KELUN-BIOTECH ANNOUNCED 2025 ANNUAL RESULTS: MULTIPLE PRODUCTS SUCCESSFULLY LAUNCHED WITH TIERED PIPELINE READY FOR TAKE-OFF

• Revenue amounted to approximately RMB2057.92 million, and gross profit amounted to approximately RMB1478.78 million, representing a year-on-year increase.
• R&D Expenses was approximately RMB1319.68 million.
• Loss for the period was RMB381.97 million, adjusted annual loss^[1] was approximately RMB211.28 million.
• Cash and financial assets^[2] amounted to approximately RMB4559.36 million, with ample cash reserves.
• The debt-to-asset ratio^[3] further declined to 18.7%.

CHENGDU, China, March 23, 2026 /PRNewswire/ — Sichuan Kelun-Biotech Pharmaceutical Co., Ltd. (“Kelun-Biotech” or the “Company“, Stock Code: 6990.HK) announced its audited consolidated results for the year ended 31 December 2025 (the “Reporting Period“).

Kelun-Biotech is leveraging its core strengths and proprietary OptiDC™ technology platform to continue deepening its presence in the ADC and novel DC drug field. The company is actively advancing cutting-edge modalities including bispecific ADCs, RDCs, iADCs, and DACs, building a differentiated pipeline with strong global competitiveness. At the same time, Kelun-Biotech is steadily advancing product commercialization, achieving transformational growth across its business. To date, the company has four products with eight indications approved for marketing in China, including Sacituzumab Tirumotecan (佳泰莱^®), Trastuzumab Botidotin (舒泰莱^®), Tagitanlimab (科泰莱^®), and Cetuximab N01 (达泰莱^®). Among them, three products with five indications have been included in the 2025 National Reimbursement Drug List (NRDL), establishing a fully integrated drug development ecosystem that spans R&D through commercialization.

As of now, the company has built a robust pipeline of more than 30 drug candidates, with over 10 in the clinical stage, and are gradually expanding into broader non-oncology therapeutic areas such as autoimmune diseases and metabolic disorders. Looking ahead, the company will leverage its innovative and differentiated pipeline to deliver high-quality therapeutic solutions for major unmet medical needs worldwide.

Core ADC Products’ Commercialization Realized to Solidify Long-term Performance Foundation 

Sac-TMT (sacituzumab tirumotecan, TROP2 ADC) (also known as SKB264/MK-2870) (佳泰莱^®)

TNBC:

• The Company received marketing authorization in China from the NMPA for sac-TMT in adult patients with 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).
• The Company has initiated a Phase 3 registrational study of sac-TMT monotherapy versus ICC for 1L advanced TNBC.

HR+/HER2- BC:

• In February 2026, a new indication application for sac-TMT for the treatment of adult patients with HR+/HER2- BC who have received prior endocrine therapy (ET) and at least one line of chemotherapy in advanced setting has been approved for marketing by the NMPA.
• A Phase 3 registrational study of sac-TMT versus ICC for treatment of patients with HR+/HER2- BC who received prior ET is in progress.

EGFR-mutant NSCLC:

• In March 2025, the Company received marketing authorization in China from the NMPA for sac-TMT for the treatment of adult patients with EGFR mutant-positive NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy. This is the first TROP2 ADC drug approved for marketing in LC globally.
• In October 2025, the company received marketing authorization in China from the NMPA for sac-TMT for the treatment of adult patients with EGFR mutant-positive NSCLC who progressed after treatment with EGFR-TKI therapy. This is the first ADC globally to show an OS benefit compared with platinum doublet chemotherapy and be approved for advanced NSCLC following progression on only TKI therapy (2L).
• The Phase 3 registrational study of sac-TMT combined with osimertinib as first-line treatment of EGFR-mutant NSCLC and a Phase 2 study of sac-TMT monotherapy or in combination with osimertinib as neoadjuvant therapy for EGFR-mutant NSCLC are in progress.

EGFR-wild type NSCLC:

• The Phase 3 registrational study of sac-TMT in combination with KEYTRUDA®^[1] (pembrolizumab) versus pembrolizumab as first-line treatment of PD-L1 positive NSCLC met its primary endpoint. This is the first Phase 3 clinical trial of ADC combined with immune checkpoint inhibitor to achieve its primary endpoint in the first-line treatment of NSCLC.
• In January 2026, sac-TMT in combination with pembrolizumab for the first-line treatment of PD-L1 positive NSCLC were granted Breakthrough Therapy Designation by the NMPA.
• The Phase 3 registrational study of sac-TMT in combination with pembrolizumab as first-line treatment of PD-L1 negative NSCLC is in progress.

Other indications: The company is actively exploring the potential of sac-TMT both as a monotherapy and in combination with other therapies for treating other solid tumors, including GC, EC, CC, OC, UC, CRPC, HNSCC, and TC, etc.

Trastuzumab botidotin (HER2 ADC, also known as A166, 舒泰莱^®)

• In October 2025, trastuzumab botidotin was approved for marketing by the NMPA for adult patients with HER2+ BC who have received one or more prior anti-HER2 therapy. This is the first domestically developed HER2 ADC approved for 2L+ HER2+ BC in China.
• An open, multicenter Phase 2 clinical study of trastuzumab botidotin in the treatment of HER2+ BC that previously received a topoisomerase inhibitor ADC is in progress.

Key Clinical Data Highlighted at International Academic Conferences and in Top Journals

• Results from the Phase 3 study of sac-TMT for the treatment of 2L EGFR-mutant NSCLC were selected for LBA and presented as an oral report in the Presidential Symposium session at the 2025 ESMO Congress. Sac-TMT achieved statistically significant and clinically meaningful improvements in ORR, PFS, and OS compared to chemotherapy. The study findings were published simultaneously online at the New England Journal of Medicine and in the first issue of 2026.
• Results from the study of sac-TMT for the treatment of 3L EGFR-mutant NSCLC were presented as an oral report at the ASCO Annual Meeting and published at the British Medical Journal. The final OS analysis of this study will be selected for LBA and presented as a mini oral report at the 2026 ELCC.
• Results from the Phase 3 study of sac-TMT for the treatment of 2L+ HR+/HER2-BC were selected for LBA and presented as an oral report at the 2025 ESMO Congress.
• Results from the Phase 3 study of trastuzumab botidotin for the treatment of 2L+ HER2+ BC were selected for LBA and presented as an oral report at the 2025 ESMO Congress.

Sustained Value Release of ADCs Under Development with Tiered Advancement of Innovation Pipeline

Phase 2 clinical stage

SKB315 (CLDN18.2 ADC):

• The Phase 1b clinical trial of SKB315 is in progress, for the treatment of GC/GEJC/PDAC, etc.
• Results of a Phase 1 study of SKB315 in patients with advanced solid tumors including GC/GEJC were presented at 2025 ESMO Congress in October 2025.

SKB410/MK-3120 (Nectin-4 ADC):

• Its partner MSD has launched 4 global Phase 1/2 clinical trial of SKB410/MK-3120 in advanced solid tumor including bladder cancer, etc.

SKB571/MK-2750 (novel bsADC): The Phase 2 clinical trial in China is ongoing.

SKB518 (novel ADC with a potential FIC target): The Phase 2 clinical trials are ongoing in China.

SKB500 (novel ADC): The Phase 2 study is ongoing in China.

Phase 1 clinical stage

SKB107 (RDC)^[2]: The Phase 1 study is ongoing.

SKB535/MK-6204 (novel ADC with potential FIC target): The Phase 1 clinical trial for SKB535 is ongoing in China.

SKB445 (novel ADC with potential FIC target): The Phase 1 clinical trials for SKB445 is ongoing in China.

SKB105/CR-003 (ITGB6 ADC): In January 2026, an IND application was approved by the CDE of NMPA for the treatment of advanced solid tumor. A Phase 1/2 trial is ongoing in China.

Strategic Layout of Non-DC Assets with Focus on Combination Therapy & Indication Expansion

Drug candidates for oncology

• Tagitanlimab (PD-L1 mAb, also known as A167) (科泰莱^®): In January 2025, the Company received marketing authorization of tagitanlimab used in combination with cisplatin and gemcitabine for the first-line treatment of NPC from NMPA. Tagitanlimab is the first PD-L1 mAb globally to receive authorization for the first-line treatment of NPC.
• In May 2025, the results of a Phase 3 clinical study of tagitanlimab in combination with cisplatin and gemcitabine for the first-line treatment of NPC were presented at the ASCO Annual Meeting.

Cetuximab N01 (EGFR mAb, also known as A140) (达泰莱^®):

• In February 2025, the Company received marketing authorization in China from the NMPA for Cetuximab N01 Injection used in combination with FOLFOX or FOLFIRI regimens for first-line treatment of RAS wild-type mCRC.

Lunbotinib Fumarate Capsules (RET inhibitor, also known as A400/EP0031)(宁泰莱^®)^[3]：

• An NDA was accepted for review by the CDE of the NMPA of China for the 1L+ treatment of RET-fusion positive NSCLC.
• The company is also conducting a Phase 1b/2 clinical study for RET+ MTC and solid tumor in China.
• Ellipses Pharma is progressing their phase 2 clinical study globally outside of China.
• In May 2025, results from the Phase 1 study of Lunbotinib Fumarate Capsules in patients with advanced RET-mutant MTC were presented at the ASCO Annual Meeting.

SKB118/CR-001 (PD-1/VEGF bsAb):

• In January 2026, Crescent Biopharma announced the regulatory clearance of the IND application for SKB118 by FDA to initiate its global ASCEND Phase 1/2 clinical trial for the treatment of advanced solid tumors, and the first patient has been dosed in February, 2026.
• The company is planning to initiate the Phase 1/2 clinical study for SKB118 in China in the first half of 2026.

Drug candidates for autoimmune diseases

SKB378/WIN378 (TSLP mAb):

• In January 2025, an IND application for SKB378 for the treatment of COPD was approved by the NMPA.
• Its collaboration partner, Windward Bio, has launched the Phase 2 POLARIS global trial in patients with asthma.

SKB575 (TSLP/undisclosed target bsAb): In March 2026, an IND application for SKB575 for the treatment of atopic dermatitis was approved by the NMPA.

Drug candidates for other non-oncology diseases

SKB336 (FXI/FXIa mAb): The company completed Phase 1 clinical trial in China.

Multiple Products First Included in National Reimbursement Drug List with Accelerated Market Coverage 

In 2025, the Company witnessed an explosive growth in the commercialization of its innovative achievements. The Company has also filed an NDA for Lunbotinib Fumarate Capsules and expects to commence its commercialization in the second half of 2026 or the first half of 2027, subject to regulatory communications and marketing approval. To date, the company’s initial commercial product portfolio, consisting of five products, has taken shape.

Supported by national innovation policies, the Company has successfully secured the first-time inclusion of three of its commercialized products, namely 佳泰莱^®, 科泰莱^® and 达泰莱^®, in the National Reimbursement Drug List (國家醫保藥品目錄), which officially took effect on January 1, 2026, and is expected to benefit more patients faster and better.

Steady Advancement of Global Collaboration and Comprehensive Strength Authoritatively Recognized

Collaboration with MSD: As at the date of this announcement, MSD is evaluating initiated 17 ongoing Phase 3 global clinical studies of sac-TMT as a monotherapy or with pembrolizumab or other agents for several types of cancer, including BC, LC, gynecological cancers, GI cancer and GU cancer. In addition to sac-TMT, the company is also collaborating with MSD on certain ADC assets to continuously explore favorable ADC pipeline portfolios.

Collaboration with Ellipses Pharma: The Company has deepened its collaboration with Ellipses Pharma on A400/EP0031, which has cleared by the FDA to progress into Phase 2 clinical development. As at December 31, 2025, a total of 39 clinical sites in the United States, Europe and UAE were set up for Lunbotinib Fumarate Capsules.

Collaboration with Windward Bio: In January 2025, the Company and Harbour BioMed had entered into an exclusive license agreement with Windward Bio, under which the Company and Harbour BioMed granted Windward Bio an exclusive license for the research, development, manufacturing and commercialization of SKB378/WIN378 globally (excluding Greater China and several Southeast and West Asian countries). Windward Bio has launched the Phase 2 POLARIS global trial in patients with asthma.

Collaboration with Crescent Biopharma. In December 2025, the company and Crescent Biopharma entered into a strategic collaboration for SKB105/CR-003 and SKB118 (a PD1 x VEGF bsAb, also known as CR-001). Under the collaboration, the company granted Crescent Biopharma exclusive rights to research, develop, manufacture and commercialize SKB105/CR-003 in the United States, Europe and all other markets outside of Greater China. In return, the compamy obtained exclusive rights from Crescent Biopharma to research, develop, manufacture and commercialize SKB118/CR-001 in Greater China.

In January 2026, Crescent Biopharma announced the regulatory clearance of the IND application for SKB118 by FDA to initiate its global ASCEND Phase 1/2 clinical trial for the treatment of advanced solid tumors, and the first patient has been dosed in February, 2026.

Continuous Improvement of ESG Capabilities to Consolidate the Foundation for Sustainable Development

Through the establishment and continuous improvement of the ESG governance structure, the Company comprehensively enhances ESG performance ability and ensures the Company’s sustainable development. In May 2025, the company was awarded “Best ESG” by Extel. In March 2026, the Company had received a rating of “AA” in the MSCI ESG Rating Assessment.

Outlook

In 2026, 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; innovating on and 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 business landscape and 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.

About Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (referred to as “Kelun-Biotech” Stock Code: 6990.HK) is a subsidiary of Sichuan Kelun Pharmaceutical Co., Ltd., specializing in the R&D, manufacturing, commercialization, and global collaboration of innovative biological drugs and small molecule drugs. The Company focuses on addressing unmet clinical needs both globally and in China, with a strategic emphasis on major disease areas such as oncology, autoimmune disorders, and metabolic diseases. It is dedicated to building an international platform for drug R&D and industrialization, with the aim of becoming a global leader in the innovative drug sector. Currently, Kelun-Biotech has over 30 key innovative drug projects, including 4 projects covering 8 indications that have received market approval, 1 project at the NDA stage, and more than 10 projects in clinical trials. The Company has also successfully established its internationally renowned proprietary ADC and novel conjugated drug platform, OptiDC^TM, with 2 ADC projects covering 5 indications approved for market launch, and several ADC or novel conjugated drug projects in clinical or preclinical development.

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