Pfizer IncPFE
▲ PositiveRegulationrelevance
EMA validated Pfizer's Marketing Authorization Application for Lyme vaccine candidate PF-07307405, advancing it into formal regulatory review.
Impact on stocks 2
Biotech & Genomic Medicine▲ · 1 stocks
Pfizer IncHealth Care▲ · 1 stocks
Valneva SEVLA
▲ PositiveRegulationrelevance
EMA validated the MAA for PF-07307405, Valneva's most advanced Lyme vaccine candidate developed under its Pfizer partnership.
Theme Impact 1
Off-coverage companies
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▲impact 4
Ten ministries jointly release the 15th Five-Year Plan for the pharmaceutical industry, bringing major positives to the innovative drug sector
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.
Vaxcyte Hires Pfizer and Teva Veterans, Moves VAX-31 Phase 3 Data to October
Vaxcyte announced two C-suite hires on September 3 and narrowed the timeline for its most important catalyst, saying it now expects topline safety, tolerability and immunogenicity data from the VAX-31 adult Phase 3 OPUS-1 trial by the end of October rather than sometime in the fourth quarter. Luis Jodar joins as Chief Medical Officer after 17 years at Pfizer, where he was Chief Medical Officer for Vaccines and Infectious Diseases and helped lead clinical development and medical affairs for Prevnar 13 and Prevnar 20, the pneumococcal vaccines VAX-31 is trying to displace. David McAvoy joins as Chief Legal Officer from Teva Pharmaceutical, where he ran a 235-person legal, compliance and government affairs organization as Executive Vice President and Chief Legal Officer, and previously served as General Counsel of Endocyte through its $2.1 billion acquisition by Novartis and spent 27 years at Eli Lilly. The OPUS-1 trial alone dosed 4,049 participants in a head-to-head comparison against Prevnar 20 and Capvaxive, part of a broader Phase 3 program that has dosed 6,191 adults in total, roughly 3,500 of them with VAX-31, and Vaxcyte held about $2.5 billion in cash, cash equivalents and investments as of June 30, 2026. The trial measures safety, tolerability and immunogenicity against Prevnar 20 and Capvaxive rather than a fresh efficacy claim, so the near-term thesis rests on VAX-31 clearing a noninferiority bar, and the company still has no approved product or product revenue, with OPUS-2 and OPUS-3 data and the VAX-31 infant Phase 2 study not expected until the first half of 2027 and the VAX-A1 Group A Strep candidate not guided to topline data until the second half of 2027.
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GSK Buys Chimagen Trispecific T Cell-Engager for Multiple Myeloma
GSK agreed to acquire Chimagen's trispecific T cell-engager candidate for multiple myeloma, a drug asset the parties describe as a potential best in class trispecific T cell therapy. The deal expands GSK's blood cancer research portfolio and complements recent moves such as the Nuvalent acquisition that brought in Jideytro. Separately, GSK plans to close its German vaccine manufacturing site and consolidate production in Canada, with associated job reductions and supply chain changes. The key test will be whether GSK hits its stated timeline to move the trispecific T cell-engager into phase I trials in 2027, while advancing Jideytro's first line FDA submission planned for 2026. GSK is a £74.8b pharmaceuticals group that develops vaccines, specialty treatments and general medicines across major markets.