Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that SHR‑1918 (brand name: Aiqingda), a Category 1 innovative drug independently developed by its subsidiary Shengdi Pharmaceutical, has been approved for marketing by China’s National Medical Products Administration (NMPA). The product can be used in combination with a low‑fat diet and other lipid‑lowering drugs for the treatment of homozygous familial hypercholesterolemia (HoFH) in adults and adolescents aged 12 and above, to reduce low‑density lipoprotein cholesterol (LDL‑C) levels.
Regulatory Milestone
| Item | Detail |
|---|---|
| Agency | NMPA (China) |
| Approval Type | Marketing approval – Category 1 innovative drug |
| Product | SHR‑1918 (brand name: Aiqingda) |
| Modality | ANGPTL3 monoclonal antibody – China’s first independently developed |
| Indication | HoFH in adults and adolescents ≥12 years, as an adjunct to a low‑fat diet and other lipid‑lowering drugs, to reduce LDL‑C |
| Developer | Shengdi Pharmaceutical (subsidiary of Jiangsu Hengrui) |
| Approval Date | 13 Nov 2026 |
| Data Basis | Randomized, double‑blind, placebo‑controlled Phase III trial (SHR‑1918‑301) |
Drug Profile & Mechanism of Action
- Molecule: SHR‑1918 is China’s first independently developed angiopoietin‑like protein 3 (ANGPTL3) monoclonal antibody.
- Target: Precisely inhibits ANGPTL3, a key regulatory protein in lipid metabolism.
- Mechanism: By inhibiting ANGPTL3, SHR‑1918 accelerates LPL‑ and EL‑mediated lipid catabolism through an LDLR‑independent pathway – critical for HoFH patients whose LDL receptors are nonfunctional.
- Lipid Coverage: Reduces levels of various atherogenic lipoproteins, including LDL‑C and triglycerides.
- Use Regimen: Approved for use in combination with a low‑fat diet and other lipid‑lowering drugs.
Clinical Evidence – Phase III Trial SHR‑1918‑301
| Endpoint | Result (SHR‑1918) | Comparator | Relative Benefit |
|---|---|---|---|
| LDL‑C Reduction at 12 Weeks | 64.2 % vs. placebo | Placebo | Statistically robust reduction |
| Safety | Generally well tolerated | – | No hepatotoxicity or nephrotoxicity observed |
The approval is based on the randomized, double‑blind, placebo‑controlled SHR‑1918‑301 study in HoFH patients aged ≥12 years. At 12 weeks of treatment, the SHR‑1918 group achieved a 64.2 % LDL‑C reduction compared with placebo, with a generally well‑tolerated profile and no observed hepatotoxicity or nephrotoxicity. Sample size and secondary endpoint details were not disclosed.
HoFH – Disease Landscape
- Classification: HoFH is included in China’s “First Batch of Rare Disease Catalog”.
- Pathology: A rare and life‑threatening hereditary disease in which patients have loss or severe deficiency of low‑density lipoprotein receptor (LDL‑R) function.
- Clinical Burden: Patients face extremely elevated LDL‑C from birth, driving accelerated atherosclerosis and early cardiovascular events if untreated.
- Treatment Gap: Because conventional statins and PCSK9 inhibitors depend on functional LDL‑R, HoFH patients respond poorly – making the LDLR‑independent ANGPTL3 mechanism a distinct therapeutic advantage.
Market Impact & Outlook
- First‑Mover in China: As China’s first independently developed ANGPTL3 monoclonal antibody, SHR‑1918 gives Hengrui a domestic first‑mover position in a rare‑disease niche historically served by imported therapies.
- Rare Disease Positioning: Inclusion of HoFH in the national Rare Disease Catalog may support expedited access, reimbursement consideration, and specialist‑center adoption in China.
- Portfolio Expansion: The approval deepens Hengrui’s cardiometabolic franchise alongside its established lipid‑lowering portfolio, reinforcing the company’s innovation‑driven pivot.
- Adolescent Coverage: Labeling from age 12 addresses a pediatric‑onset population with lifelong disease burden and few approved options.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding the commercialization of SHR‑1918 (Aiqingda) in China, including market adoption, reimbursement outcomes, and potential label expansion. Actual results may differ materially due to risks including pricing and reimbursement decisions, real‑world safety experience, rare‑disease patient identification, and competitive dynamics in lipid‑lowering therapies.-Fineline Info & Tech
