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OSAKA, Japan, January 8, 2026 – Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) announced that its group company, Shionogi China Co., Ltd. (Head Office: Shanghai, China; Chairman: Hirofumi Nagatome), has received approval from the National Medical Products Administration (NMPA) of China for cefiderocol (generic name: Cefiderocol Sulfate Tosylate for Injection; hereinafter “cefiderocol”) for the treatment of complicated urinary tract infections including pyelonephritis caused by Gram-negative bacteria.
This approval is based on positive results from an international multicenter clinical study¹ and a randomized, double-blind, multicenter study² conducted in China. In both studies, which aimed to verify non-inferiority to the comparator drug, cefiderocol demonstrated non-inferiority to imipenem/cilastatin and achieved the primary endpoint. Furthermore, no new safety concerns were identified, and cefiderocol was well tolerated.
Antimicrobial resistance (AMR) occurs when bacteria develop resistance to antibiotics, making infections harder to treat. AMR is often referred to as a “silent pandemic” and is recognized as one of the most pressing global public health threats requiring urgent action3. In 2021, AMR was estimated to have caused 1.14 million deaths worldwide4. Without coordinated international efforts, it is projected that more than 39 million lives could be lost over the next 25 years5. Meanwhile, treatment options remain limited, making this an area of high unmet medical need. With this approval, cefiderocol is expected to provide a new treatment option for patients in mainland China suffering from difficult-to-treat complicated urinary tract infections.
Shionogi has identified “Protecting people from the threat of infectious diseases” as a material issue and is committed to realizing total care for infectious diseases. We will continue to work toward delivering essential anti-infective treatments to patients worldwide as quickly as possible, contributing to global efforts to combat AMR. For more information on Shionogi’s initiatives against AMR, please visit.
Clich here to learn more about our efforts to address antimicrobial resistance.
About Cefiderocol
Cefiderocol is an antibiotic that penetrates the outer membrane of Gram-negative bacteria, including multidrug-resistant strains, to exert its antibacterial activity. As of December 2025, cefiderocol is marketed in 27 countries and regions, including Japan, Europe, U.S., Taiwan and China. It is listed on the WHO Model List of Essential Medicines, demonstrating its continued importance in improving outcomes for patients with some of the most difficult-to-treat Gram-negative infections. Prior to this approval, the Hainan Provincial Medical Products Administration had authorized its clinical use in the Boao Lecheng International Medical Tourism Pilot Zone in China6.
References
1. Press release: January 12, 2017
2. Chinese Clinical Trial Registry: Phase III clinical trial registration number CTR20223300
3. Antimicrobial Resistance Collaborators. Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis. Lancet 2022; 399: 629–55.
4. GBD 2021 Antimicrobial Resistance Collaborators. Global burden of bacterial antimicrobial resistance 1990-2021: a systematic analysis with forecasts to 2050. Lancet. 2024 Sep 28;404(10459):1199-1226. doi: 10.1016/S0140-6736(24)01867-1. Epub 2024 Sep 16. PMID: 39299261.
5. Antimicrobial resistance (who.int) WHO. Antimicrobial resistance. Who.int. Published October 13, 2020.
6. Press release: August 5, 2024
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 Website Inquiry Form: https://www.shionogi.com/global/en/contact.html
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12 Indian AI Start-ups, who have qualified for the AI for ALL: Global Impact Challenge in the India AI Impact Summit 2026, present their ideas and work
These Start-ups are working in a diverse set of areas like healthcare, multilingual LLMs, material research, data analytics, engineering simulations among others
Start-ups highlight the rapid growth and vast future potential of the AI sector and observe that the centre of gravity of AI innovation and deployment is beginning to shift towards India
Start-ups commended India’s strong commitment to advancing the artificial intelligence ecosystem
PM emphasises that startups and AI entrepreneurs are the co-architects of India’s future
PM suggests that Indian AI models should promote local and indigenous content and regional languages
PM emphasises the need to ensure that Indian AI models are ethical, unbiased, transparent, and based on data privacy principles
PM assures full government support for the success of their AI models
Prime Minister Shri Narendra Modi chaired the Roundtable with Indian AI Start-Ups at his residence at 7, Lok Kalyan Marg earlier today.
Ahead of the India AI Impact Summit 2026 to be held in India next month, 12 Indian AI start-ups who have qualified for the AI for ALL: Global Impact Challenge in the Summit attended the roundtable and presented their ideas and work.
These Start-ups are working in a diverse set of areas including Indian language foundation models, multilingual LLMs, speech-to-text, text-to-audio and text-to-video; 3D content using generative AI for e-commerce, marketing, and personalized content creation; engineering simulations, material research and advanced analytics for data-driven decision-making across industries; healthcare diagnostics and medical research, among others.
The AI Start-Ups commended India’s strong commitment to advancing the artificial intelligence ecosystem in the country. They highlighted the rapid growth and vast future potential of the AI sector, observing that the centre of gravity of artificial intelligence innovation and deployment is beginning to shift towards India. The leaders said that India now offers a robust and enabling environment for AI development, firmly placing the country on the global AI map.
During the meeting, Prime Minister highlighted the importance of artificial intelligence in bringing about transformation in society. He noted that India will host the India AI Impact Summit next month, through which the country will play a major role in the technology sector. He highlighted that India is making efforts to bring about a transformation with & leveraging AI.
Prime Minister emphasised that startups and AI entrepreneurs are the co-architects of India’s future and said that the country has immense capacity for both innovation and large-scale implementation. He added that India should present a unique AI model to the world that reflects the spirit of “Made in India, Made for the World.”
Prime Minister said that the world’s trust in India is the country’s biggest strength. He emphasised the need to ensure that Indian AI models are ethical, unbiased, transparent, and based on data privacy principles. He said startups should also work towards global leadership from India, and noted that India can promote affordable AI, inclusive AI, and frugal innovation globally. He also suggested that Indian AI models should be distinct and should promote local and indigenous content and regional languages.
The meeting was attended by CEOs, Heads and representatives of Indian AI start-ups including Avataar, BharatGen, Fractal, Gan, Genloop, Gnani, Intellihealth, Sarvam, Shodh AI, Soket AI, Tech Mahindra and Zenteiq. Union Minister for Electronics and Information Technology, Shri Ashwini Vaishnaw and Minister of State, Shri Jitin Prasada were also present during the meeting.
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