Recently, Meinnet.com has sorted out the sales of domestically produced Class 1 innovative drugs in China's public medical institutions and Chinese urban physical pharmacies from 2018 to 2020, including domestically produced PD-1 monoclonal antibodies and safety products that have been listed for four indications. Rotinib, Hausen’s Ametinib, etc.
According to data from Meinenet, a total of 32 Class 1 new drugs have been approved for marketing within 3 years. 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 varieties of anesthetics, immunosuppressants, antihypertensive, anemia, and diabetes drugs, accounting for more than 31%.
Among them, the sales of 10 category 1 innovative drugs have grown rapidly after the launch. Among them, CP Tianqing's Anlotinib has the most outstanding performance. Since entering the medical insurance in October 2018, it has immediately achieved a mass effect-in China in 2019 The terminal sales of public medical institutions exceeded 2 billion yuan.
Four types of pd-1, the heroes compete
Among the 10 domestically-made innovative drugs with rapidly rising sales, four domestically-made PD-1 accounted for half of the total, or more than 10 billion yuan in total.
According to data from Meinenet, Hengrui's Carrelizumab, Cinda's Sintilizumab, and Junshi's Teriplizumab have domestic sales of 1.08 billion yuan, 997 million yuan, and 874 million respectively in 2019. The sales in 2020 (H1 sales of Chinese public medical institutions + annual forecast sales of Chinese urban physical pharmacies) will exceed 2.3 billion, 1.9 billion, and 1.1 billion respectively. The total sales of the three PD-1 models may reach 100 Billion scale.
It is worth noting that at the end of 2020, the four PD-1s mentioned above will be included in the National Medical Insurance Catalog. The new catalog will be launched nationwide on March 1 this year. Pharmaceutical companies must face a drop of more than 80% for a single drug, and their profit margins are relatively large. compression.
Therefore, the four pharmaceutical companies involved have successively announced that they will join hands with overseas pharmaceutical companies to launch their products abroad. Among them, BeiGene authorizes the rights and interests of most countries in Europe and the United States to Novartis, involving an amount of US$2.2 billion down payment/milestone payment + royalties of 20%-30% of net sales, setting the current record for the highest authorized transaction amount of a single drug in China .
Southwest Securities' Du Xiangyang team believes that in the case of domestic PD-1 monoclonal antibody competition and price decline, it is a better way to develop overseas equity exposure. With the help of partners' mature overseas sales channels, there is an opportunity to share the global PD-1 monoclonal antibody market.
According to the forecast of Research and Markets, with the continuous approval of indications and the continuous acceleration of new drug listings, the global sales of PD-1/PD-L1 will maintain a compound annual growth rate of 23.4% in the future, and it is expected to reach 50 billion US dollars by 2025 . To gain a place in the PD-1 monoclonal antibody market, it is necessary to deploy non-squamous non-small cell lung cancer, gastric cancer (her2 negative), liver cancer, and squamous non-small cell lung cancer with a combined market share of more than 70%.
According to the Southwest Securities Research Report, approval of major indications, access to medical insurance, and improvement of the commercial promotion team are essential features of the large variety of PD-1. Therefore, it is particularly important to look at the pace of a company's PD-1 monoclonal antibody volume, and to track the approval time of its major indications and the time to enter the medical insurance.
On February 19, Junshi Bio announced that the company’s self-developed anti-PD-1 monoclonal antibody drug teriprizumab injection was approved by the National Food and Drug Administration for relapses that have previously received second-line and above systemic treatment failures. / For the treatment of patients with metastatic nasopharyngeal cancer, it became the world's first anti-PD-1 monoclonal antibody approved for the treatment of nasopharyngeal cancer, or achieved market occupation through the differentiation of indications.
Anlotinib, the highest sales
Because of the time advantage and rich commercialization experience of the approval, the first class innovative drug Anlotinib Hydrochloride Capsules independently developed by CP Tianqing Pharmaceutical was approved for marketing in 2018 and entered the 2018 medical insurance negotiation catalog.
The detailed timetable shows that Anlotinib Hydrochloride Capsules was approved in May 2018 for the treatment of advanced or metastatic non-small cell lung cancer (third-line); June 2019 was approved for the treatment of soft tissue sarcoma (second-line); 2019 Approved in September for the treatment of small cell lung cancer (third-line). The fourth indication for medullary thyroid carcinoma was also approved not long ago.
According to data from Mi Nei.com, as new indications continue to be approved, the brand's sales have also continued to rise. In 2019, the sales of public medical institutions in China exceeded 2 billion yuan, and it became the TOP17 variety of anti-tumor drugs.
Ametinib, rapidly breaking through 100 million in the first year of listing
In addition to the above-mentioned products, Hausen’s Ametinib was the only company whose sales exceeded 100 million in the first year of the market.
Data show that the incidence of lung cancer ranks first in malignant tumors, and more than 40% of patients in my country are non-small cell lung cancer (NSCLC) patients with EGFR mutations. For patients with EGFR sensitive mutations, the first and second-generation EGFR-TKI targeted drugs are currently used for the treatment, which has obvious advantages over traditional chemotherapy, but drug resistance and disease progression will appear after about one year, and more than half of them are caused by the T790M mutation.
It is understood that 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 for the treatment of EGFR-mutant non-small cell lung cancer. , The main sales channel is the retail pharmacy terminal, and the forecasted sales for 2020 will exceed 130 million yuan.
Based on the above data, in 3 years, we have a total of 31 domestic Class 1 new drugs approved, but only 10 drugs have achieved rapid volume. To some extent, how to predict the commercialization prospects of new drugs in the future will gradually become a course for joint research and learning between pharmaceutical companies and investors.
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