Kelun-Biotech Secures License for Breakthrough Antibody SKB378

Kelun-Biotech Enters Partnership for SKB378 Monoclonal Antibody

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. has made significant strides in the field of immunology with its recent partnership with HBM Holdings Limited. This collaboration has resulted in an exclusive license agreement with Windward Bio AG for SKB378, a pioneering monoclonal antibody targeting anti-thymic stromal lymphopoietin (TSLP). This agreement underscores Kelun-Biotech's commitment to addressing severe immunological conditions, particularly in relation to respiratory diseases.

Details of the License Agreement

The License Agreement grants Windward Bio complete rights for the research, development, manufacturing, and global commercialization of SKB378, excluding certain regions. In exchange for these rights, Kelun-Biotech, along with Harbour BioMed, stands to receive up to $970 million through upfront and milestone payments, alongside a tiered royalty system based on net sales of the product.

Financial Dimensions

The initial payment of $45 million represents a combination of cash and equity in Windward Bio's parent company. The structure of this agreement allows for further financial benefits should Windward Bio undergo significant organizational changes or engage in sublicensing agreements with third parties. Payments under the agreement are to be equally distributed between Kelun-Biotech and Harbour BioMed.

Windward Bio’s Mission and Vision

Windward Bio is dedicated to enhancing treatment options for individuals facing severe immunological conditions. Their current focus includes the advancement of a top-tier TSLP monoclonal antibody into phase 2 clinical trials while developing innovative bispecific programs tailored for various immunological diseases. This talented team boasts substantial success, highlighted by 15 product launches and significant public offerings.

Funding to Propel Development

In conjunction with the licensing announcement, Windward Bio has initiated a $200 million Series A funding round. This financing is backed by notable investors such as OrbiMed and Novo Holdings, aiming to expedite the development of its groundbreaking therapies, including SKB378.

Understanding SKB378/HBM9378

SKB378 is jointly developed by Kelun-Biotech and Harbour BioMed, establishing a solid foundation of shared expertise. This novel fully human monoclonal antibody is designed to effectively bind with the TSLP ligand, thereby inhibiting the pathway associated with TSLP signaling. This mechanism can be particularly beneficial for patients with various inflammatory conditions, like asthma and chronic obstructive pulmonary disease (COPD).

Recent Clinical Developments

A research application for SKB378's use in treating COPD has been submitted to the National Medical Products Administration (NMPA), marking an important milestone in its regulatory journey. Additionally, a successful phase 1 clinical trial was conducted to assess its safety and efficacy among healthy subjects, paving the way for future advancements.

About Kelun-Biotech

Kelun-Biotech (6990.HK) operates as a subsidiary of Kelun Pharmaceutical (002422.SZ), dedicated to developing innovative biological and small molecule drugs. The firm emphasizes addressing significant health issues, including cancer and autoimmune diseases, by implementing a robust, global drug development model that meets the diverse medical requirements across various global markets. Currently, Kelun-Biotech is advancing over thirty innovative drug projects, two of which have progressed to marketing approval.

Innovative Platforms and Projects

Among their significant achievements is the establishment of the OptiDC™ platform, recognized for its leading role in the development of antibody-drug conjugates (ADCs). With one ADC product already approved and additional projects in various stages of research and development, Kelun-Biotech is well-positioned to make substantial contributions to the medical landscape.

Frequently Asked Questions

1. What is SKB378/HBM9378?

SKB378/HBM9378 is a monoclonal antibody developed to target TSLP, shown to be important in the treatment of inflammatory conditions like asthma and COPD.

2. Who are the partners involved in the license agreement?

The license agreement involves Sichuan Kelun-Biotech, HBM Holdings Limited, and Windward Bio AG.

3. What are the financial terms of the license agreement?

The agreement could yield up to $970 million in total, including upfront payments and royalties on net sales. Initial upfront payments are set at $45 million.

4. What are the future plans for SKB378?

Future plans include advancing SKB378 through clinical trials and expanding its use in treating various immunological conditions.

5. How is Kelun-Biotech positioned in the pharmaceutical industry?

Kelun-Biotech is recognized as a leader in innovative drug development, focusing on major disease areas and maintaining a solid pipeline of drug projects to cater to global health needs.

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