Sunshine Biopharma Advances Lead Coronavirus Drug Candidate into IND-Enabling Studies

Gilead Sciences has reached an agreement with the Pan American Health Organization to expand access to its twice-yearly HIV-prevention drug lenacapavir across Latin America and the Caribbean, creating a regional procurement pathway for 14 countries including Brazil, Mexico, Argentina, Colombia and Peru that were outside Gilead's existing voluntary generic-licensing arrangements. Availability will still depend on individual countries' regulatory approvals and decisions to adopt the drug. Gilead expects lenacapavir to generate about $1 billion in 2026 sales, and reported 12% year-over-year HIV sales growth in the second quarter of 2026, with Yeztugo sales reaching $232 million, above the $210 million analyst estimate, after which the company raised its expected 2026 HIV-product sales growth to 9%-10%. Reuters reported that new HIV infections in Latin America and the Caribbean rose 13% between 2010 and 2024, and that lenacapavir demonstrated nearly 100% efficacy in large prevention trials, while Yeztugo carries a U.S. annual list price above $28,000. Gilead has already granted royalty-free voluntary licenses to generic manufacturers for resource-limited countries and is still discussing possible local production with Brazil's Health Ministry, so the expanded access may come with lower pricing and margins than in wealthier markets.

Chiome Bioscience announced that the results of joint research with a research group from the Infectious Pathology Division of the National Institute of Infectious Diseases at the National Center for Global Health and Medicine has been published in the international academic journal Protein Science. In the study, the researchers designed a unique antigen targeting influenza virus that utilizes molecular mimicry by anti-idiotype antibodies, and showed that it can induce antibodies in inoculated animals that react broadly to multiple types of the virus. Following the announcement, shares of Chiome Bioscience widened their gains in the afternoon session and are currently at 94 yen, up 6 yen from the previous day.

A federal appeals court ruled in favor of Gilead Sciences on August 13, upholding a preliminary injunction that bars the defendants from importing or facilitating the sale of foreign-market Gilead-branded medications in the United States. The US Court of Appeals for the Fourth Circuit found that the differences between Gilead's HIV medication for the US market and the foreign versions being imported were material, not theoretical. The dispute dates to December 2024, when Gilead sued third-party administrator Meritain Health, pharmacy benefit manager ProAct, and pharmacies Rx Valet and Advanced Pharmacy over illegal imports of its best-selling HIV drug Biktarvy, a case that arose after a patient in Maryland received the medicine by mail from Turkey with label instructions written in Turkish. A federal district court in Baltimore granted the preliminary injunction after finding Gilead likely to succeed on its Lanham Act trademark violation and unfair competition arguments, and the order was later expanded to include new sellers CanaRx, ElectRx, and ScriptSourcing. The Fourth Circuit rejected the defendants' central argument that the imported and domestic versions of Biktarvy are interchangeable, holding that the two differ materially not only in packaging and labeling but also in the quality-control protocols each version undergoes before reaching a patient. A Gilead representative called the decision a patient-safety victory, and patient advocacy groups that filed amicus briefs supporting the company praised the ruling in similar terms.