Sichuan Kelun-Biotech

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. announced that its partner, Windward Bio, reported positive interim results from the Phase 2 portion of the POLARIS-1 trial evaluating twice-yearly dosing of SKB378/WIN378 in asthma, and the first Phase 3 study has been initiated. The interim analysis, conducted on the first 98 of 147 enrolled patients with uncontrolled moderate-to-severe asthma, showed a half-life of up to 75 days, with clinical effects consistent with twice-yearly dosing. SKB378/WIN378 produced significant and sustained effects on FEV1 (up to 174 mL mean increase, placebo-adjusted mean increase up to 256 mL, p=0.033), FeNO, and blood eosinophils, with effects seen as early as Week 2 and sustained through Week 24. The drug was well tolerated, with no treatment-related serious adverse events, withdrawals, or discontinuations; adverse events were balanced between active arms and placebo, with low rates of injection site reactions and anti-drug antibodies. Two twice-yearly doses were selected for the Phase 3 portion of POLARIS-1, and a second Phase 3 trial, POLARIS-2, is planned to begin in the first half of 2027.

Kelun Pharmaceutical released its 2026 interim report, showing first-half net profit attributable to the parent of 1.13 billion yuan, up 12.7% year on year. Operating revenue was 8.84 billion yuan, down 2.7% year on year. Net profit attributable to the parent after deducting non-recurring items was 699 million yuan, down 29.0% year on year. Net cash flow from operating activities was 2.341 billion yuan, up 96.8% year on year. In the second quarter, net profit attributable to the parent was 674 million yuan, up 61.9% year on year, but net profit attributable to the parent after deducting non-recurring items was 318 million yuan, down 24.5% year on year. The company said that prices of some products declined due to the impact of centralized procurement policies, but increased sales revenue from innovative drugs and receipt of settlement income drove profit growth at Kelun-Biotech.

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. announced its unaudited consolidated results for the six months ended June 30, 2026, with total revenue of approximately RMB 978 million and pharmaceutical product sales of RMB 657 million, up 112% year-over-year. The company attributed the growth to expert recognition of high-quality clinical data, shifts in treatment paradigms, and enhanced drug accessibility, including NRDL inclusion for three indications of sac-TMT and cetuximab N01 effective January 1, 2026. Sac-TMT received marketing approval for a fourth indication, 2L+ HR+/HER2- breast cancer, and two new indication applications were accepted for review, while the global Phase 3 TroFuse-005 trial met primary endpoints of overall survival and progression-free survival in advanced or recurrent endometrial cancer. Kelun-Biotech also completed a placing of H Shares in July 2026 with net proceeds of approximately HK$2,723.4 million and removed the "B" marker from its stock code on April 14, 2026.

Kelun Pharmaceutical's controlling subsidiary Kelun Biotech has received a clinical trial notice from the Center for Drug Evaluation of the National Medical Products Administration, approving the clinical trial application for the novel dual-payload ADC drug SKB565 for the treatment of advanced solid tumors. SKB565 is the first dual-payload antibody-drug conjugate from Kelun Biotech to enter the clinical stage, featuring an innovative dual-payload design with a dual anti-tumor mechanism.

Kelun-Biotech announced that the Phase III OptiTROP-Lung06 study of its TROP2-directed ADC sacituzumab tirumotecan combined with pembrolizumab met its primary endpoint of progression-free survival in first-line treatment of PD-L1-negative locally advanced or metastatic non-squamous non-small cell lung cancer. The combination showed a statistically significant and clinically meaningful improvement in PFS compared with pembrolizumab plus pemetrexed and platinum-based chemotherapy, with a positive overall survival trend and no new safety signals. This is the world's first Phase III trial of an ADC plus an immune checkpoint inhibitor to meet its primary endpoint in this patient population. The company plans to discuss the results with China's Center for Drug Evaluation, building on prior positive Phase III data for the same combination in PD-L1-positive NSCLC.