H1 2022: Top 12 China Generic Drug Approval Winners
Overview of the Top 12 Companies
Yangtze River Pharmaceutical is the biggest winner, owning 14 approved generic drugs, followed by Sichuan Kelun Pharmaceutical and Beite Pharmaceutical with 11 approved generics respectively. Jiangsu Hengrui Pharmaceutical takes the fourth and fifth places with 9 generic products and CSPC Pharmaceutical with 8 generics.
| Ranking | Company | Approved Generic Drugs | Approved Generic Drug Applications |
| 1 | Yangtze River Pharmaceutical | 14 | 18 |
| 2 | Sichuan Kelun Pharmaceutical | 11 | 18 |
| 2 | Beite Pharmaceutical | 11 | 15 |
| 4 | Jiangsu Hengrui Pharmaceuticals | 9 | 12 |
| 5 | CSPC Pharmaceutical | 8 | 12 |
| 6 | CR Pharmaceutical | 7 | 7 |
| 6 | SSY Group | 7 | 7 |
| 8 | Reyoung Pharmaceutical | 6 | 8 |
| 9 | Qilu Pharmaceutical | 5 | 7 |
| 9 | Easton Biopharmaceuticals | 5 | 6 |
| 9 | Sino Biopharmaceutical | 5 | 5 |
| 9 | Tianyu Pharm | 5 | 5 |
| Data source: Menet.com.cn | |||
* Notes: The approved generic applications outnumber the approved drugs. The reason is that for products with the same active ingredient but with different strengths and/or dosage forms, the generic drug products’ applications are different.
Among the approved generic drugs made by the top 12 companies, 18 are the first generics in China, including 6 drugs by Hengrui Pharmaceuticals, 5 by Kelun Pharmaceutical, 2 by Yangtze River Pharmaceutical, and 1 by Beite Pharmaceutical.
“First generic drug in China” refers to the first generic drug developed by Chinese companies and approved by China NMPA. They can enjoy 12-month market exclusivity as they are the first generics to have successfully challenged the patents of innovator drugs.
Top 4 Companies’ Approved Generics
Top 1: Yangtze River Pharmaceutical
Yangtze River Pharmaceutical was the champion in 2021 with 31 approved drugs and comes in first again with 14 approved generics in H1 2022.
| No. | Approved Generic Drug | Registration Classification | Therapeutic Area |
| 1 | Ropivacaine Hydrochloride Injection | Class 4 | Nervous system |
| 2 | Levofloxacin and Sodium Chloride Injection | Class 4 | Systemic anti-infection |
| 3 | Magnesium Sulfate, Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution | Class 3 | Gastrointestinal system and metabolism |
| 4 | Levofloxacin Injection | Class 3 | Systemic anti-infection |
| 5 | Aripiprazole Orally Disintegrating Tablets | Class 3 | Nervous system |
| 6 | Nifedipine Controlled-release Tablets | Class 4 | Cardiovascular and cerebrovascular system |
| 7 | Tedizolid Phosphate for Injection | Class 4 | Systemic anti-infection |
| 8 | Levetiracetam Tablets | Class 4 | Nervous system |
| 9 | Olmesartan Medoxomil Tablets | Class 4 | Cardiovascular and cerebrovascular system |
| 10 | Sugammadex Sodium Injection | Class 4 | Musculoskeletal system |
| 11 | Sitafloxacin Tablets | Class 4 | Systemic anti-infection |
| 12 | Rocuronium bromide Injection | Class 4 | Musculoskeletal system |
| 13 | Levosalbutamol Hydrochloride Nebuliser Solution | Class 3 | Respiratory system |
| 14 | Bivalirudin for Injection | Class 4 | Blood and hematopoietic system |
| *First generics are in green and bold.
*To learn about drug registration class, please refer to China Chemical Drug Registration Classification. |
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Top 2: Sichuan Kelun Pharmaceutical
Kelun has 11 generics approved in H1 2022, among which five are first generics.
| No. | Drug | Registration Classification | Therapeutic Area |
| 1 | Linagliptin Tablets | Class 4 | Gastrointestinal system and metabolism |
| 2 | Trelagliptin Succinate Tablets | Class 3 | Gastrointestinal system and metabolism |
| 3 | Medium and Long Chain Fat Emulsion / Amino Acids (16) / Glucose (36%) Injection | Class 3 | Blood and hematopoietic system |
| 4 | Medium and Long Chain Fat Emulsion / Amino Acids (16) / Glucose (30%) Injection | Class 3 | Blood and hematopoietic system |
| 5 | Tirofiban Hydrochloride and Sodium Chloride Injection | Class 3 | Blood and hematopoietic system |
| 6 | Sildenafil Citrate Orodispersible Tablets | Class 4 | Reproductive & urinary systems and sex hormones |
| 7 | Sugammadex Sodium Injection | Class 4 | Musculoskeletal system |
| 8 | Ipratropium Bromide Solution for Inhalation | Class 4 | Respiratory system |
| 9 | Gadoteridol Injection | Class 4 | Others |
| 10 | Linezolid and Glucose Injection | Class 4 | Systemic anti-infection |
| 11 | Palonosetron Hydrochloride Injection | Class 4 | Gastrointestinal system and metabolism |
| *First generics are in green and bold. | |||
Top 3: Beite Pharmaceutical
Beite also has 11 generic drugs approved in H1 2022, most of which are for anti-infection and the respiratory system.
| No. | Drug | Registration Classification | Therapeutic Area |
| 1 | Terbutaline Sulfate Nebuliser Inhalation | Class 4 | Respiratory system |
| 2 | Levosalbutamol Hydrochloride Nebuliser Solution | Class 3 | Respiratory system |
| 3 | Pramipexole Dihydrochloride Sustained-release Tablets | Class 4 | Nervous system |
| 4 | Salbutamol Sulfate Injection | Class 3 | Respiratory system |
| 5 | Oseltamivir Phosphate for Oral Suspension | Class 4 | Systemic anti-infection |
| 6 | Oseltamivir Phosphate Capsules | Class 4 | Systemic anti-infection |
| 7 | Voriconazole for Injection | Class 4 | Systemic anti-infection |
| 8 | Tranexamic Acid Injection | Class 4 | Blood and hematopoietic system |
| 9 | Voriconazole Tablets | Class 4 | Systemic anti-infection |
| 10 | Cefuroxime Axetil for Suspension | Class 3 | Systemic anti-infection |
| 11 | Benzbromarone Tablets | Class 3 | Musculoskeletal system |
| *First generics are in green and bold. | |||
Top 4: Jiangsu Hengrui Pharmaceuticals
Though Hengrui is not among the top 3 generic approval winners, the company has the highest number of 6 approved first generics in H1 2022.
At the end of 2018, China started mandating that generic drugs must pass the quality and therapeutic equivalence evaluation before applying for joining the volume-based procurement. Since then, Hengrui has shifted its focus to innovator drugs and high-end generic drugs.
| No. | Drug | Registration Classification | Therapeutic Area |
| 1 | Nimodipine Oral Solution | Class 3 | Cardiovascular and cerebrovascular system |
| 2 | Paracetamol and Mannitol Injection | Class 3 | Nervous system |
| 3 | Ondansetron Oral Soluble Pellicles | Class 3 | Gastrointestinal system |
| 4 | Gadobutrol Injection | Class 4 | Other |
| 5 | Ambroxol Hydrochloride Oral Solution | Class 3 | Respiratory system |
| 6 | Omega-3-acid Ethyl Ester 90 Soft Capsules | Class 3 | Cardiovascular and cerebrovascular system |
| 8 | Medium and Long Chain Fat Emulsion / Amino Acids (16) / Glucose (16%) Injection | Class 4 | Blood and hematopoietic system |
| 9 | Diquafosol Sodium Eye Drops | Class 4 | Sensory system |
| 10 | Tacrolimus Sustained-release Capsules | Class 4 | Anti-neoplasm and immunomodulation |
| *First generics are in green and bold. | |||
Reprinted from: ChemLinked
Reference Links
Generic Drug Application (ANDA) in China
Webinar: Generic Drug Application Procedures in China
How Does China’s Drug Patent Linkage System Work?
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