On October 15, 2026, according to the official website of the National Medical Products Administration (NMPA ) of China, Ponatinib tablets, submitted by Chengdu ShuoDe Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Yuandong Bio, were approved for marketing. Public information indicates that this drug is derived from traditional Chinese medicine preparations from medical institutions. Ponatinib tablets are a third-generation BCR-ABL tyrosine kinase inhibitor for leukemia, suitable for patients with chronic myeloid leukemia, acute lymphoblastic leukemia, and other conditions .
Chronic myeloid leukemia (CML) is a malignant tumor affecting the blood and bone marrow, accounting for approximately 15% to 20% of adult leukemia cases. According to data released in the "2021 China Chronic Myeloid Leukemia Patient Report White Paper," 20.2% of the 2,533 patients surveyed were intolerant to drug treatment. Mutations in the BCR-ABL kinase domain are one of the important mechanisms leading to resistance to tyrosine kinase inhibitor (TKI) therapy, and are currently one of the most difficult mutations to overcome.
As a Bcr-Abl kinase inhibitor, ponatinib targets the original Bcr-Abl kinase, as well as all known single, treatment-resistant mutations, including the most common T315I mutation. Ponatinib exhibits highly efficient and specific inhibitory activity against the T315I mutant Bcr-Abl kinase, effectively addressing the common deficiency of existing Bcr-Abl inhibitors caused by kinase mutations leading to resistance.
Compared to first- and second-generation inhibitors, ponatinib not only targets the Bcr-Abl prototype but also covers all known single, treatment-resistant mutations, including the most common T315I mutation. Furthermore, ponatinib also exhibits inhibitory activity against various other kinases such as VEGFR, PDGFR, and FGFR, further expanding its therapeutic potential.
Publicly available information shows that ponatinib (trade name Iclusig) is a third-generation Bcr-Abl kinase inhibitor, originally developed by Ariad Pharmaceuticals. In December 2014, Otsuka Pharmaceuticals partnered with Ariad, acquiring the rights to jointly develop and commercialize ponatinib in Asian countries including Japan, China, and South Korea. In early 2017, Takeda acquired the product through its acquisition of Ariad.
Ponatinib, a landmark third-generation BCR-ABL tyrosine kinase inhibitor, has been approved by the FDA since December 2012, followed by approval by the EMA in 2013 and the PMDA in 2016, and officially entered the Chinese market in September 2024.
Regarding the domestic generic drug situation, both Qilu Pharmaceutical and Chengdu Shuode Pharmaceutical submitted their applications for production approval in August 2025. Among them, Chengdu Shuode Pharmaceutical recently obtained approval for production, successfully becoming the first domestic generic manufacturer of Ponatinib tablets .
According to the press release from Yuandong Bio, the approved indications are : (1) adult patients with chronic myeloid leukemia in the chronic phase who are resistant to and/or intolerant to first- and second-generation tyrosine kinase inhibitors; (2) adult patients with relapsed or refractory chronic myeloid leukemia in the accelerated or blast crisis phase, and Philadelphia chromosome-positive acute lymphoblastic leukemia, for whom no other tyrosine kinase inhibitors are applicable; and (3) adult patients with chronic myeloid leukemia (chronic, accelerated, and blast crisis) or Philadelphia chromosome-positive acute lymphoblastic leukemia with the T315I mutation who are resistant to any tyrosine kinase inhibitor and diagnosed by a fully validated assay.
A phase II study called PACE, conducted abroad, evaluated the efficacy and safety of ponatinib in patients with chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL). The clinical study enrolled a total of 449 patients who had received 2 to 3 prior TKI treatments and received ponatinib 45 mg once daily.
The results showed that, during a median follow-up of 56.8 months, the major cytogenetic remission (MCyR) rate was 60% for chronic myeloid leukemia patients in the chronic phase who were previously resistant to or intolerant of other medications, the complete cytogenetic remission (CMR) rate was 54%, and the major molecular remission (MMR) rate was 40% . At a median follow-up, it was estimated that 82% of patients achieved MCyR at 12 months and 59% achieved MMR at 5 years.
Furthermore, researchers found that remission was associated with long-term outcomes. The 5-year progression-free survival (PFS) and overall survival (OS) were as high as 53% and 73%, respectively.
According to relevant data, ponatinib has shown strong growth in the global market. In 2024, global sales of the drug exceeded $600 million, representing a year-on-year increase of nearly 15%, with a compound annual growth rate of over 10% over the past five years. Focusing on the Chinese market, given that ponatinib only entered the Chinese market in September 2024, it is still in the market introduction phase. Based on incomplete statistics, the product has been on the market in China for a relatively short time, with sales of approximately RMB 2.61 million in the first half of 2026. As an original drug, ponatinib is currently priced at over RMB 8,000 per box in the Chinese market, a price level that to some extent affects the drug's accessibility.

Source: https://mp.weixin.qq.com/s?__biz=MzI1NTM5MDg5Ng==&mid=2247518451&idx=2&sn=e80cf53759f41b1a9d712dbf747e4235&chksm=eb226d585a6dbc8e9b8e3a762f2cf9aab893e6685df0eba36a2e2ee990a8a01537092193fa81&scene=126&sessionid=0#rd