On 28 March China's National Medical Products Administration (NMPA) published a list of an additional 30 drugs that are "urgently needed" in China, and for which NMPA seeks to encourage the submission of marketing applications.

To that end, the agency has:

  • Waived the requirement to conduct clinical trials in China, if the sponsor has data demonstrating that racial or ethnic differences between the study population and Chinese patients would not affect the product's efficacy.
  • Established an expedited six-month review period (three months for orphan drugs) for the identified drugs.

Each of the drugs identified by NMPA meets at least one of the following criteria: (1) an orphan drug; (2) a drug intended to treat a life-threatening disease for which there is currently no approved product; or (3) a drug intended to treat a life-threatening disease and offering a substantial clinical advantage over existing approved therapies.

This is the second time NMPA has taken this step to encourage pharmaceutical companies to bring to China new treatments approved in the United States, European Union, or Japan, but unavailable in China. See our previous blog for the list of 48 "urgently needed" drugs published in August 2018. Reportedly, 11 of the drugs on that first list have been approved in the months since then.

Although comments disagreeing with the listing of any of the 30 drugs as "urgently needed" may be submitted to NMPA by 4 April, the list seems unlikely to change. We will continue to monitor the status of any regulatory changes and reforms by NMPA. With offices in Washington, D.C., Beijing, and Shanghai and a team of Life Sciences lawyers well-versed in both Food and Drug Administration (FDA) and NMPA regulations, we are well-positioned to assist pharmaceutical companies with regulatory and legal issues in China. Please contact one of the authors of this alert if you have any questions or if we can be of further assistance.

Appendix:

Second list of drugs urgently needed in China (unofficial translation by Hogan Lovells)

(Source: Center for Drug Evaluation, NMPA)

Serial

New drug

Manufacturer/sponsor

First

Indication

no.

approval

date outside

of China

(jurisdiction)

1

Biopten Granules 10

Daiichi Sankyo Co. Ltd.

2013/8/20

Type A

percent, 2.5 percent

(Japan)

hyperphenylalaninemia;

(sapropterin

BH4 reactive

hydrochloride)

hyperphenylalaninemia

2

Levemir Insulin Detemir

Novo Nordisk Inc.

2007 for

Noonan; Prader-Willi

[rDNA origin] Injection

Noonan,

2018 for

Prader-

Willi (U.S.)

3

Crysvita (Burosumab)

Kyowa Kirin Ltd.

2018/2/19

X-linked

(EU)

hypophosphatemia

4

Increlex (Mecasermin

Tercica Inc.

2005/8/30

Severe primary insulin-

[rDNA origin]) Injection

(U.S.)

like factor 1 deficiency in

children; defective

growth hormone

receptor gene; growth-

deficient and antibody-

induced undergrowth in

children

5

Aldurazyme (laronidase)

BioMarin Pharmaceutical

2003/4/30

Mucopolysaccharidosis

Inc.

(U.S.)

type I

6

Elaprase (Indursulfase)

Shire Human Genetic

2006/7/24

Mucopolysaccharidosis

Injection

Therapies Inc.

(U.S.)

type II

7

Fabrazyme (Agalsidase

Genzyme Europe B.V.

2001/3/8

Fabry disease

Beta)

(EU)

8

Replagal (Agalsidase

Shire Human Genetic

2001/3/8

Fabry disease

alfa)

Therapies AB

(EU)

9

Galafold (Migalastat

Amicus Therapeutics UK

2016/5/25

Fabry disease

hydrochloride)

Ltd.

(EU)

10

Erleada (apalutamide)

Janssen Biotech Inc.

2018/2/14

Non-metastatic

(U.S.)

castration resistant

prostate cancer

11

Lysodren(mitotane)

Bristol-Myers Squibb Co.

1970/7/8

Adrenal cortical

(U.S.)

carcinoma

12

ALPROLIX [Coagulation

Bioverativ Therapeutics

2014/3/28

Hemophilia B

Factor IX

Inc.

(U.S.)

(Recombinant), Fc

Fusion Protein]

13

Inavir (laninamivir

Daiichi Sankyo Co. Ltd.

2010/9/10

Influenza A and B

octanoate hydrate)

(Japan)

infections

14

Xofluza (Baloxavir

Shionogi & Co. Ltd.

2018/2/23

Influenza A and B

marboxil)

(Japan)

15

Maviret

AbbVie Deutschland

2017/7/26

Hepatitis C

(Glecaprevir/Pibrentasvi

GmbH Co. KG

(EU)

r)

16

BIKTARVY (bictegravir,

Gilead Sciences Inc.

2018/2/7

AIDS

emtricitabine, and

(U.S.)

tenofovir alafenamide)

Tablets

17

Tracleer 32 mg

Janssen-Cilag

2009/6/3

Pulmonary hypertension

dispersible tablets

International NV

(EU)

18

Revatio (Sildenafil

Pfizer Inc.

2009/11/18

Pulmonary hypertension

Citrate)

(U.S.)

19

Careload LA (Beraprost

Toray Industries Inc.

2007/10/19

Pulmonary hypertension

sodium)

(Japan)

20

Praluent Alirocumab

Sanofi-Aventis U.S. Inc.

2015/7/24

Hypercholesterolemia

(U.S.)

21

Ruconest (Recombinant

Pharming Group N.V.

2010/10/28

Hereditary angioedema

human C1-inhibitor)

(EU)

22

STELARA (ustekinumab)

Janssen Biotech Inc.

2016/9/23

Crohn's disease

Injection

(U.S.)

23

Lokelma (sodium

AstraZeneca AB

2018/3/22

Hyperkalemia

zirconium cyclosilicate)

(EU)

24

Verkazia (ciclosporin)

Santen OY

2018/7/6

Severe spring

(EU)

keratoconjunctivitis

25

Humira (adalimumab)

AbbVie Deutschland

2016/6/24

Non-infectious

GmbH Co. KG

(EU)

intermediate uveitis,

posterior uveitis and

total uveitis

26

Lemtrada

Sanofi Belgium

2013/9/12

Multiple sclerosis

(Alemtuzumab)

(EU)

27

Radicava (Edaravone)

Mitsubishi Tanabe

2015/6/1

Amyotrophic lateral

Pharma Corp.

(Japan)

sclerosis

28

Vigadrone(vigabatrin)

Aucta Pharmaceuticals

2018/6/21

Infantile spasm (IS) for

(U.S.)

infants from 1 month to

2 years of age; together

with other therapies for

the treatment of

refractory complex

partial seizures (CPS) in

adults and children aged

10 years and older

29

DUPIXENT Injection

Regeneron

2017/3/28

Moderate to severe

Pharmaceuticals Inc.

(U.S.)

atopic dermatitis

30

Eucrisa (crisaborole)

Anacor Pharmaceuticals

2016/12/14

Mild to moderate atopic

Ointment

Inc.

(U.S.)

dermatitis 2 years and

older

 

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