Summary of the Conference Call for Ascentage Pharma Industry and Company Overview - The conference call focuses on Ascentage Pharma, a biopharmaceutical company specializing in innovative cancer therapies, particularly in the field of apoptosis and targeted therapies [2][3]. Key Points and Arguments 1. **Orebatein Expansion**: Orebatein, a third-generation TKI, expanded its indications in October 2023 to cover more CML patients, with expectations to be included in the national health insurance by the end of 2024, significantly enhancing market potential. The domestic sales reached 217 million yuan, with a forecasted doubling for the year [2][4]. 2. **BCL-2 Inhibitor Launch**: Ascentage Pharma launched its first domestic BCL-2 inhibitor, targeting relapsed CLL/SLL, which has a superior administration method compared to venetoclax, faster cellular uptake, and higher safety. Multiple phase III registration trials are ongoing, indicating a broad market outlook [2][4]. 3. **Collaboration with Takeda**: The company entered a licensing agreement with Takeda for the drug Nilotinib, with a total transaction value of 1.3 billion USD, including an upfront payment of 100 million USD. The remaining amount consists of milestone payments and sales sharing, with three phase III registration trials currently in progress [2][5]. 4. **Sales and R&D Expenses**: In the first half of 2024, sales expenses were 138 million yuan, with an annual estimate of 250 to 300 million yuan. R&D expenses reached 529 million yuan, with expectations to exceed 1 billion yuan for the year, indicating a continued increase in R&D investment [2][5]. 5. **Clinical Trials**: Orebatein is undergoing three phase III registration trials, while the BCL-2 inhibitor is also in multiple phase III trials covering AML, CLL/SLL, MDS, and multiple myeloma [2][6]. 6. **CML Market Size**: The global TKI market for CML is approximately 6 billion USD, with the domestic market around 4 billion yuan. The rapid growth of third-generation TKIs is noted, with Nilotinib being the only domestic third-generation TKI, providing a competitive edge [2][7][8]. Additional Important Information 1. **Market Competition**: The global CML TKI market is characterized by the expiration of patents for first and second-generation TKIs, with significant market players like Novartis and Takeda. Orebatein is positioned to complete its overseas phase III trials and apply for market approval by 2026 [7][9]. 2. **Advantages of BCL-2 Inhibitor**: Compared to venetoclax, Ascentage's BCL-2 inhibitor offers advantages in administration, faster cellular uptake, and lower side effects due to a shorter half-life. Ongoing trials include combinations with other therapies for various indications [2][11]. 3. **Future Directions**: Ascentage Pharma aims to continue its focus on apoptosis pathways and advance new L-type inhibitors for solid tumors, while also pursuing international expansion and product innovation to meet market expectations [3][12].