20210610-招银国际-亚盛医药-B-06855.HK-Encouraging_results_of_APG-2575_and_APG-115_released_at_2021_ASCO_Annual_Meeting_6页_1mb
报告摘要
Ascentage Pharma (6855 HK) Company Update Summary
Core Content Overview
Ascentage Pharma is a biopharmaceutical company that has released encouraging results from four studies at the 2021 ASCO Annual Meeting, highlighting the progress of its drug candidates in clinical development. The report also includes financial performance data, valuation models, and analyst ratings.
Key Drug Candidates and Clinical Results
APG-2575 (Bcl-2 Inhibitor)
- Study: Global phase 1 study in r/r CLL and other hematologic malignancies.
- Results:
- 36 patients treated with doses ranging from 20mg to 1,200mg.
- 15 patients with r/r CLL/SLL, of which 12 achieved PR (ORR=80%).
- All patients had previously received CD20-based therapy, with 27% having received BTK inhibitors.
- No DLT observed at the maximum dose of 1,200mg, and no TLS reported.
- RP2D selected at 600mg daily.
- Expected to enter pivotal phase 2 by end-2021 or early-2022.
- Demonstrated superior safety profile and shorter daily ramp-up schedule compared to venetoclax.
APG-115 (MDM2-p53 Inhibitor)
- Study: Global phase II study in combination with pembrolizumab for melanoma and advanced solid tumors resistant to IO drugs.
- Results:
- 102 patients treated with 150mg Q2D.
- Among 29 evaluable melanoma patients, 1 CR, 6 PR, and 9 SD, indicating 24.1% ORR and 55.2% DCR.
- PR cases also observed in MPNST, liposarcoma, NSCLC, and UC.
- Shows promising efficacy in MPNST and liposarcoma where pembrolizumab has no approved indications.
Other Candidates
- APG-1252: Phase 1b/2 study in combination with paclitaxel for r/r SCLC.
- APG-2449: Targeting FAK/ALK/ROS1 for NSCLC and solid tumors.
- APG-5918: EED-selective inhibitor for oncology.
Analyst Ratings and Target Price
- Ratings: BUY (Maintain)
- Target Price: HK$66.04 (Previously HK$62.04)
- Upside: +50.96% from current price of HK$43.75
Financial Summary
Revenue
- FY19A: 15 RMB mn
- FY20A: 12 RMB mn
- FY21E: 12 RMB mn
- FY22E: 269 RMB mn
- FY23E: 3,170 RMB mn
- YoY Growth: 113% (FY19A to FY20A), 0% (FY20A to FY21E), 2,061% (FY21E to FY22E), 1,078% (FY22E to FY23E)
Net Profit
- FY19A: (1,481) RMB mn
- FY20A: (678) RMB mn
- FY21E: (857) RMB mn
- FY22E: (943) RMB mn
- FY23E: 85 RMB mn
EPS (RMB)
- FY19A: (12.69)
- FY20A: (3.14)
- FY21E: (3.39)
- FY22E: (3.73)
- FY23E: 0.34
Earnings Revisions
- CMBIS vs. Consensus:
- Revenue: -67% (FY21E), -49% (FY22E), +75% (FY23E)
- Gross Profit: -64% (FY21E), -56% (FY22E), +64% (FY23E)
- Net Profit: +10% (FY23E)
- EPS: +10% (FY23E)
Valuation
DCF Valuation
- Terminal Growth Rate: 2.0%
- WACC: 11.72%
- Equity Value (HK$ mn): 16,701
- DCF per Share (HK$): 66.04
- Equity Beta: 1.1
- Risk-Free Rate: 3.0%
- Market Risk Premium: 10.5%
Share Performance and Structure
- Market Cap (HK$ mn): 11,063
- Average 3-month Turnover (HK$ mn): 81.64
- 52-Week High/Low (HK$): 54.7 / 24.6
- Total Issued Shares (mn): 253
- Shareholding Structure:
- Management: 32.17%
- Collected Mind (3SBio): 4.85%
- Sino Biopharma: 2.2%
- Institution Investors: 26.28%
- Free Float: 34.5%
Key Financial Ratios
- Gross Margin: 100.00% (FY21E), 70.00% (FY22E), 80.00% (FY23E)
- Current Ratio: 4.5 (FY19A), 3.9 (FY20A), 3.3 (FY21E), 2.2 (FY22E), 4.2 (FY23E)
- License Fee Income: 73% (FY19A), 79% (FY20A), 79% (FY21E)
- Provision of R&D Services: 27% (FY19A), 21% (FY20A), 21% (FY21E)
Key Pipeline Overview
| Product | Target | Indications | Clinical Stage | Trial Regions | Rights Regions |
|---|---|---|---|---|---|
| HQP1351 | BCR-ABL/KIT | Resistant CML, GIST, Ph+ ALL, CLL/SLL, WM | Phase I/II | Global | Global |
| APG-2575 | Bcl-2 | AML, MM, T-PLL, Solid tumors | Phase I/II | Global | Global |
| APG-115 | MDM2-p53 | Solid tumors+IO, AML, MDS | Phase II | Global | Global |
| APG-1252 | Bcl-2/Bcl-xL | SCLC+SOC, NSCLC+TKI, MF, NET | Phase I/II | Global | Global |
| APG-2449 | FAK/ALK/ROS1 | NSCLC/Solid tumors | Phase II | Global | Global |
| APG-5918 | EED Selective | Oncology | Phase II | Global | Global |
| AS1266 | Allosteric BCR-ABL | Oncology | Phase I | Global | Global |
| PROTACs MDM2 | MDM2 | Oncology | Phase I | Global | Global |
| APG-1842 | KRAS | Oncology | Phase I | Global | Global |
Conclusion
Ascentage Pharma is showing promising progress in its clinical trials, particularly with APG-2575 and APG-115, which have demonstrated favorable safety and efficacy profiles. The company's financial performance is expected to improve significantly as its drug candidates move closer to market approval. The analyst maintains a BUY rating with an updated target price of HK$66.04, reflecting a higher probability of success for APG-2575.
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