Yaojie Ankang Tinengotinib Cholangiocarcinoma Indication Market Space Analysis

Based on the latest market data and research materials, I will systematically analyze the market space of Yaojie Ankang’s Tinengotinib (Tiengotinib) for cholangiocarcinoma indication from multiple dimensions.

According to the analysis data from Frost & Sullivan, the global incidence of cholangiocarcinoma increased from 243,400 in 2019 to 290,000 in 2024, with a compound annual growth rate (CAGR) of 3.6%. It is expected to reach 354,900 by 2030 [0]. The incidence of cholangiocarcinoma in China increased from 94,400 in 2019 to 106,600 in 2024, with a CAGR of 2.5%, and is expected to reach 121,600 by 2030 [0].

The global cholangiocarcinoma drug market size shows a significant growth trend: the market size reached $20 billion in 2024 (equivalent to approximately RMB 14 billion), with a CAGR of 16.2% from 2019 to 2024. It is expected to grow to $32 billion in 2027 and further to $46 billion in 2030, with CAGRs of 17.1% and 12.8% for 2024-2027 and 2027-2030, respectively [0][1].

The Chinese cholangiocarcinoma drug market also shows strong growth momentum: the market size reached RMB 3.2 billion in 2024, with a CAGR of 16.4% from 2019 to 2024. It is expected to reach RMB5.5 billion in2027 and further to RMB7.6 billion in 2030 [0][1].

Tinengotinib is an independently developed innovative kinase spectrum-selective small molecule inhibitor in the global Phase III clinical stage, which exerts anti-tumor effects by simultaneously targeting tumor cells and improving the tumor microenvironment [2]. Its core mechanisms include:

• FGFR inhibition
  : Has unique binding properties to FGFR2 and can inhibit multiple FGFR2 kinase domain mutations
• VEGFR inhibition
  : Blocks tumor angiogenesis
• Aurora A/B inhibition
  : Interferes with tumor cell mitosis
• JAK inhibition
  : The world’s first to simultaneously block FGFR and JAK signaling pathways

This multi-target synergy strategy enables it to effectively overcome tumor resistance mechanisms, especially the acquired resistance problem after FGFR inhibitor treatment [3].

The core competitive advantage of Tinengotinib lies in its unique positioning for

. Although cholangiocarcinoma patients with FGFR fusion genes can obtain clinical benefits after FGFR inhibitor treatment, they usually experience disease progression within 5-7 months. Polyclonal mutations secondary to the FGFR2 kinase domain are one of the main mechanisms leading to resistance. Tinengotinib can effectively inhibit these resistance mutations and provide a new treatment option for such patients with no available drugs [2][3].

According to the pooled analysis data reported at the 2025 European Society for Medical Oncology (ESMO) Congress:

• In cholangiocarcinoma patients who relapsed/resisted after previous systemic therapy and FGFR inhibitor treatment, the objective response rate (ORR) reached 40% and the disease control rate (DCR) reached 90%
• In cholangiocarcinoma patients with FGFR2 alterations (n=55), the median progression-free survival (PFS) and overall survival (OS) data are encouraging
• Tumor target lesions shrank by more than 30%, which was associated with a reduction in the level of FGFR2 kinase domain mutations [2][3]

Tinengotinib has received several important regulatory designations:

• U.S. FDA “Orphan Drug Designation” (Orphan-Drug Designation)
• U.S. FDA “Fast Track Designation” (Fast Track Designation)
• China NMPA “Breakthrough Therapy Designation” list (July 2023)
• In December 2023, the first patient was dosed in the global multi-center registrational Phase III clinical trial (FIRST-308) for FGFR-altered cholangiocarcinoma [2]

The exploratory Phase 2 clinical results of this drug have been published in The Lancet Gastroenterology & Hepatology (impact factor:38.6) [4].

Approximately 25.2% of cholangiocarcinoma patients have FGFR abnormalities, of which about55.5% are FGFR2 alterations (including FGFR2 fusion/rearrangement 41.8% and FGFR2 mutation30.9%) [3]. Approximately62% of patients with advanced unresectable or metastatic cholangiocarcinoma receive second-line treatment, and32% receive third-line treatment, which means Tinengotinib faces a refractory patient population with huge unmet medical needs [0].

Market space estimation is based on the following assumptions:

Prediction Dimension	2024	2027 (Expected)	2030 (Expected)
Global Cholangiocarcinoma Patients (10,000 people)	29.0	32.1	35.5
Proportion of FGFR Abnormal Patients	25.2%	25.2%	25.2%
FGFR Abnormal Patients (10,000 people)	7.3	8.1	8.9
Second-line/Third-line Treatment Patient Ratio	62%/32%	62%/32%	62%/32%
Global Market Size (100 million USD)	20	32	46

Considering Tinengotinib’s differentiated positioning (post-resistance treatment) and potential best-in-class potential, if it can achieve positive results in Phase III clinical trials and be approved for marketing, it is expected to occupy an important share in this segmented market.

###5. Competitive Landscape Analysis

As of now, there are 3 small molecule targeted therapies approved by the FDA globally for cholangiocarcinoma treatment: Pemigatinib (福巴替尼), Infigratinib (佩米替尼), and Ivosidenib (艾伏尼布). In China, 1 has been approved by NMPA (Infigratinib) [0].

1. Mechanism Innovation: Multi-target synergy, can overcome FGFR inhibitor resistance
2. Leading Clinical Progress: Advanced global multi-center Phase III clinical progress
3. Regulatory Advantages: Received FDA breakthrough therapy and fast track designations
4. Data Support: High-quality clinical data published in The Lancet

There are 33 small molecule targeted therapies for cholangiocarcinoma in Phase II or later clinical development globally, of which 12 are in China [0]. Tinengotinib is in a relatively favorable leading position in this competitive landscape.

###6. Investment Value and Risk Tips

1. Continuous increase in the number of cholangiocarcinoma patients
2. Increased penetration rate of targeted therapy
3. Scarcity of post-resistance treatment options
4. Commercialization potential in the U.S. market

1. Uncertainty of Phase III clinical trial results
2. Competition from rivals and substitution
3. Price reduction pressure from medical insurance negotiations
4. Global commercialization capacity building

Yaojie Ankang’s Tinengotinib for cholangiocarcinoma indication has significant market space. In terms of market size, the global cholangiocarcinoma drug market is expected to grow from $2 billion in2024 to $4.6 billion in2030, with a CAGR of12.8%. With its unique multi-target mechanism of action, differentiated positioning for FGFR inhibitor-resistant patients, and leading clinical progress, Tinengotinib is expected to occupy an important share in this fast-growing market.

If the FIRST-308 Phase III clinical trial achieves positive results and is successfully approved for marketing, combined with its breakthrough therapy designations in China and the United States, Tinengotinib is expected to become an important drug in the field of resistant cholangiocarcinoma treatment and bring considerable commercial benefits to the company.

[0] Yaojie Ankang Hong Kong Stock Prospectus Industry Overview (https://www1.hkexnews.hk/listedco/listconews/sehk/2025/0623/11721543/sehk25060901201_c.pdf)
[1] Frost & Sullivan Report: Global and Chinese Cholangiocarcinoma Drug Market Size (https://www.frostchina.com/content/insight/detail/68aff0542cd88e5f3d941015)
[2] Yaojie Ankang Tinengotinib Global Multi-Center Registrational Phase III Clinical Trial Completes First Patient Dosing (https://bydrug.pharmcube.com/news/detail/28b8707def2e8e83800044df216c62d8)
[3] New Cholangiocarcinoma Drug Tiengotinib (TT-00420) Domestic NDA Accepted (https://medfind.link/info/45976)
[4] Yaojie Ankang Tinengotinib Exploratory Clinical Results for Cholangiocarcinoma Published in The Lancet (https://hk.finance.yahoo.com/news/藥捷安康-02617-發表核心產品針對膽管癌探索性臨床結果-041310891.html)