironment-Activatable Linker) platform with a camptothecin payload. In January 2026, MediLink Therapeutics announced an exclusive licensing agreement with Roche for Tam-Peli. Under the collaboration, MediLink will grant Roche an exclusive license to develop, manufacture, and commercialize Tam-Peli worldwide, excluding the mainland of China, the Hong Kong Special Administrative Region, and the Macau Special Administrative Region. Both companies will leverage their respective strengths to accelerate global development and regulatory filings for Tam-Peli and jointly advance its clinical exploration and commercialization across multiple solid tumor indications. MediLink will receive an upfront and near-term milestone payments totaling approximately US$ 570 million, and will be entitled to additional development, regulatory, and commercial milestone payments, along with tiered royalties on net sales outside of China.

MediLink has filed New Drug Applications (NDAs) for Tam-Peli in China. Concurrently, Tam-Peli is being evaluated in multiple clinical studies across various advanced solid tumors all over the world. Tam-Peli has received five Breakthrough Therapy Designations (BTDs) from the China Center for Drug Evaluation (CDE) for indications including Small Cell Lung Cancer (SCLC), Nasopharyngeal Carcinoma (NPC), Esophageal Squamous Cell Carcinoma (ESCC), pancreatic cancer, as well as one BTD from the U.S. Food and Drug Administration (FDA) for SCLC. In addition, Tam-Peli has been granted three Orphan Drug Designations by the U.S. FDA for SCLC, NPC, and ESCC.

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.

Reference:

1. Zhang L, Zhao Y, Liu H, et al. Tam-Peli, an Anti-B7-H3 Antibody-Drug Conjugate, Versus Topotecan in Relapsed SCLC: A Randomized, Open-Label, Phase 3 Study (TAISHAN-302). WCLC 2026: Abstract PL02.03.

2. The results have also been accepted by New England Journal of Medicine (NEJM) and will be published online at NEJM.org.

3. Xu J, et al. Cancer Res. 2023;83:6304.

4. Ma Y, et al. Nat Med. 2025;31:1949-1957.

5. Rudin CM, et al. Small-cell lung cancer. Nat Rev Dis Primers. 2021;7(1):3.