According to statistics, from 2001 to 2017, in a period of up to 17 years, NMPA approved a total of 13 Class 1 chemical drugs and 17 biological products. The number of innovative drugs is really a bit pitiful.
In August 2015, the State Council issued a heavy document, "Opinions on Reforming the Review and Approval System for Drugs and Medical Devices" (Circular 44), to speed up policy reforms such as the review and approval of innovative drugs, and the launch of pilot marketing license holder systems. The prelude to China's innovative drugs.
In 2018, the drug regulatory reform and capital catalysis completely changed the situation of domestic new drugs going public. In that year, NMPA approved a total of 9 domestic first-class new drugs for listing, and 2018 was therefore called the "first year of Chinese innovative drugs".
Since 2018, a total of 20 domestic Class 1 new drugs have been launched, involving many popular areas such as cancer, liver disease, and diabetes.
So, what is the proportion of these 20 new medicines and biological medicines? What areas does the indication involve? Which pharmaceutical company has the largest number? How did it perform after listing? Which medicines are covered by Medicare? What are the future trends?
What is the proportion of chemical and biological drugs?
Of the 20 domestic first-class new drugs, 15 are chemical drugs and 5 are biologic drugs. The absolute percentage of chemical drugs is 75%.
Among the top 10 global pharmaceutical sales in 2019, 6 are biopharmaceuticals and 4 chemical drugs. Among them, total sales of biopharmaceuticals amounted to 58.86 billion yuan, total sales of chemical drugs were 37.90 billion yuan, and biopharmaceuticals were more than 20 billion more than chemical drugs. The potential of biopharmaceuticals in the future is still huge.
In the next few years, the author expects that more domestic Class 1 biological products will be declared for market. By then, the proportion of biological drugs will gradually increase.
What areas does the indication involve?
In terms of indications, of the 20 domestic first-class new drugs, 10 are tumors, accounting for half of the total, followed by liver disease, 3. In addition, Alzheimer's disease, diabetes, anesthesia, psoriasis and infections are all covered.
From the target point of view, PD-1 is the most popular, and there are four domestic first-class new drugs that all belong to PD-1 monoclonal antibodies, namely Junshi's Triprelimumab, Cinda's Sintilimab, Hengrui's Carrizumab and BeiGene's Tirelizumab. In addition to PD-1, PARP, GLP-1 and other popular targets are also involved.
From a strategic perspective, many of these drugs have certain titles. Treprinumab is the first domestically produced PD-1 monoclonal antibody, losenatide is the first domestically produced GLP-1 agonist, and flumatinib is an "upgraded version" of Gleevec, Nila Pali is the second PARP inhibitor listed in the country, Danorevir sodium tablets are the first domestically produced hepatitis C DAA, and Abovite is the first domestically produced long-acting anti-moxamol.
Which pharmaceutical company has the largest number?
Among the 20 domestic first-class new drugs, Hengrui and Hansen have the largest number, both of which are 3, and the rest are each one. Hengrui's are pirotinib, remazolam and carellizone, while Hansen's are losenatide, flumatinib and ametinib.
There is a trend in domestic pharmaceutical companies that is becoming more and more obvious. For comprehensive pharmaceutical giants such as Hengrui, Hansen, and Zhengda Tianqing, the full coverage of multiple hot targets is a development strategy. For example, Hengrui has a hot PD- 1 monoclonal antibody, and there is remazolam inheriting its own special anesthesia business. For emerging small pharmaceutical companies such as Cinda, Geli and Hutchison Medicine, develop key businesses and find special areas, such as Geli, focusing on the field of liver disease. In addition to the first domestic hepatitis C DAA, the second domestic hepatitis C drug Lavida Wei will also be listed soon. Cinda is focused on biological drugs, and small molecule drugs are rarely involved.
How did it perform after listing?
These 20 class 1 new drugs currently perform better with anrotinib and domestic PD-1. Among them, anlotinib has the highest sales in 2019, between 2.5-3 billion yuan, and the total sales of three domestic PD-1s in 2019 are nearly 3 billion yuan.
In addition to the volume of tillelizide and the products that have not been put on the market since then, nine of the remaining 14 drugs are expected to have sales of over 100 million yuan in 2019. They are anlotinib, danorevir sodium, pirotinib, and furfur. Quinitinib, teriprilumab, sentirimab, losenatide, carilizumab, and mannooligosaccharide diacid. Disclosure of specific sales are: danorevir sodium is 124 million yuan, fruquintinib is 120 million yuan, teripril monoclonal antibody is 774 million, and cindilimumab is 1.016 billion.
There are three with more than 1 billion yuan, namely anrotinib, sentirimab and carilizumab. Among these new drugs, it is expected that anrotinib and anrotinib will perform very well in the next 2-3 years. Domestic PD-1.
Which medicines are covered by Medicare?
On November 28, 2019, the results of the medical insurance negotiations were announced (all innovative pharmaceutical products approved before December 31, 2018 are eligible to participate in the selection). Prior to this, the National Medical Insurance Catalog has been adjusted four times since 2000. In 2004, 2009, 2017 and 2018, the national medical insurance catalog was updated more frequently, which is conducive to the rapid connection of new drugs from marketing to medical insurance access . At present, of the 20 new class 1 new drugs, 6 new drugs have been included in the medical insurance, namely, recombinant cytokine gene-derived protein injection, anrotinib capsules, pirotinib tablets, fruquintinib capsules, roxastat Capsules and Sintilimab. In the future, more Class 1 domestic new drugs will be included in medical insurance.
What are the future trends?
In the future, the gap between the time to market of domestic and imported drugs will become smaller.
Take PD-1 as an example. In 2014, the world's first PD-1 monoclonal antibody K drug was launched. In 2018, the first domestically produced PD-1 monoclonal antibody Trepride was domestically listed, only 4 years apart, compared with the previous one. The gap has narrowed a lot, and the gap will become smaller in the future.
In the future, domestic medicines will be listed in foreign countries and then domestically.
Zebutinib of BeiGene was approved for marketing in the United States in December last year and became the first domestically produced new drug approved by the FDA. It is expected that it will be marketed in the first half of the year. In the future, there will be more and more cases of domestic medicines being marketed abroad first and then domestically.
In the future, pharmaceutical companies will be blooming, and new drugs are no longer the specialty of pharmaceutical giants.
A good new medicine is enough to support a pharmaceutical company, such as Xindili to Xinda, and Tripreg to Junshi. In the future, domestic new drug declarations will be in full bloom, in addition to traditional pharmaceutical giants, emerging companies will also shine.