Hua Hui Anjian's Liribetab Receives FDA Breakthrough Therapy Designation for Chronic Hepatitis D

　　【Pharmaceutical Network Industry DynamicsRecently, Leribivirtamab developed by Huahui Health was granted Breakthrough Therapy Designation by the U.S. FDA (Food and Drug Administration) for the treatment of chronic hepatitis D virus (HDV) infection.
 

Data show that Libevetumab, developed by Huahui Health, is a neutralizing antibody targeting the pre-S1 region of the large envelope protein on the surface of the hepatitis B virus. It can block both hepatitis D virus and hepatitis B virus from binding to their receptor NTCP, thereby preventing the viruses from entering liver cells and neutralizing the infection.
 

According to estimates by the World Health Organization, there are 15 to 20 million people chronically infected with HDV worldwide. The disease progresses rapidly and often develops into severe liver conditions such as cirrhosis and liver cancer, making it a serious type of chronic viral hepatitis. Currently, there are no approved drugs for the treatment of chronic HDV infection in China or the United States. Industry experts indicate that the breakthrough therapy designation granted to Libevirtamab in the U.S. is expected to accelerate the development of this innovative drug.
 

"Breakthrough Therapy Designation" is an important review procedure by the U.S. FDA to accelerate the development and approval of drugs that treat serious conditions and address significant unmet medical needs.
 

According to the review, since this year, multiple innovative drugs produced in China have received the FDA's Breakthrough Therapy Designation. For instance, on September 2, Simcere announced that its investigational innovative drug for stroke, Xianbixin Sublingual Tablets (Edaravone Dexborneol Sublingual Tablets), received the FDA Breakthrough Therapy Designation for the treatment of Acute Ischemic Stroke (AIS).
 

The announcement shows that Xianbixin Sublingual Tablets are a type of neuroprotective agent with antioxidant, anti-inflammatory, and synergistic effects, capable of reducing brain cell damage caused by acute ischemic stroke. The drug contains two active ingredients, edaravone and dexborneol, which together exert synergistic anti-inflammatory effects, improve acute onset in patients with acute ischemic stroke, and may even enhance patient prognosis while reducing disability rates.
 

On August 20, Hansoh Pharma announced that its partner, GlaxoSmithKline (GSK), had received Breakthrough Therapy Designation from the U.S. FDA for HS-20093. Reportedly, Hansoh Pharma entered into an exclusive licensing agreement with GSK in December 2023, granting GSK a worldwide exclusive license to develop, manufacture, and commercialize HS-20093. This B7-H3-targeted antibody-drug conjugate is being evaluated for the treatment of patients with extensive-stage small cell lung cancer (recurrent or refractory) who have progressed during or after platinum-based chemotherapy.
 

On April 7, Dizal announced that the U.S. FDA granted Breakthrough Therapy Designation to its first self-developed novel targeted lung cancer drug "Sunvozertinib" (generic name: Sunvozertinib Tablets) for the first-line treatment of patients with advanced non-small cell lung cancer carrying epidermal growth factor receptor exon 20 insertion mutations.
 

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