CHENGDU, China, Aug. 17, 2026 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company", Stock Code: 6990.HK) announces its unaudited consolidated results for the period ended 30 June 2026 (the "Reporting Period").
Key information is as follows:
- Revenue amounted to approximately RMB 978 million, with sales of pharmaceutical products reaching RMB 657 million, up by 112% compared to the same period last year, driven by two factors: expert recognition of high quality clinical data and shift in treatment paradigms, and comprehensive enhancement of drug accessibility.
- The Company has established a comprehensive operational system in China encompassing R&D, manufacturing, quality management, and commercialization, with integrated drug development capabilities. The Company is also pursuing global expansion through international collaborations, leveraging external partnerships to accumulate global clinical development and commercialization experience, while exploring diversified pathways to progressively achieve independent overseas market entry.
- Focusing on ADC and novel DC, the Company not only has two ADC products that have been approved for marketing, but has also built a product pipeline that is differentiated and complimentary to approved ADCs in indications, efficacy performance and safety profile. Through the free combination of conjugation drug components, as well as the pairing with a diverse range of targeting conjugates including antibodies, small molecules, and peptides that leverage TAA/IO/ anti-angiogenetic-based mechanisms, the Company has proactively positioned innovative DC assets, including single-payload DCs such as radioisotope-based/ immuno-agonist-based/degrader-based, and dual-payload DCs such as cytotoxin + cytotoxin or immuno-agonist or degrader combinations, among others.
- Doubling down on ADC + IO therapies, including the combination of ADCs with PD-(L)1 or PD-1/VEGF agents, as well as the development of drug candidates with synergetic MoAs within one ADC compound.
- Beyond oncology, the Company has also expanded into important therapeutic areas such as autoimmune and metabolic diseases, and is currently conducting multiple clinical studies for asthma, chronic obstructive pulmonary disease (COPD), and atopic dermatitis.
Clinical development progresses efficiently, with a tiered expansion of the pipeline matrix
Focusing on high-incidence tumors such as lung cancer and breast cancer, the Company has built a well-layered clinical pipeline with significant synergistic potential, covering drug modalities including ADCs, immunotherapies, and small-molecule targeted therapies, while further expanding into major therapeutic areas such as autoimmune and metabolic diseases.
Approved ADC Products
Sac-TMT (TROP2 ADC, sacituzumab tirumotecan) (also known as SKB264/MK-2870) (佳泰莱®)
The product has currently received marketing approval for four indications, namely 2L+ TNBC, 2L/3L EGFR-mutant NSCLC, and 2L+ HR+/HER2- BC. In addition, two new indication drug applications have been accepted for review, covering the combination with pembrolizumab for 1L PD-L1-positive NSCLC, and as a monotherapy for 1L TNBC.
Clinical progress in the reporting period:
- Marketing approval for 2L+ HR+/HER2- BC
- New indication drug applications accepted for 1L TNBC and 1L PD-L1-positive NSCLC
- The OptiTROP-Lung06 registrational trial in China for 1L PD-L1-negative non-squamous NSCLC met primary endpoint
- The global Phase 3 TroFuse-005 trial for 2L+ EC met primary endpoints
- Two global Phase 3 trials for OC & UC initiated in H1 2026
- Phase 2 study in combination with SKB118 for NSCLC initiated
- Granted BTD for 1L PD-L1-positive NSCLC from NMPA
Drawing on all the aforementioned key advances, sac‑TMT has clearly embodied four core development strategies: advancing from monotherapy to combo-therapy, shifting from later-line to earlier-line treatment settings, expanding indications, and conducting clinical research from China to the global.
Trastuzumab botidotin (HER2 ADC, also known as A166) (舒泰莱®)
One indication has received marketing approval for the treatment of 2L+ HER2+ BC. Its Phase 2 clinical study in HER2+ BC patients previously treated with topoisomerase inhibitor ADCs is ongoing.
Other ADC and novel DC assets
The Company has also built a pipeline of innovative assets that are differentiated from and complementary to approved ADCs in indications, efficacy and safety profile, including SKB315 (CLDN18.2 ADC), SKB410 (Nectin-4 ADC), SKB571 (novel bsADC), SKB107 (RDC), SKB103 (TAA-IO bsADC), and SKB565 (novel dual-payload ADC), among others.
Non-DC Assets
Clinical progress in the reporting period:
SKB118/CR-001 (PD-1/VEGF bsAb): The IND application for the treatment of solid tumors has been approved by the NMPA, and a Phase 1/2 clinical trial is ongoing.
SKB378/WIN378 (TSLP mAb): A Phase 1 clinical trial in healthy subjects has been completed in China, and its IND application for the treatment of COPD has also been approved by the NMPA.
SKB575 (TSLP/undisclosed target bsAb): Phase 1 clinical trials for atopic dermatitis and asthma are ongoing in China.
Major Key Research Findings Presented at International Academic Conferences & Journals
- The Phase 3 trial evaluating sac-TMT plus pembrolizumab versus pembrolizumab monotherapy for first-line treatment of PD-L1-positive advanced NSCLC was delivered as an oral presentation at ASCO 2026 and concurrently published in The Lancet. Compared with single-agent immunotherapy, this combination regimen yielded a significant prolongation in PFS (HR = 0.35), with consistent PFS benefits observed across all predefined subgroups; an OS benefit trend was also observed (HR = 0.55).
- The final OS analysis results from the pivotal study of sac-TMT for 3L EGFR-mutant NSCLC were selected as a LBA at ELCC 2026 and presented as a mini oral presentation.
- Lunbotinib Fumarate Capsules (RET inhibitor, also known as A400/EP0031) (宁泰莱®[1]): Key Phase 2 clinical results for advanced RET fusion-positive NSCLC were presented in an oral presentation at ASCO 2026.
Multiple products gain market traction, with robust commercial growth momentum
To date, the Company has received marketing authorization for sac-TMT (佳泰莱®), tagitanlimab (科泰莱®), Cetuximab N01 (达泰莱®) and trastuzumab botidotin (舒泰莱®), of which 3 products covering 5 indications have been included in the National Reimbursement Drug List (NRDL). The Company has also submitted an NDA for Lunbotinib Fumarate Capsules, and upon regulatory communication and marketing approval, commercialization is expected to commence in the first half of 2027. With this, the Company's initial commercial product portfolio, comprising 5 products, has taken shape.
In the first half of 2026, the total revenue from sales of pharmaceutical products reaching RMB 657 million, up by 112% compared to the same period last year.
Major growth drivers:
Expert Recognition of High‑Quality Clinical Data and Shift in Treatment Paradigms:
- Data from a number of high‑quality clinical studies of international caliber have continued to be released, thereby continuously reinforcing the evidence-based clinical foundation of our products.
- Recognized through authoritative endorsement from clinical guideline experts, as reflected in guidelines (CSCO, etc.) and clinical expert consensus.
- 佳泰莱® is recognized as the "standard of care in 2L and the preferred regimen in 3L" in the LC, and is also the preferred brand among TROP2 ADC in TNBC.
- Through ongoing medical education and academic exchange activities, clinicians have gained a deeper understanding of the products. Treatment paradigms have also evolved gradually.
Comprehensive Enhancement of Drug Accessibility
- Effective translation of the benefits of NRDL inclusion: 3 indications of 佳泰莱® and 达泰莱® have been included in the 2025 NRDL, which officially took effect on January 1, 2026. This marks 佳泰莱® the only TROP2 ADC and the only domestic ADC in TNBC/NSCLC under the NRDL
- Broader hospital access channels: Covers 30 provinces, over 300 prefectures and over 2,000 hospitals; Broaden reimbursement channels, including formal access, temporary procurement and dual-channel reimbursement;
- Continuous expansion of the commercialization team: Established a team of 800+; nearly doubling YoY; Achieved extensive grassroots coverage of top-tier hospitals in high-potential districts
Sac-TMT (佳泰莱®) achieved positive results in its first global Phase 3 trial, accelerating global collaboration progress
- Collaboration with Merck Sharp & Dohme (hereinafter referred to as the "MSD") (默沙东): MSD has initiated 17 ongoing Phase 3 global clinical studies of sac-TMT as a monotherapy or in combination with pembrolizumab or other agents for several types of cancer, with indications covering breast cancer (BC), lung cancer (LC), gynecologic cancers, gastrointestinal (GI) cancers, and genitourinary (GU) cancers.
In May 2026, MSD announced that the pivotal Phase 3 Trofuse-005 trial met its primary endpoints of OS and PFS in certain patients with advanced or recurrent EC. TroFuse-005 is the first global Phase 3 trial to demonstrate statistically significant improvement in both OS and PFS compared to chemotherapy for these patients, and sac-TMT is the first and only ADC to do so for patients with EC in this setting.
Beyond sac‑TMT, the Company has also entered into collaborations with MSD on certain ADC assets, continuously exploring the optimal ADC pipeline portfolio. - Collaboration with Ellipses Pharma: Lunbotinib Fumarate Capsules (A400/EP0031) have received FDA approval to proceed into Phase 2 clinical development. A total of 42 clinical trial sites has been established in the United States, UK, Europe, and the United Arab Emirates for Lunbotinib Fumarate Capsules.
- Collaboration with Windward Bio: Windward Bio is evaluating SKB378/WIN378 in the POLARIS Phase 2/3 global trial in patients with asthma and has dosed the first patients in the SIRIUS Phase 2 global study in patients with COPD.
- Collaboration with Crescent Biopharma: Entered into a licensing collaboration with Crescent Biopharma for SKB105/CR-003.
ESG capabilities continue to strengthen, delivering outstanding results in capital market performance.
In terms of ESG, in May 2026, the Company was included in the "China ESG Impact List" by Fortune and was awarded bronze medal for "Most Committed to ESG (China)" under "Asia's Best Company" by FinanceAsia. In March 2026, the Company had received a rating of "AA" in the MSCI ESG Rating Assessment.
In terms of capital markets, the Company was approved by the Hong Kong Stock Exchange to officially remove the "B" marker from its stock code on April 14, 2026. In addition, the Company completed the placing of H Shares in July 2026, with net proceeds from the Placing amounting to approximately HK$2,723.4 million.
Prospect
Kelun-Biotech will continue to drive innovation and strengthen its operational capabilities, steadily advancing towards becoming a world-class biopharmaceutical company. Specifically, the Company will implement the following development strategies: advancing differentiated pipelines targeting indications with significant medical needs; optimizing payload-linker strategies and novel DC designs and structures, while expanding applications in non-oncology diseases; enhancing its end-to-end drug development and commercialization capabilities; expanding its global footprint through strategic partnerships and improve our capabilities for the development, registration and commercialization of our products in ex-China market; and optimizing its operational systems with the aim of becoming a leading global biopharmaceutical company.
－End－
About Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
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, 2 projects with 3 indications are in the NDA stage and 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/.
[1]Trade name to be approved by NMPA. |
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