Hansoh Pharma's Five Innovative Drugs All Included in China's Updated National Reimbursement Drug List

On December 3, the results of the 2021 National Medical Insurance Drug Catalog adjustment were officially announced, with a total of 74 drugs newly added to the catalog. Among them, Hansoh Pharma's self-developed Class 1 new drug, Hengmu (Amibufenovir Tablets), was included in the medical insurance catalog for the first time. So far, all five of Hansoh Pharma's self-developed Class 1 new drugs that have been marketed have entered the national medical insurance catalog.

As the first domestically developed oral anti-hepatitis B virus (HBV) drug in China, Aimitinovir was officially approved for marketing by the NMPA on June 23 this year. It took only five months from its market launch to being included in the medical insurance system.

According to media reports, China has approximately 70 million people infected with HBV, of which about 20-30 million are chronic hepatitis B patients in need of antiviral treatment, ranking first in the world. In the past decade, the number of newly reported infections each year has been around 1 million, accounting for one-third of Class A and B infectious diseases. Hepatitis B remains one of the most serious public health issues facing China.

From the project initiation to market launch over a span of 8 years, Aimitenofovir conducted 7 clinical studies. Among them, the pivotal Phase III clinical trial adopted a multi-center, randomized, double-blind, double-dummy, positive drug parallel control, non-inferiority Phase III clinical study design, with a total enrollment of 1002 participants. The head-to-head clinical trial compared it with the first-line hepatitis B treatment drug "Tenofovir Disoproxil Fumarate." This is the largest Phase III clinical trial for a new hepatitis B drug in terms of the number of Chinese patients enrolled to date.

Researchers from Nanfang Hospital of Southern Medical University and Hansoh Pharma, a subsidiary of Hansoh Pharmaceutical Group Company Limited, jointly presented a large-scale Phase III clinical study at the 2021 Asian Pacific Association for the Study of the Liver (2021 APASL) Annual Meeting. The 48-week results of tenofovir amibufenamide in Chinese patients with chronic hepatitis B (CHB) showed that the drug ensured good anti-HBV efficacy while demonstrating superior safety.

It goes without saying that in recent years, with the further acceleration of China's new drug research and development and the internationalization of the pharmaceutical industry, an increasing number of Class 1 new drugs with significant efficacy have been successfully launched. Against the backdrop of medical insurance negotiations and bulk procurement, the accessibility of innovative drugs has greatly improved.

Data shows that new drugs approved for marketing in the past five years have been rapidly included in China's national medical insurance directory. Taking Hansoh Pharma as an example, after years of continuous R&D investment, its innovative drug pipeline has entered the harvest period. Products such as Almonertinib Mesylate (Ameile), Flumatinib Mesylate Tablets (Haosen Xinfu), Peglopride Injection (Fulaimai), and Morinidazole Sodium Chloride Injection (Mailingda) have all been included in the national medical insurance directory.