Drugs / SHR-1918
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | homozygous familial hypercholesterolemia | 2026-02-25 | “2026年2月，芮弗西拜单抗治疗成人和12岁及以上的未成年人纯合子家族性高胆固醇血症（HoFH）患者的适应症上市申请已获NMPA受理” hengrui.com ↗ “SHR-1918注射液的药品上市许可申请获受理且被纳入优先审评程序” hengrui.com ↗ “收到国家药监局下发的《受理通知书》” hengrui.com ↗ |
Trials 10
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05432544 | Jun 2022 → Dec 2023 | hyperlipidemia | Beijing Suncadia Pharmaceuticals Co., Ltd | Unknown | No outcome recorded |
| Phase 25 trials · 1 met primary | ||||||
| Phase 2 | NCT07308392 | Feb 2026 → Jun 2027 expected | metabolic disease | Fujian Shengdi Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT07133815 | Aug → Dec 2025 overdue | homozygous familial hypercholesterolemia | Beijing Suncadia Pharmaceuticals Co., Ltd | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06471218 | Jul 2024 → May 2025 | hyperlipidemia | Beijing Suncadia Pharmaceuticals Co., Ltd | Completed | No outcome recorded |
| Phase 2 | NCT06009393 | Dec 2023 → Jun 2024 | homozygous familial hypercholesterolemia | Beijing Suncadia Pharmaceuticals Co., Ltd | Completed | Met primary |
| Phase 2 | NCT06109831 | Nov 2023 → Jul 2025 | hyperlipidemia | Beijing Suncadia Pharmaceuticals Co., Ltd | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT07404553 | Apr 2026 → Jul 2028 expected | hyperlipidemia | Beijing Suncadia Pharmaceuticals Co., Ltd | Recruiting | No outcome recorded |
| Phase 33 trials · 1 met primary | ||||||
| Phase 3 | NCT07349615 | Apr 2026 → Nov 2027 expected | hypertriglyceridemia | Beijing Suncadia Pharmaceuticals Co., Ltd | Recruiting | No outcome recorded |
| Phase 3 | NCT07230730 | Jan 2026 → Oct 2027 expected | hyperlipidemia | Beijing Suncadia Pharmaceuticals Co., Ltd | Recruiting | No outcome recorded |
| Phase 3 | NCT06723652 | Feb → Aug 2025 | homozygous familial hypercholesterolemia | Beijing Suncadia Pharmaceuticals Co., Ltd | Completed | Met primary |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2026-09-02 | Jiangsu HengRui Medicine Co., Ltd. | Results ESC 2026 LBA｜HoFH患者LDL-C降幅相对安慰剂达64.2%！恒瑞医药创新药芮弗西拜单抗Ⅲ期研究重磅亮相 hengrui.com ↗
研究结果显示，第12周时，相比安慰剂，芮弗西拜单抗组低密度脂蛋白胆固醇（LDL-C）的降幅达64.2% 1 。 |
| 2026-02-25 | Jiangsu HengRui Medicine Co., Ltd. | Regulatory 恒瑞创新药SHR-1918纯合子家族性高胆固醇血症上市申请获受理且被纳入优先审评 hengrui.com ↗
近日，恒瑞医药子公司北京盛迪医药有限公司收到国家药监局下发的《受理通知书》，公司1类创新药血管生成素样蛋白3（ANGPTL3）全人源单克隆抗体SHR-1918注射液的药品上市许可申请获受理且被纳入优先审评程序，适应症为： 治疗成人和12岁及以上的未成年人纯合子家族性高胆固醇血症（HoFH）患者 ，有望为这一罕见病治疗带来新选择。 |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-09-02 | Jiangsu HengRui Medicine Co., Ltd. | ESC 2026 LBA｜HoFH患者LDL-C降幅相对安慰剂达64.2%！恒瑞医药创新药芮弗西拜单抗Ⅲ期研究重磅亮相 hengrui.com ↗ |
| 2026-02-25 | Jiangsu HengRui Medicine Co., Ltd. | 恒瑞创新药SHR-1918纯合子家族性高胆固醇血症上市申请获受理且被纳入优先审评 hengrui.com ↗ |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 12 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SHR-1918 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07230730 ↗ |
| Action | Inhibit | “ANGPTL-3 inhibition with SHR-1918 further reduces LDL-C” PMID 40167414 ↗ Mar 2025 |
| Modality | Monoclonal antibody | “SHR-1918 is a monoclonal antibody against ANGPTL3.” PMID 40576753 ↗ Jun 2025 |
| Route | Subcutaneous | “each containing 12 healthy subjects randomized (9:3) to receive a single dose of subcutaneous SHR-1918 or placebo.” PMID 40576753 ↗ Jun 2025 |
| Target | ANGPTL3 | “SHR-1918 is a monoclonal antibody against ANGPTL3.” PMID 40576753 ↗ Jun 2025 |