Shionogi, Inc

Ildong Pharmaceutical will resubmit its COVID-19 treatment candidate Ensitrelvir's product approval application, incorporating data from Shionogi's SCORPIO-PEP trial on preventive efficacy, aligning with Shionogi's global strategy.

Nxera Pharma and Shionogi announce the launch of QUVIVIQ™ (daridorexant) in Japan for adult insomnia treatment. Nxera holds approval and Shionogi handles distribution. This milestone underscores Nxera's commitment to novel therapeutics for the Japanese market.

QUVIVIQ™ (daridorexant), a dual orexin receptor antagonist, achieved positive Phase 3 results in Japanese insomnia patients in 2022. Approved in the US, Europe, and Canada, it received Japanese manufacturing and marketing approval in 2024. Insomnia, defined by persistent sleep difficulty impacting daytime functioning, affects 20% of Japanese adults. Treatments aim to improve sleep quality and daytime functioning. Shionogi focuses on healthcare solutions, while Nxera Pharma develops new medicines for unmet needs.

GSK announced that ViiV Healthcare, with Pfizer and Shionogi as shareholders, received a positive CHMP opinion for Vocabria in combination with J&J's Rekambys for treating HIV-1 in adolescents.

Nxera Pharma initiated a phase 3 trial in South Korea to evaluate daridorexant for insomnia, aiming to meet regulatory requirements. Daridorexant, already approved in Japan (marketed as Quviviq) and other regions, seeks additional data for South Korea's approval, with results expected in early 2026.

Nxera's daridorexant, a dual orexin receptor antagonist, is in a Phase 3 trial for insomnia in South Korea, with results expected in 1H 2026. Daridorexant 25mg and 50mg were approved in Japan in September 2024 and are expected to launch as QUVIVIQ™ in Q4 2024.

India's new drugs aim to combat antibiotic-resistant superbugs, with Enmetazobactam and Zaynich showing promise. Antibiotic resistance caused 1.14 million deaths globally in 2021, with India facing significant challenges. Innovative drugs and better prescription practices are crucial to address this growing threat.

Shionogi announced that its Phase 3 study, SCORPIO-PEP, met its primary endpoint. Ensitrelvir significantly reduced symptomatic SARS-CoV-2 infection in household contacts compared to placebo, with no new safety concerns.

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Despite 16 new antibacterial drugs approved since 2017 and 97 more in development, superbugs continue to evolve faster than treatments can be developed. Organizations like CARB-X are funding unconventional approaches, including phage therapy and synthetic antimicrobials, to combat antimicrobial resistance. However, the lack of private investment and slow legislative action hinder progress, emphasizing the urgent need for increased funding and recognition of the threat posed by superbugs.