Over 100 Generic Drugs Pass Consistency Evaluation, Involving 123 Pharma Companies; Lunan Pharma Among Four Firms with Three Products Each

　　【Pharmaceutical Network Industry DynamicsAccording to data statistics, in February 2025, a total of 118 varieties passed/were considered to have passed the consistency evaluation, involving 123 group enterprises.
 

Data analysis shows that in February, Chengdu Bright, Lunan Pharmaceutical, Shanghai Fosun Pharmaceutical, and Shijiazhuang Siyao each had 3 varieties pass/be considered to pass the consistency evaluation; Beijing Fuyuan, Qilu, and 12 other enterprises each had 2 varieties pass the evaluation, and the remaining enterprises all had single variety evaluations.
 

Among them, the Finasteride Tablets (brand name: Hesu; specification: 5mg) produced by Lunan Betta Pharmaceutical Co., Ltd. of Lunan Pharmaceutical Group Corporation were approved by the National Medical Products Administration on February 25 for the consistency evaluation of quality and efficacy of generic drugs. The clinical indications of this product are: (1) Suitable for the treatment and control of benign prostatic hyperplasia (BPH) and the prevention of urinary system events: reducing the risk of acute urinary retention; reducing the need for transurethral resection of the prostate (TURP) and prostatectomy. (2) This product can reduce the size of an enlarged prostate, improve urine flow, and alleviate symptoms related to prostate enlargement. Patients with an enlarged prostate are suitable for treatment with this product.
 

Hengsi® Atomoxetine Hydrochloride Capsules [Specification: 40mg (as C17H21NO)] of Lunan Pharmaceutical Group Shandong New Era Pharmaceutical Co., Ltd. were approved for marketing by the National Medical Products Administration on February 8, and are deemed to have passed the quality and efficacy consistency evaluation for generic drugs. This medication is a first-line treatment for ADHD, which can significantly reduce symptoms of hyperactivity and inattention in children and also improve their social interaction abilities with peers.
 

In terms of the number of companies that passed the evaluation for product varieties, among the 118 varieties that passed the evaluation in February 2025, 18 varieties were evaluated by multiple companies. Specifically, four companies passed the evaluation for Phloroglucinol Injection and Lactulose Oral Solution, while three companies passed the evaluation for Glucosamine Sulfate Capsules, Ambroxol Terbutaline Oral Solution, and Esomeprazole Magnesium Enteric-Coated Capsules.
 

Data shows that phloroglucinol injection is a smooth muscle relaxant, which is mainly used in the clinical treatment of various types of pain caused by smooth muscle spasms. Statistics indicate that in 2023, the sales revenue of phloroglucinol injection in China's hospital market exceeded 800 million yuan, representing a year-on-year increase of 11.08%.
 

The indications for lactulose oral solution are chronic or habitual constipation, regulating the physiological rhythm of the colon; hepatic encephalopathy: for the treatment and prevention of hepatic coma or pre-coma states.
 

Esomeprazole is a proton pump inhibitor developed by AstraZeneca. The drug is the S-isomer of omeprazole and blocks the final step of gastric acid secretion by specifically inhibiting the H+-K+ ATPase in gastric parietal cells. Esomeprazole magnesium enteric-coated capsules are mainly used to treat gastroesophageal reflux disease, as well as erosive reflux esophagitis. When used in combination with appropriate antibiotics, it can eradicate Helicobacter pylori, thereby promoting the healing of peptic ulcers associated with its infection.
 

Glucosamine Sulfate Capsules are suitable for treating primary and secondary arthritis caused by other diseases, relieving symptoms such as joint pain and swelling, and improving joint mobility functions. Ambroxol and Terbutaline Oral Solution is used to treat acute and chronic respiratory diseases, such as acute bronchitis, chronic bronchitis, emphysema, etc.
 

Notably, there were five first-generic versions launched in February, namely Ilaprazole Enteric-Coated Tablets, Tapentadol Hydrochloride Tablets, Guanfacine Hydrochloride Extended-Release Tablets, Risperidone Microspheres for Injection, and Empagliflozin Metformin Hydrochloride Extended-Release Tablets (Ⅳ).
 

It is reported that Aipulazol Enteric-Coated Tablets, under Shijiazhuang Zhongnuo Pharmaceutical Co., Ltd. of CSPC, were approved on February 8. This drug is a potent acid-suppressing medication primarily used to treat peptic ulcers and gastroesophageal reflux disease caused by excessive stomach acid. Data shows that the sales revenue of Aipulazol Enteric-Coated Tablets in China's hospital market exceeded 1.3 billion yuan in 2023.
 

On February 26, Renfu Pharmaceutical announced that its holding subsidiary, Yichang Renfu's Tapentadol Hydrochloride Tablets, obtained a drug registration certificate. This medication is suitable for treating acute pain in adult patients who require opioid therapy and for whom alternative treatments are not sufficiently effective. Data shows that global sales of Tapentadol Hydrochloride Tablets were approximately US$700 million in 2023.
 

On February 26, Shengzhao Pharmaceuticals announced that it had obtained a drug registration certificate for its injectable risperidone microspheres. This drug encapsulates risperidone within a biodegradable polymer of polylactide/glycolide to form spherical microparticles, which achieve stable drug release through three stages after injection: hydration, drug diffusion, and polymer erosion. Data shows that the global market size for the original injectable risperidone microsphere formulation was $490 million in 2022. With future reductions in medical insurance pricing and the promotion of complex formulations, the market size for risperidone microspheres in China is expected to grow rapidly, reaching an estimated 920 million RMB by 2030.
 

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