By Fineline Cube 
PegBio Co., Ltd. (HKG: 2565) announced that its next‑generation GLP‑1 receptor agonist PB‑119, marketed under the brand name Paidakang, has received full approval from the China National Medical Products Administration (NMPA) for use in patients with type 2 diabetes mellitus (T2DM).
What Is PB‑119?
- Molecule class: Long‑acting glucagon‑like peptide‑1 (GLP‑1) receptor agonist.
- Dosing: Once‑weekly subcutaneous injection.
- Technology: Site‑specific PEGylation that extends plasma half‑life, reduces immunogenicity and mitigates gastrointestinal adverse events.
Clinical Profile
| End‑point | Outcome (PB‑119) | Clinical significance |
|---|---|---|
| HbA1c reduction | −1.2 % vs. baseline | Meets ADA target for glycaemic control |
| β‑cell function (HOMA‑β) | ↑ 22 % | Improves insulin secretory capacity |
| Weight change | −3.4 kg (average) | Supports obesity management in T2DM |
| Blood pressure | ↓ 5 mmHg systolic | Cardiovascular risk reduction |
| Lipid profile | ↓ 12 % LDL‑C, ↑ 8 % HDL‑C | Improves dyslipidaemia |
| GI tolerability | < 5 % discontinuation (nausea/vomiting) | Better patient adherence than first‑generation GLP‑1 agents |
Market Impact
- Unmet need – Over 140 million Chinese adults are living with T2DM; current GLP‑1 options are limited by injection frequency and GI side‑effects.
- Revenue potential – Assuming a 10 % market capture of the weekly GLP‑1 segment (≈ 14 million patients) at an average price of CNY 5,800 per treatment course, PB‑119 could generate ≈ CNY 81 billion (~US$11.5 billion) in annual sales.
- Strategic positioning – PegBio’s proprietary PEGylation platform differentiates PB‑119 from competitors, giving the company leverage for future pipeline extensions (e.g., combination fixed‑dose products).
Forward‑Looking Statements
This brief contains forward‑looking statements regarding regulatory approval, clinical benefits, and market expectations for PB‑119. Actual results may differ due to clinical outcomes, regulatory actions, competitive dynamics, and other risk factors.-Fineline Info & Tech