Respiratory Syncytial Virus Vaccine (GSK)

SYS6057, a recombinant respiratory syncytial virus (RSV) vaccine candidate developed by CSPC Pharmaceutical Group (HKEX: 01093), has received FDA clearance to begin clinical trials in the US, less than a month after China's National Medical Products Administration (NMPA) granted the same authorization on 30 July 2026. The back-to-back regulatory clearances give the Hong Kong-listed company a simultaneous development path in two of the world's largest markets for RSV prophylaxis in older adults. SYS6057 combines the RSV prefusion F (Pre-F) protein antigen with a proprietary second-generation nano-adjuvant system. CSPC says the adjuvant uses a different nanocarrier compared with its earlier RSV vaccine candidate, conferring distinct physicochemical and immunological properties. Preclinical data, according to the company, showed the vaccine can simultaneously elicit high-titre neutralising antibodies and cellular immune responses — a dual-arm immune profile the company attributes to adjuvant optimization. No clinical efficacy or safety data have been disclosed. The planned clinical development in both countries targets prevention of RSV-associated lower respiratory tract disease in adults aged 60 and older. Trial design, participant numbers, dosing, and primary endpoints have not been disclosed. CSPC enters a market where three RSV vaccines are already approved in the US for older adults: GSK's Arexvy (RSVPreF3-AS01E), Pfizer's Abrysvo (RSVpreF), and Moderna's mRESVIA (mRNA-1345), first approved in May 2023, May 2023, and May 2024, respectively. Arexvy and Abrysvo use prefusion F protein antigens, while mRESVIA uses mRNA encoding the prefusion F protein. SYS6057 similarly targets prefusion F but combines the recombinant antigen with CSPC's proprietary nano-adjuvant system, broadly resembling Arexvy's protein-plus-adjuvant strategy while using different adjuvant technology. CSPC describes SYS6057 as its second recombinant protein vaccine candidate to enter clinical trials. Spot something wrong? Report an issue with this article

GlaxoSmithKline (GSK) Pharmaceuticals has announced its financial results for the first quarter ended June 30, 2026. During the quarter, the company delivered strong growth across both its core and innovative portfolios. The performance reflects continued progress in the company's portfolio transformation strategy, supplemented by execution excellence, and a favorable base effect from the comparable period last year. Revenue for the quarter stood at INR 924 crore, up 15 percent Year-on-Year (YoY). Profit After Tax (PAT) increased by 24 percent to INR 253 crore, while EBITDA margins stood at 32 percent. The General Medicines portfolio grew strongly during the quarter, with the top 5 promoted brands outperforming the market (EI* >100; Source: IQVIA). Key promoted brands such as Augmentin, Ceftum and T-Bact reinforced their leadership positions in their respective categories, driven by a combination of deeper scientific and in-clinic engagement, omnichannel execution, and pricing measures. The Respiratory portfolio continued to further the management of chronic respiratory diseases with Nucala (mepolizumab) benefitting a large number of patients and Trelegy Ellipta gaining traction through new access pathways. The vaccines business grew through continued leadership in the self-pay private pediatric vaccines market, led by Infanrix Hexa and Fluarix Tetra. In the adult vaccination space, the company’s focus on elderly patient-cohorts with underlying Cardiovascular and Metabolic Diseases (CVMD) led to stronger endorsement from the healthcare professional community, translating to higher vaccinations with Shingrix (Recombinant Herpes Zoster Vaccine, Adjuvanted). The oncology business, led by specialised therapies Jemperli (dostarlimab) and Zejula (niraparib), has grown significantly since its launch in August last year. Jemperli is now the leading immunotherapy for first line primary advanced and recurrent endometrial cancer while Zejula is among the top PARP inhibitors in the maintenance treatment of recurrent ovarian cancer. Together, both therapies have touched the lives of a growing number of women suffering from gynecological malignancies, with GSK committed to expanding access and patient reach. Commenting on the results, Bhushan Akshikar, Managing Director (MD), GSK India, said, "GSK India's broad-based growth demonstrates the resilience of the core General Medicines and Vaccines portfolio and the growing contribution of the innovative business. This growth was enabled by a relentless focus on scientific excellence, sharper execution in the field and meaningful investments in technology and talent development. With a strong innovation pipeline and launch opportunities ahead, we are well-positioned to deliver sustainable growth and meaningful impact for millions of patients in India." The company has made progress in strengthening supply chain resilience through diversified sourcing, enhanced contingency planning and improved end-to-end visibility, substantially mitigating disruptions experienced in recent quarters. Looking ahead, GSK India is preparing for key pipeline launches. Blenrep (belantamab mafodotin), an anti-BCMA ADC therapy indicated for second-line treatment in relapsed or refractory multiple myeloma in adults, is set for launch. Arexvy, a vaccine to prevent Lower Respiratory Tract Disease (LRTD) caused by Respiratory Syncytial Virus (RSV) in adults over 60 years of age and older adults (50 to 59 years) at high-risk, has received Marketing Authorisation (MA).