Company Announcements

CHENGDU, China , April 13, 2026 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company", 6990.HK) announced that results from both the ovarian cancer cohort and the cervical cancer cohort of Phase II study SKB264-II-06/MK-2870-002 of the TROP2 ADC sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870) (佳泰莱^®), in combination with MSD's^[1] anti-PD-1 monoclonal antibody pembrolizumab (KEYTRUDA^®[2]), were selected for oral presentation at the 2026 Society of Gynecologic Oncology (SGO) Annual Meeting in San Juan, Puerto Rico. The data were presented by Professor Xiaohua Wu of Fudan University Shanghai Cancer Center.

Ovarian cancer

This presentation reported, for the first time, important data on sac-TMT as maintenance treatment in breast cancer susceptibility gene (BRCA) wild-type, second-line platinum-sensitive recurrent ovarian cancer. Among the 40 patients enrolled in the ovarian cancer cohort, 27 received sac-TMT (4 mg/kg, every other week (Q2W)) in combination with pembrolizumab, and 13 received sac-TMT (5 mg/kg, Q2W) in combination with pembrolizumab. Among the enrolled patients, 70% had prior bevacizumab therapy, and 58% had prior PARP inhibitor therapy. The median follow-up was 22.2 months (data cutoff date: November 17, 2025).

The data showed that median progression-free survival (PFS) in the overall population was 20.9 months; median overall survival (OS) was not reached;and the 12-month OS rate was 92%. Additionally, the adverse events of sac-TMT in combination with pembrolizumab were manageable. The most common treatment-related adverse events (TRAEs) were anemia, stomatitis, and decreased neutrophil count. No deaths or discontinuations due to sac-TMT-related TRAEs was reported.

The study results showed that sac-TMT in combination with pembrolizumab as maintenance therapy for platinum-sensitive recurrent ovarian cancer demonstrated positive efficacy signals and a favorable safety profile, providing important evidence for further clinical exploration of this combination regimen in the ovarian cancer population.

Cervical cancer

A total of 68 patients with previously treated second-line or third-line recurrent or metastatic cervical cancer were enrolled in the cervical cancer cohort to receive sac-TMT at doses of 3 mg/kg, 4 mg/kg, or 5 mg/kg Q2W in combination with pembrolizumab. Among the enrolled patients, 57% had prior bevacizumab therapy, and 51% had prior immunotherapy. The median follow-up was 24.7 months (data cutoff date: November 17, 2025).

The data showed that after treatment with sac-TMT in combination with pembrolizumab, the objective response rate (ORR) in the total population was 51% and 54% in IO-pretreated population. The median PFS was 7.3 months and the median OS reached 18.9 months in the total population. Furthermore, the safety profile of sac-TMT in combination with pembrolizumab was manageable, with no new safety signals identified and no deaths due to TRAEs.

The study results demonstrated promising and durable antitumor activity with a manageable safety profile in patients with pre-treated second-line or third-line recurrent or metastatic cervical cancer receiving sac-TMT in combination with pembrolizumab, providing robust data to support further clinical development.

About sac-TMT

Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as NSCLC, breast cancer (BC), gastric cancer (GC), gynecological tumors and genitourinary tumors, among others. Sac-TMT is developed with a unique, bifunctional linker that maximizes payload delivery to tumor cells both through its irreversible connection with the anti-TROP2 monoclonal antibody sacituzumab and its pH-sensitive cleavage from a belotecan-derivative topoisomerase I inhibitor in the lysosome, with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases the payload KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells.

In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc, Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (which includes Mainland China, Hong Kong, Macao and Taiwan).

To date, four indications for sac-TMT have been approved and marketed in China for: EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy; unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting); EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC who progressed after treatment with EGFR-TKI therapy; unresectable or metastatic HR+/HER2- (IHC 0, IHC 1+ or IHC 2+/ISH-) BC who have received prior ET and at least one line of chemotherapy in advanced setting. The first two indications listed above have been included in China's National Reimbursement Drug List (NRDL). This inclusion is expected to bring clinical benefits to a greater number of patients with BC and NSCLC. Additionally, sac-TMT has been granted six Breakthrough Therapy Designations (BTDs) by the NMPA.

Sac-TMT is the world's first TROP2 ADC drug approved for marketing in lung cancer. As of today, Kelun-Biotech has initiated 9 registrational clinical studies in China. MSD is evaluating 17 ongoing Phase III global clinical studies of sac-TMT as a monotherapy or with pembrolizumab or other anti-cancer agents for several types of cancer. These studies are sponsored and led by MSD.

About Kelun-Biotech

Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical, which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. Kelun-Biotech focuses on major disease areas such as solid tumors, autoimmune, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. Kelun-Biotech is committed to becoming a leading global enterprise in the field of innovative drugs. At present, Kelun-Biotech has more than 30 ongoing key innovative drug projects, of which 4 projects with 8 indications have been approved for marketing, more than 10 projects are in the clinical stage. Kelun-Biotech has established one of the world's leading proprietary ADC and novel DC platforms, OptiDC™, and has 2 ADC projects with 5 indications approved for marketing, and multiple ADC and novel DC assets in clinical or preclinical research stage. For more information, please visit https://en.kelun-biotech.com/.

 

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