April 11, 2022

Marketing Authorization Application ofPertussis, Diphtheria, Tetanus, Inactivated Polio and Hib
Combined Vaccine (BK1310/MT-2355)
The Research Foundation for Microbial Diseases of Osaka University(Headquarters: Suita City, Osaka; Director General: Koichi Yamanishi; hereafter,“BIKEN”) and Mitsubishi Tanabe Pharma Corporation (Head Office: Chuo-ku,Osaka; Representative Director: Hiroaki Ueno; hereafter, "MTPC") announced that
BIKEN submitted today to the Ministry of Health, Labour and Welfare anapplication for marketing authorization of combination vaccine (BIKEN
Clinical Trial Code: BK1310, MTPC Clinical Trial Code: MT -2355) for
prophylaxis of pertussis, diphtheria, tetanus, acute poliomyelitis (polio) andHaemophilus influenzae type b (Hib), which they have jointly developed.
This vaccine combines TETRABIK (Adsorbed Diphtheria-purified Pertussistetanus-inactivated polio [Sabin strain] Combined Vaccine) with Hib vaccine. The
combination vaccine for five diseases has been selected as one of the vaccineswith high development priority according to the “National Immunization Plan”
stipulated in 2014. At present, the total number of shots of routine vaccinations
required by two years old is twenty or more, and combination vaccines will reduce
the number of shots and the burden on infants and guardians.
BIKEN and MTPC will continue to contribute to the prevention of various
infectious diseases and the health of people around the world through themanufacture and stable supply of vaccines and therapeutic drugs.
◆Contact information
Public Relations Section, The Research Foundation for Microbial Diseases ofOsaka University

TEL: 06-6877-4802

Mitsubishi Tanabe Pharma Corporation (Mitsubishi Chemical Holdings Group,Corporate Communications Div., Osaka Corporate Communications Dept.)TEL: 06-6205-5119

1◆Please refer to the following URL for the infections to be prevented with pertussis,
diphtheria, tetanus, inactivated polio and Hib combined Vaccine.
https://www.cdc.gov/vaccines/parents/diseases/index.html◆Research Foundation for Microbial Diseases of Osaka University
The BIKEN is a Specialty Bio-Pharmaceutical Organization engaged in theResearch, Development and Supply of Vaccines. Since its establishment in 1934,
BIKEN has contributed to public health by developing, manufacturing and supplying
a number of first vaccines made in Japan and providing advanced laboratory testservices. Based on its mission "Protect the precious lives of people around the world
through excellent vaccines." the BIKEN will continue to pursue the advancement ofadvanced science and unique biotechnology toward a healthy society free from
disease anxiety. https://www.biken.or.jp/english◆About Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma Corporation (MTPC), the pharma arm of Mitsubishi
Chemical Holdings Group (MCHC Group), is one of the oldest pharmaceuticalcompanies in the world, founded in 1678, and focusing on ethical pharmaceuticals.
MTPC is headquartered in Doshomachi, Osaka, the birthplace of Japan’s
pharmaceutical industry. The MCHC Group has positioned Health Care as its
strategic focus in its management policy, “Forging the future”. MTPC set theMISSION of “Creating hope for all facing illness”. To that end, MTPC is prioritizing
work on “precision medicine” to provide drugs with high treatment satisfaction byidentifying patient populations with high potential for efficacy and safety, focusing
on the disease areas of central nervous system and immuno-inflammation. Inaddition, MTPC is working to develop “around the pill solutions” to address specificpatient concerns based on therapeutic medicine, including prevention of diseases,
pre-symptomatic disease care, prevention of aggravation and prognosis. For more
information, go to https://www.mt-pharma.co.jp/e/2