On August 18, 2025 Sichuan Kelun-Biotech Pharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company", Stock Code: 6990.HK) reported its unaudited interim results for the six months ended 30 June 2025 (the "Reporting Period") (Press release, Kelun, AUG 18, 2025, View Source [SID1234655363]).
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In the first half of 2025, China’s biopharmaceutical industry reached an inflection point for high-quality growth, driven by accelerated innovation in drug research and development, the rollout of favorable policies, increasing momentum in industry collaboration and mergers and acquisitions. Kelun-Biotech capitalized on these opportunities by its proprietary technology platforms, innovation-led R&D, and a well-established commercialization infrastructure. These elements have worked together to enable the Company to establish a fully integrated model covering R&D, clinical development, manufacturing, and commercialization.
Focusing on addressing significant unmet medical needs in both oncology (such as breast cancer (BC), non-small cell lung cancer (NSCLC), and gastrointestinal (GI) cancers including gastric cancer (GC) and colorectal cancer (CRC)) and non-oncology diseases, the Company has developed a rich and diverse pipeline of over 30 candidates. More than 10 of these candidates have already entered clinical stage. At the same time, the Company continues to invest in next-generation conjugation technologies and a diversified portfolio of assets, aiming to deliver innovative therapies for patients worldwide and contribute to the improvement of global healthcare.
ADC & novel DC assets breakthroughs are redefining the treatment landscape.
sac-TMT (sacituzumab tirumotecan, SKB264/MK-2870,佳泰萊)
The first TROP2 ADC drug approved for marketing in LC globally.
TNBC: Approved by the National Medical Products Administration ("NMPA") for the treatment of adult patients with unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies. The Company has initiated a Phase 3 registrational study of sac-TMT monotherapy versus investigator-choice chemotherapy for 1L advanced TNBC.
HR+/HER2- BC. In May 2025, the NDA for sac-TMT for the treatment of adult patients with unresectable locally advanced or metastatic HR+/HER2- BC who have received prior endocrine therapy and other systemic treatments in the advanced or metastatic setting was accepted by the NMPA, and was included in the priority review and approval process. A Phase 3 registrational study of sac-TMT versus investigator’s choice of chemotherapy for treatment of patients with unresectable locally advanced, recurrent or metastatic HR+/HER2- BC who received prior endocrine therapy 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 locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy. Sac-TMT monotherapy demonstrated a statistically significant and clinically meaningful improvement in ORR, PFS and OS compared with docetaxel. In addition, a Phase 3 registrational study of sac-TMT combined with osimertinib as first-line treatment of locally advanced or metastatic non-squamous EGFR-mutant NSCLC is in progress.
EGFR-wild type NSCLC. Two Phase 3 registrational studies of sac-TMT in combination with pembrolizumab are in progress. In June 2025, sac-TMT in combination with tagitanlimab was granted Breakthrough Therapy Designation by the NMPA for the first-line treatment of locally advanced or metastatic non-squamous NSCLC without actionable genomic alterations.
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 and HNSCC.
Global clinical development. As of August 18, 2025, MSD is progressing 14 ongoing Phase 3 global, multi-center clinical studies for sac-TMT for several types of cancer including BC, LC, gynecological cancer and GI cancer. The Company is also collaborating with MSD on several global Phase 2 basket studies for sac-TMT as monotherapy or in combination with other agents for multiple solid tumors and those studies are ongoing.
Trastuzumab Botidotin (HER2 ADC, A166, 舒泰萊[1])
In January 2025, an NDA for the treatment of adult patients with HER2+ unresectable or metastatic BC who have received at least one prior anti-HER2 therapy was accepted by the CDE of the NMPA.
Trastuzumab botidotin has met the primary endpoints of its pivotal Phase 2 trial for 3L+ and advanced HER2+ BC based on results from the primary analysis, and the NDA has been submitted to the NMPA.
The Company has initiated an open, multicenter Phase 2 clinical study of trastuzumab botidotin in the treatment of HER2+ unresectable or metastatic BC that previously received a topoisomerase 1 inhibitor ADC.
Other ADC Products
SKB315 (CLDN18.2 ADC): the company is conducting a Phase 1b clinical trial of SKB315 and have initiated the exploration in combination with immunotherapy for the treatment of GC/GEJC. Results of a Phase 1 study of SKB315 will be presented at 2025 ESMO (Free ESMO Whitepaper) Congress in October 2025.
SKB410/MK-3120 (Nectin-4 ADC): has shown promising Phase 1 clinical data. MSD, as the partner, has launched the global Phase 1/2 clinical trial of SKB410.
SKB571/MK-2750: a novel bsADC that primarily targets various solid tumors such as LC and CRC etc. being developed in collaboration with MSD. The Phase 2 clinical trial in China is to be initiated.
SKB518, SKB535/MK-6204 and SKB445: novel ADC drugs with potential FIC targets. The Phase 2 clinical trial for SKB518 and the Phase 1 clinical trials for SKB535 and SKB445 are ongoing in China. The Company has entered into a license and collaboration agreement with MSD to develop SKB535.
SKB500 and SKB501: novel ADC drugs with verified targets but differentiated payload-linker strategies. The company been received a clinical trial notice approving the IND application of SKB501 and SKB500, respectively, for advanced solid tumors from the NMPA.
SKB107: a RDC drug jointly developed by the Company and the Affiliated Hospital of Southwest Medical University (西南醫科大學附屬醫院) targeting bone metastases in solid tumors. In March 2025, an IND application for SKB107 was approved by the NMPA and the Phase 1 study is ongoing.
Non-DC asset advancements are diversifying the innovation pipeline.
Tagitanlimab (PD-L1 mAb; A167; 科泰莱):
The first PD-L1 mAb globally to receive authorization for the first-line treatment of NPC.
We have received marketing authorization of tagitanlimab in China from NMPA for the treatment of patients with recurrent or metastatic NPC who have failed after prior 2L+ chemotherapy. In January 2025, we received marketing authorization of tagitanlimab used in combination with cisplatin and gemcitabine for the first-line treatment of patients with recurrent or metastatic NPC in China from NMPA.
Cetuximab N01 (EGFR mAb; A140; 达泰莱)
An EGFR mAb compared with Cetuximab Solution for Injection (Erbitux)
In February 2025, we 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.
A400/EP0031 (RET inhibitor): The Company is currently conducting pivotal clinical studies for 1L & 2L+ advanced RET+ NSCLC as well as a Phase 1b/2 clinical study for RET+ MTC and solid tumor in China. Through the Company’s collaboration and license agreement, Ellipses Pharma is progressing their phase 2 clinical study globally outside of China.
SKB378/WIN378 (TSLP mAb): In January 2025, an IND application for SKB378 for the treatment of COPD was approved by the NMPA. The Company’s collaboration partner, Windward Bio, has launched the Phase 2 POLARIS trial in patients with asthma.
SKB336 (FXI/FXIa mAb): The Phase 1 clinical trial has been completed in China.
A296 (STING agonist): A Phase 1 trial is being carried out in China.
Commercialization Accelerates: Sales & Market Access Expanding Footprint
Sac- TMT (佳泰莱), tagitanlimab (科泰莱) and Cetuximab N01 (达泰莱) have been successively launched, marking the full-scale initiation of commercialization. The Company expects to launch trastuzumab botidotin (舒泰莱) in the China market and file one NDA for A400 in the second half of 2025.
Sales performance: The total commercial sales reached RMB309.8 million for the first half of 2025. Among them, the sales of sac-TMT (佳泰莱) accounted for 97.6%. At the same time, all accounts receivables from sales of pharmaceutical products were collected within the payment period, ensuring efficient and stable cash flow.
Market coverage and academic promotion: Currently, the company’s businesses have covered 30 provinces, over 300 prefectures, and over 2,000 hospitals, where over 1,000 hospitals generated sales, and reached tens of thousands of healthcare professionals through various types of marketing campaigns to convey product and medical professional information. In addition, the company has obtained authoritative endorsement for its products from experts in clinical guidelines, providing further support for the commercialization process.
Commercialization system: The Company has established a fully-fledged marketing team of over 350 people, with a departmental structure that includes marketing, sales, medical affairs, strategic planning and commercial excellence, among other departments, as well as marketing compliance and KA functions. Through the efficient execution of the marketing team, the company has established relationships with multiple leading commercial and distribution groups, including 60+ Tier 1 distributors and 400+ DTP pharmacies. A hierarchical management system for pharmacy retail has been adopted and trainings have been provided to around 4,500 pharmacists in the first half of 2025. By organizing nationwide pharmacy trainings, the company has significantly enhanced the professionalism of terminal services and improved the ability to provide patients with medication guidance.
Market access: In the first half of 2025, sac-TMT (佳泰莱), tagitanlimab (科泰莱) and Cetuximab N01 (达泰莱) have been included in 29, 25 and 15 provincial networks, respectively, ensuring rapid market access through provincial procurement channels. Meanwhile, preparations for the National Reimburesement Drug List (國家醫保藥品目錄) access of marketed products are underway. Currently, sac-TMT (佳泰莱), tagitanlimab (科泰莱) and Cetuximab N01 (达泰莱) have all passed the preliminary formal examination of National Reimbursement Drug List.
Meanwhile, to further reduce the burden of patients and implement the concept of inclusive healthcare, the company been proactively facilitating the enrollment of sac-TMT (佳泰莱) in provincial and prefecture city level Inclusive Insurance (惠民保). As at the end of the Reporting Period, sac-TMT (佳泰莱) has been enrolled in more than 7 provinces and 20 cities.
Global market: Globally, we will continue to pursue a flexible strategy to capture the commercial value in major international markets, through forging synergistic license and collaboration opportunities worldwide.
Global Collaboration Network Expansion & Authoritative Industry Recognition
In the first half of 2025, the Company continued to expand its global collaboration network and deepen partnerships. Working closely with collaborators, it is advancing clinical research worldwide with the goal of maximizing the global value of its pipeline, delivering high-quality medical solutions to patients, and strengthening its leading position in the biopharmaceutical sector.
Collaboration with MSD: As of the date of this announcement, MSD has initiated 14 ongoing Phase 3 global clinical studies of sac-TMT as monotherapy or in combination with pembrolizumab or other agents, for several types of cancer including BC, LC, gynecological cancer and GI cancer.
In addition to sac-TMT, the Company is also collaborating with MSD on certain ADC assets including SKB410/MK-3120, SKB571/MK-2750, SKB535/MK-6204, etc. 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 been cleared by the FDA to progress into Phase 2 clinical development. As of June 30, 2025, Ellipses Pharma had set up a total of 36 clinical sites in the United States, Europe and UAE for EP0031.
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).
In the first half of 2025, the Company earned high recognition from professional institutions and industry associations for its outstanding corporate management, product innovation, and strong performance in the capital market. In May 2025, the Company received "Asia’s Best Company" award from FinanceAsia (亞洲金融), as well as a series of awards from Extel, including "Most Honored Company", "Best Company Board", "Best CEO", "Best CFO", "Best ESG" and etc.. The Company was also awarded "IRM OF CHINESE LISTED COMPANIES" by Securities Times (證券時報). In July 2025, the Company was recognized with the "China Pharmaceutical Emerging Innovative Force Award" by the China National Pharmaceutical Industry Information Center (中國醫藥工業信息中心).
Additionally, the Company continues to strengthen its ESG strategy and improve its ESG governance structure to support sustainable development. The Company has established a comprehensive three-tier ESG governance structure consisting of the Board of Directors, ESG Working Group and ESG Executive Body. Through the establishment and continuous improvement of the ESG governance structure, the Company comprehensively enhances ESG performance ability.