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YS Biopharma's new HBV vaccine enters Phase I trials

EditorEmilio Ghigini
Published 04/18/2024, 08:18 AM

GAITHERSBURG, Md. - YS Biopharma Co., Ltd. (NASDAQ:YS), a company focusing on vaccines and biologics for infectious diseases and cancer, has received approval from the Philippine Food and Drug Administration to begin Phase I clinical trials for its YS-HBV-002 vaccine, targeting chronic hepatitis B virus (HBV) infection. The trial is set to commence in June 2024.

Chronic HBV is a significant public health issue worldwide, with an estimated 254 million people affected and 1.2 million new infections annually. The condition can lead to serious liver diseases, including cirrhosis and cancer, and was responsible for approximately 1.1 million deaths in 2022. Despite available preventive vaccines, treatments for chronic HBV remain limited.

The YS-HBV-002 vaccine represents a potential new therapeutic option for those already infected with chronic HBV. Dr. David Shao, the CEO of YS Biopharma, stated that the approval for the clinical trial marks an important step in addressing the unmet need for effective chronic HBV treatments.

The upcoming Phase I trial will utilize a double-blind, randomized, placebo-controlled, dose-escalation design to assess the vaccine's safety, immunogenicity, and efficacy. YS-HBV-002 aims to activate both humoral and cellular immune responses, potentially overcoming immune tolerance in chronic HBV patients.

YS-HBV-002 builds on the company's proprietary technology and the results of its first-generation HBV vaccine, YS-HBV-001. It includes recombinant core and surface hepatitis B antigens, combined with YS Biopharma's proprietary PIKA adjuvant, to stimulate a comprehensive immune response.

YS Biopharma, with operations across China, the United States, Singapore, and the Philippines, continues to develop its PIKA® immunomodulating technology platform and its portfolio of vaccines and biologics.

The information in this article is based on a press release statement from YS Biopharma Co., Ltd.

InvestingPro Insights

As YS Biopharma Co., Ltd. (NASDAQ:YS) ventures into clinical trials for its innovative YS-HBV-002 vaccine, investors may be eyeing the company's financial health and stock performance with keen interest. According to InvestingPro, YS Biopharma has been showcasing an impressive gross profit margin of 80.05% over the last twelve months as of Q2 2024, signaling a strong ability to control costs relative to its revenue.

InvestingPro Data reveals a market capitalization of 176.27 million USD, which may reflect investor confidence in the company's potential despite its challenges. Additionally, the stock has experienced a strong return over the last month, with a 30.71% price total return, which could suggest growing investor optimism around the company's prospects.

Nevertheless, the company is not without its financial concerns. An InvestingPro Tip highlights that YS Biopharma is quickly burning through cash, a critical factor for investors to consider as the company progresses through costly clinical trials. Moreover, the stock has been identified as trading in overbought territory, based on the Relative Strength Index (RSI), hinting at potential volatility ahead.

For investors seeking more in-depth analysis and additional InvestingPro Tips, such as anticipated sales declines and expectations around profitability, the InvestingPro platform provides a comprehensive suite of tools and insights. With the use of coupon code PRONEWS24, readers can gain an additional 10% off a yearly or biyearly Pro and Pro+ subscription to access these valuable resources. In total, there are 16 additional InvestingPro Tips available for YS Biopharma, which could further guide investment decisions.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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