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荃信生物-B(02509)与中美华东就QX005N的开发及潜在商业化合作订立合作协议

Quansheng Biotech-B (02509) has entered into a cooperation agreement with China-America East for the development and potential commercialization of QX005N.

Zhitong Finance ·  Jul 21 18:26

Quanxin Biology-B (02509) released an announcement. On July 19, 2024, the company reached a cooperation agreement with Huadong Medicine, its shareholder...

As reported by the Zhitong Finance APP, Quanxin Biology-B (02509) released an announcement. On July 19, 2024, the company entered into a cooperation agreement with China and the United States Huadong Medicine, a wholly-owned subsidiary (whose shares are listed on the Shenzhen Stock Exchange (stock code: 000963.SZ)), to grant exclusive and joint development rights to the targeted product in the authorized region and authorized field; exclusive market promotion rights; and priority rights to transfer the holding of the listing permit.

The targeted product QX005N is a monoclonal antibody (mAb) that blocks IL-4Rα. It has obtained 7 IND licenses and is suitable for atopic dermatitis, nodular prurigo, and chronic sinusitis with nasal polyps.

According to the cooperation agreement, China and the United States Huadong and the company will jointly carry out clinical and non-clinical research and registration-related work. If China and the United States Huadong exercise the selection right, it will be responsible for the marketing and promotion of the target product in the authorized area, while the company will be responsible for the supply and quality control of the target product and clinical trial samples. The target product and clinical trial samples will be produced by the company's indirectly owned subsidiary Saifushi.

The scope of cooperation includes clinical trials for the following indications: phase III clinical trials of adult atopic dermatitis (AD) and related extended treatment research; and phase III clinical trials of nodular prurigo (PN) and related extended treatment research. Development of other indications (including other indications that have obtained IND approvals and other potential new indications) will be carried out after discussion and unanimous agreement with JDC, and confirmed in writing by both parties.

The announcement stated that cooperation with a large pharmaceutical company with strong development and commercialization capabilities and sufficient clinical resources nationwide is in the best interests of the Group to accelerate the development of the targeted product. This is also in line with industry practices and brings commercial benefits to the Group, as cooperation with China and the United States Huadong is conducive to fully expanding the target product into multiple indications; accelerating the development progress of the existing phase III clinical trials of the target product and bringing more financial support to the Group; enhancing the future commercial potential of the target product. The cooperation agreement enables the Group to quickly establish an advantageous position in the relevant market using the resources and existing capabilities of China and the United States Huadong, and enhance the Group's long-term growth potential and overall competitiveness.

The translation is provided by third-party software.


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