GC Biopharma's BARYCELA Secures Marketing Authorization

GC Biopharma's Breakthrough with BARYCELA

GC Biopharma, a prominent South Korean pharmaceutical company, has achieved a significant milestone with the recent marketing authorization of its varicella vaccine, BARYCELA, in Vietnam. This accomplishment follows earlier domestic approval and WHO Pre-Qualification, demonstrating the company’s commitment to expanding its presence in the global vaccine market.

Regulatory Compliance and Clinical Trials

In order to gain this approval, GC Biopharma executed extensive local clinical trials in Vietnam. These trials were crucial in proving the vaccine's safety and effectiveness, showcasing the company’s adherence to the rigorous regulatory requirements set forth by the Drug Administration of Vietnam (DAV). The regulatory process in Vietnam demands high standards, particularly for vaccines intended for children, making this authorization a testament to the quality of BARYCELA.

Strategic Market Approach

GC Biopharma intends to harness its local affiliate to maximize sales in Vietnam, targeting the vibrant private market for vaccines, which has seen impressive growth in recent years. From 2018 to 2021, the private vaccine sector in Vietnam experienced a remarkable CAGR of 32%, reflecting an increasing demand for vaccination services. BARYCELA, as a relatively new entrant, aims to capture a share of this dynamic market.

Significance of the Approval

"This marketing authorization represents more than just an export of our product; it signifies a strategic move towards expanding our footprint in Southeast Asia," commented Jae Woo Lee, the Head of the Development Department at GC Biopharma. With this development, the company is poised to establish itself as a trustworthy brand in the international vaccine market, adhering to clinical and quality standards that meet global expectations.

BARYCELA: Product Overview

BARYCELA is formulated as a live attenuated vaccine developed from the proprietary MAV/06 virus strain. Its unique manufacturing process not only ensures a high viral titer and yield but is also noteworthy for being the world’s first varicella vaccine produced without the use of antibiotics, leveraging a fully aseptic manufacturing protocol.

About GC Biopharma

GC Biopharma, historically known as Green Cross Corporation, boasts a robust legacy of over 50 years in the development and production of vaccines and plasma-derived products. The company's ambitions continue to evolve, with an expanding global footprint marked by the success of its immunoglobulin G product, Alyglo, in the U.S. market in the coming years. GC Biopharma is dedicated to pioneering innovations in healthcare by leveraging cutting-edge technology in mRNA, protein engineering, and lipid nanoparticle delivery platforms.

Frequently Asked Questions

What is BARYCELA?

BARYCELA is a live attenuated varicella vaccine developed by GC Biopharma to provide immunization against the varicella virus, commonly known as chickenpox.

Why is the marketing authorization significant?

The authorization marks GC Biopharma's entry into the Vietnamese vaccine market, enabling them to meet local healthcare needs while promoting public health through vaccination.

How does BARYCELA stand out in the market?

BARYCELA is unique as it is produced without antibiotics, using a fully aseptic process, which enhances its safety profile.

What future plans does GC Biopharma have?

GC Biopharma aims to strengthen its market presence in Southeast Asia through local partnerships and continued innovation in vaccine development.

What is the significance of local clinical trials?

Local clinical trials are essential for ensuring the safety and efficacy of vaccines in specific populations, complying with regulatory standards set by health authorities.

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