Lukang Pharmaceutical Receives Drug Registration Certificate for Cefuroxime Sodium for Injection

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.

Lingkang Pharmaceutical announced that its wholly-owned subsidiary Hainan Lingkang Pharmaceutical has received the Drug Registration Certificate for Isavuconazonium Sulfate for Injection approved and issued by the National Medical Products Administration. The specification is 0.2 grams, the registration classification is Category 4 chemical drug, and it is deemed to have passed the consistency evaluation. The drug is indicated for the treatment of invasive aspergillosis and invasive mucormycosis infections in adult patients. The company first submitted the domestic drug registration application in December 2024 and it was accepted, with cumulative research and development investment of approximately 7.32 million yuan. The company stated that this approval marks its qualification for production and sales in the domestic market, further enriching its anti-infective product line and helping to enhance market competitiveness, but the launch and sales of the drug are still subject to uncertainties.

Gilead Sciences expanded the scope of its six royalty-free voluntary licensing agreements for lenacapavir on September 16 to cover an investigational once-yearly formulation for HIV pre-exposure prophylaxis. The expanded framework covers 120 high-incidence, lower-income countries and aims to accelerate manufacturing readiness and technology transfer during the ongoing Phase 3 PURPOSE 365 study. The move follows the efficacy shown by twice-yearly lenacapavir in the PURPOSE 1 and PURPOSE 2 trials, and Gilead is extending its global access strategy while clinical development continues. In the second quarter of 2026, Gilead's HIV product sales rose 12% year over year to $5.7 billion, led by Biktarvy at $3.8 billion, up 7%, and Descovy at $967 million, up 48%, while base product sales excluding Veklury grew 10% to $7.6 billion and quarterly operating cash flow reached $3.6 billion. Those gains were offset by a GAAP diluted loss per share of $(8.45) and a non-GAAP loss per share of $(6.75), reflecting $(9.08) per share in acquired in-process R&D charges totaling $11.2 billion tied mainly to the acquisitions of Arcellx, Tubulis, and Ouro Medicines, which helped cut cash, cash equivalents, and marketable securities to $3.2 billion from $10.6 billion at year-end 2025.

Eli Lilly & Co. will pursue slightly larger acquisitions, along the lines of its $7.8 billion purchase of Centessa Pharmaceuticals Plc, as it searches for assets in the "white spaces" of science, Chief Executive Officer Dave Ricks said. Lilly, now the world's largest pharmaceutical company, has been on a record spending spree funded by its weight-loss and diabetes shots, and Ricks told Bloomberg that reinvesting in human health is more attractive than buying back shares or issuing dividends. He pointed to infectious disease, women's health and psychiatric conditions as areas of opportunity, noting the company acquired three vaccine-makers for as much as $3.8 billion earlier this year and recently agreed to buy psychedelics firm AtaiBeckley Inc. for about the same price. Lilly has completed about 40 deals so far this year, with a total value of more than $20 billion, the highest ever in a single year according to Bloomberg-compiled data. Ricks said the company favors more mature assets when they address brand new problems, a shift from its historical focus on earlier-stage, cheaper drugs.