Medical Network October 9th As of September 27, 2018, 33 generic imported products have been approved for listing. Among them, April and July 2018 are the most approved months for product listing. Merck is the new product launcher of the multinational pharmaceutical company in the first three quarters of 2018. It has harvested 6 generic products, mainly in the field of gynecology and anti-infection.
Affected by the 2015 self-inspection verification and registration reform, a new round of new imported drugs was approved in 2017. The new imported drugs approved in 2017 are mainly anti-tumor drugs, diabetes drugs and cardiovascular drugs. Approved in 2018 The new imported drugs are mainly anti-tumor drugs and respiratory drugs, and monoclonal antibodies, inhalants and patches are the highlights of 2018.
Table 1 List of imported new drugs approved in 2018
Source: Salta Pharmaceuticals Tour Database, as of September 27, 2018
1, oncology drug field: PD-1 listing is a bright spot
Newly approved imported cancer drugs in 2018 are Paclicilili capsules (Palbociclib capsules), Ixazomib citrate capsules (Ixazomib capsules), Olapali tablets, Seritinib capsules, Pabolizumab injections Six products were approved (pembrolizumab injection) and Navolizumab injection (Nivolumab injection). The above six products were included in the priority review list, and the reason for inclusion was 'compared with existing treatments Has a clear therapeutic advantage'.
In the CSCO meeting held in Xiamen in September, CDE review officials mentioned that as clinical knowledge of oncology drugs deepens and targeted drugs work for specific genetic groups, targeted cancer drugs must be determined before application. Crowd and corresponding targets. In use, targeted cancer drugs require genetic testing. Among the newly approved products in 2018, sirinib capsules and naruvozumab injections were included in the September 14th, 2018. The “Guidelines for the Clinical Application of New Anticancer Drugs (2018 Edition)” issued by the Planning Commission: Before using the siridineib capsule, it must be confirmed that the ALK is detected by the ALK test method approved by the State Drug Administration; Yudan anti-injection should exclude patients with EGFR gene mutation and anaplastic lymphoma kinase (ALK) fusion.
On August 18, 2018, the National Health Insurance Bureau issued the 2018 anti-cancer drug insurance access special negotiation drug range. Only the oxazide citrate capsule entered the negotiation catalogue. The remaining imported drugs approved in 2018 have not entered the medical insurance negotiation catalogue. .
The status of the guide will affect the amount of cancer, and will also affect the scope of medical insurance restrictions. CDE review officials in the CSCO meeting also mentioned that the future will be in line with international standard therapy, the introduction of international standard therapy is the guideline for the status of imported cancer drugs. Listed in China's Listed Drugs, Pipersilili Capsules are suitable for hormone receptor (HR)-positive, locally advanced or metastatic breast cancer that is negative for human epidermal growth factor receptor 2 (HER2) and should be used in combination with aromatase inhibitors as menopause. The initial endocrine therapy of female patients, as a first-line medication for endocrine therapy in locally advanced or metastatic breast cancer, has a large market potential. In view of the treatment of piperacillin Adverse reactions It is neutropenia, and it is necessary to monitor the number of indicators of Absolute Neutrophil Count (ANC) for a long time. The usage and dosage of piracetin capsules is complicated. It is expected that long-term education will be required for doctors after marketing.
Ixazosin citrate capsules are positioned as second-line medications and are used as a combination therapy with lenalidomide and dexamethasone to treat adult patients with multiple myeloma who have received at least one previous treatment. Seritinib capsule is also a second-line drug for locally advanced or metastatic non-small cells positive for anaplastic lymphoma kinase (ALK) that has progressed after treatment with crizotinib or that is intolerant to crizotinib. Lung cancer (NSCLC) patients.
The CSCO meeting mentioned that Pabolizumab injection and Navulitis monoclonal antibody injection were accelerated based on one-arm clinical trials in 2018. The industry's most concerned Pabolizumab injection and Navulitis monoclonal antibody injection The price of liquid has also been unveiled in recent days.
The official retail price of Pabolizumab injection is 17918 yuan / 100 mg, which is limited to mainland China. Corresponding to Hong Kong, China: 30000 Hong Kong dollars (about 26,200 yuan), US 4,800 dollars (about 33,000 yuan), China's price Count the lowest price in the world.
On August 29, 2018, Navulitis Monoclonal Injection was marketed, 9260 yuan for 100mg/10ml, and 4591 yuan for 40mg/40ml. If the weight is 60kg, the dosage is 3mg/kg, once every 2 weeks, once. Need to use 1 100mg/10ml and 2 40mg/4ml, a total of 18442 yuan every two weeks; a total of 36884 yuan per month. Weight 50kg patients, each time need to use 1 large size 1 small size, a total of 13851 yuan every two weeks, each The total amount is 27,702 yuan per month. For patients of the same weight, Hong Kong spends 55,782 Hong Kong dollars (about 48,335 yuan) per month. Compared with the United States, the annual treatment cost of 169,000 US dollars (about 91,400 yuan / month) is much cheaper.
It is reported that the background of the significant reduction of the price of PD-1 drugs in two multinational pharmaceutical companies in China is the great enthusiasm and investment of domestic pharmaceutical companies in the development of immunotherapy. Currently, Junshi Bio, Cinda Bio, Hengrui medicine And Baiji Shenzhou four domestic enterprise The PD-1 product has become the 'first echelon', and all submitted the listing application and received the acceptance of the Drug Evaluation Center of the State Food and Drug Administration. The CSCO meeting reported that more than 30 PD-1 products entered the clinical stage and entered the clinical trial. The number of patients is not enough for the number of patients required for clinical trial design.
In addition, the Paphosizumab Injection '5% off' drug-granting program has also been announced recently. China's Primary Health Care Foundation has announced the pabolizumab injection for charitable drug delivery programs for patients with malignant melanoma, involving low income. And low-income patients. For low-income patients, meeting medical conditions and corresponding economic conditions, China Primary Health Care Foundation can help up to 24 months of the use of Pabolizumab injection. For low-income patients, meet Medical conditions and corresponding economic conditions, after three courses of self-use, the China Primary Health Care Foundation can assist in three courses of treatment, and so on, for a total of no more than 24 months.
On September 16, 2018, Pabolibumab injection was held in China. It is reported that the first day of commercial shipments has exceeded 100 million yuan. The 2018 CSCO meeting also mentioned that cancer patients have heard of PD-1 injections. Going after going public hospital Asked if there is PD-1 injection, if not, go to the hospital.
2, respiratory system: the main market is inhalation
In 2018, the respiratory system was mainly marketed as an inhaler. The approved indications were mainly chronic obstructive pulmonary disease and asthma.
Chronic obstructive pulmonary disease is a common severe lung disease. Among the drugs listed in China for chronic obstructive pulmonary disease, there are only single and two drugs. In 2018, the new drugs imported from chronic obstructive pulmonary disease were approved by Boehringer Ingelheim. Datrot inhalation spray, GlaxoSmithKline's Ume bromide Vilantra powder inhaler and Novartis's Glycopyrrolate inhalation powder capsules, all single and dual drugs.
For the treatment of asthma, GlaxoSmithKline's fluticasone furoate inhalation powder (II), fluticasone furoate inhalation powder (III).
Inhalation due to the dosage form, the threshold of the device, the number of manufacturers currently imitation in China is small. For multinational pharmaceutical companies, it is a different path. Previously, AstraZeneca announced the performance of the product is the inhalation of budeina German suspension (treatment of asthma) and budesonide formoterol powder inhaler (for asthma and chronic obstructive pulmonary disease), the first half of 2018 results were 482 million US dollars (3.298 billion yuan) and 241 million US dollars (16.49) 100 million yuan)
3, external skin medication: Parkinson and chemotherapy antiemetic new drugs
Similar to inhalants, transdermal patches are also a field with less industrialization in China. Currently, the approved fields in China are mainly painkillers.
In 2017, Novalis' clear transdermal patch, the world's first patch approved for the treatment of mild to moderate Alzheimer's disease, has been approved by CFDA. The newly approved transdermal patch is no longer limited to the analgesic field. 2018 The approved transdermal patches for the treatment of Parkinson's and chemotherapy to stop vomiting.
Optimum's rotigotine patch is approved for marketing in China, for monotherapy with early symptoms and signs of idiopathic Parkinson's disease (not in combination with levodopa), or in combination with levodopa At each stage of the disease, it is the first approved transdermal patch for Parkinson's disease in China.
The granisetron transdermal patch is the first transdermal patch for chemotherapy. It is used to prevent nausea and vomiting caused by moderate and/or highly vomiting chemotherapy.
4, summary
In the first three quarters of 2018, the number of imported new drugs was approved more than 30. It can be seen that the drug regulatory department has made efforts to synchronize domestic treatment with international treatment standards. The consistency evaluation and quantity procurement policy will expire for multinational pharmaceutical companies. The price of the original drug and the sales volume in China have been impacted. The new product has been accelerated to be approved for listing, and the Chinese medical insurance procurement policy is increasingly inclined to the clinical needs. drug Such policies are relatively friendly to multinational pharmaceutical companies, and multinational pharmaceutical companies are expected to adjust their marketing strategies in China during policy reforms.
In addition to the generic drugs will directly affect the price of multinational pharmaceutical companies and sales in China, the competition of domestic new drugs of similar targets will also affect. In recent years, domestic research and development of new drugs, such as biological analogues, tumor hot spot drugs The pricing effect of macromolecules, small molecules as innovative drugs for new drug entities on imported new drugs, is expected to be similar to the case of PD-1. However, formulation innovations, such as inhalants and transdermal patches, are less industrialized in domestic enterprises. In the short term, it is also the world of multinational pharmaceutical companies.
