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 desig...
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