Vaccines (Recombinant & Traditional)

Vaxcyte shares jumped about 32% in Monday morning trading after the company reported positive phase 3 topline data for VAX-31, its 31-valent pneumococcal conjugate vaccine candidate. The OPUS-1 trial tested non-inferiority and immunogenicity of VAX-31 against Merck's Capvaxive and Pfizer's Prevnar 20 in patients aged 50 and over. For the 11 serotypes shared by the three shots, VAX-31 met all primary noninferiority assessments, and three serotypes unique to VAX-31 plus cross-reactive serotype 20B met the OPA GMR superiority criterion. Vaxcyte plans to release results from two other phase 3 trials, OPUS-2 and OPUS-3, in the first half of 2027, with a BLA eyed for the first half of 2028. Approved vaccines cover significantly fewer pneumonia strains than VAX-31: Capvaxive covers 21 strains and Prevnar 20 covers 20.

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.

Merck's CAPVAXIVE has been included in Ontario's publicly funded adult pneumococcal immunization program, the company announced. The vaccine, approved by Health Canada for adults 18 and older, helps prevent invasive pneumococcal disease caused by 21 Streptococcus pneumoniae serotypes, including serious infections such as sepsis, meningitis, and bacteremic pneumonia. Canadian surveillance data from 2019 to 2023 showed that the serotypes included in CAPVAXIVE accounted for approximately 65% of IPD cases in adults aged 18 to 49, approximately 74% of cases in adults aged 50 to 64, and approximately 80% of cases in adults aged 65 and older, based on data from the Public Health Agency of Canada. Matthew Thornhill, Executive Director of the Vaccines and HIV Business Unit at Merck Canada, said Ontario's decision reflects the importance of ensuring immunization programs continue to respond to changing public health needs and disease trends. In Canada, approximately 3,000 cases of invasive pneumococcal disease are reported each year.

Moderna and Merck reported that their Phase 3 INTerpath-001 trial of personalized cancer vaccine intismeran autogene plus Keytruda met its primary endpoint in melanoma, with full data presented earlier this month at the European Society for Medical Oncology Congress 2026. Moderna is also in talks with Middle East partners about potential investment and manufacturing cooperation, pairing its mRNA oncology push with efforts to extend its geographic footprint and industrial capabilities beyond its original COVID-19 franchise. The company recently won FDA approval of mFlusiva, its mRNA flu vaccine for adults 50 and older, underscoring its push to build a non-seasonal respiratory portfolio. Moderna's narrative projects $4.5 billion revenue and $782.2 million earnings by 2029, yielding a $119.56 fair value, a 40% downside to its current price, while some of the most optimistic analysts assume revenue could reach about US$8.5 billion and earnings turn positive by 2029.

Sanofi's new and acquired drugs are emerging as a broadening growth base beyond its flagship immunology medicine Dupixent, with sales of those newer products rising 48.3% at constant exchange rates to €1.3 billion in the second quarter, led by Altuviiio, Ayvakit and Sarclisa. Dupixent, marketed in partnership with Regeneron, remains the company's primary growth engine and accounted for roughly 42% of Sanofi's first-half 2026 revenues. Altuviiio achieved blockbuster sales in 2025, while Ayvakit, added through the Blueprint Medicines acquisition, is expected to become the next blockbuster drug in 2026, and Beyfortus, developed with AstraZeneca, reached blockbuster sales in its first full year in 2024. Sanofi now expects its Pharma launches to generate approximately €10 billion of annual sales by 2030, compared with about €25 billion for Dupixent, as it positions the newer medicines to gradually reduce reliance on its top-selling drug. The Zacks Consensus Estimate for 2026 earnings has risen from $4.96 per share to $5.07 per share over the past 60 days, while 2027 estimates climbed from $5.18 to $5.29 per share, and Sanofi stock has fallen 15.5% year to date against an 11.7% gain for the industry.

Sailun Bio announced that the company has received a GMP Compliance Certificate issued by the Food and Drug Administration of the Department of Health of the Republic of the Philippines. The production address is located at 1288 Huaqing Road, Qingpu District, Shanghai. The certified dosage form is injection, covering tetanus antitoxin, equine tetanus immunoglobulin F(ab')2, antivenom serum, and anti-rabies serum, valid until October 24, 2028. The announcement shows that passing this certification and obtaining the certificate marks that the production quality management system for the relevant products meets the requirements of the Philippine FDA, establishing the basic conditions for drug registration and commercial launch in the Philippines. The company plans to initiate registration of the relevant products in the Philippines and subsequent market promotion work, and gradually expand into the Southeast Asian market. The company also cautioned that the products still need to complete the local drug registration approval process in the Philippines, and the registration cycle, approval results, and final launch timing all remain uncertain. There are certain risks regarding whether commercialization can be successfully achieved and expected returns obtained.

The CDC has acknowledged one of the four measles-related deaths reported by Pennsylvania, ending weeks of resistance by the agency. The CDC's "Measles Cases and Outbreaks" page lists 3,471 cases nationwide as of Sept. 18, compared with 2,289 in all of 2025. Of the 3,471 cases, 9 percent, or 301 individuals, have resulted in hospitalizations, and 95 percent of all cases were in people not vaccinated with the MMR shot, which Merck and GSK market in the U.S. Pennsylvania is the hardest-hit state, with 792 cases as of Sept. 21. Pennsylvania Secretary of Health Debra Bogen recently asked the CDC for rapid-response assistance known as Epi-Aid, but only if the agency recognizes the state's four measles-associated deaths.

CSL has secured a multi-year Advance Purchase Agreement extension with the UK government for its Aujemflu vaccine, making the UK the first country to commercially launch CSL Seqirus' adjuvanted, trivalent cell-based influenza vaccine. The agreement highlights the role of CSL's UK manufacturing hub in supporting national pandemic preparedness and large-scale flu vaccine supply. CSL, an A$86.5b biopharmaceutical group, already runs vaccine and specialty medicine operations across several regions, so the UK-first rollout plugs into an existing global manufacturing and distribution footprint rather than a one-off product launch. Analysts expect CSL earnings to recover from a US$2.6b loss and move toward US$3.4b by 2029, with the first full Aujemflu season in 2027/28 serving as the clearest test of how much of the extended UK commitment is actually manufactured and supplied on time from Liverpool. The deal also raises the bar on restructuring risk, since any stumble in delivering over 100 million pandemic doses would weaken the case that operational transformation can reliably support margin expansion.

Pfizer is reallocating resources toward newer and acquired medicines, vaccines and oncology products while reducing its reliance on COVID-19 products, according to chief international commercial officer and executive vice president Alexandre de Germay. COVID-related revenue is projected to fall from about $11 billion in 2024 to approximately $6.7 billion in 2025 and $4 billion in 2026. New and newly acquired products in Pfizer's international business generated about $500 million in 2023 and have since risen to $4 billion, while at the global level new acquired and launched products produced $3.2 billion in the second quarter, up 18% after 22% growth in the first quarter. De Germay said Pfizer has cut operating expenses, halted less productive launches and clinical studies, and tripled international sales-force productivity over three years. Pfizer has 31 Phase III clinical studies underway, including three thoracic cancer candidates, and its obesity portfolio includes bempaglutide in Phase III and a GLP-1 and amylin combination expected to read out by year-end.

Beijing has unveiled a five-year plan aimed at making China a global leader in drug innovation, with a target of developing 25% of the world's first-in-class drugs by 2030. The plan, issued in a joint notice from multiple government ministries, lays out 25 priority tasks spanning innovation capacity, research and technology, including expanded R&D, the use of AI and quantum computing in drug discovery, and the building of pharmaceutical ecosystems beyond pipelines. The government aims for the industry to reach 3.5tn yuan, or $520bn, in annual revenue by 2030, with 50 companies exceeding $1.5bn in annual revenue, and at least five Chinese drugs achieving global annual sales above $1bn. The notice singled out next-generation therapies including antibody-drug conjugates, cell and gene therapies, and CAR-T, along with vaccines and newer platforms such as mRNA, and included a section on industrialising traditional Chinese medicine. Citi analysts said the plan signals a shift from scale-driven growth toward innovation-driven, quality-oriented development, with a broad whole-value-chain policy push covering innovative drugs, medical devices, AI-driven drug discovery, and CDMO/CRO. The biomedical plan was released alongside counterparts for other strategic sectors, including integrated circuits, aerospace, the low-altitude economy, new energy storage and intelligent robotics.

On September 18, the Ministry of Industry and Information Technology, the National Development and Reform Commission, and eight other ministries jointly released the 15th Five-Year Plan for the Development of the Pharmaceutical Industry, proposing that by 2030, biopharmaceutical R&D and application will rank among the world's leaders, and the biopharmaceutical industry will accelerate its rise as a national emerging pillar industry. The plan sets 10 expected indicators covering industrial scale and efficiency, innovative development, enterprise cultivation, and cluster development, including operating revenue of pharmaceutical industrial enterprises above designated size exceeding 3.5 trillion yuan, an average annual growth rate of the innovative drug industry scale exceeding 20 percent, more than 5 products with global annual sales exceeding 1 billion US dollars, first-in-class innovative drugs accounting for more than 25 percent of the global total, more than 200 innovative medical devices launched, 50 pharmaceutical industrial enterprises with annual operating revenue exceeding 10 billion yuan, and 20 pharmaceutical industrial parks at the 100-billion-yuan level. Boosted by this news, the three major stock indices all rose more than 1 percent in early trading that day. Huatian Technology hit the daily limit up, with turnover of 6.065 billion yuan, nearly 1.47 million lots of sealed buy orders on the limit-up board, and nearly 3.3 billion yuan of main capital rushing in, ranking first in the A-share market. Zhou Sicong, fund manager of Ping An Pharmaceutical Select, believes innovative drugs are likely to become an important growth theme, and CITIC Securities said China's innovative drugs have entered a stage of global value realization. According to statistics from Securities Times Data Treasure, since September, Chengdu Leading Pharmaceutical, Asymchem Laboratories, Porton Pharma Solutions, and Hunan Warrant Pharmaceutical have led gains, all rising more than 10 percent, with Chengdu Leading Pharmaceutical up a cumulative 16.87 percent.

The European Medicines Agency has validated the Marketing Authorization Application for PF-07307405, the experimental Lyme disease vaccine candidate from Pfizer and French biotech Valneva, and will now begin its official review. The filing rests on the Phase 3 VALOR trial, a placebo-controlled, randomized study of 9,437 participants aged five and older in high-incidence Lyme disease locations across the US, Canada, and Europe, which reported efficacy of over 70% in reducing confirmed Lyme disease cases with no safety issues detected. The statistical picture was less clean than the headline number: the first prespecified analysis, which served as the primary endpoint, showed 73.2% efficacy but failed the trial's predefined statistical criterion because the lower bound of the 95% confidence interval was 15.8%, below the required 20%, while a second prespecified analysis showed 74.8% efficacy and did meet that threshold. Under the 2020 partnership and license agreement, Pfizer holds exclusive rights to produce and commercialize the vaccine if approved, with Valneva benefiting as development partner; Valneva says PF-07307405 is the most advanced Lyme disease vaccine candidate currently in clinical development. Pfizer shares were essentially flat on the news, and hedge fund ownership stood at 83 funds in the second quarter of 2026, unchanged from the first quarter, while Valneva's hedge fund exposure rose to 4 funds from 1. MAA validation means the application meets the standards for the EMA to begin evaluating it, not that approval is near or guaranteed, and formal reviews of this nature often take many months to complete.

Merck is relying on a growing pipeline and an expanding portfolio of newer medicines, including acquired assets, to offset the eventual loss of exclusivity for its blockbuster cancer drug Keytruda. Keytruda generated sales of $16.40 billion in the first half of 2026, up nearly 4.2% year over year, and is expected to remain strong until it loses patent exclusivity in 2028, after which biosimilars entering around 2028-2029 are likely to drive a sharp decline. Merck's phase III pipeline has almost tripled since 2021, and the company expects to launch 20 new drugs by 2030, with newer products already emerging as growth drivers: pulmonary arterial hypertension drug Winrevair and 21-valent pneumococcal conjugate vaccine Capvaxive generated $1.1 billion and $325 million, respectively, in first-half 2026 sales, while cancer drug Welireg sales surged 57% year over year to $470 million. Merck expects more than $70 billion of potential non-risk-adjusted commercial opportunity for the current pipeline by the mid-2030s, more than double the peak consensus sales estimate for Keytruda of $35 billion in 2028, and has stepped up acquisitions ahead of the patent expiry with deals for Verona Pharma, Cidara Therapeutics and Terns Pharmaceuticals. Management expects the Keytruda LOE period to look like a shallow dip with a fast return back to growth, even as Keytruda faces competition from Bristol Myers' Opdivo, Roche's Tecentriq and AstraZeneca's Imfinzi.

Vaxcyte expects to report topline results from its pivotal Phase 3 OPUS-1 trial of the pneumococcal vaccine candidate VAX-31 by the end of October, narrowing its previous guidance for a fourth-quarter readout. The OPUS-1 study, which is part of a three-trial adult program involving 6,191 participants, will provide safety, tolerability, and immunogenicity data from a noninferiority study in adults. The company also appointed former Pfizer vaccine executive Luis Jodar as chief medical officer and David McAvoy, formerly of Teva Pharmaceutical Industries, as chief legal officer, as it prepares for a potential Biologics License Application and commercial launch. VAX-31 is the broadest-spectrum pneumococcal conjugate vaccine in clinical development, designed to protect against 31 bacterial serotypes, and results from the other two trials, OPUS-2 and OPUS-3, are expected in the first half of 2027.

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.

Pfizer and BioNTech announced that the U.S. Food and Drug Administration has approved their 2026-2027 COVID-19 vaccine formula targeting the XFG variant, for use in adults aged 65 and older and in individuals aged 5 to 64 with high-risk underlying conditions. The approval is based on clinical, non-clinical, and real-world data showing strong immune responses against circulating variants including XFG, XFG.1.1, NB.1.8.1, PQ.17, and PQ.2.8.1. The XFG variant was selected following FDA guidance for the fall 2026 season. Shipping begins immediately, with availability in U.S. pharmacies, hospitals, and clinics in the coming days. To date, more than five billion doses of COMIRNATY have been distributed globally.

Pfizer and Valneva announced that the European Medicines Agency has validated the Marketing Authorization Application for their Lyme disease vaccine candidate, PF-07307405, initiating the regulatory assessment process for what could become a first-in-class vaccine for the disease in North America and Europe. The application is backed by Phase 3 efficacy data, with the companies highlighting an unmet medical need in Lyme disease prevention. This development is part of Pfizer's broader strategy to address widespread infectious diseases, complementing its existing vaccine portfolio. Investors should monitor the EMA's review milestones, including committee opinions and formal decisions expected into 2027, as well as any disclosures on manufacturing readiness and uptake expectations for the vaccine.

The Food and Drug Administration has registered a 9-valent cervical cancer vaccine and a bivalent botulinum antitoxin, both produced domestically for the first time in Thailand and ASEAN. The 9-valent HPV vaccine resulted from technology transfer cooperation with INNOVAX and received marketing authorization on 24 July 2026. The Botulinum Antitoxin was developed with the Queen Saovabha Memorial Institute of the Thai Red Cross Society and was registered on 6 July 2026, helping reduce import dependence and strengthening emergency preparedness. Prime Minister and Interior Minister Anutin Charnvirakul joined an event showcasing these achievements at Government House. The National Vaccine Institute has managed funding under the Science, Research and Innovation Promotion Fund since 2022 to elevate Thailand into an ASEAN vaccine security hub.

Zhejiang Wolwo Bio-Pharmaceutical announced that its Class 1 new drug, a cat hair film agent, has received approval from the National Medical Products Administration to conduct clinical trials for adult patients with allergic rhinitis related to cat hair and dander sensitization. The product is a Class 1 therapeutic biological product in the form of a sublingual film. It will work in coordination with the already marketed cat hair and dander allergen skin prick test solution to provide a combined diagnostic and therapeutic solution, and will complement the dust mite drops and mugwort pollen allergen sublingual drops. As of the announcement date, no other domestic company has obtained a registration certificate for this product. The company cautioned that subsequent stages, including Phase I to Phase III clinical trials and marketing authorization applications, are still required and involve uncertainty.

Biotech stocks reached their highest level since the height of the pandemic after Moderna and Merck announced that a late-stage trial testing their messenger RNA-based cancer therapy met its main goals. Healthcare became the best-performing sector in the S&P 500, with the State Street SPDR S&P Biotech ETF adding more than 4% to reach its highest level since February 2021. The individualized neoantigen therapy intismeran autogene, combined with Merck's Keytruda, improved recurrence-free survival with a statistically significant and clinically meaningful effect in the Phase 3 INTerpath-001 trial. Moderna shares more than doubled, Merck added over 12%, and rival vaccine makers BioNTech and Novavax also gained sharply. Gene editing companies including Prime Medicine, Intellia, CRISPR, Editas Medicine, and Beam Therapeutics were notable gainers, while AI-related biotechs Absci and Recursion Pharmaceuticals rallied after Anthropic selected Twist Bioscience as an independent evaluator.

A team of researchers in Australia has discovered a new way to prevent malaria by turning the mosquito bite from the source of infection into a trigger for disease-fighting immunity. The Walter and Eliza Hall Institute of Medical Research, or WEHI, revealed that the research team has demonstrated a new vaccination approach that primes the immune system to fight malaria parasites before they cause illness. Subsequent mosquito bites then act as boosters that strengthen immunity over time. The research report, published in the journal Science, states that the method protected laboratory mice from malaria for up to two years, covering two malaria transmission seasons in real-world conditions. The researchers developed the immunization strategy by pairing mosquito-borne malaria parasites with an experimental antimalarial drug developed by WEHI and the biopharmaceutical company MSD. The study results show that the drug can trap late-stage malaria parasites in the liver in time, before they enter the bloodstream and cause disease. This triggers a strong immune response and provides long-lasting protection against malaria. The researchers said that subsequent mosquito bites help strengthen immunity even further, which could open the way to vaccination and natural boosting approaches in areas where malaria is endemic. A long-acting injectable formulation developed from the drug is now in development ahead of human studies. The World Health Organization says malaria caused about 610,000 deaths worldwide in 2024.

The European Medicines Agency has validated the Marketing Authorization Application for Pfizer and Valneva's Lyme disease vaccine candidate PF-07307405, beginning its assessment of the submission. The application is based on efficacy of more than 70% observed in the Phase 3 VALOR trial, which enrolled 9,437 participants aged five and older across the U.S., Canada, and Europe, with no safety concerns identified. Pfizer's Chief Vaccines Officer Annaliesa Anderson said the vaccine could be the first of its kind in Europe, where Lyme disease affects more than 100,000 people annually and over 200 million live in risk areas. Valneva CEO Thomas Lingelbach called the acceptance a major milestone for the collaboration established in April 2020, under which Pfizer will exclusively manufacture and commercialize the vaccine if approved.

CanSino Biologics' self-developed adsorbed acellular DTP combined vaccine for infants, Pancocin, has received the Biologics Batch Release Certificate for its first batch, officially entering the market supply stage. On August 13, the bioproducts sector rose 3.01% intraday, with Novoprotein up 13.99%, Staidson up 11.12%, ACROBiosystems up 9.03%, OPM Biosciences up 8.78%, and Junshi Biosciences up 8.08%. Huayuan Securities research notes that the biologics market continues to expand, expected to reach 904.8 billion yuan by 2029, with a compound annual growth rate of 11.28% from 2020 to 2029, directly driving demand for upstream core consumables such as cell culture media. The Chinese market is expected to reach 683 million US dollars by 2029, with a compound annual growth rate of 14.00%, and the trend toward domestic self-reliance is clear.

Xiamen Innovax Biotech, a wholly owned subsidiary of Wantai Biological, has received approval from the Thai Food and Drug Administration to market its independently developed nine-valent HPV vaccine. The vaccine is indicated for females aged 9 to 45 and covers seven high-risk HPV types—16, 18, 31, 33, 45, 52, and 58—as well as two low-risk types, 6 and 11. Earlier, the vaccine was approved by China's National Medical Products Administration in 2025, becoming the first domestically developed nine-valent HPV vaccine and the second globally.