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.

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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H1 2022: Top 12 China Generic Drug Approval Winners

Overview of the Top 12 Companies