Shaanxi's first Class 1 innovative drug approved for market launch

Xi'an Xintong Pharmaceutical Research Co said on Wednesday that its groundbreaking hepatitis B targeted Class 1 innovative drug, "Xinshumu," has received approval for market release.

A press conference announcing approval of the "Xinshumu" drug is held in the Silk Road Innovation Valley, Xi'an High-tech Zone.

The greenlighting of Xi'an Xintong’s Previver Mesylate Tablets (Xinshumu), represents a significant breakthrough in the treatment of chronic hepatitis B, and in Shaanxi province's Class 1 innovative drug landscape.

As the world's inaugural drug targeting hepatitis B, this medication utilizes the HepDirectTM liver-targeted delivery system to concentrate active metabolic components in the liver, enhancing efficacy while reducing toxicity.

Xinshumu represents a key new drug development in line with the initiative outlined during China’s 12th and 13th Five-Year Plans. Phase III clinical data underscores its robust efficacy and superior safety profile compared to similar medications. Over time, its efficacy strengthens and endures more than existing drugs, particularly benefiting patients with low viral loads.

Current frontline hepatitis B treatments largely comprise foreign product imitations, failing to cater to patients' diverse needs and leaving clinical gaps unaddressed.

In development since 2011 and now approved for the market, Xinshumu signifies China's progress in liver disease medicine. This breakthrough diminishes import monopolies, enhances Shaanxi's innovative drug ecosystem, propels pharmaceutical industry transformation and fosters high-quality development.

Xi'an Xintong Pharmaceutical Research Co is headquartered in Xi'an High-tech Zone.

Headquartered in Xi'an High-tech Zone, Xi'an Xintong Pharmaceutical Research Co is one of the pivotal high-tech innovation enterprises to be backed by the zone.

In recent times, Xi'an High-tech Zone has concentrated on biopharmaceutical industry development and innovation, executing the life technology catch-up project and fostering a hub for innovative drug research and development.

Recently, an industrial chain framework has emerged, centered on innovative research and development, pharmaceutical manufacturing, medical services and pharmaceutical distribution.

Last year, the total output value of the biopharmaceutical industry in Xi'an High-tech Zone reached 24.9 billion yuan ($3.50 billion), with more than 5,000 registered biopharmaceutical entities and a cumulative registration of 3,755 intellectual property rights.

As a core component of the modern industrial system, the high-tech zone boasts a strategic advantage in biomedicine and anticipates constructing a burgeoning industry worth 100 billion yuan in the foreseeable future.