<div id="readability-page-1"><div>         <div>                                                                  <p>,  /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (&#34;Kelun-Biotech&#34; or the &#34;Company&#34;, 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 atopic dermatitis.</p> <p>Atopic dermatitis is a chronic, inflammatory skin disease characterized by persistent itching, redness, and irritation. It affects around 20% of children and up to 10% of adults worldwide<sup>[1]</sup>. Though not infectious, atopic dermatitis has a profound impact on patients' quality of life due to its cyclical nature of flare-ups and remissions. Current treatments, including topical corticosteroids, biologics, and Janus kinase (JAK) inhibitors, provide symptomatic relief for many patients, but often fail to deliver sustained disease control, especially in moderate-to-severe cases. Therefore, there is an urgent need for safer, more effective, and durable treatments that address underlying disease mechanisms and improve long-term outcomes.</p> <p>Dr. Michael Ge, CEO of Kelun-Biotech, stated: &#34;We are delighted to see the approval of SKB575/HBM7575 for clinical trials in atopic dermatitis. This marks an important milestone in our strategic expansion in the field of autoimmune diseases and holds promise for offering a novel therapeutic option to patients with atopic dermatitis. As a bispecific antibody with a differentiated innovative mechanism and a long-acting profile, SKB575/HBM7575 holds the potential to deliver durable and stable disease control while improving patient treatment experience through reduced dosing frequency.&#34;</p> <p>Dr. Jingsong Wang, Founder, Chairman, and CEO of Harbour BioMed, commented: &#34;The NMPA's IND approval for HBM7575/SKB575 marks an important step forward in addressing the significant unmet needs in autoimmune diseases such as atopic dermatitis. By targeting TSLP, a key upstream driver of type 2 inflammation, and an undisclosed target, HBM7575/SKB575 has the potential to be a best-in-class bispecific antibody for this disease. We look forward to advancing this investigational therapy through clinical development and believe its long-acting profile may offer a differentiated treatment option for patients worldwide.&#34;</p> <div>  <div>   <div>    <div><p><span><sup>[1]</sup> https://www.atopicdermatitisatlas.org/en/atopic-dermatitis/how-common-is-atopic-dermatitis</span></p></div>   </div>  </div> </div> <p><b>About SKB575/HBM7575</b></p> <p>SKB575/HBM7575 is a long-acting bispecific antibody targeting thymic stromal lymphopoietin (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, overcoming resistance issues associated with TSLP single-target antibodies. SKB575/HBM7575 has been engineered to possess an extended half-life and favorable developability, enabling subcutaneous 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.</p> <p>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.</p> <p><b>About </b><b>Kelun-Biotech</b></p> <p>Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical, which focuses on the R&amp;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/.</p> <p><b>About Harbour BioMed</b></p> <p>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&amp;D capabilities, strategic global collaborations in co-discovery and co-development, and selective acquisitions.</p> <p>Harbour BioMed's proprietary antibody technology platform, Harbour Mice<sup>®</sup>, 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<sup>®</sup>) bispecific antibody technology enables tumor-killing effects that traditional combination therapies cannot achieve. Additionally, the HCAb-based bispecific immune cell antagonist (HBICA<sup>TM</sup>) technology empowers the development of innovative biologics for immunological and inflammatory diseases. By integrating Harbour Mice<sup>®</sup>, HBICE<sup>®</sup>, and HBICA<sup>TM</sup> 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 www.harbourbiomed.com.</p> <p>SOURCE Kelun-Biotech</p> <p><img src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwMzA5Jk5ld3NJdGVtSWQ9Q04wNTI3MCZUcmFuc21pc3Npb25fSWQ9MjAyNjAzMDkwNjQ3UFJfTkVXU19VU1BSX19fX19DTjA1Mjcw?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" original-src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwMzA5Jk5ld3NJdGVtSWQ9Q04wNTI3MCZUcmFuc21pc3Npb25fSWQ9MjAyNjAzMDkwNjQ3UFJfTkVXU19VU1BSX19fX19DTjA1Mjcw"/></p></div>       </div></div>

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<p>Sichuan Kelun-Biotech and Harbour BioMed announced that the National Medical Products Administration (NMPA) of China has approved their IND application for SKB575/HBM7575, a bispecific antibody for treating atopic dermatitis. This innovative therapy targets thymic stromal lymphopoietin (TSLP) and aims to provide durable disease control with reduced dosing frequency. The approval marks a significant milestone in addressing unmet needs in autoimmune diseases, with both companies optimistic about advancing this treatment through clinical development.</p>

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06:47 ETKelun-Biotech and Harbour BioMed Announce NMPA Approval of IND Application for SKB575/HBM7575 for the Treatment of Atopic Dermatitis