Today is Great Cold
WINTER
The Great Cold
and it is a snow-white scene

WINTER
As Great Cold arrives, winter's chill deepens.

Amid the winter snow, glad tidings arrive. Anweituo's HPV therapeutic vaccine has received dual approvals from the National Medical Products Administration (NMPA), marking Shandong's first therapeutic nucleic acid vaccine. This technological breakthrough brings warmth to Yantai's biomedical industry in the winter cold, strengthening the defense line for health protection.

GREAT COLD
Blue Pharma Valley — A Highland for Pharmaceutical Innovation
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Recently, Anweituo (Yantai) Biomedical Technology Co., Ltd. (a wholly-owned subsidiary of Beijing Xunsheng Biomedical Research Co., Ltd.), a resident enterprise of Blue Pharma Valley · Life Island Park, has delivered exciting and major good news — its independently developed HPV therapeutic vaccine has successfully obtained two Drug Clinical Trial Approval Notices from the National Medical Products Administration (NMPA) and has officially been implemented for clinical application in the national "Pilot and Demonstration Zone." These two approvals precisely cover the entire course of HPV infection: one targets patients with HPV infection and precancerous lesions (CIN 1/2/3), and the other targets patients with HPV-associated tumors, achieving full-life-cycle treatment coverage for HPV patients from the initial infection stage, through precancerous lesions, to the tumor stage. This breakthrough achievement not only makes this vaccine the first therapeutic nucleic acid vaccine in Shandong Province, but also the first gene-based innovative product in the province to be implemented in the Pilot and Demonstration Zone.

Technological Deep Dive

Anweituo (Yantai) has fully leveraged the technological accumulation of its parent company, Xunsheng Biotech, integrating cutting-edge technologies such as gene editing and synthetic biology to build a complete innovation chain from basic R&D to industrialization. The newly approved HPV therapeutic vaccine is an innovative therapeutic nucleic acid vaccine targeting high-risk HPV-16 and HPV-18. The precise positioning of the two approvals breaks through the limitations of traditional treatment scenarios. The approval for patients with HPV infection and CIN 1/2/3 specifically addresses the core pain points of ineffective preventive vaccines and high recurrence rates with conventional treatments, thereby blocking disease progression to malignancy. The approval for HPV-associated tumor patients provides a new immunotherapeutic direction for patients with advanced disease, filling a gap in the full-course HPV treatment system. This vaccine innovatively combines nucleic acid medicine with immunotherapy, utilizing Xunsheng's proprietary nucleic acid sequence optimization technology, achieving a dual breakthrough in enhanced efficacy and clinical convenience.

Tackling the Challenge of HPV

Preclinical research data has fully validated the product's outstanding potential: it can effectively trigger specific cellular immune responses, significantly inhibit rapid tumor growth, and prolong the survival of tumor-bearing animals. In over 30 IIT (Investigator-Initiated Trial) cases completed, more than 95% of patients showed therapeutic effects, laying a solid foundation for the promotion of the two approvals in their respective clinical scenarios. This full-life-cycle treatment approach not only provides personalized therapeutic pathways for HPV patients at different stages but also enables China to achieve a technological leap in HPV treatment from "symptomatic management" to "whole-course protection."

Domestic and International Patents
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As Shandong's first therapeutic vaccine and the first gene-based product to be implemented in the Pilot and Demonstration Zone, this dual-approval breakthrough will not only benefit the high-risk HPV-infected population nationwide, but will also leverage the policy advantages of the Pilot and Demonstration Zone to rapidly accumulate real-world research data across different stages of the disease.

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Park and Enterprises Cultivate Together
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From the company's settlement in Blue Pharma Valley · Life Island to the impactful delivery of dual approvals, the success of Anweituo (Yantai)'s HPV therapeutic vaccine is a vivid illustration of the resonance between the park's premium services and the enterprise's technological innovation. In the future, Anweituo (Yantai) will take this breakthrough as an opportunity to steadily advance subsequent clinical trials and industrialization for the HPV-infected population, generating more breakthrough innovative achievements. This will help propel Yantai into the nation's top tier of biomedical industries, enable high-quality medical resources "cultivated in Yantai" and "incubated in Blue Pharma Valley" to benefit more people, and inject stronger momentum into safeguarding public health and promoting high-quality regional economic development.