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2018-2020 is the three years in which domestic innovative drugs have been approved, and the three years in which China's innovative pharmaceutical companies have laid out global clinical trials and achieved outstanding results in overseas listing.
from the Mienet terminal data, a number of innovative drugs on the market the next year or even the first year of sales broke billion, is bound to become the future of domestic innovative drugs marketization of the iconic starting point.
meters intranet based on the sales data after the launch of innovative drugs, combed the 2018-2020 domestic 1 type of innovative drugs in China's urban public hospitals, county-level public hospitals, urban community centers and township hospitals (referred to as China's public medical institutions) terminal and Sales of physical pharmacies terminals in Chinese cities focus on the 10 domestic innovative drugs that quickly "take off" after the listing, including the three PD-1 mono-resistance, the four adaptive drugs listed in Arodini, Haussen's Amedini and so on. according to
-meter intranet data, in 2018-2020, a total of 32 new class 1 drugs (excluding vaccines, in terms of varieties and enterprises, including categories 1, 1.3, 1.5, etc.) were approved for listing (excluding approved new adaptations).
, there were 14 varieties of anti-tumor drugs, accounting for 43.7% of the total, and 8 varieties of systemic antiviral/bacterial drugs, accounting for 25%.
, immunosuppressants, antihypertensives, anemia, diabetes and other drugs a total of 10 varieties, accounting for 31.3% of the total.
Table 1: New Class 1 Drugs Approved for Listing in 2018-2020 (Without Vaccines) Source: MED2.0 China Drug Review Database Table 2: 10 Innovative Drugs listed in 2018-2020 with rapid sales Growth: 2020 Sales for China's public medical institutions H 1 data and China's urban brick-and-mortar drugstore full-year forecast data source: MiNet database 2018-2020 newly approved market and sales growth faster of the first year of the first year in China's urban brick-and-mortar drugstore terminal sales are higher than the sales of China's public medical institutions terminal, it can be seen that just approved the listing of innovative drugs into the hospital tender time, its main sales channels in retail pharmacies.
but after a year of market layout, especially after opening up the hospital market through health-care negotiations, sales of innovative drugs at hospital terminals will outsell sales at retail pharmacies.
growth slowed after the "outbreak" of atrotini, and of the innovative drugs approved for the past three years, the brightest selling was the sunny Anrodini.
first approved for listing in May 2018, and in October of that year negotiated the inclusion of National Health Insurance, which quickly achieved sales of more than $600 million in the year.
its health care effect is fully reflected in 2019, the year Andrrotini in China's public medical institutions terminal sales of more than 2 billion yuan, the second year of listing has become a veritable big variety.
the first half of 2020, Theronini's growth momentum slowed slightly as a result of the outbreak.
According to MED2.0 China Drug Review Database data, on February 2nd the status of the listing application for Arotini's new adaptive disease was changed to "approved - pending certification", which means that its fourth adaptive disease was officially approved in China.
according to public information, the drug was approved for advanced or metastatic thyroid myelin-like cancer.
, Arondini has been approved in China for the treatment of advanced non-small cell lung cancer, soft tissue sarcoma and small cell lung cancer.
According to Milnet China Drug Clinical Trials Public Library data show that atrotinib currently has more than 20 clinical trial status is "ongoing", including esophageal cancer, cervical cancer, triple negative breast cancer, head and neck squamous cancer, external T-cell lymphoma and more than 10 adaptation phase II clinical trials are under way.
Phase III clinical trials of advanced renal cell carcinoma, triple-yin breast cancer, advanced hepatocellular carcinoma (HCC), gastric or gastroesophageal combined adenocarcinoma, and extensive stage small cell lung cancer are recruiting patients.
can see that The Antitini has officially become a positive fist variety, for the company's innovative research and development continued to inject fresh blood, it is foreseeable that the future of the variety market space will be further opened, sales prospects are immeasurable.
four PD-1 "Fairy Race", a total or more than 10 billion yuan in PD-1 drugs "approved tide" after the marketization of several domestic PD-1 drugs has become the focus of industry attention.
, Henri's Karelli Pearl Single Resistance, Xinda's Xindili Single Resistance, Junshi's Terripley Single Resistance 2019 domestic sales reached 1.080 billion yuan, 997 million yuan, 8.8 million yuan, respectively. 7.4 billion yuan, 2020 sales (China's public medical institutions H1 sales and China's urban physical pharmacies full-year forecast sales) exceeded 2.3 billion yuan, 1.9 billion yuan, 1.1 billion yuan, three PD-1 combined sales or reached 10 billion scale.
based on Baiji Shenzhou's 2020 Q3 results, the company achieved sales of US$49.94 million (approximately RMB330 million) worldwide for the Reilly Pearl Single Anti-Q3, with impressive sales growth.
's move on January 12, 2021, was also noteworthy, as the state announced that it had reached a cooperation and licensing agreement with global pharmaceutical giant Novarma for the development, production and commercialization of Reilly's single-drug unit in several countries, with a down payment of $650 million, a milestone payment of $1.55 billion and a total transaction value of more than $2.2 billion, the largest deal to date for the sale of overseas interests in domestic drugs.
, and it is expected that its competitiveness will be greatly enhanced as the three new adaptations that have been declared for listing are approved.
At the end of 2020, Junshi BioPripri single resistance, Hengrui medicine Karelli Pearl single resistance, Baiji Shenzhou for Reilly Zhu single resistance 3 Chinese domestic enterprises PD-1 together into the 2020 national health insurance drug catalog, to this four local enterprises PD-1 qi appearance of the health insurance catalog, domestic PD-1 "gods" into a new chapter.
oncology drug growth is strong, other innovative drugs or difficult to enter the hospital market in addition to atrotinib and four PD-1, the first year of the market sales quickly broke 100 million only Hausen's Amedini.
Amedini is the world's second third-generation EGFR-TKI innovative drug, and the first domestic third-generation EGFR-TKI drug, approved for sale in China on March 31, 2020 for the treatment of EGFR mutation non-small cell lung cancer, the main sales channels in retail pharmacy terminals, the full-year 2020 forecast sales of more than 130 million yuan.
another innovative drug, polyglycol locena peptide, with sales of more than 70 million in its second year on the market.
It is worth noting that in the first half of 2020, China's public medical institutions terminal sales of only about 4.5 million yuan, and in China's urban physical pharmacy terminal full-year forecast sales of nearly 70 million, it can be seen that even the industry giants such as Howson, in the diabetes pipeline to open up the hospital market is also facing challenges.
anti-anemia drug Rosastal Capsules was approved for sale on December 21, 2018, with sales of more than 120 million yuan at the terminals of public medical institutions in China in the first half of 2020.
, Japan, was approved by Japan's Ministry of Health, Labour and Health on November 29, 2020 for non-dialysis-dependent patients to treat chronic kidney disease-related anemia.
sales of the oral hepatitis C drug Dano Riveri, which is used by 18th-year-old Goliath Pharmaceuticals, are in trouble.
2019 sales of about 110 million yuan, of which about 90% of China's public medical institutions terminal sales.
first half of 2020, Dano Riveri's sales at china's public health facilities terminals were only about 25 million yuan, a sharp decline.
said the main reason for the decline in sales was that the full oral treatment programme had become the standard for hepatitis C treatment by 2020, that many hepatitis C patients no longer opted for Danorievega's interferon injection treatment, and that In the November 2019 national health care negotiations, Danorive had been out of the picture, had lost support for health insurance and had a worrying future market outlook.
Redding Pharmaceuticals' nirapali, the first homegrown PARP inhibitor, was approved for sale at the end of December 2019 for the maintenance of treatment in adult patients with relapsed epithelyl ovarian cancer, fallopian tube cancer or primary peritoneal ovarian cancer with full or partial remission of platinum chemotherapy.
first half of 2020, its sales at public medical facilities terminals in China will be about 16 million yuan.
it is worth noting that the drug was first approved in the United States in March 2017, in Europe in November of the same year, and based on its approval in the United States and Europe, Nirapali was approved in Hong Kong and Macau, China, in October 2018 and June 2019.
The market forecast of new drugs is a difficult problem, Wall Street in the past 15 years more than half of the prediction distortion in the domestic biopharmaceutical innovation is in full swing, approved drugs springing up at the present time, the evaluation of the market potential of new drugs, forecast sales curve, will gradually become China's pharmaceutical companies and investors common attention to the subject.
, predicting sales of new drugs has never been easy, even for mature European and American markets.
half of the drugs launched in the U.S. since 2004 are more than 20 percent lower than Wall Street's expected sales, according to Fierce Pharma, a Western pharmaceutical media outlet.
of these, more than half of cardiovascular, immunological and 48 percent of anti-infective drugs failed to meet analysts' expectations, while only 38 percent of cancer drugs failed to meet analysts' forecasts.
industry insiders say analysts and small biotech companies tend to underestimate the cost of educating and training clinicians to prescribe new drugs, overestimating the acceptance of clinical trial data for their products among doctors.
another point of view, however, it is not so much that sales of new drugs are falling short of expectations as that there is a discrete from the current state of the market in terms of forecasting models.
, the report notes that BigPharma has better resource allocation and commercialization capabilities than small biotech companies, with average peak sales 50 percent higher than small businesses.
This trend in China's innovative drugs approved after the market sales are also reflected, Hengrui, Zhengda Tianqing, Baiji Shenzhou, Howson and other enterprises not only in the innovation input leading the industry, its professional market team has also greatly promoted the marketization of new drugs, steady growth in sales for innovation and re-investment in a steady stream of blood.
In short, in the domestic market, not only innovative drugs are just beginning, around the market-oriented strategy of innovative drugs research, including hospital promotion and marketing, participation in national health insurance negotiations and collection, head enterprises are also actively exploring.
how to predict the market more accurately and judge the potential of sales of innovative drugs is a question that the industry will continue to explore in the coming years.
source: MiNet Database Note: Data statistics as of February 17, 2021, if there are omissions, welcome to point out!