Antiviral & Infectious-Disease Therapeutics

Huayuan Bio-tech announced that it has signed a Cooperation Agreement on the 25-Hydroxycholesterol New Drug R&D Project with Guangzhou National Laboratory. The two parties plan to establish a joint venture to advance the research and development, registration, production, and commercialization of 25-hydroxycholesterol and its prodrug-based broad-spectrum antiviral drugs. The joint venture will be led and operated by the company, which will hold no less than 51 percent of the shares. This cooperation marks the company's entry into the innovative drug R&D field, but the project is at an early stage and involves uncertainty.

SymBio Pharmaceuticals announced that it has begun consultations with the UK Medicines and Healthcare products Regulatory Agency toward obtaining conditional early marketing authorization in the UK for brincidofovir, which targets adenovirus infection following hematopoietic stem cell transplantation. The UK's conditional early marketing authorization scheme is a framework that grants early market access for medicines addressing unmet medical needs such as life-threatening diseases, even before comprehensive clinical data are available, when the confirmed benefits are judged to outweigh the risks; after approval, continued data collection and monitoring of safety and efficacy are mandatory. While advancing the process toward obtaining this approval, the company will also complete its global Phase III clinical trial, currently underway in the United States and Europe, as quickly as possible and focus on establishing evidence of high medical validity. As of September 17, 2026, the trial had enrolled 30 patients, with targets of 69 patients by the end of 2026 and 180 patients by the end of 2027. Brincidofovir is a compound for which the company acquired global rights in September 2019, and it is advancing development centered on three therapeutic areas: post-transplant viral infections, cancer, and neurodegenerative diseases. This matter will have no impact on the company's consolidated earnings forecast for the fiscal year ending December 2026.

RQ Bio has appointed Gavin Koh as Chief Medical Officer, strengthening its leadership as the company prepares to advance its lead influenza antibody candidate RQB01 into the clinic. Dr Koh brings 20 years of pharmaceutical drug development and infectious disease experience, having held senior roles at AstraZeneca and GSK, where he led programmes from discovery to registration and launch, including Evusheld during the COVID-19 pandemic. The appointment follows RQ Bio's $115 million, or £85.5 million, Series A financing announced in June 2026, which is supporting the clinical development of RQB01, currently in IND-enabling studies. RQ Bio also named Debra Nevin as Vice President, Head of CMC; Brad Norton as Vice President, Head of Clinical Operations; and Vicky Wheeler as Senior Director, Head of Programme Management. RQB01 is a long-acting antibody product designed to provide potent and broad protection against influenza across an entire season with a single administration for high-risk and immunocompromised populations.

Moberg Pharma AB announced the publication of new analyses demonstrating potent antifungal activity of terbinafine against dermatophytes causing onychomycosis, with mycological cure achieved with MOB-015 across the full range of baseline terbinafine susceptibility, including in patients with reduced in vitro susceptibility. The analyses are based on data from the previously completed North American Phase 3 study evaluating daily treatment with MOB-015 for 48 weeks, and included 506 dermatophyte isolates from onychomycosis patients. Only 3.2% of baseline isolates showed elevated MIC values of at least 0.5 micrograms per milliliter, and among MOB-015-treated patients with evaluable end-of-study results, 74.3% achieved mycological cure, including two of three patients with elevated baseline MIC values. The work was conducted in collaboration with Professor Mahmoud Ghannoum at Case Western Reserve University in Cleveland, Ohio, and the article, titled In Vitro Terbinafine Susceptibility of Dermatophytes and Mycological Cure Outcomes from a Multicenter Phase III Onychomycosis Trial, is published in Journal of Fungi, 2026, 12(10), 739. Amir Tavakkol, CSO of Moberg Pharma, said the results are encouraging, particularly given the increasing attention to antifungal resistance, and that the findings further strengthen the scientific foundation for MOB-015.

Lukang Pharmaceutical announced that the company has received the Drug Registration Certificate for Cefuroxime Sodium for Injection issued by the National Medical Products Administration, and the drug has been approved for registration. The drug is a Category 4 chemical medicine, with specifications including 0.75 grams and 1.5 grams. Cefuroxime is a cephalosporin antibiotic, and 46 domestic companies have currently passed consistency evaluation or obtained approval for generic drugs under the new registration classification. As of the disclosure date of the announcement, the company has invested approximately 2.79 million yuan in the research and development of this drug. The approval of this drug will enrich the company's formulation product line, but drug sales are subject to uncertainties due to factors such as policies and market conditions.

Lingkang Pharmaceutical announced that its wholly-owned subsidiary Hainan Lingkang Pharmaceutical has received the Drug Registration Certificate for Isavuconazonium Sulfate for Injection approved and issued by the National Medical Products Administration. The specification is 0.2 grams, the registration classification is Category 4 chemical drug, and it is deemed to have passed the consistency evaluation. The drug is indicated for the treatment of invasive aspergillosis and invasive mucormycosis infections in adult patients. The company first submitted the domestic drug registration application in December 2024 and it was accepted, with cumulative research and development investment of approximately 7.32 million yuan. The company stated that this approval marks its qualification for production and sales in the domestic market, further enriching its anti-infective product line and helping to enhance market competitiveness, but the launch and sales of the drug are still subject to uncertainties.

Gilead Sciences expanded the scope of its six royalty-free voluntary licensing agreements for lenacapavir on September 16 to cover an investigational once-yearly formulation for HIV pre-exposure prophylaxis. The expanded framework covers 120 high-incidence, lower-income countries and aims to accelerate manufacturing readiness and technology transfer during the ongoing Phase 3 PURPOSE 365 study. The move follows the efficacy shown by twice-yearly lenacapavir in the PURPOSE 1 and PURPOSE 2 trials, and Gilead is extending its global access strategy while clinical development continues. In the second quarter of 2026, Gilead's HIV product sales rose 12% year over year to $5.7 billion, led by Biktarvy at $3.8 billion, up 7%, and Descovy at $967 million, up 48%, while base product sales excluding Veklury grew 10% to $7.6 billion and quarterly operating cash flow reached $3.6 billion. Those gains were offset by a GAAP diluted loss per share of $(8.45) and a non-GAAP loss per share of $(6.75), reflecting $(9.08) per share in acquired in-process R&D charges totaling $11.2 billion tied mainly to the acquisitions of Arcellx, Tubulis, and Ouro Medicines, which helped cut cash, cash equivalents, and marketable securities to $3.2 billion from $10.6 billion at year-end 2025.

Eli Lilly & Co. will pursue slightly larger acquisitions, along the lines of its $7.8 billion purchase of Centessa Pharmaceuticals Plc, as it searches for assets in the "white spaces" of science, Chief Executive Officer Dave Ricks said. Lilly, now the world's largest pharmaceutical company, has been on a record spending spree funded by its weight-loss and diabetes shots, and Ricks told Bloomberg that reinvesting in human health is more attractive than buying back shares or issuing dividends. He pointed to infectious disease, women's health and psychiatric conditions as areas of opportunity, noting the company acquired three vaccine-makers for as much as $3.8 billion earlier this year and recently agreed to buy psychedelics firm AtaiBeckley Inc. for about the same price. Lilly has completed about 40 deals so far this year, with a total value of more than $20 billion, the highest ever in a single year according to Bloomberg-compiled data. Ricks said the company favors more mature assets when they address brand new problems, a shift from its historical focus on earlier-stage, cheaper drugs.

Morgan Stanley reaffirmed its Overweight rating on Gilead Sciences after meeting privately with Chairman and CEO Daniel O'Day and Chief Commercial and Corporate Affairs Officer Johanna Mercier at its 2026 Global Healthcare Conference, with the bank singling out the company's HIV prevention franchise as the biggest reason to stay positive. Analyst Terence Flynn, who has held the Overweight rating since January 2025, based his price target on a discounted cash flow model using a 10% weighted average cost of capital and a 3% terminal growth rate, referenced to the September 15 close of $146.30. Gilead guided its first full year of Yeztugo sales at approximately $1 billion, with the total prevention portfolio running at about $4 billion annually; Yeztugo is the twice-yearly HIV prevention shot launched in 2025. Current PrEP users number roughly 550,000, more than double the 2022 level, against CDC estimates that about 2.2 million Americans could benefit, a penetration of about 25% in a market growing 14% to 15% each year, and more than 70% of Yeztugo patients returned for their six-month reinjection. Management described Gilead as being at an important inflection point with no patent expiring until 2036, while Biktarvy still controls more than 50% of the global HIV treatment market and more than two-thirds of patients new to HIV therapy, and the company raised its HIV franchise growth guidance to 9% to 10% for the year from 8%. The near-term catalyst is anito-cel, Gilead's cell therapy for a type of blood cancer, with an FDA decision due in December and an estimated initial opportunity in advanced-stage patients of approximately $3.5 billion, alongside late-stage results expected before year-end for two experimental drugs in immunology and inflammation.

Gilead Sciences has expanded its royalty-free voluntary licensing of once-yearly lenacapavir for HIV prevention to 120 high-incidence countries. The biopharma group also signed a regional agreement with the Pan American Health Organization to widen access to twice-yearly lenacapavir across Latin America and the Caribbean, creating a direct pathway for 14 additional countries in the region to obtain the drug for HIV prevention programs. The expanded royalty-free licenses and the PAHO agreement tilt Gilead further toward a volume-based access model in HIV prevention, particularly in low and lower middle income markets, with partners such as Dr. Reddy's and Hetero expected to handle much of the production and local distribution. The company said the clearest test over the next couple of years will be whether countries move from agreements to funded rollouts, especially as Phase 3 PURPOSE 365 data matures and PAHO's revolving funds translate into concrete procurement. Uptake in the 14 additional Latin American and Caribbean markets outside the core licensing pool will be a particularly useful early signal.

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.

GSK's Specialty Medicines unit, which now accounts for more than 40% of the company's sales and is expected to exceed 50% of total revenues by 2031, posted 14% sales growth at CER in the first half of 2026 on double-digit gains across HIV, Respiratory, Immunology & Inflammation and Oncology. New long-acting HIV injectables Cabenuva and Apretude account for around 25-30% of total HIV sales, while newer oncology drugs Jemperli and Ojjaara and recent launches including Blenrep, Exdensur and Penmenvy broaden the growth base, and GSK expects low double-digit percentage sales growth in the segment for 2026 at CER. The company now expects more than 20 phase III starts in 2026, more than twice the 10 originally contemplated, and has 19 assets in late-stage development or under regulatory review, with FDA decisions on bepirovirsen for chronic hepatitis B and neladalkib for non-small cell lung cancer expected later this year. GSK faces the loss of exclusivity for dolutegravir, the backbone of HIV medicines including Tivicay, Triumeq and Dovato, with patents expected to begin expiring in major markets around 2028-2029; dolutegravir-based products generated £2.74 billion in sales in the first half of 2026. GSK expects to launch twice-yearly long-acting injectables for treatment and PrEP between 2028 and 2030, and competes in Specialty Medicines with AstraZeneca, Merck, Sanofi, Gilead, Pfizer, J&J and Novartis, among others.

Assembly Biosciences has exercised its option to share 40% of U.S. development costs and profits for its herpes simplex virus helicase-primase inhibitor program under its collaboration with Gilead Sciences. The decision follows review of Gilead's complete development plan and budget for the program, which includes candidates GS-1179 and GS-5366. Gilead retains sole responsibility for further clinical development and commercialization, while Assembly Bio is eligible for up to $280 million in milestones and tiered royalties outside the U.S., with potential conversion to up to $330 million if certain opt-out rights are exercised. GS-1179 is expected to enter a Phase 2 trial in recurrent genital herpes by the end of 2026, with possible evaluation in combination with HIV pre-exposure prophylaxis. Assembly Bio's cash runway remains projected into 2029, including a $75 million collaboration extension fee from Gilead due in the fourth quarter of 2026.

AirNexis Therapeutics announced that AN01, a dual PDE3/4 inhibitor dry powder inhaler, met its primary endpoint in a Phase 2b COPD study conducted in China by its partner Haisco Pharmaceutical Group. The study, HSK39004-T1-202, randomized 195 patients on background single or dual bronchodilator therapy to receive AN01 0.75 mg, 1.5 mg, or placebo for four weeks. Both doses significantly improved lung function versus placebo, with treatment differences of 116 mL and 127 mL in FEV₁ AUC₀₋₁₂h at Week 4. AN01 was well tolerated, with no treatment-related adverse events in the 0.75 mg dose group, which is the dose being investigated in the Phase 3 program. AirNexis has completed its Phase 1 multiple ascending dose study in Australia and is preparing to initiate its Phase 2 program in 2027.

GSK plc has reached two regulatory milestones: its hepatitis B treatment Hibsago, also known as bepirovirsen, received its first global approval in Japan, and the FDA granted priority review to its cancer therapy Jemperli for locally advanced rectal cancer. Hibsago is the first and only treatment approved in Japan to deliver a functional cure for chronic hepatitis B, with late-stage studies showing nearly one in five patients achieved that outcome. GSK forecasts peak annual sales of more than £2 billion, approximately $2.73 billion, for Hibsago, contributing to its goal of over £40 billion in annual revenue by 2031. The FDA has set an action date for Jemperli in February 2027, though GSK notes the program's structure may allow an earlier decision. Jemperli already holds Breakthrough Therapy and Fast Track designations for this use, and an approval would expand its indications beyond endometrial cancer subtypes.

Gilead Sciences has received FDA approval for Bixlenvo, the smallest once-daily single-tablet regimen for HIV in virologically suppressed adults, making it the first and only option for patients unable to take existing single-tablet regimens. The drug combines bictegravir and lenacapavir, offering a high barrier to resistance and no cross-resistance to current antiretrovirals. This approval strengthens Gilead's HIV portfolio, which already includes Biktarvy, Descovy, and the rapidly growing Yeztugo, and the company has raised its 2026 HIV sales growth outlook to 9-10%, supported by a roughly $4 billion annualized PrEP business. Gilead expects Yeztugo sales to approach $1 billion in 2026, and its pipeline, including a once-weekly oral combination with Merck, offers additional upside. Shares of Gilead have gained 20.3% year to date, and the company currently holds a Zacks Rank #1 (Strong Buy).

Pfizer and BioNTech received U.S. FDA approval for their updated COMIRNATY COVID-19 vaccine targeting the XFG variant for high-risk individuals, while Pfizer and Valneva's Lyme disease vaccine candidate PF-07307405 had its Marketing Authorization Application validated by the European Medicines Agency based on Phase 3 trial data. These milestones highlight Pfizer's role in infectious disease prevention, with the Lyme vaccine potentially becoming a key proof point for its pipeline. However, unresolved legal and pricing pressures, including the Depo Provera settlement program, remain overhangs. Pfizer's narrative projects $54.9 billion in revenue and $9.2 billion in earnings by 2029, implying a 4.6% yearly revenue decline and a $1.7 billion earnings increase from $7.5 billion today, yielding a $29.19 fair value, a 4% upside to its current price. Some analysts assume revenue could fall to about US$50.6 billion by 2029, reinforcing concerns that pipeline wins may not fully offset pricing pressure and patent losses.

Gilead Sciences has snapped out of its slump, with shares surging from around $130 to $146 following its Q2 2026 earnings release on Aug. 4. The biotech reported $7.8 billion in sales, up 10% year over year and ahead of forecasts, but recorded a net loss of $8.45 per share due to in-process R&D charges from acquisitions including Arcellx. Investors focused on the HIV drug portfolio, where PrEP medicines hit over $1 billion in quarterly sales for the first time, with Descovy sales rising 48% and Yeztugo jumping from $15 million to $232 million. Management expects continued growth, with Yeztugo potentially reaching blockbuster status, and forecasts call for 2027 earnings between $9.19 and $11.10 per share, putting Gilead at 13 to 16 times forward earnings versus Amgen's nearly 20 times.

Sinocelltech's controlling subsidiary has received clinical trial approval from the National Medical Products Administration for its independently developed SCTA02A injection, which will be used in a clinical trial for chronic hepatitis B. This product is the first approved clinical candidate in the company's portfolio designed with the goal of achieving a functional cure for chronic hepatitis B. In the first quarter of 2026, Sinocelltech reported revenue of 323 million yuan and a net loss attributable to the parent company of 176 million yuan.

Zhixiang Jintai announced that it has received a drug clinical trial approval notice issued by the National Medical Products Administration. The clinical trial application for its investigational product GR2302 injection for subcutaneous use has been approved, with the indication being chronic hepatitis B. GR2302 injection is a bispecific antibody independently developed by the company, based on a TCR-mimic antibody and an anti-CD3 antibody. Currently, no drug targeting the same target has been approved for clinical trials in China. The company cautioned that after completing clinical trials, the drug still needs to submit a new drug application for marketing, and there are risks of uncertainty.

Merck and Gilead Sciences reported first-quarter 2026 earnings and announced two joint clinical milestones. Merck posted $16.3 billion in total sales, up 5% year-over-year, while Gilead reported $7.0 billion in total revenue, up 5% year-over-year. The European Medicines Agency's CHMP recommended Gilead's Trodelvy in combination with Merck's Keytruda for first-line PD-L1-positive triple-negative breast cancer. Phase 3 results from the ISLEND-1 and ISLEND-2 trials showed a once-weekly oral combination of Gilead's lenacapavir and Merck's islatravir achieved noninferior virologic suppression compared to daily regimens. Both companies raised full-year guidance, with Merck targeting $65.8 billion to $67.0 billion in sales and Gilead targeting $30.0 billion to $30.4 billion in product sales.

Omeros Corporation reported a second-quarter 2026 net income of $13.23 million, or $0.18 per share, swinging from a net loss of $25.42 million, or $0.43 per share, a year earlier. Net revenue reached $28.55 million, driven entirely by YARTEMLEA sales of $32.2 million, which grew 190% from the first quarter of 2026. The company plans to begin enrollment by the end of 2026 in two YARTEMLEA studies, one for hyperinflammatory acute respiratory distress syndrome and another for prophylactic use in pediatric patients with predictably severe transplant-associated thrombotic microangiopathy. Omeros is also initiating a nonclinical study for OMS527 in response to an FDA request, with an inpatient clinical trial targeted to start by year-end 2026, while IND-enabling studies for OMS805 are underway ahead of a planned Phase 1b trial in late 2027. As of June 30, 2026, the company held $132.0 million in cash and short-term investments, and shares surged 15.85% to $15.61 in overnight trading.

Atea Pharmaceuticals outlined peak annual U.S. net revenue potential in excess of $700 million for its hepatitis C program, with a focus on a mid-2028 launch. The company reported positive top-line results from its Phase III C-BEYOND trial, where bemnifosbuvir met both primary and secondary endpoints and demonstrated statistical non-inferiority to Epclusa, achieving a 93.9% SVR rate in the mITT population compared with 94.8% for SOF/VEL. Atea's second Phase III trial, C-FORWARD, is fully enrolled with more than 880 patients, and top-line results are expected in early Q1 2027, with an NDA submission anticipated in the second quarter of 2027. The company also initiated a first-in-human Phase I trial of AT-587 for chronic hepatitis E and reported cash and investments of $219.5 million as of June 30, 2026, with runway anticipated through 2027.

Fosun Pharma Industrial, a controlled subsidiary of Fosun Pharma, announced on August 13, 2026, the initiation of a Phase II clinical trial in China for FXS7553 in the treatment of chronic obstructive pulmonary disease. FXS7553 is a small-molecule oral DPP-1 inhibitor independently developed by the group, intended for the treatment of non-cystic fibrosis bronchiectasis, chronic obstructive pulmonary disease, and other conditions. Another indication, non-cystic fibrosis bronchiectasis, is also in Phase II clinical development in China. As of July 2026, cumulative R&D investment in this drug amounted to approximately 151 million yuan.

Merck has secured acceptance from both the FDA and the European Medicines Agency for supplemental applications to expand the use of its antibody ENFLONSIA for preventing RSV in young children at elevated risk. The filings seek to broaden the indication into vulnerable pediatric groups where preventative options remain limited. The dual regulatory milestones underscore Merck's efforts to diversify its portfolio beyond oncology as attention on the future of Keytruda intensifies. A key signpost will be the FDA's March 22, 2027 PDUFA decision on the supplemental Biologics License Application, alongside the EMA outcome, which will determine whether this potential second-season use can become a meaningful pediatric RSV franchise.

Gyre Therapeutics reported second quarter 2026 revenue of $29.1 million and a GAAP basic loss per share of $0.12, while affirming its full-year 2026 revenue guidance of $100.5 to $111.0 million. The company's lead product ETUARY generated $28.0 million in sales, up from $23.5 million a year earlier, though total revenue dipped 2% due to the end of a collaboration agreement with Astellas Pharma. In May, China's Center for Drug Evaluation accepted the New Drug Application for F351 as a treatment for chronic hepatitis B-induced liver fibrosis, and Gyre closed its all-stock acquisition of Cullgen valued at approximately $300 million. Research and development expenses surged to $19.1 million from $8.4 million, driven by clinical trial costs and a milestone payment tied to the F351 application, contributing to a net loss of $14.3 million compared to a $2.2 million loss in the prior-year period.

Zhejiang Wolwo Bio-technology announced that the clinical trial application for its chemical Class 1 new drug S01D tablets has been formally accepted by the National Medical Products Administration. The drug is indicated for adult patients with drug-resistant pulmonary tuberculosis and is a Class 1 chemical drug with a new molecular entity and novel mechanism. Non-clinical studies suggest superior activity against Mycobacterium tuberculosis. As of the disclosure date, no identical chemical drug has been approved for marketing domestically or internationally. According to regulations, the Center for Drug Evaluation will decide within 60 days of acceptance whether to approve the clinical trial. Subsequent steps, including Phase I, II, and III clinical trials and the marketing authorization application, must still be completed, and outcomes are subject to significant uncertainty. The company stated that this acceptance marks an important R&D milestone in the field of drug-resistant pulmonary tuberculosis.

Vir Biotechnology announced that top-line data from its ECLIPSE 1 study in hepatitis delta will be reported in the fourth quarter of 2026, with readouts from ECLIPSE 2 and ECLIPSE 3 following in the first quarter of 2027. The company completed enrollment in ECLIPSE 2 during the second quarter and has now finished enrollment across all three registrational ECLIPSE studies. Vir ended the quarter with approximately $1.01 billion in cash, cash equivalents and investments, an increase of $198.5 million, and projects its cash runway into the second half of 2028. License and collaboration revenue was $238.9 million, largely tied to an upfront payment from Astellas, and net income was $80.1 million. The company also highlighted progress in its oncology program, with VIR-5500 advancing through multiple expansion cohorts and a goal to initiate Phase III registrational trials next year.

Youcare Pharmaceutical announced that its YKYY017 inhalation aerosol has received clinical trial approval from the National Medical Products Administration for a new indication, intended for the treatment and prevention of human coronavirus OC43-related respiratory infections. The drug is a lipopeptide compound jointly developed by the company and the Institute of Pathogen Biology at the Chinese Academy of Medical Sciences. It belongs to the latest generation of coronavirus membrane fusion inhibitors, blocking virus-host cell fusion by competitively binding to the HR1 region of the S2 subunit of the coronavirus spike protein. It exhibits broad-spectrum inhibitory activity against multiple coronaviruses, including SARS-CoV-2 and HCoV-OC43.

Merck & Co., Inc., Rahway, N.J., USA announced second-quarter 2026 worldwide sales of $16.6 billion, a 5% increase from the prior year, and narrowed its full-year 2026 sales outlook to between $66.3 billion and $67.3 billion. KEYTRUDA and KEYTRUDA QLEX sales reached $8.4 billion, including $463 million from the newly launched KEYTRUDA QLEX, while WINREVAIR sales grew 75% to $588 million and Animal Health sales rose 8% to $1.8 billion. The company reported a GAAP loss per share of $0.54 and a non-GAAP loss per share of $0.13, both reflecting a $2.31 per share charge for the acquisition of Terns Pharmaceuticals. Key regulatory milestones included U.S. FDA approval of LIPFENDRA, the first once-daily oral PCSK9 inhibitor, and positive Phase 3 results for the investigational sacituzumab tirumotecan in endometrial cancer and for a once-weekly oral HIV regimen of islatravir and lenacapavir in collaboration with Gilead. Merck now expects full-year non-GAAP EPS between $2.66 and $2.76, which includes charges of $2.43 per share related to the Terns acquisition.

The positive rate for COVID-19 tests has recently climbed to 20.3%, driving up market demand for antiviral drugs. Yet physical pharmacies are widely out of stock, with some staff even recommending anti-flu medications such as oseltamivir and baloxavir marboxil. Six domestically developed oral COVID-19 treatments have now been approved in China, including Genuine Biotech’s Jiebeian, Simcere Pharmaceutical’s Xiannuoxin, Junshi Biosciences’ Mindewei, Zonsen Pharmaceutical’s Leruiling, Cosunter’s Taizhongding, and Aisen Pharmaceutical’s Aoweining. However, multiple pharmacies reported that none of these drugs appeared in their inventories. Online platforms, by contrast, all have them available. Data from JD Pharmacy shows that transaction volumes for COVID-19 medications in July rose nearly fourfold month on month. Faced with surging demand, Simcere Pharmaceutical said it has activated an emergency production mechanism. Cosunter noted that sales of Taizhongding have increased and it will broaden hospital coverage. Junshi Biosciences has also launched an emergency plan to ensure supply. Industry insiders point out that earlier regulatory restrictions confined COVID-19 drugs mainly to hospitals and online sales, and they are calling for a reassessment of retail channel controls.