Recently, the Ministry of Finance, the General Administration of Customs, the State Administration of Taxation and the State Food and Drug Administration jointly issued the Announcement on Issuing the Third Batch of Anti-Cancer Drugs and Rare Disease Drugs Subject to the VAT Policy (hereinafter referred to as the "Announcement"
).
According to the announcement, from December 1, 2022, for the drugs on the list, the domestic link can choose to charge VAT at 3% simplified method, and the import link will be charged VAT at a reduced rate of 3
%.
Judging from the announcement, the third batch of lists includes 51 anti-cancer drug preparations and APIs, and 20 rare disease drug preparations and APIs
.
It is worth mentioning that there are many star products
that have only been approved in the past two years.
For example, Fosun Kite's Aquilencel injection is the first domestic CAR-T cell therapy product officially approved by the State Food and Drug Administration on June 23, 2021, with a single price of more than one million yuan; WuXi JW Therapeutics' relma-cel injection is the second CAR-T cell therapy product approved in China on September 3 of the same year, with a proposed online price of 1.
29 million; In addition, Remegen Biologics' class 1 new drug vedicitumab was approved for marketing in June 2021, which is the first self-developed ADC drug
in China.
Industry analysts believe that patients need to take drugs for a long time and the burden of drugs is high, so the VAT preferential treatment for anti-cancer drugs and rare disease drugs is a policy that benefits the people, which will help reduce drug prices, ensure more patients' drug needs, and also support the development of
the pharmaceutical industry.
It is understood that since 2018, in order to encourage the development of the pharmaceutical industry and reduce the cost of patients, China has successively published a number of batches of anti-cancer drugs and rare disease drugs subject to value-added tax policies
.
Including the Notice on the VAT Policy for Anticancer Drugs issued in 2018, involving 103 preparation drugs and 51 APIs
.
The Notice on the VAT Policy for Rare Disease Drugs issued in 2019 involves 21 rare disease drugs and 4 APIs; In the Second Batch of Anticancer Drugs and Rare Disease Drugs Covered by VAT Policy released in 2020, 39 varieties of anti-cancer drug preparations and 14 varieties of rare disease drug preparations
were involved.
In the case of the same cost and selling price, analysts believe that enjoying VAT concessions can improve the profit margins
of enterprises.
However, it is not yet known
whether it will trigger the impact of product price reductions.
If JW Therapeutics has previously said that it has noticed the release of the above announcement, relmacel is on the list of anticancer drugs
.
The relevant teams within the company are studying the content of this policy announcement and the business impact, and there is no conclusion at this time
.
In addition, a number of companies have also said that the specific impact is still being
measured.
In general, at present, China's rare disease drugs mainly rely on imports
.
Therefore, the industry expects that through the adjustment of tax policies, it is expected to promote more drugs to enter the domestic market, and will improve the enthusiasm and initiative of relevant enterprises, and promote the domestic innovative drug research and development to gather strength
in this field.
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