Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKEX: 6990) reported robust commercial momentum in its unaudited consolidated results for the first half of FY26, with total revenue reaching RMB 978 million. Pharmaceutical product sales accounted for RMB 657 million, representing a 112% increase compared to the same period last year. This growth was primarily driven by expanded drug accessibility following National Reimbursement Drug List (NRDL) inclusion and heightened expert recognition of clinical data for its approved assets.

Financial and Capital Market Highlights

The company’s financial performance was underpinned by strong top-line growth in its core pharmaceutical segment. Beyond operational metrics, Kelun-Biotech executed significant capital market activities during the reporting period.

In April 2026, the Hong Kong Stock Exchange approved the removal of the "B" marker from the company’s stock code, signaling the commercialization of its innovative drugs. Subsequently, in July 2026, the company completed a placing of H Shares, generating net proceeds of approximately HK$2,723.4 million.

Commercial Drivers: NRDL Inclusion and Market Access

The 112% surge in pharmaceutical sales reflects the effective translation of regulatory benefits into market traction. Three indications for sacituzumab tirumotecan (佳泰莱™) and Cetuximab N01 (达泰莱™) were included in the 2025 NRDL, which took effect on January 1, 2026. This inclusion positioned 佳泰莱™ as the only TROP2 ADC and the only domestic ADC in triple-negative breast cancer (TNBC) and non-small cell lung cancer (NSCLC) under the NRDL.

Market access expanded significantly, covering 30 provinces, over 300 prefectures, and more than 2,000 hospitals. The company leveraged formal access, temporary procurement, and dual-channel reimbursement mechanisms to broaden reach. Additionally, the commercialization team grew to over 800 members, nearly doubling year-on-year, enabling extensive grassroots coverage in high-potential districts.

Pipeline Progress: ADCs and Global Collaborations

Kelun-Biotech continues to advance its differentiated pipeline, focusing on antibody-drug conjugates (ADCs) and novel drug conjugates (DCs). Key developments include:

• Sacituzumab tirumotecan (佳泰莱™): Received marketing approval for four indications, including second-line or later hormone receptor-positive/HER2-negative breast cancer. Two new indication applications were accepted for review: combination with pembrolizumab for first-line PD-L1-positive NSCLC and monotherapy for first-line TNBC. The global Phase 3 TroFuse-005 trial for endometrial cancer met primary endpoints for overall survival (OS) and progression-free survival (PFS).
• Trastuzumab botidotin (舒泰莱™): Approved for second-line or later HER2-positive breast cancer. Phase 2 studies are ongoing.
• Lunbotinib Fumarate Capsules (A400/EP0031): An NDA has been submitted, with commercialization expected in the first half of 2027 upon approval. Key Phase 2 results for RET fusion-positive NSCLC were presented at ASCO 2026.

The company is pursuing global expansion through strategic partnerships. MSD initiated 17 ongoing Phase 3 global clinical studies of sac-TMT across multiple cancer types. Ellipses Pharma received FDA approval to proceed into Phase 2 clinical development for Lunbotinib, with 42 trial sites established globally. Windward Bio is evaluating SKB378/WIN378 in global trials for asthma and COPD.

What the Numbers Show

Pharmaceutical product sales constitute approximately 67% of total reported revenue (RMB 657 million out of RMB 978 million). This concentration highlights that while the core pharma business is experiencing rapid double-digit growth, nearly one-third of current revenue stems from other sources, likely including licensing fees or other income streams not detailed as product sales. The significant capital raise of HK$2,723.4 million provides substantial liquidity to support the ongoing costs of global Phase 3 trials and future commercialization efforts outside China.

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (6990.HK) announced on July 30, 2026, that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has accepted its new indication application for sacituzumab tirumotecan (sac-TMT), also known as SKB264/MK-2870. The application seeks approval for the first-line treatment of patients with recurrent or metastatic triple-negative breast cancer (TNBC) who have a programmed death ligand 1 (PD-L1) combined positive score (CPS) <10, or who have recurred after prior PD-1/PD-L1 inhibitor therapy in the early stage.

This acceptance marks the sixth indication application for sac-TMT reviewed by the NMPA. Crucially, this new application has been included in the priority review and approval process, which is expected to expedite the regulatory timeline and allow the treatment to reach patients sooner. The decision follows positive results from the randomized, open-label, multicenter Phase III registrational OptiTROP-Breast03 study.

Clinical Basis and Regulatory Progress

The acceptance is based on data from the OptiTROP-Breast03 study, which evaluated sac-TMT versus investigator’s choice of chemotherapy in patients with unresectable recurrent or metastatic TNBC who had not received prior systemic therapy for advanced disease. The enrolled population included patients with PD-L1 CPS <10 and those who recurred after prior PD-1/PD-L1 inhibitor therapy in the early stage.

The study demonstrated that sac-TMT achieved statistically significant and clinically meaningful improvements in key efficacy profiles compared with chemotherapy, showing a clear clinical benefit. Previously, sac-TMT was granted Breakthrough Therapy Designation (BTD) by the NMPA for the first-line treatment of unresectable locally advanced, recurrent or metastatic PD-L1-negative TNBC.

Portfolio Status and Global Rights

Sac-TMT is a novel human TROP2-directed antibody drug conjugate (ADC) developed by Kelun-Biotech with proprietary intellectual property rights. It features a unique bifunctional linker and a drug-to-antibody-ratio (DAR) of 7.4. The drug releases KL610023, a topoisomerase I inhibitor, intracellularly to induce DNA damage and apoptosis, while also exerting a bystander effect on adjacent tumor cells due to its membrane permeability.

In May 2022, Kelun-Biotech licensed the exclusive rights to Merck & Co., Inc. (MSD) to develop, manufacture, and commercialize sac-TMT in all territories outside of Greater China. MSD has initiated 17 ongoing global Phase III clinical studies of sac-TMT as a monotherapy or in combination with other agents.

Approved Indications and Pipeline

To date, four indications for sac-TMT have been approved and marketed in China:

The first two indications are included in China’s National Reimbursement Drug List (NRDL). Additionally, sac-TMT has received six BTDs from the NMPA. Another new indication application, for sac-TMT in combination with pembrolizumab as first-line treatment for locally advanced or metastatic NSCLC, has also been accepted by the NMPA and entered the priority review process.

What the Numbers Show

The expansion of sac-TMT’s regulatory footprint highlights a strategic shift toward earlier-line treatments. By securing acceptance for first-line TNBC therapy, Kelun-Biotech is moving beyond second-line or later treatments where traditional chemotherapy efficacy is limited. With six indication applications accepted and multiple projects in clinical stages, the company is leveraging its proprietary ADC platform to address unmet medical needs across solid tumors, including lung cancer, where sac-TMT is the world’s first TROP2 ADC approved for marketing.