GSK's Hepatitis B Drug Wins First Approval in Japan

Huayuan Bio-tech announced that it has signed a Cooperation Agreement on the 25-Hydroxycholesterol New Drug R&D Project with Guangzhou National Laboratory. The two parties plan to establish a joint venture to advance the research and development, registration, production, and commercialization of 25-hydroxycholesterol and its prodrug-based broad-spectrum antiviral drugs. The joint venture will be led and operated by the company, which will hold no less than 51 percent of the shares. This cooperation marks the company's entry into the innovative drug R&D field, but the project is at an early stage and involves uncertainty.

SymBio Pharmaceuticals announced that it has begun consultations with the UK Medicines and Healthcare products Regulatory Agency toward obtaining conditional early marketing authorization in the UK for brincidofovir, which targets adenovirus infection following hematopoietic stem cell transplantation. The UK's conditional early marketing authorization scheme is a framework that grants early market access for medicines addressing unmet medical needs such as life-threatening diseases, even before comprehensive clinical data are available, when the confirmed benefits are judged to outweigh the risks; after approval, continued data collection and monitoring of safety and efficacy are mandatory. While advancing the process toward obtaining this approval, the company will also complete its global Phase III clinical trial, currently underway in the United States and Europe, as quickly as possible and focus on establishing evidence of high medical validity. As of September 17, 2026, the trial had enrolled 30 patients, with targets of 69 patients by the end of 2026 and 180 patients by the end of 2027. Brincidofovir is a compound for which the company acquired global rights in September 2019, and it is advancing development centered on three therapeutic areas: post-transplant viral infections, cancer, and neurodegenerative diseases. This matter will have no impact on the company's consolidated earnings forecast for the fiscal year ending December 2026.

RQ Bio has appointed Gavin Koh as Chief Medical Officer, strengthening its leadership as the company prepares to advance its lead influenza antibody candidate RQB01 into the clinic. Dr Koh brings 20 years of pharmaceutical drug development and infectious disease experience, having held senior roles at AstraZeneca and GSK, where he led programmes from discovery to registration and launch, including Evusheld during the COVID-19 pandemic. The appointment follows RQ Bio's $115 million, or £85.5 million, Series A financing announced in June 2026, which is supporting the clinical development of RQB01, currently in IND-enabling studies. RQ Bio also named Debra Nevin as Vice President, Head of CMC; Brad Norton as Vice President, Head of Clinical Operations; and Vicky Wheeler as Senior Director, Head of Programme Management. RQB01 is a long-acting antibody product designed to provide potent and broad protection against influenza across an entire season with a single administration for high-risk and immunocompromised populations.

Moberg Pharma AB announced the publication of new analyses demonstrating potent antifungal activity of terbinafine against dermatophytes causing onychomycosis, with mycological cure achieved with MOB-015 across the full range of baseline terbinafine susceptibility, including in patients with reduced in vitro susceptibility. The analyses are based on data from the previously completed North American Phase 3 study evaluating daily treatment with MOB-015 for 48 weeks, and included 506 dermatophyte isolates from onychomycosis patients. Only 3.2% of baseline isolates showed elevated MIC values of at least 0.5 micrograms per milliliter, and among MOB-015-treated patients with evaluable end-of-study results, 74.3% achieved mycological cure, including two of three patients with elevated baseline MIC values. The work was conducted in collaboration with Professor Mahmoud Ghannoum at Case Western Reserve University in Cleveland, Ohio, and the article, titled In Vitro Terbinafine Susceptibility of Dermatophytes and Mycological Cure Outcomes from a Multicenter Phase III Onychomycosis Trial, is published in Journal of Fungi, 2026, 12(10), 739. Amir Tavakkol, CSO of Moberg Pharma, said the results are encouraging, particularly given the increasing attention to antifungal resistance, and that the findings further strengthen the scientific foundation for MOB-015.

Lukang Pharmaceutical announced that the company has received the Drug Registration Certificate for Cefuroxime Sodium for Injection issued by the National Medical Products Administration, and the drug has been approved for registration. The drug is a Category 4 chemical medicine, with specifications including 0.75 grams and 1.5 grams. Cefuroxime is a cephalosporin antibiotic, and 46 domestic companies have currently passed consistency evaluation or obtained approval for generic drugs under the new registration classification. As of the disclosure date of the announcement, the company has invested approximately 2.79 million yuan in the research and development of this drug. The approval of this drug will enrich the company's formulation product line, but drug sales are subject to uncertainties due to factors such as policies and market conditions.