How Meiji Seika Pharma Aims to Lead Global Health With New Vaccines and Antibiotics

By Daniel de Bomford

Vaccine programs are a culmination of all that makes humanity exceptional. Hundreds of years of collective research, spanning dozens of disciplines, carried out by supply chains involving scores of people, result in life-preserving medicine in every corner of the globe. Whether it is a child in a remote African clinic or a Japanese salaryman at his local doctor’s office, it is a shared experience. The swab, the flutter of anxiety as the needle pierces the skin and the relief afterwards of knowing you’ll be a little stronger than you were this morning.

Meiji Seika Pharma Chairman Daikichiro Kobayashi has high hopes that the vaccines his company develops will be the ones administered in clinics both far away and close to home. The chairman states that vaccine coverage in certain parts of Asia and Africa is inadequate, and infectious diseases continue to pose a significant threat to human life. “If we can establish ourselves as the most trusted partner in these regions, that will be both a growth driver for our company and a meaningful contribution to global health,” he says.

Meiji Seika Pharma, a subsidiary of Meiji Holdings, is a Japanese pharmaceutical company that specializes in treatments for infectious diseases, vaccines, central nervous system drugs, and generic medications. Founded in 1946 with the production of penicillin, it now operates globally through subsidiaries such as those in Indonesia and Thailand, as well as Medreich in India. With its recent expansion into Taiwan, Meiji Seika Pharma is pursuing innovation in AMR therapies, universal influenza vaccines and global vaccine supply.

Fighting the Silent Pandemic of AMR

The chairman views antimicrobial resistance (AMR) as one of the most significant challenges facing the pharmaceutical industry and humanity. The number of patients remains low, but AMR is spreading steadily. “We see this as an urgent area for innovation,” he states.

Kobayashi is focusing on one of today’s most urgent health threats: bacteria that no longer respond to carbapenem antibiotics, which are often the last option for patients with severe infections. The World Health Organization now ranks Carbapenem-resistant Enterobacterales (CRE) as a “critical priority” for new drug development.

To address this, the company is developing nacubactam (OP0595), a new β-lactamase inhibitor. This drug is not an antibiotic itself but a helper medicine that restores the power of existing antibiotics like cefepime or aztreonam, making them effective again against resistant bacteria.

In a major Phase 3 clinical trial, patients with complicated urinary tract infections or kidney infections were treated with cefepime or aztreonam combined with nacubactam and compared to those receiving the carbapenem imipenem/cilastatin. Results showed that the nacubactam combinations were at least as effective as carbapenems, with cefepime plus nacubactam even showing superior results. Importantly, the side effects were similar across all treatments, with no major safety concerns.

The chairman notes that AMR is not only a public health issue, but also an economic issue. The cost of developing anti-AMR drugs is incredibly high, but these drugs are used as a limited treatment option to prevent newly emerging AMR. Due to this paradox, many large pharmaceutical companies have ceased investment and R&D efforts in countering AMR.

President Toshiaki Nagasato believes this is where the government needs to step in. “Just as with COVID-19, where governments funded vaccine development and stockpiled doses, we need similar mechanisms for AMR,” he says.

International Contributions of the Smallpox/Mpox Vaccine to Mpox Outbreaks

Meiji Seika Pharma is actively seeking opportunities to contribute to the control of ongoing mpox outbreaks through the use of its smallpox/mpox vaccine, LC16-KMB. This freeze-dried live-attenuated, minimally replicating smallpox vaccine was originally licensed in Japan in 1975. In 2022, its indication was expanded to include the prevention of both smallpox and mpox (monkeypox), in response to the first Public Health Emergency of International Concern (PHEIC) declared by the World Health Organization (WHO) for mpox.

In November 2024, the WHO granted Emergency Use Listing (EUL) status to LC16-KMB in response to the second PHEIC. Following a request from the government of the Democratic Republic of the Congo (DRC), the Japanese government donated LC16-KMB as humanitarian aid. The vaccine is currently being used in mass vaccination campaigns to help control the severe outbreak in the DRC.

Prior to 2022, mpox outbreaks were limited to small-scale occurrences in Africa, resulting in limited clinical data on vaccine efficacy against natural mpox infection. However, the current large-scale outbreak has prompted Meiji Seika Pharma to collaborate with a research consortium comprising both Japanese and international organizations to collect clinical effectiveness data on LC16-KMB in the DRC.

Meiji Seika Pharma is working toward obtaining WHO prequalification for LC16-KMB, which would facilitate wider global distribution. This effort is supported by updated data, including clinical evidence for mpox aligned with WHO requirements.

Currently, only Denmark’s MVA-BN and Japan’s LC16-KMB are widely available for mpox prevention under WHO-EUL or prequalification status. LC16-KMB may be particularly valuable because it can be administered to children aged one year and older, who are at higher risk of severe illness from mpox.

As several countries and organizations have expressed interest in procuring LC16-KMB, Meiji Seika Pharma is actively exploring opportunities for international contribution through the provision of this promising and practical vaccine.

Pushing the Boundaries of Vaccine Innovation

The pandemic was a transformative event for the pharmaceutical industry, and President Nagasato says that urgency has been ingrained in Meiji Seika Pharma’s response to infectious diseases. The company is actively pursuing research for a universal influenza vaccine with the same sense of urgency.

Nagasato sees influenza as the next looming threat. “Unlike COVID, where the spike protein was a clear target, influenza presents multiple antigens—hemagglutinin and neuraminidase—that change frequently, making it extremely difficult for vaccines to keep pace,” the president explains.

To overcome this challenge, Meiji Seika Pharma is investing in R&D and collaborating with global institutions, including in France and the United States.  “We believe these collaborations, alongside our own development programs, will help us prepare for the inevitable next pandemic threat,” the president says.

Targeting Dengue: A Global Health Threat

Meiji Seika Pharma is currently conducting a Phase 2 clinical study of its dengue vaccine candidate, supported by research funding from the Japan Agency for Medical Research and Development (AMED), the Strategic Center of Biomedical Advanced Vaccine Research and Development for Preparedness and Response (SCARDA), and the Ministry of Health, Labour and Welfare of Japan.

Dengue continues to spread across Asia, Central and South America and Africa. “An effective vaccine is urgently needed. Our candidate, KD-382, demonstrated strong immunogenicity and favorable safety/tolerability in a Phase 1 clinical study conducted in Australia. It is expected to become a best-in-class vaccine, capable of inducing well-balanced neutralizing antibody responses against all four dengue virus serotypes with a single dose,” says Nagasato.

Expanding Horizons in ASEAN, India and Africa

As Japan’s domestic market shrinks due to the aging population, Meiji Seika Pharma is looking to bolster its growth overseas. In the company’s sights are ASEAN, India and Africa. “Our focus is on high-growth regions where populations are expanding and healthcare spending is rising—particularly ASEAN, India and eventually Africa,” the chairman states.

Through its subsidiary, Meiji Farma, the company has maintained a presence in Thailand and Indonesia for more than 50 years. This longstanding footprint gives the company a strong base in the region. Furthermore, Meiji Seika Pharma is the sole owner of its Indian subsidiary, Medreich, which focuses on generic products. “India also provides an important platform for future expansion into Africa, including potential exports of our innovative drugs,” the chairman explains.

Currently, ASEAN and India are the company’s primary focus, with Africa as a longer-term frontier. With populations expected to grow in the regions for the foreseeable future, Kobayashi predicts their healthcare budgets will increase significantly, perhaps even tripling. “That combination of volume and value is where we expect to achieve sustainable overseas growth,” he states. With these new markets, the company aims to increase its overseas revenue share to over 30% percent in FY2026.

For both the president and the chairman, the company’s goals are clear: to establish Meiji Seika Pharma as a globally recognized leader in vaccines and treatments for infectious diseases. Experts in the R&D division are working diligently in laboratories around the world—collecting real-world data, conducting tests, refining processes and developing essential treatments for the future.

Perhaps the next global health crisis will be prevented thanks to Meiji Seika Pharma’s proactive approach to therapeutic development. The company aspires to ensure that, regardless of a patient’s location, its vaccines and medicines will be accessible to prevent and cure diseases—contributing to a healthier world for all.