2024 Guidelines for the Diagnosis and Treatment of Myeloid Leukemia and Analysis of the Competitive Landscape of the Drug Market – Moshang Pharmaceuticals

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FIC/BIC/Me-too/Me-copy: Confused? PharmaNews 2022-03-04 Market Insight Center Pharmaceutical Market Sales Data Analysis Intelligent Insight Competitive Landscape Monitoring Myeloid leukemia (MDS) is a malignant blood disease originating in the bone marrow, primarily affecting hematopoietic function and leading to abnormal production of white blood cells, red blood cells, and platelets.

Myeloid leukemia (ML) is classified into acute and chronic types. Acute myeloid leukemia (AML) is the more common and rapidly progressing type clinically, usually requiring timely treatment. Chronic myeloid leukemia (CML), on the other hand, often relies on long-term management to maintain patients’ quality of life. With the development of molecular targeted therapy, the drugs for treating ML are becoming increasingly diversified. This article, based on the latest “Leukemia Drugs – Market Research Special Report” released by Moshang Consulting, explores the latest treatment guidelines for acute and chronic myeloid leukemia, as well as the competitive landscape of the drug market, and analyzes the market dynamics and prospects of various drugs.

FMS-like tyrosine kinase 3 (FLT3) is a receptor tyrosine kinase that plays an important role in hematopoiesis and lymphocyte proliferation. Approximately one-third of AML patients exhibit abnormal FLT3 activation. IDH1/2 mutations occur in approximately 15%–20% of AML patients, and these mutations lead to cellular dysfunction.

For relapsed/refractory acute myeloid leukemia, treatment guidelines recommend FLT3 inhibitors, IDH inhibitors, and BCL-2 inhibitors. Specifically, FLT3 inhibitors are divided into first-generation (sorafenib and midostaurin) and second-generation FLT3 inhibitors (such as quizartinib and gipritinib). First-generation FLT3 inhibitors have lower specificity, broader kinase profiles, and more off-target effects.

Second-generation FLT3 inhibitors are more specific and effective. Sorafenib was approved for marketing in China in 2009, with indications for liver cancer, kidney cancer, and thyroid cancer, but not AML. However, it is still recommended in treatment guidelines. According to data from Moshang Pharmaceuticals, sorafenib’s sales remained stable at around 1.6 billion yuan in 2019-2020. However, with the successive launches of generic drugs and intensified competition, its overall sales in 2023 were only 247 million yuan.

Gefitinib fumarate tablets were approved for marketing in China in February 2021 for the treatment of adult patients with relapsed or refractory (drug-resistant) AML harboring FLT3 mutations. It is currently still in the market introduction phase. Annual sales have not yet exceeded 100 million RMB, but there is still a steady growth trend. There are also two other FLT3 inhibitors that have been approved by the FDA but not yet approved in China (as of December 2024): Midotuxuel (Novartis, FDA approved in 2017) and Quizartinib (Daiichi Sankyo, FDA approved in 2023).

Evonib is a potent oral targeted inhibitor for cancers with isocitrate dehydrogenase-1 (IDH1) mutations. It is used to treat adult patients with relapsed or refractory acute myeloid leukemia (R/R AML) carrying IDH1 susceptibility mutations. It was originally developed by Agios Pharmaceuticals. In 2018, CStone Pharmaceuticals entered into an exclusive agreement with Agios for development and commercialization in Greater China. It was approved for marketing in China in February 2022. In 2023, its sales reached 20 million yuan, and it is still in the market introduction phase.

Veneclare, the world’s first BCL-2 (B-lymphocytoma-2 gene) inhibitor, is a small molecule targeted drug developed by AbbVie. It was approved by the FDA in 2016 and by China in 2020 for the treatment of acute myeloid leukemia (AML), small lymphocytic lymphoma (SLL), and chronic lymphocytic leukemia (CLL).

Sales reached 300 million yuan in 2023. Approximately 90% of chronic myeloid leukemia (CML) patients have a gene abnormality called the Philadelphia chromosome. This chromosome produces a protein called BCR-ABL, which can promote the proliferation of malignant white blood cells in patients. Tyrosine kinase inhibitors (TKIs) targeting BCR-ABL have become the first-line treatment for most CML patients.

In 2024, the Chinese Society of Clinical Oncology (CSCO) recommended imatinib (a first-generation drug) and three second-generation drugs approved in China as first-line treatment for chronic myeloid leukemia (CML). Second- or third-generation drugs should be used after resistance develops with first-generation drugs. In 2001, the first tyrosine kinase inhibitor (TKI), imatinib (the drug based on in the TV series “Dying to Survive”), was approved, increasing the ten-year survival rate of CML from less than 50% to approximately 90%.

In April 2013, patent protection in China expired, and generic versions were subsequently launched. Second-generation Bcr-Abl inhibitors bind more specifically to the Bcr-Abl target, resulting in improved efficacy. They are also effective against first-generation resistance mutations. The patents for dasatinib and nilotinib have both expired. Third-generation products are effective against BCR-ABL and multiple mutations, including the T315I mutation. The T315I mutation accounts for approximately 12% of mutations in first-generation resistant patients and 27%–34% in second-generation resistant patients.

In China, Ascentage Pharma’s olaribatinib leads the market, Takeda’s ponatinib received a “black box warning” from the FDA, and Novartis’ asnibu just submitted its application for marketing approval. Note: Philadelphia chromosome positive (Ph+); malignant gastrointestinal stromal tumors (GIST); hypereosinophilic syndrome (HES) and chronic eosinophilic leukemia (CEL);

Osteoporosis/myeloproliferative disorders (MDS/MPD) 3. Market size of chronic myeloid leukemia drugs: The rise of BCR-ABL inhibitors Although the patent of the first-generation products expired in 2013, sales still showed strong performance. According to statistics from the Moshang Pharmaceutical Database, its total sales in hospitals and pharmacies in 2019 were still 3.8 billion yuan, while the sales of the second-generation products were 1.1 billion yuan.

Looking at the trends, first-generation products, which only offer imatinib and have been used for many years, have shown significant drug resistance issues. Coupled with intense price competition from generic drugs, their performance in 2023 was weaker than that of second-generation products, with sales of 2.1 billion yuan and 2.5 billion yuan respectively. Third-generation products were approved for market launch at the end of 2021, and sales reached 166 million yuan in 2023. Still in the market introduction phase, their future prospects are promising.

4. Competitive Landscape of Chronic Myeloid Leukemia Drugs: Competition in BCR-ABL Inhibitors is Fierce. Numerous manufacturers produce generic versions of imatinib. Looking at the competitive landscape in 2023, Novartis, the original manufacturer, still held more than half the market share (58%), followed by Hansoh Pharmaceutical and Chia Tai Tianqing Pharmaceutical, each holding more than 10%. The competition among second-generation BCR-ABL inhibitors presents a three-way balance. Hansoh Pharmaceutical’s original flumatinib had sales of 1 billion yuan in 2023, accounting for 42% of the market share, followed by Novartis’ nilotinib with sales of 900 million yuan, accounting for 36%.

Dasatinib has been largely captured by generic drug manufacturer Chia Tai Tianqing Pharmaceutical Group, holding 18.5% of the overall market share for second-generation products. Significant progress has been made in the treatment of myeloid leukemia in recent years, particularly in the research and application of targeted therapies. However, despite the wide variety of treatment options and intense competition in the market, efficacy and drug resistance remain key challenges that need to be addressed in treatment.

With continuous advancements in technology and the development of new drugs, the future prospects for myeloid leukemia treatment will be even brighter. The emergence of more efficient and safe treatment options will bring greater benefits to patients. 2. 2024 Lymphocytic Leukemia Diagnosis and Treatment Guidelines and Drug Market Competition Analysis. The above content is from Moshang Consulting’s {Leukemia Drugs – Market Research Special Report}. To view or download the full report, please click here!

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