LEADS BIOLABS-B (09887.HK): Updated Phase II Data of Vilxin® Combined with Chemotherapy as First-Line Treatment for NSCLC Presented in Oral Presentation at WCLC 2026

NewTimeSpace News: On 14 September 2026, Nanjing Leads Biolabs Co., Ltd. (stock code: 09887.HK) made a voluntary announcement. The board of directors of the Company is pleased to announce that the Company presented updated Phase II clinical study data for its self-developed investigational drug Vilxin^® (Opatilimab, PD-L1/4-1BB bispecific antibody) in combination with chemotherapy as first-line treatment for patients with non-small cell lung cancer ("NSCLC") in an oral presentation at the 2026 World Conference on Lung Cancer ("WCLC 2026").

According to the updated data, unprecedented high response rates were demonstrated, with nearly identical clinical benefits observed in squamous NSCLC patients regardless of PD-L1 status, both negative (PD-L1 tumour proportion score ("TPS") <1%) and positive (PD-L1 TPS≥1%), while non-squamous NSCLC patients with PD-L1 TPS≥1% achieved deep and durable tumour responses. As at 1 July 2026, a total of 63 patients with previously untreated NSCLC were enrolled, including 31 with non-squamous NSCLC and 32 with squamous NSCLC, with over 90% having Stage IV disease; the proportion of patients with PD-L1 TPS≥1% was 35.5% and 43.8% in non-squamous and squamous NSCLC, respectively, far below the 60% to 70% PD-L1 positivity rate in the natural patient population; and the median follow-up time was 7.1 months. Among 62 efficacy-evaluable patients, Vilxin^® combined with chemotherapy demonstrated encouraging antitumour activity in both squamous and non-squamous NSCLC first-line treatment: in the overall patient population, the ORR reached 71.0%, the disease control rate ("DCR") reached 95.2% and the 6-month PFS rate reached 70.6%; in the squamous NSCLC subgroup, the ORR reached 87.1%, the DCR reached 96.8% and the 6-month PFS rate reached 86.7%; the benefit trend was consistent between PD-L1-positive and PD-L1-negative patients, with ORRs of 84.6% and 88.2% and 6-month PFS rates of 84.6% and 87.4%, respectively; and in the non-squamous NSCLC PD-L1-positive subgroup, the ORR reached 81.8%, the DCR reached 100.0% and the 6-month PFS rate reached 90.0%. Vilxin^® combined with chemotherapy demonstrated a favourable overall safety profile, with safety characteristics similar to PD-L1 monoclonal antibody combined with chemotherapy, and no new safety signals were observed.

The announcement further stated that, as the world's first PD-L1/4-1BB bispecific antibody to have entered the marketing authorisation review stage, Vilxin^® is currently being studied in clinical trials across 14 solid tumour indications, has demonstrated breakthrough efficacy data in seven tumour types, and has shown a favourable safety profile in approximately 800 patients with solid tumours; the Company is actively advancing the Phase III clinical study layout for Vilxin^® as first-line treatment for NSCLC. The announcement also contained the warning statement required under Rule 18A.05 of the Listing Rules, stating that the Company cannot guarantee that it will be able to successfully develop or ultimately market Vilxin^®.

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