Table of Contents

1. Basic Information  

2. Domestic Market Approval Status  

   2.1. Domestic Registration of Original Drug  

   2.2. Generic Drug Approvals  

   2.3. Consistency Evaluation Applications and Approvals  

   2.4. Generic Drug Applications  

   2.5. Clinical Trial Filings  

3. Reference Listed Drug (RLD)  

4. Patent Information of the Reference Listed Drug  

5. Market Overview  

   5.1. Inclusion in Medical Insurance  

   5.2. Volume-Based Procurement Information  

   5.3. Sales Data  

   5.4. Tender Information  

6. Active Pharmaceutical Ingredient (API) Research  

   6.1. API Pharmacopeia Information  

   6.2. API Filing Information  

7. Formulation Research  

   7.1. Target Product Quality Overview  

   7.2. Formulation Pharmacopeia Information  

1 Basic Information

Pemafibrate (also known as ペマフィブラート or Pemafibrate) is a drug that reduces plasma triglyceride levels and increases HDL cholesterol levels by binding to the PPARα receptor and regulating target gene expression. It is clinically used for the treatment of hyperlipidemia.  

Pemafibrate tablets were developed by **Kowa Co., Ltd.** in Japan and were approved in Japan in 2017 under the brand name パルモディア/PARMODIA with a specification of 0.1 mg. The marketing authorization holder is Kowa Co., Ltd.. The original product is undergoing import registration in China.  

Currently, the original Japanese product (0.1 mg specification) has been designated by the National Medical Products Administration (NMPA) as the reference listed drug (RLD). Detailed information about the RLD is provided in Table 1-1.

2 Domestic Market Approval Status

2.1 Registration Status of the Original Drug in China

Table 2-1 Registration Information of the Original Drug 

 2.2 Generic Drug Approvals

As of September 11, no applications for the marketing of generic drugs for Pemafibrate have been submitted by any company.

2.3 Consistency Evaluation Applications and Approvals

As of September 11, Pemafibrate has not been marketed in China.

2.4 Generic Drug Applications

As of September 11, no applications for the marketing of generic drugs for Pemafibrate have been submitted.

2.5 Clinical Trial Filings

As of September 11, seven companies have filed for BE (bioequivalence) trials of Pemafibrate, three of which have completed the trials.

CTR20223127

Study Title: Bioequivalence Study of Pemafibrate Tablets (0.1 mg) Under Fasting and Fed Conditions in Healthy Chinese Subjects: A Randomized, Open-Label, Single-Dose, Two-Sequence, Two-Period, Crossover Study.
Sample Size: 60
Status: Completed
Sponsor:

Trial Site: The First Affiliated Hospital of the University of Science and Technology of China.

3 Reference Listed Drug (RLD)

Table 3-1 Reference Listed Drug Information Published by NMPA

4 Patent Information for the Reference Listed Drug

The compound patent for Pemafibrate (WO2005023777) has not been filed in China. The combination use patent (CN200880003381.1) is protected until March 27, 2028.

Formulation-related patent applications, CN201880044027.7 and CN201880043984.8, are currently under substantive examination. If granted, the protection period will extend to 2038. Details are shown in Table 4-1. 

Table 4-1 Patent Information

5 Market Overview

5.1 Medical Insurance Information

None.

5.2 Volume-Based Procurement Information

None.

5.3 Sales Information

None.

5.4 Tender Information

None.

6 API Research

6.1 API Pharmacopeia Information

No pharmacopeial standards for the quality of pemafibrate API were found.

6.2 API Filing Information

As of September 11, four API registration numbers have been filed, all with status "I." Details are shown in Table 6-1.

Table 6-1 API Filing Information

7 Formulation Research

7.1 Target Product Quality Profile (QTPP)

Table 7-1 Target Product Quality Profile (QTPP)

7.2 Formulation Pharmacopeia Information

No pharmacopeial standards for the quality of this product formulation were found.