China adds 30 drugs to its "urgently needed" list Faster review periods and waiver of requirement for Chinese clinical trials are intended to encourage marketing applications 2 April 2019 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. China adds 30 drugs to its "urgently needed" list 2 Appendix: Second list of drugs urgently needed in China (unofficial translation by Hogan Lovells) (Source: Center for Drug Evaluation, NMPA) Serial no. New drug Manufacturer/sponsor First approval date outside of China (jurisdiction) Indication 1 Biopten Granules 10 percent, 2.5 percent (sapropterin hydrochloride) Daiichi Sankyo Co. Ltd. 2013/8/20 (Japan) Type A hyperphenylalaninemia; BH4 reactive hyperphenylalaninemia 2 Levemir Insulin Detemir [rDNA origin] Injection Novo Nordisk Inc. 2007 for Noonan, 2018 for PraderWilli (U.S.) Noonan; Prader-Willi 3 Crysvita (Burosumab) Kyowa Kirin Ltd. 2018/2/19 (EU) X-linked hypophosphatemia 4 Increlex (Mecasermin [rDNA origin]) Injection Tercica Inc. 2005/8/30 (U.S.) Severe primary insulinlike factor 1 deficiency in children; defective growth hormone receptor gene; growthdeficient and antibodyinduced undergrowth in children 5 Aldurazyme (laronidase) BioMarin Pharmaceutical Inc. 2003/4/30 (U.S.) Mucopolysaccharidosis type I 6 Elaprase (Indursulfase) Injection Shire Human Genetic Therapies Inc. 2006/7/24 (U.S.) Mucopolysaccharidosis type II 7 Fabrazyme (Agalsidase Beta) Genzyme Europe B.V. 2001/3/8 (EU) Fabry disease 8 Replagal (Agalsidase alfa) Shire Human Genetic Therapies AB 2001/3/8 (EU) Fabry disease 9 Galafold (Migalastat hydrochloride) Amicus Therapeutics UK Ltd. 2016/5/25 (EU) Fabry disease 10 Erleada (apalutamide) Janssen Biotech Inc. 2018/2/14 (U.S.) Non-metastatic castration resistant prostate cancer China adds 30 drugs to its "urgently needed" list 3 11 Lysodren(mitotane) Bristol-Myers Squibb Co. 1970/7/8 (U.S.) Adrenal cortical carcinoma 12 ALPROLIX [Coagulation Factor IX (Recombinant), Fc Fusion Protein] Bioverativ Therapeutics Inc. 2014/3/28 (U.S.) Hemophilia B 13 Inavir (laninamivir octanoate hydrate) Daiichi Sankyo Co. Ltd. 2010/9/10 (Japan) Influenza A and B infections 14 Xofluza (Baloxavir marboxil) Shionogi & Co. Ltd. 2018/2/23 (Japan) Influenza A and B 15 Maviret (Glecaprevir/Pibrentasvi r) AbbVie Deutschland GmbH Co. KG 2017/7/26 (EU) Hepatitis C 16 BIKTARVY (bictegravir, emtricitabine, and tenofovir alafenamide) Tablets Gilead Sciences Inc. 2018/2/7 (U.S.) AIDS 17 Tracleer 32 mg dispersible tablets Janssen-Cilag International NV 2009/6/3 (EU) Pulmonary hypertension 18 Revatio (Sildenafil Citrate) Pfizer Inc. 2009/11/18 (U.S.) Pulmonary hypertension 19 Careload LA (Beraprost sodium) Toray Industries Inc. 2007/10/19 (Japan) Pulmonary hypertension 20 Praluent Alirocumab Sanofi-Aventis U.S. Inc. 2015/7/24 (U.S.) Hypercholesterolemia 21 Ruconest (Recombinant human C1-inhibitor) Pharming Group N.V. 2010/10/28 (EU) Hereditary angioedema 22 STELARA (ustekinumab) Injection Janssen Biotech Inc. 2016/9/23 (U.S.) Crohn's disease 23 Lokelma (sodium zirconium cyclosilicate) AstraZeneca AB 2018/3/22 (EU) Hyperkalemia 24 Verkazia (ciclosporin) Santen OY 2018/7/6 (EU) Severe spring keratoconjunctivitis 25 Humira (adalimumab) AbbVie Deutschland GmbH Co. KG 2016/6/24 (EU) Non-infectious intermediate uveitis, posterior uveitis and total uveitis 26 Lemtrada Sanofi Belgium 2013/9/12 Multiple sclerosis China adds 30 drugs to its "urgently needed" list 4 (Alemtuzumab) (EU) 27 Radicava (Edaravone) Mitsubishi Tanabe Pharma Corp. 2015/6/1 (Japan) Amyotrophic lateral sclerosis 28 Vigadrone(vigabatrin) Aucta Pharmaceuticals 2018/6/21 (U.S.) 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 29 DUPIXENT Injection Regeneron Pharmaceuticals Inc. 2017/3/28 (U.S.) Moderate to severe atopic dermatitis 30 Eucrisa (crisaborole) Ointment Anacor Pharmaceuticals Inc. 2016/12/14 (U.S.) Mild to moderate atopic dermatitis 2 years and older China adds 30 drugs to its "urgently needed" list 5 Contacts Philip Katz Partner, Washington, D.C. T +1 202 637 5632 [email protected] Xin Tao Senior Associate, Washington, D.C. T +1 202 637 6986 [email protected] James (Jim) R. Johnson Partner, Washington, D.C. T +1 202 637 5896 [email protected] www.hoganlovells.com "Hogan Lovells" or the "firm" is an international legal practice that includes Hogan Lovells International LLP, Hogan Lovells US LLP and their affiliated businesses. The word "partner" is used to describe a partner or member of Hogan Lovells International LLP, Hogan Lovells US LLP or any of their affiliated entities or any employee or consultant with equivalent standing. Certain individuals, who are designated as partners, but who are not members of Hogan Lovells International LLP, do not hold qualifications equivalent to members. For more information about Hogan Lovells, the partners and their qualifications, see www. hoganlovells.com. Where case studies are included, results achieved do not guarantee similar outcomes for other clients. Attorney advertising. 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