Shionogi, Inc

The report on the Antibiotic Resistance Therapeutics Market 2025-2029 highlights over 100 biotech companies, focusing on new technologies and drugs to combat antimicrobial resistance and superbugs. It identifies six key market opportunities and emphasizes the role of diagnostics in treatment strategies.

The report on the Antibiotic Resistance Therapeutics Market 2025-2029 highlights over 100 biotech companies, new technologies against antimicrobial resistance, and identifies six key market opportunities, emphasizing the role of diagnostics.

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.

ViiV Healthcare, a GSK subsidiary, received a positive opinion from EMA's CHMP for marketing authorization of a new long-acting HIV regimen, Vocabria with Rekambys, for adolescents. GSK also announced CHMP's recommendation for expanded use of Jemperli in endometrial cancer treatment and FDA's Breakthrough Therapy designation for Jemperli in rectal cancer.

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.