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Approval of Manufacturing and Marketing Approval for Synthetic Antibacterial Agent "Bactamini Combination Tablets"

Shionogi Pharma Co., Ltd. (Headquarters: Settsu City, Osaka Prefecture, President Ryuichi Kume, hereinafter "Shionogi Pharma") and the National Research and Development Agency The National Center for Child Health and Development (Location: Setagaya-ku, Tokyo, Chairman Takashi Igarashi, hereinafter referred to as "National Center for Child Health and Development") is a synthetic antibacterial agent "Bactamini ® Combination Tablets" (generic name: sulfamethoxazole / trimethoprim preparation). We are pleased to inform you that Shionogi Pharma has obtained manufacturing and marketing approval 1 for (hereinafter referred to as "this drug") on August 16.

 Bacta® combination tablets are synthetic antibacterial agents for the indications of "general infectious diseases" and "treatment and suppression of the onset of pneumocystis pneumonia". So far, for the diameter of the Bhakta ® Combination Tablets of the bitterness of the size and the drug substance that 11mm of, there was a problem that patients of the children and elderly are shown a resistance to the medication 2 .

 This drug is a tablet in which the diameter of one tablet is reduced to 6 mm for the purpose of improving medication compliance and a sweetener is added for the purpose of reducing bitterness. Shionogi Pharma, National Center for Child Health and Development, Shionogi Pharmaceutical Co., Ltd. Developed by three parties (Headquarters: Chuo-ku, Osaka, President: Isao Teshirogi) 1 . When a patient takes 4 tablets of this drug, it is equivalent to 1 conventional tablet.

 Through this drug, Shionogi Pharma and the National Center for Child Health and Development will reduce the resistance of pediatric and elderly patients to taking Bacta® combination tablets and contribute to the appropriate treatment of the indicated diseases. .. Shionogi Pharma plans to launch this drug immediately after it is listed in the NHI price standard.

About Shionogi Pharma Co., Ltd.

 Shionogi Pharma started its business on April 1, 2019 with the mission of becoming a "technology development type manufacturing company (CDMO 3 )" trusted by customers . We will continue to meet the needs of our stakeholders and aim to contribute to society by creating new solutions.

About the National Center for Child Health and Development

 It was established in 2002 by integrating the National Okura Hospital and the National Children's Hospital. Our philosophy is to promote medical care and research to foster a healthy next generation by uniting hospitals and research institutes.

The National Center for Child Health and Development Hospital is Japan's largest hospital specializing in pediatric, perinatal, obstetrics, and maternal care. (Number of beds: 490 beds, outpatient (daily average) about 1000) A comprehensive process of growing and developing from a foetation to newborns, infants, toddlers, school children, adolescents, and adults, and then nurturing generations. In addition, we provide continuous medical care = "growth medical care".

In addition, we are conducting research to elucidate and overcome the etiology and pathophysiology, and propose the ideal way of society to nurture a healthy next generation.

reference:

1. August 28, 2020 Press Release: Notice of application for manufacturing and marketing approval for additional small tablet form of synthetic antibacterial agent "Bacta ® Combination Tablets"

2. Journal of Japanese Society of Pediatric Clinical Pharmacology Vol. 32, No. 1, 2019 114-119

3. Contract Development Manufacturing Organization

[Contact]

Shionogi Pharma Co., Ltd. CDMO Division Pharmaceutical Sales

TEL: 06-6381-7402 FAX: 06-6381-5960

National Center for Child Health and Development Public Relations Planning Office

TEL: 03-3416-0181 (Representative) E-mail: [email protected]