Kangleweishi Advances World’s Most Comprehensive HPV Vaccine to Phase II Trials
By Thomas Yuan

BEIJING — Kangleweishi Biotechnology has announced that its 15-valent recombinant human papillomavirus (HPV) vaccine, co-developed with Liaoning Chengda Biotechnology, has officially entered Phase II clinical trials. The update was published on China’s National Drug Administration’s clinical trial registration platform, marking a significant milestone in what may become the most protective HPV vaccine ever developed.

The vaccine, produced using Escherichia coli expression systems, has completed Phase I trials without safety concerns and now moves into broader human studies to further evaluate efficacy, immune response, and safety profile. The 15-valent formulation targets all high-risk HPV strains classified by the International Agency for Research on Cancer (IARC), including types 6, 11, 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68.

If successful, the vaccine could offer more than 96% protection against cervical cancer, as well as other HPV-related malignancies such as vaginal, vulvar, anal, and genital cancers, and genital warts. It stands to become the highest-valency HPV vaccine globally to reach the clinical trial approval (IND) stage or beyond.

A Landmark in Preventive Biopharmaceuticals

The new vaccine candidate reflects China’s expanding capabilities in biopharmaceutical innovation, particularly in the realm of recombinant vaccine technology. Kangleweishi noted that it will work closely with Chengda Biotechnology to accelerate clinical research and regulatory submissions. “This Phase II launch demonstrates that our product development has entered a critical stage,” a spokesperson said.

In addition to public health significance, the vaccine is expected to enhance the company’s pipeline of high-value health products and bolster its position in the global medical technology and life sciences market. Its broad spectrum of protection may also make it an essential tool for national immunization programs in both developed and emerging markets.

Market Potential and Global Relevance

With HPV-related diseases affecting hundreds of millions worldwide and the existing market dominated by 9-valent vaccines, the entry of a 15-valent HPV vaccine could reshape global competition. The product’s broad protection is especially relevant for countries with high prevalence of non-16/18 high-risk HPV types — often overlooked by current vaccines.

Analysts expect strong demand from public health institutions and private healthcare providers alike, especially in regions prioritizing preventive medicine, women’s health, and cervical cancer eradication strategies.

As China continues to invest heavily in next-generation vaccines, the advancement of this candidate marks another step forward in the country’s ascent as a global innovator in medical supply development, biotech R&D, and clinical trial leadership.

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