11 月 28 日），国家医疗保障局、人力资源和社会保障部公布完整版的 2019 年《国家基本医疗保险、工伤保险和生育保险药品目录》，恒瑞医药自主研发的马来酸吡咯替尼片和硫培非格司亭注射液谈判成功，被纳入国家医保目录，同时，公司创新药甲磺酸阿帕替尼“续约”成功。 Today ( November 28 ), the National Medical Insurance Bureau, the Ministry of Human Resources and Social Security announced the full version of the "National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalogue" in 2019 , and pyrrole maleate independently developed by Hengrui Medicine Tenib tablets and thiopefilgrastim injections were successfully negotiated and included in the national medical insurance catalog. At the same time, the company ’s innovative drug apatinib mesylate “renewed” successfully. 1 月 1 日正式实施。 The new catalog will be officially implemented on January 1 .
At present, of the 5 innovative medicines that Hengrui Medicine has listed on the market, a total of 4 varieties have been included in the national medical insurance catalog.
The adjustment of the national medical insurance list mainly through the negotiation of pharmaceutical companies, which is the largest negotiation since the establishment of the medical insurance system in China. The total number of negotiated drugs was 150. The number of new negotiated drugs and the total number of negotiated drugs reached a record high. Through negotiations, 70 drugs were eventually added to the national medical insurance list, and 27 drugs were "renewed." It is reported that the drugs successfully negotiated in this period are mostly new drugs that have been marketed in recent years and have high clinical value, involving more than 10 cancer, rare diseases, hepatitis, diabetes, multi-drug resistant tuberculosis, rheumatic immunity, cardiovascular and cerebrovascular, digestion, etc. Clinical treatment areas.
For many years, Hengrui Medicine has met the health needs as the goal, focused on serving patients, focused on accelerating the development of new drugs for the Chinese disease spectrum, and is committed to solving clinical problems and meeting urgent clinical needs. The company's innovative drugs will be included in the national medical insurance directory, which will greatly reduce the burden on patients, further improve the availability of innovative drugs, improve people's livelihood and help China's health. At the same time, pirlotinib maleate and apatinib mesylate are currently undergoing clinical trials in the United States. In the future, it is expected that China's innovative drugs will go international and benefit global patients.
Pirlotinib maleate (brand name: Irini®) is a Class 1.1 innovative drug independently developed by Hengrui Medicine. It was approved for marketing in 2018. It is the first original EGFR / HER2 targeted drug in China and the first in China to rely on it. Innovative drugs that have been conditionally approved by the CFDA for phase II clinical research have become a model for priority approval of independent research and development of innovative drugs in China. Pirlotinib maleate in combination with capecitabine is the longest PFS in registered clinical institutes among the anti-HER2 drugs approved in China. In the Phase III PHENIX study published this year, Pirlotinib had a PFS of 11.1 months in the trastuzumab-treated population; meanwhile, the analysis of Pirlotinib Phase III PHOEBE has reached the criterion for superiority and achieved excellent results. Clinical advantages of lapatinib. Pirlotinib has now been included in national health insurance, which will enrich the treatment pattern of advanced HER2-positive breast cancer in China.
Thiofeigrastin injection (trade name: Edo®, referred to as 19K) is a bio-innovative drug independently developed by Hengrui Medicine. It is suitable for patients with non-bone cancer who are likely to cause clinically significant febrile neutrophils In the treatment of myelosuppressive anticancer drugs with cytopenia, the incidence of infection with febrile neutropenia is reduced, and it was approved for marketing in 2018. This product has obtained the common name of the World Health Organization (WHO). It is the first G-CSF product in China to receive the common name of the WHO, and has obtained patents in many countries and regions such as Europe, America, and Japan. CSF products. In terms of clinical effects, thiopefilgrastim is the first original long-acting preparation in China to achieve superior results when compared with the imported short-acting G-CSF drug Huerxue. This product uses innovative polyethylene glycol modified protein technology, which is more stable in structure, less ADA (anti-drug antibody), reduced immunogenicity, safe and reliable, and only needs to be used once per chemotherapy cycle, which can greatly improve patient compliance Sex, provides a new treatment option for the prevention of neutropenia. Thiofeigrastin injection has now entered the national medical insurance catalogue and will provide higher quality supportive treatment for the majority of chemotherapy patients in China.
Apatinib mesylate (brand name: Aitan®) is a national class 1.1 innovative drug with independent intellectual property rights developed by Hengrui Medicine for 10 years. It was approved for marketing in 2014 and entered the national medical insurance catalog in 2017. This drug is the world's first small molecule anti-angiogenesis targeting drug that has been proven to be safe and effective in advanced gastric cancer. It is also the only oral preparation of gastric cancer targeting drugs. Apatinib has now been “renewed” and will continue to provide high-quality and low-cost treatment for patients with advanced gastric cancer in China who have no drugs available.