Balancing Innovation and Imitation: The Cornerstone of Healthy Development in the Pharmaceutical IndustryIn recent years, first-to-market generic drugs have become a key focus in the R&D strategies of pharmaceutical companies in China, entering a golden era of密集获批. According to the MaxEntropy Pharma database, more than 170 first-to-market generics were approved for marketing between 2022 and 2023, with the number of approvals increasing year by year. In 2024, despite fierce competition from ten rounds of centralized procurement, 896 drugs passed or were deemed to have passed the consistency evaluation, among which 254 were the first to pass, including 107 blockbuster first generics. In this race for first-to-market generics, Qilu Pharmaceutical Co., Ltd. topped the annual rankings with seven first generics.

In recent years, with the opening of the pharmaceuticals market and the reform of the drug approval system, competition in China's generic drug market has become increasingly fierce, emerging as a key area in pharmaceutical companies' strategic planning. This year, the competitive situation in the tenth round of China's national centralized drug procurement has been particularly severe, bringing unprecedented pressure to the industry. The intensity of price bidding in the tenth round was so extreme that "the price of injectables became cheaper than a bottle of mineral water." B-certified enterprises were hit hardest, with some industry insiders even exclaiming that generic drug projects are becoming unsustainable.

However, in the face of a challenging market environment, generic drug companies have not abandoned their pursuit of exploration and breakthroughs. The transition from "me-too" to "fast-follow," "me-better," and even Best-in-Class (BIC) or First-in-Class (FIC) has become an industry consensus. Despite the innovation path being fraught with challenges, generic drug companies are still seeking breakthroughs in niche markets, striving to stand out in fierce market competition. Particularly in the competition for first-to-market generics, major pharmaceutical companies are vying against each other, intensifying the battle in this field. In 2024, despite the brutal competition from ten rounds of centralized procurement, there were still 896 generic drug varieties that passed or were considered to have passed the consistency evaluation, among which 254 were the first to pass, accounting for 28.34%.

In China's generic drug sector, star pharmaceutical companies such as Qilu Pharmaceutical, Kelun Pharmaceuticals, Hengrui Medicine, and Shijiazhuang No. 4 Pharmaceutical have continuously led industry development in recent years thanks to their outstanding R&D capabilities. In terms of the approval of first generics in recent years, these enterprises have consistently maintained a strong competitive position. In 2022, Hengrui and Kelun both achieved excellent results with seven first generics each, jointly reaching the pinnacle of the first generic field. In 2023, Kelun Pharmaceuticals made further progress, securing six first generics and ranking first on that year’s list of companies with first generics. Although the number of first generic approvals for Kelun Pharmaceuticals adjusted downward in 2024, it still successfully obtained four first generics, demonstrating its profound R&D foundation.

Overview of the 2024 Generic Drug Market: A Total of 896 Generic Drugs Passed or Were Deemed to Have Passed the Consistency Evaluation, Among Which 254 Were the First to Pass, and 107 Major First-to-Market Generic Drugs Were Approved. From the corporate perspective, Qilu Pharmaceutical stood out remarkably, ranking at the top in terms of the number of first-to-market generics obtained in 2024, further solidifying its leading position in the generic drug sector.

Reviewing the first-to-market generic drug competition in 2023, Kelun Pharmaceuticals took the lead with six first-to-market generics, while Qilu Pharmaceutical followed closely with five. However, entering 2024, Qilu Pharmaceutical successfully reversed the situation by achieving seven first-to-market generics, ranking at the top of the 2024 first-to-market pharmaceutical companies list. According to the Morentropy pharmaceutical database, in 2024, Qilu Pharmaceutical...(Including subsidiaries)More than 40 varieties have been approved and deemed to have passed the consistency evaluation, among whichEltrombopag Ethanolamine Tablets, Entrectinib Pyridinylpropanol Tablets, Metformin Empagliflozin Tablets (Ⅵ)The first seven generics.

At the same time, Chia Tai Tianqing has also demonstrated strong R&D capabilities. In 2023, the pharmaceutical company successfully launched five first-to-market generic drugs. Entering 2024, Chia Tai Tianqing has maintained its momentum, securing another five first-to-market generics, firmly ranking second in the industry and continuing to lead the competition in the first-to-market generics sector.

Kelon Pharmaceutical has kept pace with four other companies, achieving equally remarkable results in the 2024 market competition. According to the Mosun Pharmaceutical Database, Kelon Pharmaceutical...(Including Subsidiaries)In 2024, nearly 30 varieties were approved and deemed to have passed the consistency evaluation, of which 4 were first-to-market generics, covering areas such asω-3 Triglycerides (2%) Medium/Long Chain Fat Emulsion/Amino Acids (16)/Glucose (16%) InjectionSuch heavyweights products.

In 2024, Shanghai Xuantai Pharmaceutical's first generic drug approvals saw a significant increase, reversing the situation from having only one first generic drug in 2023.Shanghai Xuantai PharmaceuticalTogether with Kelun Pharmaceuticals, Wuhu Daorun Pharmaceuticals, and Jiangxi Simai Pharmaceuticals, they have captured the third position in the first-to-market generic drug sector. According to the Mosun Pharmaceutical Database, in 2024, Shanghai Xuantai Pharmaceuticals received approval for six products, which are considered to have passed the consistency evaluation, four of which are first-to-market generics, namely:Dagliflozin Metformin Sustained-Release Tablets (Ⅰ), Dagliflozin Metformin Sustained-Release Tablets (Ⅱ), Dagliflozin Metformin Sustained-Release Tablets (Ⅲ)AndMesalazine Enteric-Coated Sustained-Release TabletsHowever, Wuhu Daorun Pharmaceutical and Jiangxi Simai Pharmaceutical, which were absent from the 2023 first-generic list, made a stunning comeback in 2024 by each securing four first-generic drugs, strongly advancing to the forefront of this year's first-generic drug rankings.

Secondly,In the first generic drug market competition of 2024,Shijiazhuang Siyao and Beijing Fuyuan Pharmaceutical, two pharmaceutical companiesHas also achieved good results`, 2 companies`Tied for fourth place, both companies have secured 3 first-to-market generic drugs. These two enterprises also possess considerable strength and competitiveness in the generic drug sector.

In addition, six pharmaceutical companies—Guangzhou Yipinhong Pharmaceutical, Hubei Xinze Fei Pharmaceutical, Hunan Jiudian Pharmaceutical, Jichuan Pharmaceutical Group, and Yichang Renfu Pharmaceutical—each secured two first-to-market generic drugs in 2024, tying for fifth place. These enterprises also hold a certain market share in the generic drug market.

In addition to the aforementioned companies, over 60 pharmaceutical enterprises in China have successfully launched at least one first-to-market generic drug in 2024. This fully demonstrates the intense competition in China's generic drug market and the significant emphasis that many pharmaceutical companies place on the development of generic drugs.

2024 First Generic Complete Data Collection

Scan the QR code below to claim

In China's pharmaceutical industry, generic drugs play a crucial role. With the deepening implementation of the national centralized procurement policy, the prices of generic drugs have significantly dropped, causing low-level and repetitive generics to gradually lose market competitiveness. In contrast, high-quality first-to-market generics, hard-to-copy innovative drugs, and improved new drugs have become the new darlings of the market.

The first generic drugs that have been successfully approved are mainly concentrated in niche fields with high technical barriers, highlighting the significant progress made by pharmaceutical companies in technological innovation and overcoming technical challenges. In the future, with further policy guidance and continuous market changes, the competitive landscape of China's generic drug market will continue to evolve.

END

This article is original. Please leave a message to obtain authorization for reprint. 

Recent Popular Resource Acquisition

Reply to the keyword "In-depth Report", receive a report package worth 18,600 yuan

Reply to the keyword "First Generic in 2023", obtain the list of first generic drugs approved in 2023

Background Reply"GLP-1 In-depth Report", to obtain the complete "GLP-1 Industry Status and Future Development" PDF version.

Background reply"China Class I New Drug", Get the full"China Class I New Drug Targets" PDF Version.

Reply in the background“NAFLD/NASH”, to obtain the complete "NAFLD/NASH Report" PDF version.

Reply in the background"AI + Pharmaceutical", Get Complete"White Paper on China's AI Pharmaceutical Companies"PDF Version.

Background reply“XXG”, get full"Analysis Report on Cardiovascular System Drugs in China"PDF Version.

Reply in the background“FZZJ”, Get Complete"Analysis of Complex Injectable Formulations Based on Dosage Form Optimization"PDF Version.

Reply in the background"Import and Export of Pharmaceuticals", get completeWhite Paper on China's Pharmaceutical Imports and ExportsIn-depth Report - PDF Version.

Contact us to experience more professional services from Mosen Pharma.
MeetingDiscussion CombinedMade	GardenDistrict TakeWu	Database Consultation	Customization Service	Media Cooperation

???ClickImage Above, you can start the MosEntropy chemical data query

ClickReadRead the original text, apply for a free trial of Mosentropy Pharmaceutical Enterprise Edition!