Shots:
The Japanese MHLW has approved GSK's Arexvy RSV vaccine for adults (18-49yrs.) at increased risk for RSV disease, expanding its use beyond those aged ≥50yrs.
Approval was based on P-IIIb trial (n=1458) assessing Arexvy in individuals (18-49yrs.; n=426) compared to adults (≥60yrs.; n=429), which showed a non-inferior immune response in individuals (18-49yrs.) who are at increased…
Shots:
GSK has entered an exclusive strategic collaboration with Sino Biopharmaceutical, via its subsidiary CTTQ, to support the launch & commercialization of bepirovirsen (under NMPA’s priority review) in mainland China
CTTQ will manage importation, distribution, hospital access, and promotional & non-promotional activities in China under a 5.5yr. supply deal with GSK
On the other hand,…
Shots:
GSK has entered into a global collaboration & license agreement with Halozyme to develop & commercialize SC formulation of multiple oncology targets, incl. ADCs, as well as an option for additional future drug targets
As per the deal, GSK will license Enhanze drug delivery tech from Halozyme in exchange of upfront payment, as well…
Shots:
Suzhou Siran Biotechnology has granted GSK a global exclusive license to SA030, a long-acting, siRNA oligonucleotide, for the treatment of metabolic & vascular disease (excl. mainland China, Hong Kong, Macau & Taiwan)
As per the deal, Siran Bio will receive an upfront fee & potential development, regulatory & commercial milestones payments up to $1.005B,…
Shots:
The US FDA has accepted NDA & granted priority review as well as BTD to GSK's bepirovirsen for the treatment of adults with chronic hepatitis B (CHB)
NDA & designation were supported by the P-III (B-Well 1 & B-Well 2) trial results assessing bepirovirsen vs PBO in nucleos(t)ide analogue-treated pts with CHB & baseline…
Shots:
Biopharma dealmaking in 2025 continued to face significant headwinds, with collaborations frequently collapsing due to strategic reprioritization, fierce competitive pressures, unfavorable clinical readouts, and failure to meet key closing conditions highlighting the inherent uncertainty and capital risk embedded in innovation-driven partnerships
The year underscored a clear dominance of R&D-focused collaborations and licensing agreements,…
Shots:
Approval momentum accelerated in late March 2026, with the US FDA clearing five new therapies across hepatology, dermatology, rare genetic disorders, oncology, and endocrinology; highlighting both therapeutic breadth and meaningful clinical impact.
Five notable therapies crossed the regulatory finish line: GSK’s Lynavoy for cholestatic pruritus in primary biliary cholangitis, Johnson & Johnson’s Icotyde for moderate-to-severe plaque psoriasis, Denali…
Shots:
The biopharma industry is a multi-hundred-billion-dollar market, with a projected compound annual growth rate (CAGR) of 8.6%, the global biopharma market is expected to reach $1.41T by 2034. Eli Lilly and Co. ranked first with $65.17B, followed by Pfizer ($61.19B) and AbbVie ($61.16B), reflecting strong market concentration among large-cap innovators with diversified, high-value portfolios …
Shots:
The NMPA has approved Exdensur as an add-on therapy for adults with CRSwNP for whom therapy with systemic corticosteroids & /or surgery do not provide adequate disease control, based on P-III (ANCHOR 1 & 2) trials
The ANCHOR-1 & ANCHOR-2 trial assessed Exdensur(Q6M)+ intranasal corticosteroids (SoC) vs PBO + SoC in 271 & 257 pts,…
Shots:
The Chinese NMPA has approved Exdensur as an add-on maintenance therapy for asthma pts (≥12yrs.) characterised by an eosinophilic phenotype based on P-III (SWIFT-1: n=382) & (SWIFT-2: n=380) trials
Exdensur reduced asthma exacerbations by 58% (SWIFT-1) & 48% (SWIFT-2) over 52wks., with results in Chinese pts (n=58, SWIFT-1) consistent with the overall population. Pooled data…

