On December 25, the National Health Commission issued the "Third Batch of Encouraged Generic Drugs Catalogue", which included 39 varieties, involving 75 specifications and 13 dosage forms, covering 12 aspects of antineoplastic drugs and immunomodulators, anti-infective drugs, nervous system drugs, radiodiagnostic agents, cardiovascular system drugs, etc. The third batch of catalogs has three main characteristics, one is to cover a wide range of disease fields, the second is to attach importance to the coordination with the reference preparation filing information, and the third is to take into account the enthusiasm of enterprise research and development.
Judging from the third batch of encouraged generic drug lists, many of the 39 varieties of drugs are overseas marketed and domestic unmarketed varieties, which are the world's first drugs in this field and have a new mechanism of action. For example, the small interfering RNA drug patisiran of hereditary transthyroxin-mediated amyloidosis polyneuropathy, patislan, combined immunosuppressants, oral drug vorciclosine for active lupus nephritis, etc. According to the National Health Commission, the third batch of catalogues is guided by the needs of clinical drugs, enriches the selection of clinical drugs, improves the quality of clinical drugs, and fills the gap in domestic clinical drugs.
It is worth mentioning that the third batch of catalogues includes 6 radiopharmaceuticals, which can be used for imaging diagnosis and positioning, all of which are unmarketed drugs in China, which are of great significance for the timely diagnosis of diseases and the course of the disease.
Radiopharmaceuticals, also known as "nuclear medicines", refer to a special drug that contains radionuclides for medical diagnosis and **. Since the beginning of this year, progress has been made in the field of nuclear medicine, and radiopharmaceuticals of many domestic companies have been approved for clinical use. A total of 18 financing events have occurred in the global nuclear medicine field this year, including 4 in China, with a total financing amount of more than 1.3 billion yuan, and the new round of financing of more than 1.1 billion yuan completed by Xiantong Pharmaceutical is in the forefront.
In addition, among the drugs included in the third batch of catalogs, there are many domestic listed companies under development or have been listed. Among them, clobazam is a very effective broad-spectrum anti-seizure drug for rare epileptic encephalopathy, which can effectively control seizures. The drug belongs to the second class of psychotropic drugs in China, and it has not been approved before.
In September 2022, Humanwell Pharmaceutical's self-developed domestic clobazam tablets were approved, becoming the first generic drug of clobazam in China. In November 2022, Yichang Humanwell Pharmaceutical, a subsidiary of Humanwell Pharmaceutical, approved a clinical trial of clobazam oral suspension for the combination of seizures in patients with Lennox-Gastaut syndrome (LGS) aged 2 years and older**.
Eplerenone, as a new MRA drug, can bind to aldosterone receptors to block cardiac lesions and vascular damage caused by MR overactivation. On August 3, 2023, Grand Pharma announced that the new selective aldosterone receptor antagonist (MRA) eplerenone tablets cooperated by the company and Nanjing Cavendish Bioengineering Technology *** have recently been issued a drug registration certificate by the State Food and Drug Administration. Eplerenone tablets are the exclusive products marketed in China, and their successful approval for marketing has made up for the gap of second-generation MRA drugs in China.
Asenapine transdermal patches are used for psychosis, bipolar disorder, manic episodes, or mixed seizures. In January 2023, Livzon Group announced that its wholly-owned subsidiary was approved to conduct clinical trials of asenapine transdermal patch jointly developed with LTS Lohmann Therrapie-Systeme AG of Germany.
It is understood that in April 2018, the General Office of the People's Republic of China issued the "Opinions on Reforming and Improving the Policy on the Protection and Use of Generic Drugs", which requires the promotion of generic drug research and development, the regular formulation and publication of a list of drugs that encourage imitation, and the guidance of enterprise research and development, registration and production, and the generic drugs consistent with the quality and efficacy of the original drug are included in the list of drugs that can be substituted with the original drug to facilitate the choice and use of medical personnel and patients. In June 2019, the first batch of encouraged generic drugs was announced, including 33 varieties of drugs;In March 2021, the second batch of encouraged generic drugs was announced, including 19 varieties of drugs.
The National Health Commission said that the release of the catalogue has improved the current situation that some clinical diseases are not available, enriched the selection of drugs in common fields, and effectively guaranteed clinical drugs. Drugs in the generic drug catalogue are encouraged to be declared and included in the national medical insurance catalogue on a priority basis according to the procedures. In the first two batches of the catalogue, 12 varieties have been entered into the national medical insurance catalogue through negotiations. Including a variety of drugs for rare diseases, **thalassemia and breast cancer and other major diseases, reduce the drug burden of patients and improve the accessibility of clinical drugs.
Beijing Business Daily reporter Yao Qian.