Chongqing Zhifei Biological Products Co., Ltd.

In Luke Miels' first quarter as CEO, GSK's Q1 revenue of £7.6 billion marked a 5% increase year over year at constant exchange rates. In GSK’s first quarter under Luke Miels as CEO, the company’s flagship shingles vaccine, Shingrix, set a new quarterly sales record, while its closely watched asthma launch, Exdensur, showed “early signals” of commercial progress despite a recent trial flop.Sales of Shingrix in the U.S. bounced back from a 17% decline in full-year 2025 to reach 12% growth in the first quarter at constant exchange rates, fueled by inventory build related to the launch of a new, easier-to-use prefilled syringe.A boost from the U.S. market, plus strong demand in Europe, lifted Shingrix’s global Q1 sales to 1.03 billion pound sterling ($1.39 billion), setting a new quarterly record, Nina Mojas, GSK’s president, global products strategy, said Wednesday on an investor call.As the entire vaccine industry grapples with a hostile U.S. policy environment, Shingrix’s surge comes as a surprise. The turnover beat Wall Street’s expectations by 20%.In the U.S., cumulative immunizations for shingles grew 3.5 percentage points year over year and reached 45% among eligible adults, according to Miels.“If you look at the remaining effort, there’s about 70 million people above 50 who remain unvaccinated. About a third of them have intent to get vaccinated,” Miels said on the call, citing market research. “We’re concentrating on the comorbid subpopulation that are more motivated, and their doctors and pharmacists are more motivated to do that.” Meanwhile, demand in China also appears to be improving as the number of administered doses increases, although this dynamic is not being reflected in GSK’s sales numbers for at least the majority of the year because the doses are coming from existing stockpiles at its partner, Chongqing Zhifei Biological Products, Mojas said. The market for self-paid vaccines has shrunk in China in recent years, impacting major products such as Shingrix and Merck & Co.’s HPV blockbuster Gardasil, which is also distributed by Zhifei.For the rest of the year, however, Mojas cautioned about difficult year-over-year comparisons for the vaccine in Europe and Japan.“Further penetration opportunities remain with around 11% of the eligible population immunized in our top 10 markets outside the U.S.,” she said.While Shingrix drove GSK’s Q1 sales growth, numbers from the respiratory syncytial virus vaccine Arexvy do not look so rosy. The shot’s sales dropped 18% to 65 million pounds sterling with low out-of-season uptake, missing analysts’ consensus by 13%, as U.S. sales continued to decline amid slower market demand. Launch progress On Wednesday’s call, GSK’s management touted the launch momentum of several newer products. Among them, twice-yearly IL-5 drug Exdensur is one of the most important rollouts, with its peak annual sales estimated at about 3 billion pounds sterling by GSK across several respiratory diseases. Approved by the FDA to treat severe asthma in December, Exdensur only brought in 11 million pounds sterling in Q1 sales. Mojas noted that access to the drug in the U.S. is currently limited to about 20% of commercial patients ahead of the assignment of a permanent J-code for reimbursement, which is expected in July. “Unaided awareness is ahead of benchmarks and intent to use is nicely at benchmark,” Miels said of Exdensur. “And the main driver is questions around access, which is what we expect, particularly when you’re buying a six-monthly treatment.”To convince investors that Exdensur and its long-acting dosing represent “a key value driver,” Mojas noted that 65% of patients discontinued their short-acting biologic in the first 12 months. In its early launch days, about 70% of Exdensur users are coming from other biologics, she noted. Biologic compliance is a main reason for discontinuation, as some patients end up switching back to inhaled medicines, Mojas said. However, GSK recently hit a snag with its plan to convince patients that they can switch from an existing short-acting biologics to Exdensur with similar benefits. The phase 3a Nimble trial, which compared Exdensur with GSK’s own monthly Nucala or AstraZeneca’s bimonthly Fasenra, failed to meet statistical non-inferiority. Annualized rates of clinically significant exacerbations over 52 weeks were 0.57 with the GSK drug, versus 0.49 for the comparator arm. While the rate ratio was 1.16, the upper bound of the 95% confidence interval reached 1.38, which exceeded the predefined non-inferiority bar of 1.28, leading the trial to miss its main endpoint. Because Nimble was a well-controlled study, the general exacerbation rate was low, GSK’s R&D chief Tony Wood, Ph.D., said on the earnings call. The absolute difference in annual exacerbation rates was 0.08 between the two arms, meaning that a patient on therapy would need 12.5 years to realize a single additional exacerbation, he noted.“You put that into the context of the beneficial compliance that’s associated with the longer-acting agent, I think you have the importance of [Exdensur] as a long-acting agent in that population,” Wood said.In a well-controlled study, patients are closely followed and treatment adherence is typically better compared with real-world experience. Mojas also pointed out that about 30% of asthma patients are taking a biologic. She suggested that Exdensur could capture some of the biologic-naïve patients with its convenience edge once it gets the J-code. Exdensur is undergoing three phase 3 trials—Endura-1, -2 and Vigilant—in moderate to severe chronic obstructive pulmonary disease, an indication that fueled Nucala’s 12% growth at constant exchange rates to 484 million pound sterling in Q1. All told, GSK’s Q1 haul of 7.6 billion marked a 5% increase year over year at constant currencies, meeting analysts’ consensus. The British pharma affirmed its full-year 2026 guidance, including sales increase of between 3% to 5%.

The end of a partnership between Takeda and Denali, Merck and Zhifei's revamped vaccines distribution deal in China, and a BARDA award for Shionogi made our news this week. Takeda ended its neurogenerative disease partnership with Denali Therapeutics. Merck & Co. and Zhifei have scrapped a minimum purchase requirement in their vaccine distribution agreement. Shionogi secured funding from the U.S. government to boost the domestic supply of an antibiotic. And more.1. Takeda tears up Denali partnership, returning dementia asset amid restructuringTakeda has returned a dementia candidate coded DNL593 to Denali Therapeutics, effectively ending their collaboration initiated in 2018 to co-develop up to three new drugs for neurodegenerative diseases. Takeda, in restructuring mode, made the decision out of strategic considerations not related to efficacy or safety, according to a Denali securities filing.2. With Gardasil demand shortfall in China, Merck and Zhifei adjust their partnershipMerck & Co. has agreed to remove minimum purchase requirements from its vaccines partner Chongqing Zhifei Biological Products in China and use a rolling, demand-based supply model. The adjustment comes after demand for Merck’s HPV vaccine Gardasil has plummeted. Zhifei’s procurement of three Merck vaccine brands fell from 34.8 billion yuan in 2023 to below 2.2 billion yuan in 2025.3. Shionogi nabs initial $119M award from BARDA to establish US antibiotic plantShionogi unveiled a deal with the Biomedical Advanced Research and Development Authority (BARDA) to bolster U.S. production of the company’s antibiotic Fetroja (cefiderocol). The HHS agency will initially award the Japanese pharma $119 million, with additional “multiyear options” worth up to $482 million if exercised.4. Astellas unearths Dyno muscle disorder AAV capsid with $15M option agreementAstellas is exercising an option to license a Dyno Therapeutics adeno-associated virus (AAV) capsid engineered for delivery to skeletal muscle. The Japanese pharma will pay $15 million, along with potential milestone and royalty payments, and will take care of all development activities for any gene therapy candidates based on the delivery vehicle.Other News of Note:5. Akari locks arms with WuXi XDC to develop and manufacture novel ADC treatment6. Daiichi Sankyo partners with Chinese R&D platform Atlatl (release)7. DualityBio’s BioNTech-partnered ADC accepted for review in China (release)8. Gan & Lee, JW Pharma team up on biweekly GLP-1 in Korea (release)

Plus, news about Novavax, ReAlta and AtaiBeckley: Merck adjusts China vaccine supply deal: The company and its distribution partner Zhifei have tweaked their agreement as Merck continues to grapple with lower demand for its HPV vaccine Gardasil in China. The new deal no longer specifies a baseline procurement volume for Merck’s vaccines, but instead allows the companies to determine supply plans “based on anticipated market demand and actual vaccination uptake,” according to a translated regulatory filing from Zhifei. Merck supplies three products to Zhifei: Gardasil, its rotavirus vaccine RotaTeq, and the pneumococcal vaccine Pneumovax 23. — Nicole DeFeudis Soleno withdraws EU application: A day after saying it was selling to Neurocrine Biosciences for $2.9 billion, Soleno Therapeutics revealed in an SEC filing that it pulled its approval application for Vykat XR in Europe, where it expected a decision later this year in the rare genetic condition known as Prader-Willi syndrome. Neurocrine CEO Kyle Gano had hinted at this the day before, telling analysts his company had no plans to commercialize the drug in Europe. — Kyle LaHucik Large Novavax shareholder still displeased: Shah Capital, which holds about 9% of the Maryland vaccine maker, penned a letter to the company’s board Wednesday to share its continued annoyance with Novavax’s performance and its lack of confidence in the board nominees. The shareholder called for a sale of Novavax in October. In the Wednesday letter, founder and chief investment officer Himanshu Shah said the firm intends to vote against the reelection of Novavax’s board nominees and against the executive compensation package at this year’s annual meeting. Shah concluded with an ask for “a like-minded strategic long-term investor taking 10-20% ownership position to reshape Novavax entirely.” — Kyle LaHucik ReAlta Life Sciences gets $40M: The Virginia biotech got the funding for its experimental treatment for hypoxic ischemic encephalopathy, in which there’s little oxygen and blood flowing to the brain around birth. The company’s peptide, called pegtarazimod, is in Phase 2 testing. ReAlta has now raised $150 million total and recently got a new CEO , the former Coya Therapeutics leader Howard Berman. — Kyle LaHucik AtaiBeckley shares more depression data: The biotech’s psychedelic candidate, called BPL-003, produced an antidepressant response in almost 67% of patients with treatment-resistant depression who were taking a stable dose of an SSRI. The patients were enrolled in AtaiBeckley’s open-label Phase 2a study. The company reported success for its controlled Phase 2b trial of BPL-003 last year. The drug is set to enter Phase 3 in the second quarter. — Ayisha Sharma