20201216-招银国际-亚盛医药-B-06855.HK-Promising_progress_on_HQP-1351_and_APG-2575_4页_1mb

Ascentage Pharma (6855 HK) Summary

Core Content

Ascentage Pharma is a biopharmaceutical company focusing on the development of innovative cancer therapies. The company has released positive data on two of its key drug candidates, HQP-1351 (Olverembatinib) and APG-2575, highlighting promising progress in clinical trials and commercialization plans.

HQP-1351 (Olverembatinib)

• Indication: Treats TKI-resistant and T315I-mutated CML (Chronic Myeloid Leukemia) in both chronic phase (CML-CP) and accelerated phase (CML-AP).
• Clinical Data:
  • For CML-CP patients, 3m-PFS and 6m-PFS were 100% and 96.7%, respectively. MCyR was 75.6% (including 65.9% CCyR) and MMR was 48.8%.
  • For CML-AP patients, 3m-PFS and 6m-PFS were 100% and 95.5%, respectively. MaHR was 78.3% (including 60.9% CHR), MCyR was 52.2%, CCyR was 39.1%, and MMR was 26.1%.
  • The most frequent TRAE (Treatment-Related Adverse Event) was thrombocytopenia, occurring in 48.8% and 52.2% of patients in the respective trials.
• Commercialization:
  • The company has appointed Mr. Gang Zhu as Chief Commercial Officer (CCO) to lead the commercialization of HQP-1351.
  • By the end of 2021, Ascentage plans to have a commercialization team of over 100 sales personnel covering more than 1,000 hospitals.
  • The company expects NMPA approval for HQP-1351 in 2021E and maintains a BUY rating with a target price of HK$70.7, based on an 8-year DCF valuation (WACC: 10.98%, terminal growth: 3.0%).

APG-2575

• Mechanism: A novel, orally administered small-molecule Bcl-2-selective inhibitor.
• Clinical Progress:
  • 9 ongoing global clinical studies, with over 100 patients treated at doses ranging from 20mg to 1,200mg.
  • Over 30 patients with relapsed/refractory CLL have been enrolled.
  • 70% ORR (Objective Response Rate) in evaluable CLL patients, with no DLT (Dose-Limiting Toxicity) or TLS (Tumor Lysis Syndrome) observed.
• Indications: Being evaluated for CLL/SLL, WM, AML, FL, MCL, DLBCL, MM, and HCL.
• Regulatory Status:
  • Has received Orphan Drug Designations from the US FDA for CLL, MM, and WM.

Key Pipeline

Financial Summary

Revenue and Profit

Key Ratios

Stock Data

• Market Cap: HK$6,765 million
• Average 3-month trading volume: HK$7.64 million
• 52-week High/Low: HK$51.20 / HK$19.80
• Total Issued Shares: 225 million

Analyst Ratings

• CMBIS Rating: BUY
• Target Price: HK$70.7 (unchanged from previous)
• 12-month Upside: +134.81%
• Current Price: HK$30.1

Shareholding Structure

Key Financial Highlights

• Revenue Forecast for HQP1351:
  • Sales in CML: Expected to grow from RMB 116 million in 2022E to RMB 2,549 million in 2030E.
  • Probability of success for CML: 90% for all years.
• Risk-adjusted Sales: Expected to increase from RMB 150 million in 2022E to RMB 2,993 million in 2030E.
• Royalties to GIBH: 3% of sales for all years.
• Attributable Sales: Expected to grow from RMB 145 million in 2022E to RMB 2,903 million in 2030E.

Analyst Certification & Disclosures

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