Weekly Update on China's Generic Drug Consistency Evaluation: 5 Products Pass, 23 New Submissions Filed by Leading Firms Including Hansoh, Qilu, and Kelun

As of May 30, the Center for Drug Evaluation (CDE) had accepted 1,150 applications for consistency evaluation (covering 347 varieties from 361 manufacturers; counted as supplemental applications, same below), among which 205 applications (93 varieties) had passed the consistency evaluation. This week, five additional varieties passed the evaluation (two of which were deemed to have passed), and 28 applications covering 23 varieties were accepted. Companies such as Hansoh Pharma, Kelun Pharmaceutical, CSPC Pharmaceutical Group, and Qilu Pharmaceutical continue to submit applications for consistency evaluation.

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Details of Consistency Evaluation Approval

Five Varieties Pass Evaluation, Blockbuster and Popular Products Gather

This week (May 23 to May 30), four additional varieties passed the consistency evaluation, namely Hansoh Pharma's Cefdinir Capsules, Humanwell Healthcare's Isoniazid Tablets, Beijing Jingfeng Pharmaceutical's Metformin Hydrochloride Tablets, BRILLIANT PHARMACEUTICALS' Ketorolac Tromethamine Injection, and Qilu Pharmaceutical's Atorvastatin Calcium Tablets.

Details of Consistency Evaluation Approvals This Week

Cefdinir Capsules

Cefdinir, a third-generation cephalosporin and systemic anti-infective agent, was originally developed by Japan’s Astellas Pharma. The terminal market for this drug in China’s public medical institutions is nearly RMB 3 billion. Currently, cefdinir is available in China in various formulations, including dispersible tablets, capsules, and conventional tablets. Capsules account for more than half of the market share, with Hansoh Pharma holding over 50% of the capsule segment.

According to Yaozhi Data, there are currently only three domestic manufacturers of cefdinir capsules: Hansoh Pharma, Zhejiang Jutai Pharmaceutical, and Tianjin Pharmaceutical Group’s Jinkang Pharmaceutical. This week, Hansoh Pharma became the first to pass the consistency evaluation, seizing a first-mover advantage in the market and further enhancing its product competitiveness. In addition, Jinkang Pharmaceutical has completed the bioequivalence (BE) trial for this product; once its application is successfully accepted, approval through the consistency evaluation is expected to follow shortly.

Isoniazid Tablets

Isoniazid Tablets are an anti-tuberculosis medication, primarily used in combination with other anti-tuberculosis drugs. Last week, the product from Guangdong South China Pharmaceutical passed the evaluation. This week, Yichang Humanwell Pharmaceutical followed suit by passing the consistency evaluation. As of now, four companies have had their Isoniazid Tablets pass the evaluation, as detailed in the table below:

Metformin Hydrochloride Tablets

Metformin Hydrochloride Tablets are biguanide oral hypoglycemic agents, primarily used for the treatment of type 2 diabetes. Developed by Shin Nippon Shinyaku Co., Ltd., they were first launched in Japan in 1961.

Centralized drug procurement is currently in full swing. Metformin Hydrochloride Tablets, as a hotly contested pre-selected product for the second batch of volume-based procurement, are facing intense competition. From the perspective of consistency evaluation, 52 manufacturers have filed reference listings for Metformin Hydrochloride Tablets; among them, applications from 27 manufacturers have been accepted, and six manufacturers have passed the evaluation. Notably, CSPC Ouyi Pharmaceutical Co., Ltd. is listed in the "Catalogue of Marketed Drugs in China" as having deemed to have passed the consistency evaluation.

Details of the Consistency Evaluation Approval for Metformin Hydrochloride Tablets

Ketorolac Tromethamine Injection

Ketorolac Tromethamine Injection is the world’s first injectable non-steroidal drug, indicated for the short-term management of acute moderate to severe pain requiring opioid-level analgesia. It is recommended as a first-line agent for baseline analgesia in multiple domestic and international guidelines. First launched in the United States in 1989, it has been used clinically for nearly 30 years.

According to Yaozhi Data, there are currently only four domestic production approvals for Ketorolac Tromethamine Injection, involving four enterprises: Tianjin Chase Sun Pharmaceutical, Yung Shin Pharmaceutical, Sichuan Meidakang Jiale Pharmaceutical, and Shandong New Time Pharmaceutical. This week, BRILLIANT PHARMACEUTICALS’ application for market approval of its Ketorolac Tromethamine Injection as a Class 3 generic drug was approved, joining the competitive landscape, enhancing product competitiveness, and disrupting the existing market for Ketorolac Tromethamine Injection.

Atorvastatin Calcium Tablets

Atorvastatin is a selective inhibitor of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase. It is indicated for heterozygous familial and non-familial hypercholesterolemia, mixed dyslipidemia, and homozygous hypercholesterolemia. Developed collaboratively by Pfizer and Warner-Lambert, Lipitor was launched in China in 1999. With cumulative global sales of approximately $150 billion, it became the first blockbuster drug to surpass $100 billion in total sales.

Currently, there are 10 marketing approvals for domestically produced Atorvastatin Calcium Tablets in China, involving 7 manufacturers. Qilu Pharmaceutical (Hainan) received approval this week to manufacture the drug under a Class 4 chemical drug application, which is deemed as having passed the consistency evaluation. To date, a total of 4 manufacturers have either passed or are deemed to have passed the consistency evaluation for Atorvastatin Calcium Tablets. Details are as follows:

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Application Acceptance

28 Application Numbers Accepted, First for 7 Varieties

This week, the CDE accepted 28 applications for consistency evaluation, involving 23 products from 22 companies, among which 7 products were the first to be accepted.

Details of the First Acceptance of an Application for Consistency Evaluation This Week

Notably, Fuan Pharmaceutical’s Ornithine Aspartate Injection is the first product from the company to have its application for consistency evaluation accepted.

This product is primarily indicated for elevated blood ammonia levels and the treatment of hepatic encephalopathy caused by acute or chronic liver diseases (such as various types of hepatitis, liver cirrhosis, fatty liver, and post-hepatitis syndrome). It is particularly suitable for treating latent or episodic hepatic encephalopathy associated with or secondary to impaired hepatic detoxification function (e.g., in liver cirrhosis), especially for managing confusion during the early stages of hepatic coma or during hepatic coma episodes. Currently, only two manufacturers, Qingdao Jinfeng Pharmaceutical and Fu’an Pharmaceutical, hold two market approval documents for this product. Fu’an Pharmaceutical was the first to submit an application for consistency evaluation, striving to enhance its product competitiveness.

In addition, this week saw five major injectable drug submissions besides Fu’an Pharmaceutical’s Ornithine Aspartate Injection. These include CSPC Zhongnuo’s Ceftriaxone Sodium for Injection, Sichuan Kelun’s Moxifloxacin Hydrochloride and Sodium Chloride Injection, Yabao Pharmaceutical’s Alpha-Lipoic Acid Injection, and Liaoning Haisco’s Fat Emulsion, Amino Acids (17), and Glucose (11%) Injection.

Details of Acceptance of Applications for Consistency Evaluation of Injectables This Week

Attachment: Details of Acceptance of Applications for Consistency Evaluation This Week

Note: Items highlighted in red are new additions this week.

Some information is sourced from publicly available online resources such as Yaozhi.com and corporate announcements.

Data Sources: Yaozhi Data, corporate announcements, and other publicly available online information

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