政府新闻
上海医药：SRD4610获得美国FDA孤儿药资格认定 2024-12-12
Shanghai Pharma gains after new ALS treatment wins US orphan drug status
Shanghai Pharmaceutical’s shares rose after the firm said US authorities have granted orphan drug designation to its experimental treatment for amyotrophic lateral sclerosis, a rare and fatal neuromuscular disorder.
The company’s shares ended 2.4 percent higher at CNY21.93 (USD3.02) each in Shanghai, after climbing by as much as 4.1 percent earlier on Wednesday. The stock has gained 31 percent since the end of last year.
SRD4610 is a compound innovative drug based on traditional Chinese medicine for treating ALS, which results in the loss of brain and spinal cord motor neurons, the company said yesterday.
The US Food and Drug Administration’s backing will help pay for the research and development, market registration, and eventual commercialization of SRD4610 in the US market, the firm said. Shanghai Pharma will also enjoy additional support, including tax credits on clinical trial costs, new drug application fees waivers, as well as other benefits, it said.
Orphan drug designation is given to treatments for rare medical conditions that would not be profitable to produce without government support. With ODD, SRD4610 will enjoy seven years of market exclusivity in the US once it is approved.
Shanghai Pharma has invested CNY65.4 million (USD9 million) in developing SRD4610 so far and has full intellectual property rights. The drug has undergone Phase II clinical trials in China, but the company did not provide an update on its human trials in the US.
ALS patients steadily lose the ability to move, speak, eat and eventually breathe. The average life expectancy for someone with ALS is three to five years from the time of symptom onset. The ALS Ice Bucket Challenge, where people pour buckets of ice water over their heads, was a social media phenomenon which started in the US during the summer of 2014 to promote awareness of the disease.
The only effective treatment for ALS in China at present is US biotech giant Biogen’s Tofersen, which was approved for conditional marketing in the country in October. Before this, there were only two other drugs on the market which had limited efficacy and poor results.
Source: Yicai Global
