Hansoh Pharmaceutical Announces All Six Innovative Drugs Included in China's National Reimbursement Drug List

On January 18, the National Healthcare Security Administration and the Ministry of Human Resources and Social Security announced the "National Basic Medical Insurance, Work-related Injury Insurance, and Maternity Insurance Drug Catalog (2022)" (hereinafter referred to as the "Medical Insurance Catalog"). The first-line treatment indication of Almonertinib Mesylate Tablets (Ameile) and the rare disease drug Inebilizumab Injection (Xinyue) were successfully included in the Medical Insurance Catalog. Additionally, two innovative drugs have successfully renewed their listings. To date, all six innovative drugs launched by Hansoh Pharma have been included in the Medical Insurance Catalog.

　　Almonertinib: First-line NSCLC Treatment under Medical Insurance

Almonertinib is a targeted drug for EFGR-mutated non-small cell lung cancer (NSCLC) independently developed by Hansoh Pharma. It is also the first China-developed third-generation EGFR-TKI. In March 2020, Almonertinib's first indication was approved for marketing, used to treat adult patients with locally advanced or metastatic NSCLC who have disease progression during or after prior EGFR-TKI treatment and test positive for the EGFR T790M mutation. Just nine months later, Almonertinib was successfully included in the National Reimbursement Drug List (NRDL). In December 2021, Almonertinib received approval for its first-line treatment of locally advanced or metastatic NSCLC with EGFR-sensitive mutations, officially ushering in a new era of first-line treatment with China-developed third-generation EGFR-TKI. This time, both indications of Almonertinib have been included in the NRDL, providing greater accessibility for Chinese NSCLC patients.

Lung cancer is the malignant tumor with the highest incidence and mortality rate worldwide. It is estimated that nearly one-third of global non-small cell lung cancer patients (approximately 85% of lung cancer patients) have EGFR mutations. Almonertinib can irreversibly and highly selectively inhibit both EGFR-sensitive mutations and T790M resistance mutations, demonstrating better efficacy and safety. The AENEAS registration study of Almonertinib showed excellent mPFS benefits in treating patients with brain metastases, exon 19 deletions, and exon 21 (L858R) substitution mutation-positive patients, with the lowest risk of disease progression for patients receiving Almonertinib as a first-line treatment.

　Xinyue: The First and Only NMOSD Medication Covered by Medical Insurance

Xinyue (Inebilizumab Injection) is currently the world's only approved humanized anti-CD19 monoclonal antibody for the treatment of adult patients with AQP4 antibody-positive Neuromyelitis Optica Spectrum Disorder (NMOSD). Introduced by Hansoh Pharma and successfully included in the medical insurance catalog, Xinyue has become the first and only NMOSD medication covered by medical insurance in China.

NMOSD is a rare autoimmune disease of the nervous system, primarily affecting the optic nerve and spinal cord, characterized by high recurrence and severe disability. China has the largest patient population of NMOSD globally, with a high incidence among young and middle-aged women. Currently, Chinese patients lack clear treatment options and face significant challenges in drug accessibility, often leading to disability and poverty due to the disease, causing a heavy medical and societal burden. Evidence-based studies show that Inebilizumab can deplete B cells more broadly and sustainably, continuously reducing the risk of NMOSD relapse. Monotherapy for 28 weeks can reduce the risk of relapse by 77%, and with long-term use, the average annual relapse rate in the fourth year is 1%. It also reduces the risk of disability progression, is safe and reliable, and provides comprehensive benefits to patients.

In March 2022, Inebilizumab Injection was approved for marketing by the National Medical Products Administration (NMPA), ushering in a new era for NMOSD treatment in China. This time, the inclusion of Inebilizumab Injection in the national medical insurance catalog marks it as the first and only NMOSD medication covered by medical insurance in China. It is expected to break the long-standing dilemma faced by NMOSD patients of having no access to medication or being unable to afford it. The drug will genuinely help reduce relapses and hospitalizations, lower healthcare and nursing costs, minimize disability, and enable patients to return to normal social life.

　　Hansoh Pharma's Xinfu and Fulai successfully renewed in the National Medical Insurance Catalog

In the new medical insurance directory, Hansoh Pharma's innovative drugs Haosen Xinfu (Flumatinib Mesylate Tablets) and Fulaimei (Polyethylene Glycol Loxenatide Injection) have also been successfully renewed.

Haosen Xinfu is the first innovative drug for chronic myeloid leukemia (CML) independently developed in China. As a novel second-generation tyrosine kinase inhibitor (TKI), it achieves "bidirectional optimization" in efficacy and safety, enabling CML patients to achieve faster and deeper treatment responses with less progression, while significantly improving safety. The drug was approved for marketing by the National Medical Products Administration in November 2019 and was first included in the National Reimbursement Drug List in December 2020. It provides hematological oncologists in China with a new powerful tool for treating CML, effectively reducing the medication burden on patients.

The successfully renewed Fulaimei in this directory is the first original Chinese long-acting GLP-1 class hypoglycemic drug, and also the world's first PEGylated long-acting hypoglycemic drug. Fulaimei is used to improve blood glucose control in patients with type 2 diabetes, showing significant hypoglycemic efficacy and obvious cardiovascular benefits. It only needs to be injected once a week, significantly improving patient treatment compliance. Fulaimei was approved for marketing in May 2019 and was first included in the National Medical Insurance Drug Catalog at the end of December 2020.

Hansoh Pharma's Four Innovative Drugs Newly Included in Medical Insurance or Successfully Renewed Within the List, Plus Hengmu (Amitinofuvir Tablets) and Mailind (Morpholinyl Metronidazole Sodium Chloride Injection) Previously Included in Medical Insurance. To date, all six innovative drugs of Hansoh Pharma have been incorporated into the medical insurance list, which will help improve the accessibility and affordability of China’s innovative drugs, benefiting a wider range of patients in China. This also demonstrates the state’s guarantee of the value of innovative drugs and strong support for innovative drug companies. (Zhu Wen)