亚盛医药-B：聚力产品创新突破，聚焦国际化布局

Investment Rating - The report assigns a "Recommend" rating for Ascentage Pharma (6855 HK) for the first time [1] Core Views - Ascentage Pharma focuses on innovative product development and international expansion, with a strong pipeline targeting cell apoptosis pathways and next-generation small molecule TKIs [3] - The company's core product, Olverembatinib (HQP1351), is the only third-generation BCR-ABL TKI approved in China and has shown significant clinical benefits for TKI-resistant CML patients [4] - APG-2575, a BCL-2 inhibitor, has the potential to become the second globally approved BCL-2 inhibitor, with multiple Phase 3 trials underway [8] - The company has achieved profitability for the first time in H1 2024, with revenue of RMB 824 million and net profit of RMB 163 million [3] Financial Performance - Revenue for H1 2024 reached RMB 824 million, a 477% YoY increase, driven by intellectual property income of RMB 678 million [52] - Net profit for H1 2024 was RMB 163 million, marking the company's first profitable period [52] - Cash reserves stood at RMB 1.1 billion as of mid-2024, with the company filing for a US IPO to further bolster its financial position [52] Product Pipeline - Olverembatinib (HQP1351): The only third-generation BCR-ABL TKI approved in China, with two indications approved and three Phase 3 trials ongoing (POLARIS-1/2/3) [58] - APG-2575: A BCL-2 inhibitor with a domestic NDA submitted for R/R CLL/SLL, potentially becoming the second globally approved BCL-2 inhibitor [8] - APG-115 and APG-1252: Targeting MDM2-p53 and BCL-2/BCL-xL pathways, respectively, both in Phase 1b/2 trials [58] - APG-2449: A third-generation ALK inhibitor approved for Phase 3 trials in NSCLC [58] Market and Sales - Olverembatinib has achieved cumulative sales of RMB 490 million since its launch, with a 120% QoQ growth in H1 2024 [4] - The product is covered by China's national medical insurance, with access to 670 hospitals and DTP pharmacies as of mid-2024 [52] - A strategic partnership with Takeda Pharmaceuticals for global rights to Olverembatinib, with a total deal value of up to $1.3 billion [96] Clinical Development - Olverembatinib has demonstrated superior efficacy and safety in clinical trials, particularly for patients resistant to other TKIs, including ponatinib and asciminib [92] - APG-2575 has shown promising results in clinical trials for CLL/SLL, with an ORR of 73.3$6 billion, with second-generation TKIs dominating the market [79] - In China, the BCR-ABL TKI market is around RMB 4 billion, with second-generation TKIs also leading, but Olverembatinib is the only domestic third-generation TKI [84] - APG-2575 is positioned to compete with venetoclax, the first globally approved BCL-2 inhibitor, which achieved global sales of $2 billion in 2022 [108]