2018 can be said to be a year where profound changes happened to the Chinese pharmaceutical industry: confusions in the medical circle, establishment of the National Health Commission (NHC) and National Healthcare Security Administration of China, continued aftermath of Changsheng vaccine incident, strong advancement of generic drug consistency evaluation but sudden stop at the year end, implementation of zero tariff for imported oncology drugs, much attention to the 4+7 procurement with target quantity, and unveiling of the health empire by dxy.com…

The wheel of history rolls on, however, when looking back on the past, the things we experienced, the issues we considered, and the stars we looked up at will all inspire and enlighten us. Here, let’s review the approval situation of the imported pharmaceutical products in 2018:

According to the information provided by the database of the National Medical Products Administration of China (NMPA), there are 4,300 registration approvals for imported pharmaceutical products in China at present, involving nearly 30 therapeutic areas such as anti-tumor, anti-infection, cardiovascular and cerebrovascular systems, and digestive system; wherein, 461 were granted in 2018, including 359 re-registration approvals, and 102 new approvals (involving 59 products).

Table: Imported Drugs Approved through Priority Review in 2018

Oncology drugs had the largest number among the above imported pharmaceutical products that received priority review, most of which were innovative drugs with significant therapeutic advantages, followed by rare disease drugs and pediatric drugs:

★Oncology drugs:

Roche: Pertuzumab Injection, a new drug for breast cancer, is used in combination with trastuzumab and chemotherapy as adjuvant treatment of patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer at high risk of recurrence.

Roche: ALECENSA (Alectinib Hydrochloride Capsules), a new lung cancer drug, is indicated for the treatment of anaplastic lymphoma kinase (ALK)-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC). ALECENSA was approved separately in Nov. 2017 in the U.S. and in Dec. 2017 in the EU as a first-line therapy of ALK-positive NSCLC. ALECENSA entered the priority review procedure of CDE of the NMPA in Mar. 2018, and was formally approved in Aug. 2018, being marketed almost synchronously with the EU and U.S.

Pfizer: IBRANCE (Palbociclib Capsules), a new drug for breast cancer, is indicated for the treatment of hormone receptor (HR)–positive, HER2-negative locally advanced or metastatic breast cancer in combination with aromatase inhibitor as initial endocrine-based therapy in postmenopausal women. The drug was approved for marketing in 2015 in the U.S. through accelerated approval procedure, for the treatment of advanced breast cancer.

Eisai: Lenvima (Lenvatinib Mesylate Capsules), a new drug for liver cancer, is used to treat unresectable hepatocellular carcinoma (HCC) in patients without prior systemic treatment.

AstraZeneca: Olaparib, a targeted drug for ovarian cancer, is the first targeted new drug for ovarian cancer marketed in China and the first PARP inhibitor used as maintenance therapy in patients with platinum-sensitive, relapsed ovarian cancer.

BMS: Opdivo (Nivolumab Injection), an immunotherapy cancer drug, is indicated for the treatment of epidermal growth factor receptor (EGFR) mutation-negative and (ALK)-negative adult patients who have locally advanced or metastatic NSCLC with progression on or intolerance to prior platinum-based chemotherapy. The drug is a PD-1 inhibitor and is the first immunotherapy cancer drug approved for marketing in China.

MSD: PD-1 inhibitor Keytruda (pembrolizumab) is used to treat NSCLC and malignant melanoma, etc. It is a blockbuster product of MSD and has successively received 14 breakthrough therapy designations granted by FDA, and been approved for 12 indications that cover 9 different advanced cancers, being the anti-PD-1 monoclonal antibody with the approved indications covering the broadest cancer types at present.

Novartis: Oncology drug Zykadia (Ceritinib Capsules) is an orally, highly selective and potent ALK small molecule inhibitor that is indicated for patients with ALK-positive locally advanced or metastatic NSCLC who progressed on or are intolerant to crizotinib.

MSD: Recombinant Human Papillomavirus 9-Valent is indicated for females aged 16 to 26 and is provided in 3 doses. The vaccine was separately approved in the U.S. and EU in 2014 and 2015.

Takeda: Oncology drug Ninlaro (Ixazomib Citrate Capsules) is the first oral compound combined with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy;

★Rare disease drugs:

Swiss Alexion: Eculizumab Injection is used for the treatment of adults and children with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), both of which are rare diseases in the world.

Sanofi: Aubagio (Teriflunomide Tablets) is used to treat the rare disease of relapsing multiple sclerosis.

F. Hoffmann-La Roche: Rare disease drug Emicizumab Injection is used to treat patients with haemophilia A with factor VIII inhibitors.

★Pediatric drugs

Sanofi: Fasturtec (Rasburicase for Injection) is used to control uric acid levels in pediatric patients with leukemia or lymphoma who already have hyperuricemia or high tumor burden and have risks of tumor lysis syndrome (TLS) and subsequent elevations of plasma uric acid, so as to reduce TLS risk and ensure treatment continuity.

Maruho Co., Ltd.: Pediatric Faropenem Sodium Granules is a pediatric anti-infective drug.

Eli Lilly: Atomoxetine Hydrochloride Oral Solution is used to treat attention deficit / hyperactivity disorder (ADHD) in children and adolescents.

Furthermore, there were also innovative drugs with unique efficacy or breakthrough respectively in therapeutic areas such as ophthalmology and respiratory system.

Bayer: EYLEA (Aflibercept Intravitreal Injection), a new ophthalmic drug, is used to treat diabetic macular edema (DME) in adults;

Otsuka Pharmaceutical: Delamanid Tablets is indicated for use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (MDR-TB) in adult patients when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.

UCB: Vimpat? (Lacosamide Tablets) is used in in the treatment of partial-onset seizures with or without secondary generalization in adult and adolescent (aged 16-18) patients with epilepsy.

Amgen: Repatha (Evolocumab Injection), a cholesterol-lowering drug, is indicated in adults and adolescents aged 12 and over with homozygous familial hypercholesterolaemia (HoFH).

GSK: Anoro (Umeclidinium Bromide and Vilanterol Trifenatate Powder for Inhalation), a new drug for chronic obstructive pulmonary disease (COPD), is a kind of powder for inhalation that contains two bronchodilators, which is used as a long-term maintenance therapy of COPD.

Boehringer Ingelheim: Spiolto Respimat (Tiotropium Bromide and Olodaterol Inhalation Spray) is used as a long-term maintenance therapy of COPD (including chronic bronchitis and emphysema), and is currently the only dual bronchodilator in the COPD therapeutic area that contains tiotropium bromide and delivered via the unique soft mist inhaler device.

Despite the increased global competition at present, to maintain the healthy development of the pharmaceutical market in China, China needs to keep an open mind, and actively introduce advanced drugs and therapies of foreign countries and overseas innovative drugs that are clinically imperative while encouraging the innovative development of Chinese-produced pharmaceutical products, so that the public will have more drug choices and Chinese pharmaceutical enterprises can be inspired and motivated

About the Author:

zhulikou431

Zhulikou431, as a senior engineer, PDA member, ISPE member, ECA member, PQRI member, senior aseptic GMP expert, has deep knowledge in aseptic process development and verification, drug development and registration, CTD document writing and review, regulatory audit, international certification, international registration , quality system construction and maintenance, as well as sterile inspection, environmental monitoring and other fields. In recent years, he has focused on the analysis of trends in the macro pharmaceutical field and the risk management of pharmaceutical enterprise mergers and acquisitions projects. 

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