China to Cut VAT on the 3rd List of Anti-cancer and Rare Disease Drugs

by Grace Wang Nov 25, 2022

China will reduce the value-added tax (VAT) to 3% for a list of anti-cancer drugs and rare disease / orphan drugs from Dec. 1, 2022, as announced by China's Ministry of Finance, General Administration of Customs, State Taxation Administration, and National Medical Products Administration on Nov. 22, 2022.1

The tax policies are:

(1) For domestic drugs sold in China, the VAT will be reduced to 3%;

(2) For overseas drugs sold to China, the VAT will be reduced to 3% for the import stage.

For cancer therapy, the list includes 45 finished dosage forms (FDFs), such as Sugemalimab Injection, Axicabtagene Ciloleucel Injection, and 6 active pharmaceutical ingredients (APIs), including Olverembatinib and Donafenib Tosilate.

Regarding rare disease treatment, the list includes 19 FDFs, e.g., Risdiplam Oral Solution and Dimethyl Fumarate Enteric Capsules, and one API, which is Treprostinil. Please refer to the appendix at the end of this article for the full list.

The drugs and APIs shall first be approved by NMPA to enjoy the preferential tax policies. Since 2018, China has issued three drug lists for tax reduction, which is meant to encourage pharma companies to develop and market anti-neoplastic and orphan drugs.

Appendix:

The 3rd List of Anti-cancer and Rare Disease Drugs for Tax Cut

FDF for Cancer

No.

API

Approved Dosage Form

Tax Code

1

Abemaciclib

Tablet

30049090

2

Avapritinib

Tablet

30049090

3

Ivosidenib

Tablet

30049090

4

Orelabrutinib

Tablet

30049090

5

Brigatinib

Tablet

30049090

6

Darolutamide

Tablet

30049090

7

Duvelisib

Capsule

30049090

8

Fluzoparib

Capsule

30049090

9

Gilteritinib Fumarate

Tablet

30049090

10

Furmonertinib Mesilate

Tablet

30049090

11

Carfilzomib

Injection

30049090

12

Sonidegib Phosphate

Capsule

30049090

13

Larotrectinib Sulfate

Capsule

30049090

14

 [223Ra] Radium[223Ra] Chloride

Injection

28444210

15

Y-90 Microspheres

Injection

28444390

16

Pemigatinib

Tablet

30049090

17

Pralatrexate

Injection

30049090

18

Pralsetinib

Capsule

30049090

19

Dalpiciclib Isethionate

Tablet

30049090

20

Ripretinib

Tablet

30049090

21

Selinexor

Tablet

30049090

22

Surufatinib

Capsule

30049090

23

Venetoclax

Tablet

30049010

24

Procarbazine Hydrochloride

Capsule

30049090

25

Ensartinib Hydrochloride

Capsule

30049090

26

Mitoxantrone Hydrochloride

Injection

30049090

27

Utidelone

Injection

30042090

28

Paclitaxel (Albumin Bound)

Injection

30049090

29

Paclitaxel Polymeric Micelles

Injection

30049090

30

Levofolinic Acid

Injection

30049090

31

Axicabtagene Ciloleucel Injection

Injection

30025100

32

Inotuzumab Ozogamicin

Injection

30021500

33

Obinutuzumab

Injection

30021500

34

Blinatumomab

Injection

30021500

35

Dinutuximab beta

Injection

30021500

36

Envafolimab

Injection

30021500

37

Ramucirumab

Injection

30021500

38

Penpulimab

Injection

30021500

39

Relmacabtagene Autoleucel

Injection

30025100

40

Zimberelimab

Injection

30021500

41

Sugemalimab

Injection

30021500

42

Serplulimab

Injection

30021500

43

Disitamab Vedotin

Injection

30021500

44

Ipilimumab

Injection

30021500

45

Icaritin

Soft Capsule

30049059

API of Anti-cancer Drug

No.

API

-

Tax Code

1

Olverembatinib

-

29335990

2

Donafenib Tosilate

-

28459000

3

Pamiparib

-

29339900

4

Savolitinib

-

29331990

5

Icaritin

-

29329990

6

Cytarabine

-

29349990

FDF for Rare Disease

No.

API

Approved Dosage Form

Tax Code

1

Dimethyl Fumarate

Capsule

30049090

2

Fampridine

Tablet

30049090

3

Nitric Oxide

Inhalation

30049090

4

Tetrabenazine

Tablet

30049090

5

Risdiplam

Oral Solution

30049090

6

Velaglucerase Alfa

Injection

30049090

7

Ofatumumab

Injection

30021500

8

Agalsidase Alfa

Injection

30049090

9

Idursulfase beta

Injection

30049090

10

Inebilizumab

Injection

30021500

11

Eftrenonacog alfa

Injection

30021200

12

Siltuximab

Injection

30021500

13

Icatibant Acetate

Injection

30049090

14

Lanadelumab

Injection

30021500

15

Burosumab

Injection

30021500

16

Satralizumab

Injection

30021500

17

Tafamidis Meglumine

Capsule

30049090

18

Nitisinone

Capsule

30049090

19

Pirfenidone

Tablet

30049090

API of Rare Disease Drug

No.

API

-

Tax Code

1

Treprostinil

-

29375000

Related:

The 15th Rare Disease Day: China's Policy & Market Overview

FAQ on Rare Disease Drugs (Orphan Drugs) in China

China to Exempt Import Tariffs on 61 APIs for Anticancer and Rare Disease Drugs

Grace Wang
ChemLinked Regulatory Analyst
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