On April 17, 2025, Qpex and Shionogi celebrated the official opening of an expanded U.S.-based drug discovery laboratory in San Diego to support antimicrobial research and development (R&D) for decades to come. The expansion of Qpex’s capabilities as the first anti-infective drug discovery laboratory in the U.S. enhances both companies’ capabilities in antimicrobial research to address current and emerging infectious diseases.
Both Qpex and Shionogi have had success in antimicrobial R&D and in advancing new treatments to patients. Shionogi’s roots in anti-infectives date back to the 1950s while Qpex’s senior leadership brings more than 30 years of experience in antibiotic R&D, having advanced four anti-infective drugs to regulatory approval during the 2010s alone.
“These two companies, with solid histories of innovation, are now working together to continue their impressive efforts in addressing antibiotic resistance,” said Karen Bush, Ph.D., professor of practice emerita in biology (biotechnology) at Indiana University Bloomington, during her keynote speech. “Shionogi and Qpex have scientists who are able to look ahead — compare what is happening now with what they expect to happen in the future — and come forward with innovative drugs.”
Continued innovation in antibiotic discovery is needed.1 Clinicians across the U.S. are confronted with substantial antimicrobial-resistant infections, both in hospitals and in community settings.2 In 2022, antimicrobial-resistant pathogens were responsible for an estimated 570,000 cases of microbial infections among hospitalized patients in the U.S. out of about 31.7 million hospitalizations.2 Of the total estimated cases, 77 percent originated in the community and 23 percent in hospitals.2 Infections are the second leading cause of death among cancer patients.3 And the risk of infection-related death for a cancer patient is estimated to be nearly three times that of the general population.4
The need for new antibiotics is vital and the opening of this new R&D facility represents a pivotal moment for antimicrobial R&D in the U.S.
“One of the most tragic things for any of us is when we see someone who succumbs to an infection because we have not successfully, as a society, developed antibiotics to fight those sorts of infections,” noted the Honorable Paul Friedrichs, MD, retired Air Force major general; senior advisor, Center for Strategic and International Studies and adjunct professor of surgery, Uniformed Services University, in his address at the opening event. “And the projections of not having the right antibiotics to fight those infections are only going to increase over time.”
Fostering Innovation and Partnerships
In its 2019 report, the U.S. Centers for Disease Control and Prevention identified 18 pathogens as “antibiotic resistance threats” — all of which remain equally, if not more, dangerous six years later.1 “Not responding to these threats is risky for public health, with long-term repercussions,” said Isao Teshirogi, Ph.D., representative director, president and CEO, Shionogi & Co., Ltd. “At Shionogi, we’re constantly working to sustain interest and activity in anti-infective R&D that is so critical for the future of society.”
Small biotech companies like Qpex have been important for advancing new anti-infectives into clinical development.5 “Between 2010 and 2023, there were 19 anti-bacterial and anti-fungal agents that were approved in the U.S. by the FDA — 74 percent of these drugs advanced from the laboratory stage to the important stage of human testing while they were in small biotech companies like Qpex,” explained Michael N. Dudley, Pharm.D., president and CEO, Qpex Biopharma, Inc. “Most of these biotechs were based in California — a testament to the region’s talent and resources.”
Partnerships and collaboration between Qpex, Shionogi and other stakeholders across the U.S. will accelerate drug discovery and development. This theme was addressed convincingly by John Keller, Ph.D., Shionogi & Co., Ltd.’s senior executive officer, senior vice president, R&D Supervisory Unit and Pharmaceutical Technology Research Division.
“When we started this, we initially thought yes, this will be a U.S. base for our collaborative research,” Keller said. “It will also be a U.S. base for anti-infective work that will allow us to work with government, with universities, and with other venture and biotech organizations as part of an expanding collaborative network,” Keller added. “As strong as our commitment has been for many, many years in Japan — and we will always be committed to progress in effective infection disease medicines — we recognize that we can make it that much stronger and that much faster if we have this U.S. presence and capability.”
With this lab opening, Shionogi and Qpex will have more opportunities to partner with government, academia and research institutions across the country — strengthening U.S. efforts to address current and emerging pathogens, bolster bio-preparedness and advance innovation.
Antibiotic R&D Is a Team Sport
Invited guests were given a behind-the-scenes look at the new facility through guided tours that highlighted the collaborative process that occurs in a single facility of antibiotic drug discovery and advancement of new drugs into clinical studies.
Medicinal chemists provided an overview of the steps involved in conception, synthesis and purification of compounds for testing. Microbiologists explained the approach of testing compounds in assays to assess their activity against resistant pathogens with multiple drug resistance mechanisms. A critical step is building pharmacological properties into molecules that enable new drugs to be administered by the oral and intravenous route and understanding how quickly the body eliminates the drug. Guests were shown a hollow fiber infection model that Qpex scientists pioneered in the 1980s that is now part of routine preclinical testing of new antibiotics. Hollow fiber infection models allow for testing in a simulated human infection model to assess optimal dosage regimens for human testing. Finally, Qpex’s clinical team explained the important steps involved in human testing of a new antibiotic.
Impact on Patients and Medical Care: Innovation Needed
The urgency for new antibiotics is recognized by clinicians like John Bradley, MD, distinguished professor of pediatrics/infectious diseases, University of California San Diego. Dr. Bradley sees pediatric patients with complicated infections. “With children you can’t afford to miss it,” he explained. “I have a pact with parents that I’m going to do the absolute best I can — I don’t want to take chances.”
“If my research, teaching and community engagement have taught me one thing, it’s that the need for novel antimicrobial therapies is ever present,” said Jacinda Abdul-Mutakabbir, Pharm.D., MPH, assistant professor of clinical pharmacy, University of California San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences. “We must invest in innovation. We must foster collaborations between industry and academia to train the next generation of antimicrobial resistance researchers and changemakers.”
Clinicians like Drs. Bradley and Abdul-Mutakabbir underscore the need for new antibiotics. There are real patients, young and old, who could potentially benefit from these discoveries.
San Diego and California’s Biotech Ecosystem
There’s no question that California is a hotbed for innovation, with Silicon Valley and the Bay Area synonymous with transformative technological advancement, and San Diego is well-known as the third largest life sciences/R&D cluster in the country.6 It is a deeply attractive hub for entrepreneurs and biotech company founders. The location enables collaborations with nearby universities, dozens of world-renowned research institutions and U.S. government agencies.
Industry expert Patricia Cooper, executive director of the California Biotechnology Foundation, reminded guests that, “California is the home of innovation.” She also noted that California is the home of many Nobel laureates. She then commented that the life science ecosystem in the state has a $450B impact. Cooper offered her praise: “This beautiful new space here in San Diego is testament to how the winds of change can be positive. I honor the team here who is dedicated to addressing antibiotic-resistant bacteria and giving hope to patients and the doctors who treat them.”
Recognition of Japanese Heritage in a Cultural Ceremony
We were honored to welcome Shionogi’s global executive leadership, alongside U.S. scientific, clinical and biotech leaders, as well as elected officials, to celebrate the formal opening of our discovery laboratory in San Diego.
The event paid tribute to Shionogi’s Japanese heritage with a powerful taiko drum performance, and a traditional kagami-biraki ceremony. In this ritual, presided over by Dr. Teshirogi, the lid of a sake barrel was broken open by Qpex and Shionogi leaders, which was followed by a shared toast symbolizing “new beginnings and prosperity.” The celebration concluded under sunny skies with an official ribbon-cutting to mark this exciting new chapter.
With this new facility, Shionogi and Qpex will build on their past successes as leaders in antibiotic innovation, expanding their U.S.-based footprint and enhancing opportunities for partnership. We’re investing in the present and future by both addressing current and emerging pathogens, and training the next generation of scientific leaders in antimicrobial R&D.
Event Photography by J.T. MacMillan Photography.
References
- CDC. Antibiotic Resistance Threats in the United States, 2019. Atlanta, GA: U.S. Department of Health and Human Services, CDC; 2019. https://stacks.cdc.gov/view/cdc/82532. Accessed July 8, 2025. ↩︎
- Wolford H, McCarthy NL, Baggs J, et al. Antimicrobial-Resistant Infections in Hospitalized Patients. JAMA Network Open. 2025 Mar 14; 8(3): e2462059: 1-16. doi:10.1001/jamanetworkopen.2024.62059. ↩︎
- Gupta V, Satlin MJ, Yu KC, et al. Incidence and prevalence of antimicrobial resistance in outpatients with cancer: a multicentre, retrospective, cohort study. The Lancet Oncology. 2025 May; 26(5): 620-628. doi:10.1016/S1470-2045(25)00128-7. ↩︎
- Gupta V, Satlin MJ, Yu KC, et al. Burden of Antimicrobial Resistance in Adult Hospitalized Patients With Cancer: A Multicenter Analysis. Cancer Med. 2024 Dec;13(24):e70495. doi:10.1002/cam4.70495. ↩︎
- Hyun D. Pew Trusts. World Health Organization warns that antibiotic innovation still insufficient. The Pew Charitable Trusts. July 15, 2024. Available at: https://www.pewtrusts.org/en/research-and-analysis/articles/2024/07/15/world-health-organization-warns-that-antibiotic-innovation-still-insufficient. Accessed July 8, 2025. ↩︎
- CBRE. San Diego Market. Available at: https://www.cbre.com/insights/local-response/global-life-sciences-atlas-market-profiles-san-diego. Accessed July 8, 2025. ↩︎