Vaccines (Recombinant & Traditional)

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.

Zhifei Biological's wholly owned subsidiary Zhifei Lvzhu has developed a nasal spray recombinant respiratory syncytial virus vaccine using a chimpanzee adenovirus vector, and its clinical trial application has been accepted by the National Medical Products Administration. The vaccine is intended to prevent lower respiratory tract infections caused by RSV by inducing respiratory mucosal immune responses through nasal immunization, and is expected to offer a novel non-invasive prevention option for high-risk RSV populations. As of the announcement date, no respiratory syncytial virus vaccine has been approved for marketing in China. In the first quarter of 2026, Zhifei Biological achieved revenue of 2.15 billion yuan and a net loss attributable to the parent company of 388 million yuan.

Bavarian Nordic has received European Commission approval to extend its mpox and smallpox vaccine to children aged 2 to under 12 years. The approval, based on a Phase 2 trial of 227 children and 224 adults co-funded by CEPI, showed non-inferior immune responses and a comparable safety profile in children. The vaccine, marketed as IMVANEX in the EU, is now authorized for use from age 2 and up, strengthening its role in global health preparedness. CEO Paul Chaplin noted that children have been disproportionately affected in recent mpox outbreaks, particularly in parts of Africa.

The U.S. Food and Drug Administration has accepted Merck's supplemental Biologics License Application for ENFLONSIA to extend its respiratory syncytial virus lower respiratory tract disease prevention indication to children under two years of age at increased risk for severe RSV through their second RSV season, with a target action date of March 22, 2027. The European Medicines Agency also accepted a parallel application for the same population in July 2026. Both filings are supported by data from the Phase 3 SMART trial, which showed that an additional 210-milligram dose of ENFLONSIA provided protection in a second RSV season for eligible children, including those with chronic lung disease or congenital heart disease. ENFLONSIA was first approved in the U.S. in June 2025 for infants during their first RSV season and is now authorized in more than 40 countries worldwide.

Leadman announced that its subsidiary, Beijing Sinovac Xiangrui Biological Products, has received clinical trial approval from the National Medical Products Administration for its recombinant Group B meningococcal vaccine. The approval allows the company to conduct clinical trials for the prevention of epidemic cerebrospinal meningitis caused by Neisseria meningitidis serogroup B. The vaccine uses a multi-component recombinant protein technology platform and an E. coli expression system. Currently, products from GSK and Pfizer are available globally, and similar domestic projects have also entered the clinical research stage. This approval will not have a significant impact on the company's operating performance for the current year.

The European Commission has approved Sanofi’s MenQuadfi vaccine for use in infants aged six weeks and older, expanding protection against invasive meningococcal disease caused by serogroups A, C, W and Y. MenQuadfi was previously authorized in the EU only for individuals 12 months and older, and the new indication introduces infant dosing schedules aligned with routine pediatric immunization programs. The approval is supported by the MET58 pivotal study, which evaluated immunogenicity, safety and tolerability in more than 6,000 infants across 11 countries. The decision broadens Sanofi’s vaccine portfolio and gives healthcare providers an additional option to protect infants against a rapidly progressing disease associated with high mortality and long-term complications.

Richard Hatchett, CEO of the Coalition for Epidemic Preparedness Innovations, has indicated that a large-scale clinical trial for a vaccine under development against the Bundibugyo strain of Ebola, which is spreading in Congo, could begin as early as late September or October. As of July 29, cases in Congo have surged to 3,532, with 1,556 deaths, and Hatchett described the situation as extremely serious. CEPI aims to raise 2.5 billion dollars under its five-year strategy starting in 2027, and he argued that preparedness for infectious diseases should be viewed as a national security challenge.

Hilleman Laboratories, a Singapore-based joint venture between Merck and Wellcome, is preparing to manufacture doses of an experimental vaccine against the Bundibugyo strain of Ebola for clinical trials, supported by up to $8.5 million in funding from the Coalition for Epidemic Preparedness Innovations. The candidate uses the recombinant vesicular stomatitis virus platform, the same backbone as the licensed Zaire ebolavirus vaccine, and aims to address the lack of an approved vaccine for Bundibugyo as cases rise in the Democratic Republic of Congo. Hilleman will finalize the manufacturing process and produce clinical trial supplies using starting material generated by IAVI with CEPI support, while Merck acts as a technical adviser contributing proprietary expertise on the platform. If early-stage trials succeed, the partners plan to transfer the technology to large-scale manufacture for rapid and affordable supply in outbreak regions, with an updated process backed by up to $30 million in CEPI funding designed to improve yields and thermostability, potentially lowering costs and enabling refrigerated storage for several months. The initiative is part of CEPI's broader 100 Days Mission to accelerate vaccine development against epidemic threats.

GSK reported second-quarter 2026 sales rose 5% to more than GBP8.4 billion, with core operating profit up 7% and core earnings per share up 9%. Specialty Medicines revenue grew 14% and Vaccines grew 8%, while General Medicines declined 9%. The company updated its full-year 2026 sales and operating profit guidance towards the upper half of the range, but lowered its EPS outlook to the lower half due to additional interest costs of around GBP160 million from the Nuvalent acquisition. GSK also announced a new 'Accelerate Growth' program targeting GBP1.9 billion in annual cost savings by 2029, and plans to start over 20 Phase III trials in 2026, more than double initial expectations.

The University of Oxford has launched the world's first human trial of a vaccine against the Bundibugyo strain of Ebola, with the first volunteer receiving the prototype ChAdOx1 BDBV vaccine. The phase one study will enroll around 50 healthy volunteers to assess safety and immune response. The vaccine was developed by the Oxford Vaccine Group and the Pandemic Sciences Institute, both part of the University of Oxford. The Serum Institute of India manufactured and stockpiled approximately 620,000 doses, including 4,000 trial doses used in this study. Meanwhile, the Democratic Republic of the Congo has reported a cumulative total of 2,905 Ebola cases and 1,269 deaths, with the rising numbers partly due to the integration of databases from Ituri and North Kivu provinces into the national system. The Congolese government has allocated 50 million US dollars to tackle the outbreak, focusing on laboratories, medical equipment, community surveillance, and patient care.