Chazhou Tianqing Aims to Become China's Fourth Manufacturer of Axitinib Tablets, a Blockbuster Exceeding RMB 2 Billion in Sales

Recently, the CDE website showed that Nanjing Chia Tai Tianqing Pharmaceutical's axitinib tablets have been accepted for production application as a Class 4 generic drug.

Axitinib Tablets, developed by Pfizer, were launched in the United States in 2012 and in China in 2015, under the brand nameInlyta/Yinglida,It is an oral small-molecule tyrosine kinase inhibitor that primarily works by inhibiting the tyrosine kinase activity of receptors such as VEGFR1/2/3, thereby reducing tumor angiogenesis and suppressing tumor growth and metastasis.

Inlyta/InlytaGlobal sales exceeded $1 billion in 2021, making it a member of the “Billion-Dollar Club.”Axitinib tablets were initially approved in China for second-line treatment of renal cell carcinoma; in 2025, they were approved in combination with toripalimab for first-line treatment of renal cell carcinoma.This is the first and only approved targeted therapy-immunotherapy combination regimen in China, officially ushering in a new era of targeted immunotherapy for advanced renal cell carcinoma in the country.

Also starting in 2025,In China, sales of Yinglida began to grow rapidly, with the combined sales from the three channels—hospitals, pharmacies, and online platforms—exceeding RMB 2 billion in 2025.

Besides the original manufacturer Pfizer, there are currently three domestic companies with production approval for Axitinib Tablets: Lunan Pharmaceutical, Easton Bio Pharmaceuticals, and Guangzhou Kruit Pharmaceutical. Recently, Nanjing Chia Tai Tianqing Pharmaceutical’s new classification application for production has been accepted, marking its entry as the fourth domestic producer of this product.

Although three companies hold approval documents for Axitinib Tablets, only Chengdu Easton Bio Pharmaceuticals Co., Ltd. has actually listed them on the procurement platform.Lunan Pharmaceutical Group Corporation’s Shandong New Era Pharmaceutical Co., Ltd. launched the first generic version to market in 2021, but it has never been listed on the provincial drug procurement platform.

Upon investigation, Pfizer’s compound patent for this product expired as early as 2020, with only one crystal form patent remaining.CN103626739 (B), Expiration Date: March 25, 2028.

Shandong New Time has been approved for many years but has not been listed online, so it is highly likely that it failed to circumvent this crystal form patent. Among the other two companies, Chengdu Easton Bio Pharmaceuticals Co., Ltd. has most likely succeeded in circumventing it.Guangzhou Keruite Pharmaceutical is currently unclear (approved on April 17, 2026).

Additionally, a particularly noteworthy point is that the original research product has two strengths, 1 mg and 5 mg, with the 5 mg strength having higher sales volume; generic manufacturers have no intention whatsoever of developing a 1 mg generic version.

Since the beginning of this year, Nanjing Chia Tai Tianqing Pharmaceutical has had six new product applications under review for production approval, covering major therapeutic categories such as antineoplastic and immunomodulating agents, blood and hematopoietic system drugs, and nervous system drugs. Among these, ramelteon tablets and niraparib tosylate capsules currently have no approved generic versions in China. Succinylated gelatin electrolyte sodium acetate injection is poised to become the second domestically produced product of its kind, while levetiracetam and sodium chloride injection is expected to be the third domestically produced version.