Drugs / Tafolecimab
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | hyperlipidemia, combined, 2 | 2022-06-14 | “today announced that the China’s National Medical Products Administration (NMPA) has formally accepted the New Drug Application (NDA) for tafolecimab injection” innoventbio.com ↗ |
Trials 20
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 27 trials | ||||||
| Phase 2 | NCT07840677 | Sep 2026 → Sep 2029 expected | colon carcinoma | Daping Hospital and the Research Institute of Surgery of the Third Military Medical University | Recruiting | No outcome recorded |
| Phase 2 | NCT07621562 | Jun 2026 → Sep 2027 expected | gastric adenocarcinoma, gastroesophageal junction adenocarcinoma | First Affiliated Hospital of Zhejiang University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07061535 | Jul 2025 → Aug 2027 expected | small cell lung carcinoma | Second Affiliated Hospital, Zhejiang University, School of Medicine | Recruiting | No outcome recorded |
| Phase 2 | NCT07014215 | Jun 2025 → May 2027 expected | non-small cell lung carcinoma | Anhui Provincial Cancer Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06421298 | May 2024 → May 2027 expected | lung cancer | Jinghui Wang | Recruiting | No outcome recorded |
| Phase 2 | NCT06304987 | Apr 2024 → Apr 2026 | — | Beijing Friendship Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT03815812 | Mar → Dec 2019 | hyperlipidemia | Innovent Biologics (Suzhou) Co. Ltd. | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT04948008 | Nov 2019 → Jul 2020 | homozygous familial hypercholesterolemia | Shenzhen People's Hospital | Unknown | No outcome recorded |
| Phase 2/3 | NCT04031742 | Sep 2019 → Dec 2021 | homozygous familial hypercholesterolemia | Innovent Biologics (Suzhou) Co. Ltd. | Completed | No outcome recorded |
| Phase 38 trials · 3 met primary | ||||||
| Phase 3 | NCT07686796 | Jan 2027 → Jan 2030 expected | rectal cancer | Guangdong Provincial People's Hospital | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07473960 | Apr → Sep 2026 overdue | hyperlipoproteinemia | Innovent Biologics (Suzhou) Co. Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT07256197 | Apr 2026 → Dec 2028 expected | aortic valve stenosis | Beijing Anzhen Hospital | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT04968509 | Mar 2024 → Dec 2027 expected | aortic valve stenosis | Beijing Anzhen Hospital | Recruiting | No outcome recorded |
| Phase 3 | NCT04709536 | Feb → Nov 2021 | hyperlipoproteinemia | Innovent Biologics (Suzhou) Co. Ltd. | Completed | Met primary |
| Phase 3 | NCT04759534 | Sep 2020 → Oct 2021 | hypercholesterolemia, autosomal dominant, 3 | Shenzhen People's Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT04289285 | Apr 2020 → Feb 2022 | hyperlipidemia | Innovent Biologics (Suzhou) Co. Ltd. | Completed | Met primary |
| Phase 3 | NCT04179669 | Dec 2019 → Jun 2021 | familial hypercholesterolemia | Innovent Biologics (Suzhou) Co. Ltd. | Completed | Met primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT06683131 | Nov 2025 → Nov 2027 expected | acute myocardial infarction | The Affiliated Hospital of Xuzhou Medical University | Not yet recruiting | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT07341958 | Sep → Dec 2026 expected | cerebrovascular disorder | Beijing Tiantan Hospital | Not yet recruiting | No outcome recorded |
| — | NCT06096909 | Nov 2023 → Nov 2025 overdue | acute coronary syndrome | China National Center for Cardiovascular Diseases | Not yet recruiting | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 1 | NCT03366688 Comparator | Nov 2017 → Nov 2018 | hyperlipidemia | Innovent Biologics (Suzhou) Co. Ltd. | Completed | No outcome recorded |
| — | NCT05457582 Comparator | Mar 2023 → Sep 2026 overdue | acute coronary syndrome, hyperlipidemia | Nanjing First Hospital, Nanjing Medical University | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2025-06-09 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory SINTBILO® Received Approval in Macau as the First China-Developed PCSK9 Antibody , Providing a New Option for Patients with Hypercholesterolemia innoventbio.com ↗
This approval marks SINTBILO® as the first China-originated PCSK9 monoclonal antibody approved in Macau, representing a significant milestone in domestic innovation and expanding treatment options for patients with primary hypercholesterolemia and mixed dyslipidemia in the region. |
| 2024-11-28 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory Innovent Announces First-Time Inclusion of SINTBILO® and New Indication for Olverembatinib in China’s National Reimbursement Drug List innoventbio.com ↗
Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces that the updated 2024 National Reimbursement Drug List (NRDL) now includes SINTBILO® (tafolecimab injection, an anti-PCSK9 monoclonal antibody) for the first time, along with a new indication of olverembatinib (a BCR-ABL inhibitor) on the list. |
| 2023-10-11 | Innovent Biologics (Suzhou) Co. Ltd. | Results Powerful Lipid-lowering Effect: the Results of Phase 3 Clinical Study (CREDIT-1) of SINTBILO® (Tafolecimab Injection) were Published in The Lancet Regional Health-Western Pacific innoventbio.com ↗
The study showed tafolecimab dosed at both 450 mg Q4W and 600 mg Q6W was safe and demonstrated clinically meaningful lipid-lowering efficacy. |
| 2023-08-16 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory Innovent Announces the NMPA Approval of SINTBILO® (Tafolecimab Injection) for the Treatment of Adult Patients with Primary Hypercholesterolemia and Mixed Dyslipidemia innoventbio.com ↗
Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, metabolic, ophthalmology and other major diseases, announces that China's National Medical Products Administration (NMPA) has approved SINTBILO® (tafolecimab injection, anti-PCSK9 monoclonal antibody) for the treatment of adult patients with primary hypercholesterolemia (including heterozygous familial and non-familial hypercholesterolemia) and mixed dyslipidemia. |
| 2023-07-17 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent Announces Results of Phase 3 Clinical Study of Tafolecimab（IBI306）in Chinese Patients with Hypercholesterolemia were Published in JACC:Asia innoventbio.com ↗ |
| 2022-11-07 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent Releases Results of a Phase 3 Clinical Study of Tafolecimab（IBI306）in Chinese Patients with non- Familial Hypercholesterolemia at the American Heart Association (AHA) Scirntific Sessions 2022 innoventbio.com ↗ |
| 2022-06-14 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory Innovent Announces the NMPA Acceptance of the New Drug Application for Tafolecimab Injection (Anti-PCSK-9 Antibody) innoventbio.com ↗
Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, metabolic, ophthalmology and other major diseases, today announced that the China’s National Medical Products Administration (NMPA) has formally accepted the New Drug Application (NDA) for tafolecimab injection (anti-PCSK-9 antibody, R&D code: IBI306) for the treatment of primary hypercholesterolemia (including heterozygous familial hypercholesterolemia and non-familial hypercholesterolemia) and mixed dyslipidemia. |
| 2022-04-04 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent Releases Results of a Phase 3 Clinical Study of IBI306（PCSK-9 inhibitor） in Chinese Patients with Heterozygous Familial Hypercholesterolemia at the American College of Cardiology Annual Congress 2022 innoventbio.com ↗
The AAC 2022 presentation is based on CREDIT-2, a randomized, double-blind, placebo-controlled phase 3 study, evaluating the efficacy and safety of IBI306 in Chinese patients with heterozygous familial hypercholesterolemia (ClinicalTrials.gov, NCT04179669). |
| 2022-02-17 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent Announces Two Registration Studies of IBI306 (anti-PCSK-9 antibody) Met Primary Endpoint innoventbio.com ↗
Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, announces that the primary endpoint was met in two Chinese registration studies of recombinant full-human anti-PCSK-9 monoclonal antibody (R&D code: IBI306, independently developed by Innovent), the CREDIT-1 study of non-familiar hypercholesterolemia (non-FH) patients at high / very high cardiovascular risk and the CREDIT-4 study of patients with hypercholesterolemia including non-FH and heterozygous familial hypercholesterolemia (HeFH) in China. |
| 2021-08-12 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent Announces IBI306 (anti-PCSK-9 antibody) Meets the Primary Endpoint in a Phase 3 Clinical Study for Chinese Heterozygous Familial Hypercholesterolemia innoventbio.com ↗
Throughout the study, IBI306 demonstrates a favorable safety profile, similar to the reported safety profiles of other marketed PCSK-9 inhibitors. |
| 2020-08-31 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent Announces the Results of the Phase 1/2 Clinical Study of PCSK9 Antibody Tafolecimab at the European Society of Cardiology Annual Conference innoventbio.com ↗
The accepted results were from CIBI306A101 and CIBI306B101, which demonstrated satisfactory safety and efficacy profiles of Tafolecimab. |
All press releases naming this drug 12 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 24 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Tafolecimab | “Sixty patients with hypercholesterolemia (phase 1b) were randomized to receive 75 or 140 mg tafolecimab every 2 weeks, 300 or 420 mg every 4 weeks, or 450 or 600 mg every 6...” PMID 36341216 ↗ Nov 202114“Patients in experimental group are treated with PCSK9 inhibitors (150mg Tafolecimab subcutaneously every two weeks) and guideline-directed management in cardiovascular primary...” NCT07256197 ↗ “Patients in experimental group are treated with PCSK9 inhibitors (140mg with Evolocumab or 75mg with Alirocumab or 150mg with Tafolecimab subcutaneously every two weeks)” NCT04968509 ↗ “Tafolecimab is a novel fully human proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibody, developed for the treatment of hypercholesterolemia.” PMID 37614541 ↗ Jul 2023 “Alirocumab was used before June 10, 2025; Tafolecimab has been used from June 10, 2025 onward.” NCT05457582 ↗ “PD-1 inhibitor (Sintilimab) and PCSK9 inhibitor (Tafolecimab)” NCT06304987 ↗ |
| Known as | IBI306 | “IBI306 is a fully human monoclonal antibody that binds proprotein convertase substilisin/kexin type 9 (PCSK9)” NCT03366688 ↗8“IBI306 is a kind of protein convertase subtilisin/kexin type 9 inhibitor.” NCT04759534 ↗ |
| Action | Inhibit | “preventing its interaction with the low-density lipoprotein cholesterol receptor (LDL-R)” NCT03366688 ↗ |
| Modality | Monoclonal antibody | “fully human monoclonal antibody” NCT03366688 ↗ |
| Route | Intravenous | “Subcutaneous or intravenous injection of a single dose of IBI306” NCT03366688 ↗ |
| Route | Subcutaneous | “Subcutaneous or intravenous injection of a single dose of IBI306” NCT03366688 ↗ |
| Target | PCSK9 | “binds proprotein convertase substilisin/kexin type 9 (PCSK9)” NCT03366688 ↗ |