65 Generic Drug Products Pass Consistency Evaluation in April: Hengrui, Qilu, and Tianda Tianqing Among Key Players

Highlights:

1. In April, the CDE accepted 59 new applications (covering 43 drug varieties).

2. In April, 109 approvals (including those deemed as having passed the evaluation) were issued for 65 drug varieties that have passed the consistency evaluation.

   
   

According to the Consistency Evaluation Analysis System of Yaozhi Data Enterprise Edition, 59 new consistency evaluation acceptance numbers were added in April 2021; 109 approvals (including 49 approvals deemed as passing) passed the evaluation. (See the attached table at the end of the article for details on consistency evaluation applications and approvals in April.)

Figure 1. Trend of Submissions/Approvals from February 2020 to April 2021

Details of Passing the Evaluation

In April, a cumulative total of 109 application numbers passed or were deemed to have passed the consistency evaluation, involving 65 varieties from 69 enterprises. Among these, 8 varieties were listed in the 289 Catalog, and 15 varieties were the first to pass the evaluation.

In terms of companies with approved generic consistency evaluations, Qilu Pharmaceutical was the big winner in April, with seven approval documents covering five varieties passing the consistency evaluation. Qilu Pharmaceutical is a large, comprehensive, and modern pharmaceutical enterprise in China, specializing in the research, development, production, and sales of formulations and active pharmaceutical ingredients (APIs) for the treatment of tumors, cardiovascular and cerebrovascular diseases, infections, psychiatric disorders, neurological conditions, and ophthalmic diseases. According to the Chinese Marketed Drug Database, the company holds 331 approval documents covering 208 varieties. To date, the company has submitted applications (or is deemed to have submitted applications) for 96 varieties, among which 52 varieties—including Tenofovir Disoproxil Fumarate Tablets, Ceftriaxone Sodium for Injection, and Bivalirudin for Injection—have passed the consistency evaluation.

Next, Huahai, Guangshengtang, Chia Tai Tianqing, and Hengrui each have three products that have passed the evaluation.

Figure 2 Top 10 Enterprises by Number of Approved Drug Varieties in April 2021

By product, the most fiercely contested products in April were Rivaroxaban Tablets and Amoxicillin Capsules, with five manufacturers each securing approval. In addition, five other products, including Moxifloxacin Hydrochloride Eye Drops, each had three manufacturers obtain approval.

To date, 40 manufacturers have submitted applications for the consistency evaluation of rivaroxaban tablets, with 17 having passed the evaluation. Rivaroxaban tablets, a novel anticoagulant, are indicated for the prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery; for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) in adults; for reducing the risk of recurrent DVT and/or PE in patients who remain at continued risk of recurrence after completing at least six months of initial therapy; and for reducing the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation who have one or more risk factors. Data on the relative efficacy of rivaroxaban compared with warfarin in reducing the risk of stroke and systemic embolism are limited under conditions where warfarin therapy is well controlled.

Currently, 68 manufacturers have submitted applications for the consistency evaluation of amoxicillin capsules, with 32 manufacturers having passed the evaluation. Amoxicillin is indicated for the following infections in adults and children caused by susceptible bacteria (non-β-lactamase-producing strains). Its use should adhere to the official guidelines for the clinical application of antimicrobial agents.

Figure 3 Top 10 Varieties by Number of Approving Enterprises in April 2021

41 Varieties Submitted, with Injectables Accounting for Over 60%

In April 2021, the Center for Drug Evaluation (CDE) accepted 59 new applications for consistency evaluation, involving 43 products from 43 pharmaceutical companies, with injectables continuing to rank first in proportion.

Figure 4 Details of Dosage Forms Submitted in April 2021

For the declared varieties, in April 2021, five application numbers for Cefotaxime Sodium for Injection were accepted. In addition, multiple other varieties, including Alanyl Glutamine Injection, each had two application numbers accepted. See the figure below for details.

Figure 5 Top 10 Varieties by Number of Accepted Applications in April 2021

Cefotaxime Sodium for Injection is indicated for pneumonia and other lower respiratory tract infections, urinary tract infections, meningitis, sepsis, intra-abdominal infections, pelvic infections, skin and soft tissue infections, genital tract infections, and bone and joint infections caused by susceptible bacteria. Cefotaxime can be selected as the drug of choice for pediatric meningitis. Currently, there are 233 approval documents for Cefotaxime Sodium for Injection in China, involving 81 manufacturers. Four companies have submitted applications for consistency evaluation (including one under the new registration classification). As no company has yet passed the evaluation, it remains to be seen which company will become the first to achieve approval.

From a corporate perspective, in April, North China Pharmaceutical Hebei Huamin Pharmaceutical Co., Ltd., Tongfang Pharmaceutical Group Co., Ltd., and Qilu Pharmaceutical Co., Ltd. each had three acceptance numbers for consistency evaluation applications accepted.

North China Pharmaceutical Hebei Huamin Pharmaceutical Co., Ltd. (hereinafter referred to as “Huamin Company”) was established on the basis of the New Cephalosporin Project, a key construction project in the new industrial park of North China Pharmaceutical Group and a key engineering project of Hebei Province. This initiative serves as a strategic endeavor to implement the product transformation, upgrading, and supply chain integration goals of North China Pharmaceutical Group. It stands as a model project within the group’s new industrial park, a pivotal initiative for strengthening and refining North China Pharmaceutical’s core competencies, and a key project aimed at building the company into a domestically leading and world-class pharmaceutical enterprise. Huamin Company holds 124 approval documents covering 54 product varieties. Among these, consistency evaluation applications (or applications deemed equivalent) have been submitted for 13 varieties. Currently, Cephalexin Capsules and Cefuroxime Axetil Tablets have successfully passed the consistency evaluation.

Tongfang Pharmaceutical Group owns more than 10 subsidiaries, forming a comprehensive industrial layout encompassing pharmaceutical R&D, manufacturing, and sales. It has established a differentiated product portfolio covering chemical drugs, active pharmaceutical ingredients (APIs), biopharmaceuticals, traditional Chinese medicine (TCM) proprietary products, laboratory animals, and Tibetan medicine. The group operates multiple production lines for powder injections, tablets, ointments, capsules, pills, and granules, producing a full range of products including TCM proprietary medicines, chemical drugs, biochemical drugs, biological raw materials, food, and health supplements. Currently, Tongfang Pharmaceutical Group Co., Ltd. holds 27 marketing approvals covering 17 product varieties. Consistency evaluation applications (or applications deemed as such) have been submitted for four of these varieties; none have yet passed the evaluation.

Figure 6 Top 10 Corporate Application Acceptance Numbers in April 2021

Appendix 1: Details of Drugs Passing (Including Deemed as Passing) the Consistency Evaluation in April 2021

Data as of May 8, 2021

Data Source: Yaozhi Data Generic Drug Consistency Evaluation Analysis System

Appendix 2: Detailed Table of Consistency Evaluation Declarations in April 2021

Data as of May 8, 2021

Data Source: Yaozhi Data Generic Drug Consistency Evaluation Analysis System

Responsible Editor: Liuli

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