Over $600 Million Drug Market Stirs Again: Which Pharma Company Will Secure the First Generic?

　　【Pharmaceutical Network Product InformationRecently, according to the CDE website, the marketing application for the Category 4 chemical generic drug Ponatinib Tablets submitted by Chengdu Shuode Pharmaceutical Co., Ltd. has been accepted. Currently, there are no generic versions of this drug available in China. If Shuode Pharmaceutical's application is approved successfully, it will have the opportunity to secure the first generic version of Ponatinib.
 

As a landmark third-generation BCR-ABL tyrosine kinase inhibitor, ponatinib has drawn significant attention since its inception. In December 2012, it was first approved by the FDA for marketing and subsequently "gained momentum," receiving EMA approval in 2013, PMDA approval in 2016, and officially entering the Chinese market in September 2024, with Otsuka Pharmaceutical responsible for sales. Its arrival brought new hope to adult patients with chronic-phase chronic myeloid leukemia (CML) who were resistant or intolerant to prior first- and second-generation tyrosine kinase inhibitors, as well as those with relapsed or refractory CML in the accelerated or blast phase, and adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).
 

From the mechanism of action, ponatinib is truly a "precise killer." It can efficiently and specifically inhibit the T315I mutant BCR-ABL kinase. While firmly suppressing the BCR-ABL kinase, it also possesses "a full range of skills," acting on multiple kinase targets such as VEGFR, PDGFR, FGFR, EPH receptors, SRC family kinases, as well as KIT, RET, TIE2, and FLT3, all of which fall within its "range of attack." This characteristic allows it to offer potential benefits for some leukemia patients with complex mutations or multi-target dependencies, securing its particularly important position in the field of leukemia treatment.
 

In terms of market performance, ponatinib has demonstrated strong growth momentum. Looking at the global market, its sales surpassed the $600 million mark in 2024, representing a nearly 15% increase from the same period last year. Moreover, over the past five years, the compound annual growth rate (CAGR) has consistently remained above 10%. These achievements undoubtedly demonstrate its popularity and market potential worldwide. Focusing on the Chinese market, since ponatinib only entered China in September 2024, it is still in the market introduction phase. According to incomplete statistics, the drug's sales in domestic retail outlets and B2C channels reached approximately 500,000 yuan in the first half of 2025. As an original research drug, ponatinib’s current price in the Chinese market exceeds 8,000 yuan per box, which is relatively high. This pricing has, to a certain extent, limited the drug's accessibility and increased anticipation among patients and healthcare workers for the emergence of generic versions.
 

Currently, the competition for generic drugs in China has quietly begun. In addition to Shuode Pharmaceutical, which was the first to submit a generic drug marketing application, Qilu Pharmaceutical also submitted a generic application on August 1st. The interval between the two companies' applications was less than half a month, making the ownership of the first-to-market qualification highly uncertain. It is like an intense race where no one can predict the winner until the very last moment. Regardless of which company eventually secures the first-to-market status, its significance will be substantial. Once the generic drug successfully enters the market, it is highly likely to break the monopoly of the original drug in terms of price and accessibility.

 

Behind this fierce competition for the first generic drug is a contest among numerous pharmaceutical companies for a huge market potential. With the entry of generic drugs, the competitive landscape of the Ponatinib market may change. The original drug manufacturers need to consider how to respond to the impact of generics in terms of price and market, while generic drug makers must continuously improve product quality and production efficiency to gain a foothold in the market.
 

Disclaimer: In any case, the information or opinions expressed in this article do not constitute investment advice for any person.