H1 2024 Sees 44 First-to-File Generics Approved in China, with Qilu and Wuhu Daorun Leading the Pack; Takeda Tianqing Follows Closely
Qilu Pharmaceutical
Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer
As of mid-2024, competition among generic drugs in China has become increasingly fierce.The first half of this year(As of June 30)There isOver 600IndividualVarietyThrough consistency evaluation, among which128 ProductsThe FirstPassed Review，44 ProductsHeavyweightFirst Generic DrugApproval Obtained. In this intense competition,Qilu PharmaceuticalAndWuhu Daorun PharmaceuticalTwo pharmaceutical companies shine brightly, each securing four first-to-market generic varieties,Leading the Track in the First Half of the Year.
The Battle for the First Generic in the 900 Billion Yuan Generic Drug Market Intensifies
Looking Back at the Development Trajectory of the Generic Drug Market: From the Comprehensive Implementation of Consistency Evaluation to the In-depth Implementation of Volume-based Procurement, China's pharmaceutical market has undergone earth-shaking changes driven by policies. According to data from "China Generic Drug Development Report (2023 Edition)", after experiencing a peak in 2019, the generic drug market temporarily shrank due to the brief impact of the 2020 pandemic but quickly stabilized and rebounded. Between 2021 and 2023, it remained stable at around 900 billion yuan, showing promising market potential.
First-to-market generic drugs have become the focus of competition among major pharmaceutical companies due to policy preferences and market share advantages. In this field, leading domestic pharmaceutical companies in China, such asQilu Pharmaceutical, Kelun Pharmaceutical, Hengrui, ZhengdatianqingPharmaceutical companies such as Qilu Pharmaceutical have excelled in the research, development, and approval of first-to-market generic drugs in 2022.Kelon, HengruiEach has won7 ProductsFirst Generic, becoming the biggest winner in 2022. In 2023KelonContinuing its strong momentum, Qilu Pharmaceutical shines in the generic drug field, securing six first-to-market generics and topping the 2023 list of leading companies in first-to-market generics.
44 First Generic Drugs Approved, Qilu and 2 Other Pharma Companies Take the Lead!
In 2024, leading pharmaceutical companies in China are also actively making strategic moves. With the relentless efforts of numerous pharmaceutical companies, the domestic high-end generic drug market will continue to thrive. 2024(As of June 30)In the first half of the year, there wasMore than 600 varietiesThrough consistency evaluation, among which128 Products Are the First to Pass the Evaluation，44 Heavyweight First-to-Market Generics(In China)Drug Approval. Among themQilu PharmaceuticalAndWuhu Daorun PharmaceuticalTwo pharmaceutical companies shone brightly in the first half of the year, each securing four first-to-market generic varieties, leading the track for the first half.
Zhengda Tianqing(Including Subsidiaries)Following closely, successfully seizedEverolimus Tablets, Eltrombopag Ethanolamine TabletsAndLetermovir TabletsFirst Generic Versions of 3 Major Varieties in China.
At the same time,Kelun PharmaceuticalHas also achieved remarkable results, winningEltrombopag Ethanolamine Tablets, ω-3 Triglycerides (2%) Medium/Long Chain Fat Emulsion/Amino Acids (16)/Glucose (16%) InjectionThe first domestic generic versions of two varieties further enrich its product line. In addition,Guangzhou YipinhongAlso传来捷报,Oxcarbazepine Oral Suspension, Olmesartan Medoxomil Orally Disintegrating TabletsBoth of the two varieties have been approved as the first generics in China, injecting new vitality into the company's development.
Jiangsu Aosaikang PharmaceuticalSimilarly, it was not to be outdone, successfully securingEltrombopag Ethanolamine Tablets, Isavuconazole Sulfate for InjectionThe first domestic generic versions of two major varieties have added significant weight to their position in the pharmaceutical industry.
In addition,Chengdu Better, Beijing Fuyuan Pharmaceutical, Chenxin Pharmaceutical, Shijiazhuang Fourth Pharmaceutical, CSPC Ouyi PharmaceuticalThe 31 pharmaceutical companies, including Qilu Pharmaceutical Co., Ltd., have each secured one first-to-market generic drug in the first half of 2024, as shown in the table below.
In terms of drug types, the first-to-market generic drugs are often those with high technological barriers.First half of 2024, First GenericThe largest number of approved tablets reached 15, followed by injectables, with 14 approvals.
As Chinese pharmaceutical companies continue to invest heavily in the research, development, and innovation of generic drugs, China's high-end generic drug market will remain highly active. In the first half of 2024, a total of 44 first-to-market generics have been approved, leaving the challenge of reaching "over a hundred" approvals to the second half of the year.
From the enterprise level, Qilu Pharmaceutical and Wuhu Daorun Pharmaceutical stood out in the first half of 2024. Looking ahead to the second half of the year, with the further intensification of market competition, it remains to be seen which pharmaceutical companies will break through the competition, achieve a comeback, and successfully claim the top spot for the first generic drug launch in China in 2024.
This articleData manually compiled and organized by the author, limited energy and level, if there are any omissions or errorsError, JoyYour corrections are welcome. The statistical dimension of the first generic drug data is integrated into the PharmaOcean China Approval Database and the Evaluated Drug Review Database, based on the period of approval and evaluation (first) in the first half of 2024.
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