Kelun-Biotech and Harbour BioMed Announce NMPA Approval of IND Application for SKB575/HBM7575 for the Treatment of Asthma

Kelun-Biotech and Harbour BioMed Announce NMPA Approval of IND Application for SKB575/HBM7575 for the Treatment of Asthma

CHENGDU, China, July 15, 2026 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company", 6990.HK) and Harbour BioMed (HKEX: 02142) today announced that the National Medical Products Administration (NMPA) of China has approved the Investigational New Drug (IND) application for SKB575/HBM7575, a long-acting bispecific antibody targeting thymic stromal lymphopoietin (TSLP) and an undisclosed target co-developed by the two parties, for the treatment of asthma. Previously, the first participant has been dosed in a Phase I clinical study of SKB575/HBM7575 for the treatment of atopic dermatitis.

Asthma is a chronic respiratory condition affecting approximately 300 million people worldwide, with prevalence continuing to rise. Despite the availability of treatment options, many patients experience persistent symptoms, frequent exacerbations, and reduced quality of life. Current therapies - mainly inhaled corticosteroids (ICS) and bronchodilators - are inadequate for some patients, underscoring the urgent need for more effective, long-acting treatments that address the underlying disease mechanisms.

Dr. Michael Ge, CEO of Kelun-Biotech, stated: "With the company's active efforts, SKB575/HBM7575 has initiated clinical trials for two chronic immune‑mediated diseases, atopic dermatitis and asthma. As a differentially designed and engineered bispecific antibody, SKB575/HBM7575 is expected to achieve potent inflammation control and broad patient coverage through its dual-target synergistic mechanism, whilst offering convenient administration. We will vigorously advance the development of this drug to fully realize its clinical value." 

About SKB575/HBM7575
SKB575/HBM7575 is a long-acting bispecific antibody targeting TSLP and an undisclosed antigen, with a dual mechanism of action. On one hand, by blocking the interaction between TSLP and its receptor, it inhibits TSLP-mediated signaling pathways and the activation of Th2 immune cells. On the other hand, binding to and blocking the undisclosed target generates a synergistic effect, with the potential to achieve broader control of inflammation compared to single-target approaches. SKB575/HBM7575 has been engineered to allow for longer dosing intervals and a convenient subcutaneous route of administration. Based on preclinical half-life data, the anticipated human half-life is expected to support dosing intervals of more than three months, positioning it as a potential best-in-class therapy.

According to the collaboration agreement between the Company and Harbour BioMed, SKB575/HBM7575 is led by Kelun-Biotech in its design, global development and commercialization, with Harbour BioMed participating in the investment and development of this asset and sharing the benefits as agreed.

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, inflammatory, 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, 1 project is 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/.

About Harbour BioMed
Harbour BioMed (HKEX: 02142) is a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology and oncology. The company is building a robust and differentiated pipeline through internal R&D capabilities, strategic global collaborations in co-discovery and co-development, and selective acquisitions.

Harbour BioMed's proprietary antibody technology platform, Harbour Mice^®, generates fully human monoclonal antibodies in both the conventional two heavy and two light chain (H2L2) format and the heavy chain-only (HCAb) format. Building upon HCAb antibodies, the HCAb-based immune cell engagers (HBICE^®) bispecific antibody technology enables tumor-killing effects that traditional combination therapies cannot achieve. Additionally, the HCAb-based bispecific immune cell antagonist (HBICA^TM) technology empowers the development of innovative biologics for immunological and inflammatory diseases. By integrating Harbour Mice^®, HBICE^®, and HBICA^TM with a single B-cell cloning platform, Harbour BioMed has built a highly efficient and distinctive antibody discovery engine for developing next-generation therapeutic antibodies. For more information, please visit http://www.harbourbiomed.com/.

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SOURCE Kelun-Biotech