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亚盛医药-B：首次覆盖：厚积薄发，逐步迈向全球化Biopharma
06855ASCENTAGE(06855) 海通国际·2024-10-11 10:38

Investment Rating - The report initiates coverage on Ascentage Pharma (6855 HK) with an "Outperform" rating and a target price of 48.0 HKD per share [6] Core Views - Ascentage Pharma is a global biopharmaceutical company focused on developing first-in-class and best-in-class drugs, particularly in oncology, with 9 small molecule drugs in clinical development [3] - The company's core products, Olverembatinib (BCR-ABL TKI) and Lisaftoclax (BCL-2), are expected to achieve risk-adjusted global sales of 17.67 billion RMB by 2033 [4] - Ascentage Pharma has made significant progress in global expansion, with key products advancing in global registration clinical trials in both China and the US [3] Product Pipeline and Market Potential - Olverembatinib, the first and only third-generation BCR-ABL inhibitor approved in China, is expected to generate risk-adjusted global sales of 10.85 billion RMB by 2033, with 9.48 billion RMB from overseas markets [4] - Lisaftoclax, a potential second global BCL-2 inhibitor, is projected to achieve risk-adjusted global sales of 6.82 billion RMB by 2033, with 6.25 billion RMB from overseas markets [4] - The company's pipeline includes multiple first-in-class potential targets, with ongoing exploration in hematologic malignancies, solid tumors, and non-oncology indications [4] Financial and Strategic Developments - Ascentage Pharma achieved its first semi-annual profit in H1 2024, with revenue reaching 820 million RMB, a 477% YoY increase, driven by licensing income [10] - The company secured a significant partnership with Takeda, receiving a 100millionoptionfeeand100 million option fee and 75 million equity investment, with potential milestone payments totaling 1.2billion[10]−AscentagePharmahasfiledforaUSIPOin2024,aimingtofurtherexpanditsfinancingchannels[10]ClinicalProgressandRegulatoryMilestones−Olverembatinib′sglobalPhaseIIIregistrationclinicaltrialforCMLpatientsresistanttotwoormoreTKIshasbeenapprovedbytheFDA,withNDAsubmissionexpectedby2026[17]−Lisaftoclax′sPhaseIIregistrationclinicaltrialforR/RCLL/SLLinChinahasbeencompleted,withNDAsubmissionexpectedin2024[12]−Thecompanyisconductingover40PhaseI/IIclinicaltrialsglobally,with8registrationtrials,including2approvedbytheFDA[11]MarketandCompetitiveLandscape−TheglobalBCR−ABLinhibitormarketexceeds1.2 billion [10] - Ascentage Pharma has filed for a US IPO in 2024, aiming to further expand its financing channels [10] Clinical Progress and Regulatory Milestones - Olverembatinib's global Phase III registration clinical trial for CML patients resistant to two or more TKIs has been approved by the FDA, with NDA submission expected by 2026 [17] - Lisaftoclax's Phase II registration clinical trial for R/R CLL/SLL in China has been completed, with NDA submission expected in 2024 [12] - The company is conducting over 40 Phase I/II clinical trials globally, with 8 registration trials, including 2 approved by the FDA [11] Market and Competitive Landscape - The global BCR-ABL inhibitor market exceeds 6 billion, with Olverembatinib showing potential as a best-in-class product due to its efficacy and safety profile [17] - Lisaftoclax is positioned as a potential best-in-class BCL-2 inhibitor, with advantages in efficacy, safety, and dosing convenience compared to existing therapies [40] - Ascentage Pharma's focus on first-in-class targets and its global clinical strategy position it well to capture significant market share in both China and international markets [13]