By Fineline Cube 
CSPC Pharmaceutical Group Limited (HKG: 1093) announced that three drug candidates—SYH2072 (aldosterone synthase inhibitor), Priglitin/Dapagliflozin/Metformin triple‑combination SR tablets, and SYH2069 (GLP‑1/GIP dual‑biased agonist)—have received Clinical Trial Approval (IND) from China’s National Medical Products Administration (NMPA), advancing a diversified pipeline spanning hypertension, diabetes, and obesity.
IND Approvals Summary
| Product | Mechanism | Indication | Significance | Development Stage |
|---|---|---|---|---|
| SYH2072 | Aldosterone Synthase Inhibitor (ASI) | Uncontrolled hypertension & primary aldosteronism | First ASI in China; selective, no cortisol impact | Phase I ready |
| Priglitin/Dapa/Met SR | DPP‑4 inhibitor + SGLT2 inhibitor + Metformin SR | Type 2 Diabetes Mellitus (T2DM) | World’s first triple‑combo fixed‑dose | Phase I ready |
| SYH2069 | GLP‑1/GIP receptor dual‑biased agonist | Obesity + weight‑related comorbidities; potential T2DM | China’s first dual‑biased agonist; minimizes β‑arrestin recruitment | Phase I ready |
SYH2072: First‑in‑Class Aldosterone Synthase Inhibitor
Mechanism: Highly selective ASI that reduces plasma aldosterone without affecting cortisol levels, addressing a key driver of resistant hypertension and primary aldosteronism.
Clinical Rationale:
- Target Population: >50 million patients with uncontrolled hypertension in China; 2‑5% have primary aldosteronism
- Differentiation: Avoids cortisol suppression seen with earlier non‑selective CYP11B inhibitors
- Market Size: China hypertension drug market valued at ¥68 billion (2025); resistant hypertension segment growing at 15% CAGR
Safety Advantage: Preclinical data shows no HPA axis disruption, addressing a major limitation of competitor programs.
Priglitin/Dapagliflozin/Metformin SR: World’s First Triple‑Combo
Mechanism: Synergistic triple‑pathway glycemic control:
- Priglitin (DPP‑4 inhibitor): Raises endogenous GLP‑1, enhances β‑cell/α‑cell glucose sensitivity
- Dapagliflozin (SGLT2 inhibitor): Promotes urinary glucose excretion, cardio‑renal benefits
- Metformin SR: Improves insulin sensitivity, lowers basal/postprandial glucose
Clinical Indication: Adjunct to diet/exercise for T2DM patients inadequately controlled on metformin monotherapy.
Market Opportunity:
- T2DM Prevalence: 140 million patients in China; 60% fail to achieve HbA1c targets
- Combination Therapy Trend: 70% of patients require ≥2 drugs; fixed‑dose combinations improve compliance
- Pricing: Projected ¥3,000‑4,000 annual cost (vs. ¥5,000‑7,000 for separate agents)
Competitive Edge: First globally approved triple‑combo eliminates pill burden and leverages three complementary mechanisms.
SYH2069: Novel GLP‑1/GIP Dual‑Biased Agonist
Mechanism: Dual‑biased agonist selectively activates cAMP pathway while minimizing β‑arrestin recruitment, reducing receptor internalization/desensitization and enhancing potency and duration.
Clinical Indications:
- Primary: Weight management in obesity/overweight with comorbidities
- Expansion: Glycemic control in T2DM (high development value)
Differentiation:
- Bias Profile: Superior to tirzepitide (balanced agonist) in preclinical models; 50% longer receptor residence time
- Weight Loss: Animal studies show 15‑20% body weight reduction vs. 10‑12% for tirzepitide
- Tolerability: Reduced GI side effects due to β‑arrestin sparing
Market Context:
- Obesity Market: ¥50 billion by 2030; GLP‑1/GIP uptake accelerating
- T2DM Market: ¥80 billion GLP‑1 segment; demand for more potent, longer‑acting agents
Competitive Landscape
SYH2072 (Hypertension)
| Drug | Company | Mechanism | Stage | Key Limitation |
|---|---|---|---|---|
| Finerenone | Bayer | Nonsteroidal MR antagonist | Marketed | Hyperkalemia risk |
| Baxdrostat | CinCor (AZ) | ASI | Phase III (US) | Cortisol suppression at high doses |
| SYH2072 | CSPC | Selective ASI | Phase I | First in China |
Triple-Combo (T2DM)
| Product | Company | Components | Status | Differentiation |
|---|---|---|---|---|
| Xultophy | Novo Nordisk | Insulin degludec + liraglutide | Marketed | Injectable only |
| Qtern | AstraZeneca | Dapa + saxagliptin | Marketed | Dual only, no metformin |
| Priglitin/Dapa/Met | CSPC | Triple oral | Phase I | World’s first oral triple |
SYH2069 (Obesity/T2DM)
| Drug | Company | Mechanism | Stage | Differentiation |
|---|---|---|---|---|
| Tirzepatide | Eli Lilly | GLP‑1/GIP balanced | Marketed (US/EU) | First dual agonist |
| Retatrutide | Eli Lilly | GLP‑1/GIP/GcG triple | Phase III | Triple agonist |
| SYH2069 | CSPC | GLP‑1/GIP biased | Phase I | β‑arrestin sparing |
Financial Projections & Development Timeline
| Product | Peak Sales Potential (¥B) | Launch Timeline | Key Milestone |
|---|---|---|---|
| SYH2072 | 2.5‑3.0 | 2029‑2030 | Phase II data H2 2027 |
| Triple‑Combo | 4.0‑5.0 | 2028‑2029 | Phase III initiation 2027 |
| SYH2069 | 8.0‑10.0 | 2030‑2031 | Phase II obesity data 2028 |
Combined Portfolio Value: ¥14.5‑18.0 billion peak sales potential by 2032, representing 15‑20% of CSPC’s projected revenue base.
Strategic Implications
Diversification: Moves CSPC beyond mature generic/oncology into high‑growth metabolic/cardiovascular franchises.
Innovation Credibility: First‑in‑class ASI and world’s first triple‑combo enhance CSPC’s global BD appeal.
Commercial Synergy: Leverages existing cardiovascular and endocrinology sales infrastructure (3,000+ reps) for rapid market entry.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding CSPC’s clinical development timelines, peak sales forecasts, market penetration assumptions, and competitive positioning for SYH2072, the triple‑combo therapy, and SYH2069. Actual results may differ materially due to clinical trial outcomes, regulatory review timelines, competitive responses, and market access policies.-Fineline Info & Tech