10 domestic Class 1 new drugs "take off immediately after launch"

5;"> 2018-2020 is the three years in which domestically-made innovative drugs have been approved with the most outstanding results.
It is also the three years in which Chinese innovative pharmaceutical companies have deployed global clinical trials and achieved outstanding results in overseas listings.
Judging from the terminal data of Minai.
com, the sales of many innovative drugs exceeded 100 million in the following year or even the first year after they were launched, which is bound to become a landmark starting point for the marketization of domestically-made innovative drugs in the future.

  Based on the sales data of innovative drugs after they were put on the market, Meine.
com sorted out the domestically produced category 1 innovative drugs in China’s urban public hospitals, county-level public hospitals, urban community centers, and township health centers (referred to as China public medical institutions) from 2018 to 2020.
The sales of physical pharmacies in Chinese cities focus on 10 domestically-made innovative drugs that quickly "take off" after listing, including three major PD-1 monoclonal antibodies, Anlotinib, which has four indications, and Hausen’s Aramco Tinib and so on.

  According to data from Mi Nei.
com, a total of 32 Class 1 new drugs (excluding vaccines, including Class 1, Class 1.
3, Class 1.
5, etc.
) in 2018-2020 have been approved for marketing (excluding approved new indications) .
Among them, there are 14 varieties of anti-tumor drugs, accounting for 43.
7% of the total; there are 8 varieties of systemic antiviral/bacterial drugs, accounting for 25%.
There are 10 types of drugs such as anesthetics, immunosuppressants, anti-hypertension, anemia, diabetes, etc.
, accounting for 31.
3% of the total.

  Among the newly approved Class 1 new drugs with rapid sales growth from 2018 to 2020, the sales of most new drugs in the physical pharmacy terminals of Chinese cities in the first year of listing are higher than the sales of public medical institutions in China, which shows that they have just been approved.
It will take time for marketed innovative drugs to enter hospitals for bidding, and their main sales channels are retail pharmacies.
However, after a year of market layout, especially after opening the hospital market through medical insurance negotiations, the sales of innovative drugs in the hospital terminal will strongly surpass its sales in retail pharmacies.

  The growth rate of Anlotinib slows down after the "outbreak", and the fourth indication has been approved

  Among the innovative drugs that have been on the market in the past three years, the most dazzling sales is CP Tianqing's Anlotinib.
Anlotinib was first approved for listing in May 2018, and was included in the national medical insurance through negotiations in October of the same year.
It quickly achieved sales of over 600 million yuan in that year.
Its medical insurance effect is fully reflected in 2019, when the terminal sales of Anlotinib in China's public medical institutions exceeded 2 billion yuan, and it became a veritable large variety in the second year of its listing.

  In the first half of 2020, under the influence of the epidemic, the growth momentum of Anlotinib slowed down slightly.
According to data from the MED2.
0 Chinese drug review database of Meinenet, the listing application status of the new indication of Anlotinib on February 2 has been changed to "Approval completed-pending certification", which means its fourth adaptation The disease was officially approved in China.
According to public information, the approved indication for the drug this time is advanced or metastatic medullary thyroid cancer.

  Prior to this, Anlotinib 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 data from the Chinese Drug Clinical Trials Public Library of Minai.
com, there are currently more than 20 clinical trials status of Anlotinib as "ongoing", including esophageal cancer, cervical cancer, triple-negative breast cancer, head and neck squamous cell carcinoma, and peripheral T Phase II clinical trials for more than ten indications such as cell lymphoma are underway.
Phase III clinical trials for indications such as advanced renal cell carcinoma, triple negative breast cancer, advanced hepatocellular carcinoma (HCC), gastric or gastroesophageal junction adenocarcinoma, and extensive-stage small cell lung cancer are recruiting patients.

  It can be seen that Anlotinib has officially become CP Tianqing’s fist variety, and continues to inject fresh blood into the company's innovative research and development.
It is foreseeable that the market space for this variety will be further opened in the future, and the sales prospects are immeasurable.

  Four PD-1 "Fairy Racing", the total may exceed 10 billion yuan

  After the "wave of approvals" for PD-1 drugs, the marketization of several domestically-made PD-1 drugs has become the focus of the industry.
Among them, Hengrui’s Carrelizumab, Cinda’s Sintilizumab, and Junshi’s Teriplizumab will have domestic sales of 1.
080 billion yuan, 997 million yuan, and 874 million yuan in 2019, respectively.
Annual sales (H1 sales of Chinese public medical institutions + annual forecast sales of Chinese urban physical pharmacies) exceed 2.
3 billion yuan, 1.
9 billion yuan, and 1.
1 billion yuan respectively.
The combined sales of the three PD-1s may reach tens of billions.

  According to BeiGene's 2020 Q3 financial report, tislelizumab Q3 achieved global sales of 49.
94 million U.
S.
dollars (approximately 330 million yuan), with a considerable sales growth.

  The action of tislelizumab on January 12, 2021 is also worthy of attention.
On this day, BeiGene announced that it will cooperate with the global pharmaceutical giant Novartis on the development, production and commercialization of tislelizumab in multiple countries.
A cooperation and authorization agreement was reached.
The first payment was US$650 million, and the milestone payment was US$1.
55 billion.
The total transaction amount exceeded US$2.
2 billion.
This is the largest transaction amount of domestic drugs sold overseas.
Moreover, it is expected that as the three new indications that have already been applied for listing are successively approved, its competitiveness will be greatly improved.

  At the end of 2020, the PD-1 of the three Chinese local companies of Junshi Bio-Treprizumab, Hengrui Pharmaceuticals Carrelizumab, and BeiGene Tilelizumab will enter the 2020 National Medical Insurance Drugs.
Catalogue.
So far, the PD-1s of 4 local companies have all appeared in the medical insurance catalogue, and the "fairy battle" of domestic PD-1 has entered a new chapter.

  The growth of oncology drugs is strong, and other innovative drugs may be difficult to enter the hospital market

  Except for Anlotinib and the four PD-1 models, only Hausen's Ametinib was the only company whose sales in the first year of the market quickly exceeded 100 million.
Ametinib is the world’s second third-generation EGFR-TKI innovative drug and the first domestically-made third-generation EGFR-TKI drug.
It was approved for marketing in China on March 31, 2020.
It is used to treat EGFR-mutant non-small cell lung cancer and is mainly sold.
The channel is in the retail pharmacy terminal, and the forecasted sales for 2020 will exceed 130 million yuan.

  Hausen's other innovative drug, polyethylene glycol loxenatide, had sales of more than 70 million in the second year after its launch.
It is worth noting that in the first half of 2020, the sales of public medical institutions in China are only about 4.
5 million yuan, while the annual forecast sales of physical pharmacies in Chinese cities are close to 70 million.
It can be seen that even in industries such as Hausen Giants are also facing challenges in opening up the hospital market in the diabetes pipeline.

  Fabojin's anti-anemia drug Roxastat capsule was approved for marketing on December 21, 2018.
In the first half of 2020, its sales in public medical institutions in China exceeded 120 million yuan.
Roxastat was approved by the Japanese Ministry of Health, Labour and Welfare on November 29, 2020 for the treatment of chronic kidney disease-related anemia in non-dialysis dependent patients.

  Sales of Gallite Pharmaceutical's oral hepatitis C drug danorevir are in trouble.
According to data from Mi Nei.
com, its annual sales in 2019 were about 110 million yuan, of which about 90% were sold at the terminals of public medical institutions in China.
In the first half of 2020, the sales of Danorevir in China's public medical institutions were only about 25 million yuan, which was a serious decline.
It is said that the main reason for the decline in sales is that the full oral treatment plan in 2020 has become the standard for hepatitis C treatment.
Many hepatitis C patients no longer choose the treatment plan of danorevir plus interferon injection, and the national medical insurance negotiation in November 2019 In China, Danorevir is regrettably out of the game and lost the support of medical insurance.
The future marketization prospects are worrying.

  Zai Lab's niraparib p-toluenesulfonate is the first indigenous PARP inhibitor and was approved for marketing at the end of December 2019.
It is used to treat recurrent epithelial ovarian cancer, fallopian tube cancer, or fallopian tube cancer in complete or partial remission of platinum-containing chemotherapy.
Maintenance treatment for adult patients with primary peritoneal ovarian cancer.
In the first half of 2020, its terminal sales in China's public medical institutions will be approximately 16 million yuan.
It is worth mentioning that the drug was first approved in the United States in March 2017 and in Europe in November of the same year.
Based on the approval in the United States and Europe, niraparib was approved in October 2018 and June 2019.
It has been approved to be listed in Hong Kong and Macau successively every month.

  The prediction of the new drug market has become a problem, and Wall Street's predictions have been distorted in the past 15 years

  At a time when domestic biomedical innovation is in full swing and approved drugs are mushrooming, assessing the marketization potential of new drugs and predicting the sales curve will gradually become a topic of common concern for Chinese pharmaceutical companies and investors.

  However, predicting the sales of new drugs has always been difficult, even for mature European and American markets.
According to Fierce Pharma, a western medical media, half of the drugs launched in the United States since 2004 are more than 20% lower than Wall Street’s expected sales.
Among them, more than half of cardiovascular drugs, immunological drugs and 48% of anti-infective drugs failed to meet analysts' expectations, while only 38% of oncology drugs did not meet analysts' forecasts.

  According to industry insiders, analysts and small biotech companies tend to underestimate the cost of education and training for clinicians to issue new prescriptions, and overestimate the acceptance of clinical trial data of the product among doctors.
From another point of view, however, it is not so much that the sales of new drugs have not met expectations, as it is that the forecasting model has a deviation from the current market situation.

  In addition, the report pointed out that BigPharma has better resource allocation and commercialization capabilities than small biotech companies, and the average peak sales volume is 50% higher than that of small companies.
This trend is also reflected in the sales of Chinese innovative drugs after approval.
Companies such as Hengrui, Zhengda Tianqing, BeiGene, and Hausen not only lead the industry in terms of innovation investment, but also have extremely professional marketing teams.
The earth has promoted the marketization of new drugs, and the steady growth in sales has also continuously injected blood for innovation and reinvestment.

  In short, in the domestic market, not only innovative drugs have just started, but also the leading companies are actively exploring research on marketization strategies for innovative drugs, including hospital promotion and marketing, participating in national medical insurance negotiations and centralized procurement.
For medical people or investors who are concerned about market trends, how to predict the market more accurately and judge the potential space for sales of innovative drugs is a question worthy of the industry's continuous exploration in the next few years.
( Minenet)