China Grants Conditional Approval to Biogen's ALS Injection
Lin Zhiyin
DATE:  5 hours ago
/ SOURCE:  Yicai
China Grants Conditional Approval to Biogen's ALS Injection China Grants Conditional Approval to Biogen's ALS Injection

(Yicai) Oct. 9 -- US biotech giant Biogen has secured conditional approval from China for its innovative therapy for amyotrophic lateral sclerosis.

China's National Medical Products Administration yesterday approved the use of Qalsody injection in adult patients with ALS who have a mutation in the superoxide dismutase 1 gene, Biogen's Chinese subsidiary announced on the same day.

SOD1 was the first identified gene causing ALS. Qalsody is an antisense oligonucleotide therapy that can bind directly to the SOD1 messenger ribonucleic acid and degrade it, which results in less SOD1 protein being made. It is the world's first and only ALS treatment specifically targeting SOD1.

ALS is a rare, progressive, and fatal neurodegenerative disease that results in the loss of brain and spinal cord motor neurons. ALS patients steadily lose the ability to move, speak, eat, and eventually breathe. The average life expectancy for people with ALS is three to five years from the time of symptom onset.

Chinese regulators approved two other ALS treatments in the past years, but they showed limited efficacy and unsatisfactory therapeutic effects.

"ALS treatment has long been a global challenge, with approved drugs showing limited efficacy," said Fan Dongsheng, director of neurology at Peking University Third Hospital. "The approval of Qalsody in China marks the beginning of a new era in targeted therapy for ALS patients."

The prevalence of ALS in China is about three per 100,000 people. But given the country's large population, its number of ALS patients remains significant.

Editors: Tang Shihua, Futura Costaglione

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Keywords:   Regulatory Approval,Marketing Approval,Qalsody,Innovative Medicine,Gene Therapy,Amyotrophic Lateral Sclerosis,Biogen