United States: China Adds 30 Drugs To Its "Urgently Needed" List

Last Updated: April 15 2019
Article by Philip Katz, James (Jim) R. Johnson and Xin Tao

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.


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

(Source: Center for Drug Evaluation, NMPA)


New drug






date outside

of China



Biopten Granules 10

Daiichi Sankyo Co. Ltd.


Type A

percent, 2.5 percent




BH4 reactive




Levemir Insulin Detemir

Novo Nordisk Inc.

2007 for

Noonan; Prader-Willi

[rDNA origin] Injection


2018 for


Willi (U.S.)


Crysvita (Burosumab)

Kyowa Kirin Ltd.






Increlex (Mecasermin

Tercica Inc.


Severe primary insulin-

[rDNA origin]) Injection


like factor 1 deficiency in

children; defective

growth hormone

receptor gene; growth-

deficient and antibody-

induced undergrowth in



Aldurazyme (laronidase)

BioMarin Pharmaceutical





type I


Elaprase (Indursulfase)

Shire Human Genetic




Therapies Inc.


type II


Fabrazyme (Agalsidase

Genzyme Europe B.V.


Fabry disease




Replagal (Agalsidase

Shire Human Genetic


Fabry disease


Therapies AB



Galafold (Migalastat

Amicus Therapeutics UK


Fabry disease





Erleada (apalutamide)

Janssen Biotech Inc.




castration resistant

prostate cancer



Bristol-Myers Squibb Co.


Adrenal cortical




ALPROLIX [Coagulation

Bioverativ Therapeutics


Hemophilia B

Factor IX



(Recombinant), Fc

Fusion Protein]


Inavir (laninamivir

Daiichi Sankyo Co. Ltd.


Influenza A and B

octanoate hydrate)




Xofluza (Baloxavir

Shionogi & Co. Ltd.


Influenza A and B





AbbVie Deutschland


Hepatitis C


GmbH Co. KG




BIKTARVY (bictegravir,

Gilead Sciences Inc.



emtricitabine, and


tenofovir alafenamide)



Tracleer 32 mg



Pulmonary hypertension

dispersible tablets

International NV



Revatio (Sildenafil

Pfizer Inc.


Pulmonary hypertension




Careload LA (Beraprost

Toray Industries Inc.


Pulmonary hypertension




Praluent Alirocumab

Sanofi-Aventis U.S. Inc.





Ruconest (Recombinant

Pharming Group N.V.


Hereditary angioedema

human C1-inhibitor)



STELARA (ustekinumab)

Janssen Biotech Inc.


Crohn's disease




Lokelma (sodium

AstraZeneca AB



zirconium cyclosilicate)



Verkazia (ciclosporin)

Santen OY


Severe spring




Humira (adalimumab)

AbbVie Deutschland



GmbH Co. KG


intermediate uveitis,

posterior uveitis and

total uveitis



Sanofi Belgium


Multiple sclerosis




Radicava (Edaravone)

Mitsubishi Tanabe


Amyotrophic lateral

Pharma Corp.





Aucta Pharmaceuticals


Infantile spasm (IS) for


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


DUPIXENT Injection



Moderate to severe

Pharmaceuticals Inc.


atopic dermatitis


Eucrisa (crisaborole)

Anacor Pharmaceuticals


Mild to moderate atopic




dermatitis 2 years and



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