Beijing, June 6, 2025 — ZhiFei Bio (300122), a leading Chinese biopharmaceutical firm, announced Monday that its subsidiary ZhiFei Lvzhu has received formal acceptance from China’s National Medical Products Administration (NMPA) for its 15-valent pneumococcal conjugate vaccine (PCV15) production registration. If approved, this domestically developed vaccine will become the first of its kind in China to cover 15 serotypes of Streptococcus pneumoniae, addressing a critical gap in pediatric immunization and strengthening ZhiFei’s position as a pioneer in vaccine innovation.
PCV15: A Precision Tool for Pneumococcal Disease Prevention
Pneumococcal infections remain a leading cause of severe respiratory illness, particularly among infants and the elderly. Global Burden of Disease data reveals the bacterium caused 97.9 million infections and 500,000 deaths worldwide in 2021, with young children disproportionately affected due to immature immune systems. Antibiotic resistance has compounded treatment challenges, making vaccination a cornerstone of global public health strategies.
ZhiFei Lvzhu’s PCV15 is uniquely tailored to target the 15 serotypes most prevalent in Asia, including highly virulent strains like 2, 12F, and 23F. Designed for infants as young as 6 weeks old (with the first dose at 2 or 3 months), the vaccine builds a robust immune barrier against major pneumococcal pathogens. Notably, no other 15-valent conjugate vaccine is currently approved in China, positioning PCV15 as a game-changer in pediatric protection.
Upon launch, PCV15 will complement ZhiFei’s existing 23-valent pneumococcal polysaccharide vaccine (suitable for adults) and its pipeline 26-valent conjugate vaccine (in Phase I/II trials), creating a comprehensive portfolio covering all age groups and serotypes.
Accelerated Innovation Across Vaccine Platforms
ZhiFei Bio’s breakthrough in pneumococcal vaccine development is part of a broader innovation push. The company has achieved significant progress across multiple vaccine categories in 2025:
Meningitis Vaccines: The ACYW135 quadrivalent meningococcal conjugate vaccine was submitted for registration on May 30, expanding its meningitis product line alongside existing vaccines like Mennake® and Menweike®.
Global Trials: The bivalent dysentery conjugate vaccine has entered Phase III trials in Bangladesh, signaling ambitions for international market expansion.
Therapeutic Vaccines: A therapeutic BCG vaccine for non-infectious diseases has advanced to Phase III trials, exploring new applications beyond traditional prevention.
Influenza Innovation: The adjuvanted quadrivalent influenza vaccine (ZFA02) has entered Phase I/II trials, marking a first in China’s quest to develop next-generation flu vaccines.
Strategic Portfolio Builds Market Dominance
ZhiFei’s vaccine matrix now spans eight major categories, with a particular focus on combination vaccines and high-unmet-need areas
Pneumonia: The 23-valent polysaccharide vaccine (adults) and 15/26-valent conjugate vaccines (children) form a lifecycle solution, with the 15-valent filling a critical gap for infants.
Meningitis: The upcoming quadrivalent conjugate vaccine will join a full suite of meningococcal vaccines, solidifying ZhiFei’s leadership in this sector.
Influenza: A tiered pipeline includes approved quadrivalent vaccines, pending trivalent variants, and innovative adjuvanted formulations, addressing diverse consumer needs.
R&D Investment Drives Long-Term Growth
The company’s innovation momentum is supported by substantial R&D investment: ¥1.391 billion in 2024 alone, with a five-year cumulative spend exceeding ¥5.1 billion. A team of 1,072 researchers is driving breakthroughs in adjuvant technology, multi-valent vaccines, and global clinical development.
“ZhiFei Bio’s commitment to original research and rapid translation of scientific findings is reshaping China’s vaccine landscape,” said Dr. Li Wei, chief scientific officer. “The 15-valent pneumococcal vaccine exemplifies our mission to deliver affordable, high-quality immunization solutions that address unmet medical needs, both domestically and globally.”
With regulatory approval of PCV15 expected in the coming months, ZhiFei is poised to capture a significant share of China’s estimated ¥15 billion pediatric vaccine market, while setting the stage for future innovations in infectious disease prevention
Related topics：
