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
