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Shionogi|盐野义制药·· 首次发现 2026-10-06 11:08(香港时间)重要性评分40

盐野义与CEOLIA签署Actair®日本上市许可及销售业务转让协议

Transfer of Marketing Authorization and Sales Operations for the Allergen Immunotherapy treatment Actair® in Japan

AI 导读

盐野义与CEOLIA达成协议,将Stallergenes Greer旗下过敏免疫治疗片剂Actair®在日本的上市许可和销售业务转让给CEOLIA。上市许可预计2026年12月完成转移,销售业务预计2027年2月移交。该产品用于屋尘螨过敏原引起的过敏性鼻炎,CEOLIA自2025年7月3日起已在日本负责推广。

正文

Osaka (Japan), Tokyo (Japan), October 6, 2026 – Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi; hereinafter, “Shionogi”) and CEOLIA Pharma Co., Ltd. (Head Office: Chuo-ku, Tokyo, Japan; President and Representative Director: Tetsuya Sugimoto; hereinafter, “CEOLIA”) announce that Shionogi and CEOLIA have entered into an agreement regarding the transfer of the marketing authorization and sales operations for Actair®, Stallergenes Greer’s allergen immunotherapy tablet.

Under a license agreement entered into between Shionogi and Stallergenes Greer in 2010, Shionogi has obtained the marketing authorization for Actair® in Japan and has been responsible for its promotion and distribution. Since July 3, 2025, CEOLIA has been promoting the product in Japan, while Shionogi, as the marketing authorization holder, has been responsible for ensuring its stable supply.1

Following the execution of this agreement, the transfer of the marketing authorization for Actair® from Shionogi to CEOLIA is expected to take place in December 2026, followed by the transfer of sales operations from Shionogi to CEOLIA in February 2027. Shionogi and CEOLIA will continue to work together to ensure that Actair® is appropriately provided to patients suffering from allergic rhinitis caused by house dust mite allergens.

ABOUT Shionogi

Shionogi has identified “Contributing to a Healthy and Prosperous Life” as one of its key material issues. The group is committed to building a society where everyone can live vibrantly and true to themselves. With a continued focus on areas of high unmet medical needs, Shionogi strives to deliver innovative treatments that improve the quality of life (QOL) for patients and their families.

For more information, visit Shionogi & Co., Ltd.

ABOUT CEOLIA

CEOLIA is a specialty company dedicated to serving diverse healthcare needs in the otolaryngology (ENT) field. With the philosophy to pursue medical needs and contribute to human health and happiness, we develop, manufacture and market ethical drugs, medical devices, and diagnostic reagents, with a focus on the ENT field.

For more information, visit https://www.ceolia.co.jp/en/

References

1.      Press release on July 3, 2025

TRANSITION OF PROMOTIONAL ACTIVITIES FOR ALLERGEN IMMUNOTHERAPY DRUG ACTAIR IN JAPAN

Forward-Looking Statements

This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, lack of availability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.

For Further Information, Contact

Shionogi

SHIONOGI Website Inquiry Form: www.shionogi.com/global/en/contact

CEOLIA

Tel: +81 3 3243 1135

CEOLIA Website enquiry form: www.ceolia.co.jp/en/contact/enquiry_form

来源:Shionogi|盐野义制药 · shionogi.com