Traditional Chinese medicine enterprises have entered the exchange period of innovation achievements, and may continue to break out with the help of policies

【Pharma Network Market Analysis】Recently, another new Chinese medicine drug dispersing cold and wet granules has been approved for marketing, which is also the 15th new Chinese medicine drug approved by CDE since 2021, of which 12 are
listed in 2021 alone.
From the perspective of the general trend, the innovation of traditional Chinese medicine is accelerating, and enterprises are gradually entering the exchange period of
achievements.
The accelerated approval of new Chinese medicines is inseparable from the support of policies, especially in the review and approval of traditional Chinese medicines, which has been continuously improved in China in recent years, including improving the review and approval system that meets the characteristics of traditional Chinese medicines, classifying the registration of traditional Chinese medicines, and the CDE issued a document in April this year, which launched the review and approval standards
for traditional Chinese medicines based on the three-combination evidence system of "traditional Chinese medicine theory - human experience - clinical trials" 。 Historical data shows that in 2017, the approval of an innovative Chinese medicine drug sometimes lasted as long as 3,600 days, shortened to less than 2,000 days in 2018, and accelerated to about 300 days in 2021
.
Time to market has been reduced by 90%.

The new anti-cancer drug icariin softgels, which were approved for marketing in 2022, took less than 300 days to be approved for marketing
.
In addition to encouraging innovation in traditional Chinese medicine from the policy end and the approval end, on the payment side, innovative Chinese medicine drugs listed on the market are also supported
by policies such as medical insurance.
At the end of 2021, the two departments jointly issued the Guiding Opinions on Medical Insurance to Support the Innovation and Development of Traditional Chinese Medicine, which supported the increase of medical insurance payment, the inclusion of Chinese medicine medical institutions in medical insurance, and the price management of traditional Chinese medicine services, and at the same time introduced corresponding support policies
in terms of medical insurance payment scope, payment policy, fund supervision and other aspects.
The industry pointed out that the "Opinions" introduced Chinese medicine support policies from the payment end for the first time, which brought great benefits to the Chinese medicine industry and also released a positive signal
to support the innovation and development of traditional Chinese medicine.
It is understood that when the national medical insurance drug catalogue is adjusted in 2021, 3 of the 67 new drugs negotiated for new Chinese medicine provide more new options
for patients' clinical medication.
The industry believes that the inclusion of new Chinese medicine drugs in the scope of medical insurance payment will drive the growth of demand for new Chinese medicines, and from the perspective of negotiating access price adjustment, all departments have fully considered the particularity of Chinese medicine development, have a good negotiation pattern, and consider the continuous optimization of Chinese medicine review, which will give birth to the enthusiasm
for the research and development of innovative Chinese medicines with clinical value 。 At present, the enthusiasm for Chinese medicine innovation in China is high, Chinese medicine enterprises have increased their research and development efforts, and the number of Chinese medicine registration applications has shown a trend of increasing year by year, of which in 2021, Chinese medicine registration applications involve 51 varieties, a year-on-year increase of 134.
8%; In 2021, the number of INDs filed increased significantly to 52, with as many as 368 supplementary applications
.
The indications for these clinical trials of new Chinese medicines are mainly concentrated in the fields of
psychoneurological, respiratory, digestive, cardiovascular and gynecology.
With the advancement of favorable policies such as medical insurance negotiations, the launch of new Chinese medicine drugs may continue to break out
in the future.
Some institutional analysis predicts that in the next few years, the number of new Chinese medicine drugs approved and marketed
every year will not be less than 12 in 2021.
However, looking forward to the future, the competition for Chinese medicine innovation will also become more intense, and the industry believes that companies and investment institutions will be more optimistic about enterprises with the ability to transform and purify Chinese medicine, actively strive to cooperate with Chinese medicine medical institutions and Chinese medicine universities, and include better Chinese medicine categories and patents
.
"In the next few years, the basic policies for the innovation and development of traditional Chinese medicine will continue to land, and in the future, traditional Chinese medicine enterprises will have the opportunity to resonate
with the development of the industry and policies.
" Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice
to anyone.