In terms of generic drug, Sino Biopharmaceutical will have more than 20 generic drugs marketed in the next 2-3 years, wherein, the number of first generics will approach 15, making it the well-deserved "king of first generics"; in terms of innovative drug, it will have more indications approved successively in the future besides anlotinib marketed last year, and its anti-PD-L1 monoclonal antibody TQB2450 is expected to be marketed in 2021.
Next, key pharmaceutical products of each indication above will be separately analyzed in the order of the above indications.
Hepatitis medicine area—First generic of TAF and improved TAF
In the area traditionally dominated, Sino Biopharmaceutical will have two blockbuster drugs marketed in the next 2-3 years, separately, the first generic of TAF: Tenofovir Alafenamide Tablets, and salified and modified TAF: Aifenfuwei.
--Tenofovir alafenamide—the first TAF generic drug applied for production in China
Tenofovir alafenamide (TAF, trade name: Vemlidy) is a drug developed by Gilead to treat patients with chronic hepatitis B virus (HBV) infection with compensated liver disease; it is called the "most powerful" miracle drug of hepatitis B and has yet been marketed in China.
Seen from the application situation of TAF, Chiatai Tianqing applied for the marketing according to a generic drug of registration class 3, which was undertaken by CDE on Oct. 22, 2018; Jiangxi Qingfeng also did so, which was undertaken by CDE on Oct. 29, 2018; Gilead applied for import according to import registration class 5.1, which was undertaken by CDE in Oct. 2017, and Gilead has been approved to conduct confirmatory clinical trial; Gilead Sciences (Hangzhou) applied for a clinical trial according to a new drug of registration class 1, which has been approved.
Chiatai Tianqing will be highly likely to produce the first generic of TAF, however, the original drug manufacturer and the imitation manufacturer will have an intense game in connection with the patent in the future.
--Aifenfuwei—the first Class 2.1 new drug, salified and modified TAF
Aifenfuwei has been the first drug applied according to chemical drug Class 2.1 since the new chemical drug registration classification was formally implemented on Mar. 4, 2016, wherein, chemical drug Class 2.1 is defined as "APIs and preparations thereof that are not marketed in China and outside China and contain optical isomer of known active ingredients prepared with resolution or synthesis method, or esterified known active ingredients, or salified known active ingredients (including salt with hydrogen bond or coordinate bond), or with the changes in acid radical, basic group or metal elements of known salt active ingredients, or form other non-covalent bond derivatives (such as complex, chelate or clathrate compound), with significant clinical advantages", with a protection period of 3 years.
Aifenfuwei is a salified and modified TAF, which was approved for the clinical trial in June 2017.
Oncology medicine area—covering the hot tinib drug, biosimilars, and anti-PD-L1 monoclonal antibody
In the oncology medicine area, key products of Sino Biopharmaceutical to be marketed in the next 2-3 years include gefitinib, bevacizumab, trastuzumab and rituximab biosimilars, and anti-PD-L1 monoclonal antibody: TQB2450, etc.
For details of gefitinib, please refer to my previous article "Big News! The First Generic of Gefitinib: Yiruike of Qilu Pharmaceutical Approved for Marketing".
Pharmaceutical enterprises such as Innovent analyzed by me previously have all laid out bevacizumab, trastuzumab and rituximab biosimilars. It seems that the possession of blockbuster biosimilars has become an essential condition for being listed among the top 10 list. Please refer to the article "Hot Battle! Which to be the Next ‘Hanlikang’?" for the details.
Kelun analyzed by me previously also has laid out the anti-PD-L1 monoclonal antibody: TQB2450, with the code of KL-A167, both of which are expected to follow each other closely ...
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