Dupilumab

Keymed Biosciences Inc. (HKEX: 02162) has licensed its approved IL-4Rα monoclonal antibody stapokibart (Kangyueda) to Singapore-based Aeira Pte. Ltd. for marketing registration and commercialization across 18 countries and regions in Southeast Asia and Central Asia — extending the drug's geographic footprint beyond China for the first time under a dedicated regional partner. Under the agreement, Aeira takes on full responsibility for registration filings and commercialization across 11 Southeast Asian markets including Indonesia, Vietnam, Thailand, Malaysia and the Philippines, five Central Asian countries, and the Hong Kong and Macao special administrative regions. Keymed retains manufacturing and product supply obligations. Financial terms were not disclosed, though the announcement confirms an upfront payment, country-level regulatory approval milestones, commercialization milestones, and royalties described as up to a "high double-digit percentage" of net sales in the licensed territory. The deal is structured as a pure commercialization license on an already-approved asset rather than a development partnership — a structurally distinct transaction type from Keymed's larger Western-market deals. Stapokibart received China's National Medical Products Administration (NMPA) approval for moderate-to-severe atopic dermatitis in September 2024, for chronic rhinosinusitis with nasal polyposis in December 2024, and for seasonal allergic rhinitis in February 2025. Phase III data for the allergic rhinitis indication were subsequently published in Nature Medicine. Stapokibart targets the IL-4Rα subunit shared by the IL-4 and IL-13 receptor complexes, blocking both cytokine pathways simultaneously. The same mechanism underlies dupilumab (Dupixent, Sanofi/Regeneron), the established global market leader across multiple type 2 inflammatory indications. Stapokibart is the first domestically manufactured IL-4Rα antibody approved by the NMPA, according to Keymed. The Aeira deal follows a pattern of geographically segmented out-licensing that Keymed has pursued with accelerating frequency. In January 2025, Keymed and InnoCare Pharma jointly licensed the CD20×CD3 bispecific antibody ICP-B02 to Prolium for global ex-Asia rights, with a combined upfront and near-term payment of USD 17.5 million and up to USD 502.5 million in potential milestones. That same month, Keymed's anti-CD38 monoclonal antibody CM313 was licensed to Timberlyne Therapeutics for global ex-Greater China rights, anchored by a USD 180 million Series A. Both transactions involved purpose-built entities receiving broad geographic rights. Aeira was incorporated in May 2026, only months before the stapokibart agreement, raising the possibility that it represents a similar NewCo-style structure, although its ownership, financing, and relationship to Keymed have not been publicly disclosed. Spot something wrong? Report an issue with this article

GSK is looking to expand its COPD biologics franchise beyond IL-5 blockade, kicking off two Phase III studies of its long-acting anti-TSLP antibody felcorekibart (GSK5784283/AIO-001). Sanofi and Regeneron's IL-4/IL-13 inhibitor Dupixent (dupilumab) and GSK's IL-5 inhibitor Nucala (mepolizumab) are currently the only approved biologics for the condition. Earlier this year, CEO Luke Miels singled out felcorekibart as one of the pipeline programmes that could help GSK raise its game (see – Spotlight On: GSK's new CEO urges company to deliver 'more competitive products'). The programme, acquired through GSK's 2024 takeout of Aiolos Bio for $1 billion upfront, will be tested in the PERSIST COPD-1 and PERSIST COPD-2 studies. Each will enrol 624 patients with moderate to very severe COPD to assess whether felcorekibart, added to standard therapy, can cut the annualised rate of moderate and severe exacerbations, according to ClinicalTrials.gov. Primary completion is targeted for mid 2029. GSK is also starting PERSIST ASTHMA-1, a 514-patient Phase III study of felcorekibart in patients with uncontrolled asthma. Three more late-stage studies of the drug are expected to begin this half as well (see – Vital Signs: GSK management comes out swinging with pipeline refresh). The COPD programme puts GSK in the race with other companies that are looking to make TSLP blockade a new treatment option against the respiratory disease. AstraZeneca and Amgen are testing the first approved TSLP-targeting drug Tezspire (tezepelumab) – it was originally cleared in 2021 for severe asthma followed by a label extension into chronic rhinosinusitis with nasal polyps last year – in the Phase III EMBARK and JOURNEY studies, each enrolling 990 patients with moderate to very severe COPD. Both trials are expected to report in early 2029. However, according to a recent FirstWord report, Tezspire's prospects as a potential therapy for patients with non-eosinophilic COPD were clouded following disappointing results from the Phase II COURSE study last year, which raised questions about the breadth of its potential benefit (see – KOL Views Q&A: Breadth of Tezspire's activity could be key asset in COPD battle with Dupixent). EMBARK and JOURNEY are evaluating Tezspire in a refined eosinophilic patient population. "The initial thinking with tezepelumab was that because it targets early in the inflammatory cascade it may affect type 1 inflammation, which it does marginally. That makes it interesting, and so, certainly, I would like to see further development of it," one key opinion leader (KOL) told FirstWord (see – KOL Insight: Chronic Obstructive Pulmonary Disease). "However, a lot of the Phase II COURSE study wasn't positive." Another said, "The last thing we need is another type 2 eosinophilic biologic in COPD. It's a disappointment because Tezspire could really help us with the non-eosinophilic patients, which are at least 70% of the [COPD] population." Meanwhile, Sanofi is pursuing a potentially differentiated TSLP strategy with lunsekimig, a bispecific antibody targeting both TSLP and IL-13. KOLs told FirstWord that honing and clearly defining the patient population responsive to lunsekimig – aiming for a niche distinct from Dupixent and Nucala – would be a strategy for success. The drug is currently being evaluated in the Phase IIb/III PERSEPHONE and THESEUS studies, each enrolling 942 patients with inadequately controlled COPD and an eosinophilic phenotype. The content above comes from the network. if any infringement, please contact us to modify.