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) |
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Serial |
New drug |
Manufacturer/sponsor |
First |
Indication |
no. |
approval |
|||
date outside |
||||
of China |
||||
(jurisdiction) |
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1 |
Biopten Granules 10 |
Daiichi Sankyo Co. Ltd. |
2013/8/20 |
Type A |
percent, 2.5 percent |
(Japan) |
hyperphenylalaninemia; |
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(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 |
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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 |
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children |
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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) |
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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 |
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prostate cancer |
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11 |
Lysodren(mitotane) |
Bristol-Myers Squibb Co. |
1970/7/8 |
Adrenal cortical |
(U.S.) |
carcinoma |
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12 |
ALPROLIX [Coagulation |
Bioverativ Therapeutics |
2014/3/28 |
Hemophilia B |
Factor IX |
Inc. |
(U.S.) |
||
(Recombinant), Fc |
||||
Fusion Protein] |
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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) |
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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 |
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with other therapies for |
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the treatment of |
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refractory complex |
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partial seizures (CPS) in |
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adults and children aged |
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10 years and older |
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29 |
DUPIXENT Injection |
Regeneron |
2017/3/28 |
Moderate to severe |
Pharmaceuticals Inc. |
(U.S.) |
atopic dermatitis |
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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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The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.