Multiple First Generics of the Hard-to-Imitate to be Marketed Soon

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 to be marketed.

Cardio-cerebral medicine area—two xabans

Apixaban and rivaroxaban are currently the two hottest anticoagulants. According to the global top 10 best-selling drugs in 2022 forecast by EvaluatePharma, those two drugs are still listed, with annual sales separately expected to be about USD7.4 billion and USD6.6 billion.

Wherein, the first generic of apixaban will be produced by Hansoh, while, the first generic of rivaroxaban will be produced by Chiatai Tianqing. For details, please refer to "Hansoh, the Master of First Generics, to Produce the First Generic of Apixaban, the Best-selling Anticoagulant in the World in 2017" and "Another Good Target that Makes Good Drugs—Coagulation Factor Xa Making the Best-selling Anticoagulant in the World: Apixaban".

Respiratory system medicine area—budesonide and salmeterol are the most watched

Budesonide and salmeterol are the most watched respiratory system medicines of Sino Biopharmaceutical in the next 2-3 years.

--Budesonide Suspension for Inhalation—the inhalation preparation with the largest sales in China

Budesonide is an inhaled corticosteroid (ICS) with efficient local anti-inflammatory action and is used to treat bronchial asthma and asthmatic chronic bronchitis. Budesonide Suspension for Inhalation is the inhalation preparation variety with the largest sales in China, with sales reaching RMB4.29 billion in China in 2017.

The market concentration of inhalation preparations is generally high, and the market of Budesonide Suspension for Inhalation in China has been exclusively occupied by AstraZeneca’s Pulmicort Respules for 15 years since it entered China in 2004, without any Chinese-produced generic drug marketed for the competition.

Chiatai Tianqing, Taitai Pharmaceutical, and CF PharmTech have successively filed marketing applications according to the new class 4 in the first half of 2018, all of which may be approved for marketing in 2019.

 (Organized according to public data; only hospital supply companies applying for production counted)

--Salmeterol—sales champion of respiratory system drugs

Developed by Glaxo Wellcome, Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation is a fixed-dose compound preparation constituted by the long-acting β2 receptor agonist: salmeterol xinafoate and glucocorticoid: fluticasone propionate; it was first marketed in the UK in Mar. 1999, with the trade name of Seretide, and was approved by the U.S. FDA in Aug. 2000, with the trade name of Advair Diskus, and has now been widely marketed in the world, with specifications of: salmeterol xinafoate/fluticasone propionate of 50μg/100μg, 50μg/250μg, and 50μg/500μg each. Currently, it is mainly used in asthma patients aged above 4 and maintenance therapy of airway obstruction of patients with chronic obstructive pulmonary disease (COPD). It has long been the sales champion of respiratory system drugs.

Import of Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation of Glaxo Wellcome UK Limited has been approved in China, with the trade name of Seretide, with specifications of salmeterol xinafoate/fluticasone propionate of 50μg/100μg, 50μg/250μg, and 50μg/500μg each.

It is very difficult to imitate Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation, and the 3 enterprises with the fastest progress in China are separately Chiatai Tianqing, Haibin Pharmaceutical, and Suzhou Omni.

 (Organized according to public data; only pharmaceutical enterprises applying for production counted)

Blood disease medicine area—recombinant human coagulation factor VIII biosimilar expected to be marketed

Recombinant human coagulation factor VIII is mainly used to treat hemophilia A with plasma coagulation factor VIII (FVIII) deficiency and has no risk of infection compared to blood-derived products. Hemophilia is a hemorrhagic disease with inherited coagulation disorder and has been included in the First List of Rare Diseases made by the National Health Commission of China in May 2018. According to the Consensus of Chinese Experts on the Diagnosis and Treatment of Hemophilia (Version 2017), the incidence of hemophilia A is about 1/5,000 in the male population, and female hemophilia patients are relatively less. And the Chinese hemophilia A patients are estimated to exceed 100,000.

Recombinant human coagulation factor VIII products in China are almost monopolized by imported products at present, with annual sales exceeding RMB300 million. Bayer’s Kogenate FS was marketed in China in Nov. 2007, with a market share of about 62%, followed by products of Baxter and Wyeth.

Chiatai Tianqing has filed the relevant clinical trial application in 2016, and the Phase III clinical trial has now been completed; its product is expected to be approved in 2019, and, if successfully marketed, will become the first recombinant human coagulation factor VIII biosimilar in China. Furthermore, Sinocelltech and Novo Nordisk, etc. have also been conducting relevant Phase III clinical trials.

 (Organized according to public data)

Furthermore, in diabetes and autoimmunity medicine areas, the R&D strategy of Sino Biopharmaceutical is to imitate the key original products, and the relevant innovative drugs are still in embryo.

Read more:

Sino Biopharmaceutical’s R&D Investment Growing by 31% to Rank Fourth!

About  the Author:    

Caicai, a Master of Pharmacy from Shanghai Jiaotong University, used to work in the Institute of Science and Technical Information. Currently as a practitioner in the drug surveillance system, she is good at interpreting industry regulations, pharmaceutical research developments, etc.

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