On January 18, 2023, the National Healthcare Security Administration and the Ministry of Human Resources and Social Security announced the National Reimbursement Drug List for Basic Medical Insurance, Work-Related Injury Insurance and Maternity Insurance (2022) ("National Reimbursement Drug List"). Hansoh Pharma's drug for rare disease NMOSD (neuromyelitis optica spectrum disorders), Xinyue (Inebilizumab Injection), was newly added to the National Reimbursement Drug List, becoming the first and only medically insured drug for NMOSD in China.
NMOSD is a rare autoimmune disease of nervous system, mainly involving optic nerve and spinal cord, and characterized by high recurrence and high disability. China currently has the largest NMOSD patient base in the world, and the disease is highly prevalent in the young and middle-aged female population. Patients are often disabled and impoverished by the disease, resulting in serious medical and social burdens.
Evidence-based proof shows that inebilizumab depletes B cells more extensively and durably and consistently reduces the risk of NMOSD recurrence, with a 77% reduction in the risk of recurrence after 28 weeks of monotherapy and a mean recurrence rate of 1% at year 4 of long course use; and it reduces the risk of worsening disability, is safe and reliable, and provides overall patient benefit.
In March 2022, inebilizumab injections were approved for marketing by the National Medical Products Administration (NMPA), opening a new era of NMOSD treatment in China. This time, inebilizumab injections were added to the National Reimbursement Drug List, becoming the first and only medically insured drug for NMOSD in China. It is expected to break the long-term dilemma of drug availability and affordability facing NMOSD patients, and really help patients reduce the number of relapses and hospitalizations, lower medical and nursing costs, minimize disability and return to normal social life.
"We are very pleased to see Xinyue, a global breakthrough and innovative drug with clear target and definite efficacy, quickly approved and marketed in China as the first and only medically insured drug for NMOSD." Lyu Aifeng, Executive Director of Hansoh Pharma, remarked, "Hansoh Pharma is committed to benefiting Chinese rare disease patients with technological innovation and improving drug accessibility and affordability for them."
Looking ahead, Hansoh Pharma will further deepen its innovation-driven strategy, leverage the global innovation ecosystem, and explore and develop more innovative and good drugs to meet urgent clinical needs, improve the health and quality of life of human beings, and contribute to the Healthy China 2030 initiative.
Xinyue (Inebilizumab Injection) has been granted orphan drug status by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and has been granted breakthrough therapy designation (BTD) by the FDA. Inebilizumab injections were approved for marketing by the FDA in June 2020, by the Japanese Ministry of Health, Labour and Welfare (MHLW) in March 2021, and by the EMA in May 2022. Inebilizumab injections were introduced into China by Hansoh Pharma in 2019, listed as a Class A recommended drug in China's Guidelines for the Diagnosis and Treatment of Neuromyelitis Optica Spectrum Disorders (2021) in December 2021, approved for marketing by the NMPA in March 2022, and included in the National Reimbursement Drug List for Basic Medical Insurance, Work-Related Injury Insurance and Maternity Insurance (2022) in January 2023.
About Hansoh Pharma
Founded in 1995, Hansoh Pharmaceutical Group Company Limited, the main business entity of Hansoh Pharma, is a leading innovation-driven pharmaceutical company in China, focusing on major disease treatment areas such as anti-tumor, anti-infection, central nervous system, metabolism and autoimmunity, and committed to improving human health through continuous innovation. Up to now, Hansoh Pharma has marketed six innovative drugs and formed a rich pipeline, ranked among the top 100 pharmaceutical companies worldwide and the top 3 industrial companies with the best pharmaceutical R&D pipeline in China for consecutive years. It is a national key high-tech enterprise and national technology innovation demonstration enterprise. Hansoh Pharma went listed on the Stock Exchange of Hong Kong Ltd. in June 2019 (stock code: 3692.HK).