Two Major Generic Drugs Achieve First-to-Pass Consistency Evaluation in China

March 1 (Medicine Network) — Two more blockbuster drugs have received their first approval for consistency evaluation.

 

 

On February 28, Salubris announced that it had received the NationalPharmaceuticalsLevetiracetam Extended-Release Tablets (0.5g) 《Approved and Issued by the Drug AdministrationDrug RegistrationApproval Document》.

 

 

According to the announcement, Salubris’s levetiracetam extended-release tablets are the first to be marketed in China and are deemed to have passed the generic drug consistency evaluation.

 

 

It is reported that levetiracetam, developed by UCB of Belgium, is a novel antiepileptic drug with a unique mechanism of action. Belonging to the pyrrolidone class of racetams, it constitutes one of the major therapeutic classes in neurology.Adverse ReactionsLess frequent and mild, with good tolerability.

 

According to data from Menet, the national sales of levetiracetam in public hospitals across China amounted to RMB 842 million in 2017, with a market growth rate as high as 29.97%. In recent years, the growth rate has consistently remained in double digits, indicating substantial demand and significant development potential for this product in the market.

 

(Source: Menet Database)

 

 

Currently, the marketed formulations in China include tablets and oral solutions, with no extended-release tablets yet available. Salubris’s levetiracetam extended-release tablets are the first to be marketed in China, filling the gap for this formulation type domestically.

 

According to the Menet database, levetiracetam products currently on the market are predominantly available as conventional tablets, accounting for 89.4% of the share, while oral solutions constitute 10.6%. The approval of Salubris’s extended-release tablet formulation is expected to alter the current distribution of dosage forms in the market.

 

(Source: Menet Database)

 

 

In terms of market landscape, levetiracetam is originated from the original researchEnterpriseAs the sole dominant player, the originator company UCB holds a substantial 98.04% market share, with the remaining portion divided among domestic pharmaceutical companies such as Salubris, Jingxin, and Shenghuaxi. The approval of Salubris’ extended-release tablet formulation, which is deemed to have passed the consistency evaluation, is expected to exert a certain impact on the future market landscape for this product.

 

(Source: Menet Database)

 

 

On the same day (February 28), the official website of Jinan High-tech Zone announced that the National Medical Products Administration had officially approved Qilu Pharmaceutical’s registration application for Trimetazidine Hydrochloride Sustained-Release Tablets.

 

 

It is reported that Qilu Pharmaceutical’s Trimetazidine Hydrochloride Sustained-Release Tablets are the first domestically produced product of this dosage form to be marketed in China, and are deemed to have passed the consistency evaluation.

 

 

It is understood that trimetazidine is clinically indicated for stable angina pectoris that is not adequately controlled by or is intolerant to first-line antianginal therapy. By modulating myocardial energy metabolism, this product effectively alleviates myocardial ischemia symptoms in patients with angina and significantly prevents angina recurrence. The product demonstrates good tolerability, high safety, and favorable patient compliance, and is currently widely used in clinical practice.

 

Data from Menet shows that in 2017, trimetazidine in public hospitals across ChinaHospitalSales revenue reached RMB 1.699 billion, with a market growth rate of 13.58%. Based on the growth trend in recent years, the market expansion for this product has remained relatively stable.

 

(Source: Menet Database)

 

 

According to the Menet database, the dosage forms of trimetazidine sold in public hospitals across China are primarily tablets and capsules, with no sustained-release tablets currently available. The approval and market launch of Qilu Pharmaceutical’s trimetazidine hydrochloride sustained-release tablets fill the gap in this dosage form segment and are expected to impact the current distribution of dosage forms in the market.

 

(Source: Menet Database)

 

 

In terms of market landscape, 64.44% of the trimetazidine market is still occupied by the originator company, Servier. However, domestic pharmaceutical companies are also making significant efforts, with Ruiyang Pharmaceutical and Beijing Wansheng Pharmaceutical each holding more than 10% of the market share.

 

Qilu Pharmaceutical’s Trimetazidine Hydrochloride Sustained-Release Tablets Approved for Market Launch, Filling the Gap in the Sustained-Release Formulation Market and Expected to Impact the Existing Competitive Landscape

 

(Source: Menet Database)