Qilu Pharmaceutical Secures Seven First-to-File Generic Drugs in 2024 Amid Over 1,300 Products Passing Consistency Evaluation

　　【Pharmaceutical Network Industry DynamicsGeneric Drug Consistency Evaluation refers to the assessment of the quality and efficacy consistency of already approved generic drugs, ensuring their equivalence to originator drugs in terms of active ingredients, dosage forms, specifications, routes of administration, and therapeutic effects. Generic drugs that pass the consistency evaluation can clinically substitute for originator drugs, which not only improves the quality of generic drugs but also reduces drug costs, promoting healthy competition within the pharmaceuticals industry.
 

According to relevant data statistics, from 2017 to the end of 2024, currently, 1,365 varieties (counted by drug names) have passed/been deemed to pass the consistency evaluation, involving 1,326 group enterprises. In 2024 alone, a total of 3,073 varieties (counted by drug names and deduplicated by group enterprises) passed/been deemed to pass the consistency evaluation, involving 888 enterprises (counted by group enterprises).
 

Data shows that from 2017 to the end of 2024, among companies passing evaluations, Qilu Pharmaceutical has 203 products that have passed or are considered to have passed consistency evaluations, ranking highest in number; Sichuan Kelun Pharmaceutical has 184 products that have passed or are considered to have passed consistency evaluations; Yangtze River Pharmaceutical has 179 products that have passed or are considered to have passed consistency evaluations. Additionally, Zhengda Tianqing, Fosun Pharma, CSPC Holdings, Chengdu Better Pharmaceutical, Shijiazhuang No. 4 Pharmaceutical, CR Double-Crane, and Humanwell Healthcare have 164, 142, 141, 133, 123, 101, and 101 products respectively that have passed or are considered to have passed consistency evaluations.
 

Reviewing the year 2024 that just passed, a total of 920 varieties (counted by drug names) have passed/been considered to pass the consistency evaluation, involving 888 group enterprises. Among them, Shanghai Pharmaceuticals has 51 varieties passing the evaluation, Shijiazhuang Fourth Pharmaceutical has 48 varieties passing, and Qilu Pharmaceutical has 41 varieties passing. In addition, Kelun Pharmaceuticals, China Resources Double-Crane, Chengdu Better Pharmaceutical, Lunan Pharmaceutical, Shijiazhuang Pharmaceutical Holdings, Zhengdatianqing, and Shanghai Modern Pharmaceuticals have passed evaluations for 40, 38, 37, 33, 30, 29, and 28 varieties respectively.
 

According to the review, in 2024 Qilu Pharmaceutical obtained seven first-to-market generic drugs: Eltrombopag Ethanolamine Tablets, Entrectinib Capsules, Metformin Empagliflozin Tablets (VI), Riociguat Tablets, Tafamidis Meglumine Soft Capsules, Bendamustine Hydrochloride Concentrated Solution for Injection, and Apalutamide Tablets.
 

In December 2024, Qilu Pharmaceutical Co., Ltd. obtained the first generic approval for Apalutamide Tablets, a product primarily used to treat non-metastatic castration-resistant prostate cancer. Data shows that in 2023, global sales of Apalutamide Tablets exceeded $2.3 billion, representing a year-on-year increase of 26.9%.
 

In July 2024, Qilu Pharmaceutical's Entecavir and Rilpivirine Hydrochloride and Tenofovir Alafenamide Fumarate Tablets, used for the treatment of HIV-1 (Human Immunodeficiency Virus Type 1) infection, were approved for marketing in China. This marks the first generic version of the drug, originally developed by Gilead, which has not yet been approved for marketing in China. The Entecavir and Rilpivirine Hydrochloride and Tenofovir Alafenamide Fumarate Tablets are a triple combination formulation of Entecavir, Rilpivirine Hydrochloride, and Tenofovir Alafenamide Fumarate. The combination therapy of these three drugs is effective and recommended by guidelines as an antiviral treatment for adult and adolescent patients who are new to treatment. The single-tablet regimen is more convenient to take, requiring only one tablet per day, which helps reduce the medication burden on patients and increase compliance.
 

In June 2024, Qilu Pharmaceutical's nervous system disease treatment drug, Tafamidis Methylglucamine Soft Capsules, officially received marketing approval. It can be used to treat adult patients with Stage I symptoms of transthyretin amyloidosis polyneuropathy (ATTR-PN) and effectively delay peripheral nerve function damage. Industry experts indicate that the launch of Qilu Pharmaceutical's Tafamidis Methylglucamine Soft Capsules will bring greater hope for patients with transthyretin amyloidosis polyneuropathy and significantly reduce the financial burden of treatment.
 

In addition, Chia Tai Tianqing obtained 5 first-to-market generic drugs in 2024, while Kelun Pharmaceutical secured 4 first-to-market generics.
 

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