Drugs / MCV4
MCV4
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | Menhycia | meningococcemia | 2026-07-19 | “NMPA") has accepted the supplemental application for Menhycia® (Group ACYW135 Meningococcal Polysaccharide Conjugate Vaccine, CRM197 Carrier, "MCV4") to expand its approved indication” cansinotech.com ↗ |
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 33 trials | ||||||
| Phase 3 | NCT06700148 | Dec 2024 → Aug 2025 overdue | meningococcal meningitis | CanSino Biologics Inc. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06226714 | Mar → Sep 2024 overdue | meningococcal meningitis | CanSino Biologics Inc. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06011200 | Sep → Dec 2023 | meningococcal meningitis | CanSino Biologics Inc. | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT06389513 | Jun 2024 → Dec 2025 overdue | infectious meningitis | CanSino Biologics Inc. | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05935176 | Sep 2023 → May 2026 overdue | meningoencephalitis | CanSino Biologics Inc. | Active not recruiting | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 1 | NCT07203755 Comparator | Dec 2025 → Feb 2029 expected | haemophilus infectious disease, meningitis | CanSino Biologics Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT01461980 Comparator | Sep 2011 → May 2014 | meningococcal infection | Pfizer | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2026-07-19 | CanSino Biologics Inc. | Regulatory CanSinoBIO's Menhycia® Application Accepted by China's NMPA for Expanded Use in Population Aged 3 Months to 17 Years cansinotech.com ↗
July 19, 2026 – CanSino Biologics Inc. ("CanSinoBIO" or the "Company", HKEX: 06185, SSE: 688185) today announced that the National Medical Products Administration of China ("NMPA") has accepted the supplemental application for Menhycia® (Group ACYW135 Meningococcal Polysaccharide Conjugate Vaccine, CRM197 Carrier, "MCV4") to expand its approved indication to the population aged 3 months to 17 years. |
| 2026-07-08 | NPO Petrovax | Results Clinical trials of a quadrivalent meningococcal vaccine completed in Russia petrovax.com ↗
The results of the Phase III trial showed that the MCV4-CRM197 vaccine elicits a strong immune response and has a favorable safety profile, including in young children, |
| 2026-06-25 | CanSino Biologics Inc. | Regulatory CanSinoBIO's MCV4 Receives Registration Approval in Argentina, Expanding Global Reach cansinotech.com ↗
This approval represents another important milestone in the international development of CanSinoBIO's innovative vaccine products and further strengthens the Company's presence in South America. |
| 2026-02-24 | CanSino Biologics Inc. | Regulatory Breaking News | CanSino Biologics' Menhycia® (MCV4) Expands Age Indication to Include individuals up to age 6, Enhancing Meningococcal Prevention for School-aged children cansinotech.com ↗
February 24th, 2026, CanSino Biologics Inc. ("CanSinoBIO") (SSE: 688185, HKEX: 06185) announced that China's National Medical Products Administration ("NMPA") has granted approval for the supplemental application to expand the indicated population of its self-developed ACYW135 Meningococcal Conjugate Vaccine (CRM197) ("MCV4", trade name: Menhycia®). |
| 2021-12-29 | CanSino Biologics Inc. | Regulatory CanSinoBIO Announces Approval for its MCV4 Product Menhycia™ in China cansinotech.com ↗
CanSino Biologics Inc. (“CanSinoBIO”) (SSE: 688185, HKEX: 06185) announced that the National Medical Products Administration of China (“NMPA”) granted approval for its ACYW135 Meningococcal Conjugate Vaccine (CRM197) (“MCV4”, trade name: Menhycia™), making it the first of its kind to be authorized in China. |
| 2016-02-15 | CanSino Biologics Inc. | Regulatory Cansino Biotechnology: Meningococcal Group ACYW135 Quadrivalent Conjugate Vaccine is Approved for Clinical Trial cansinotech.com ↗
Meningococcal Group ACYW135 Quadrivalent Conjugate Vaccine (MCV4) developed by Tianjin Cansino Biotechnology has been approved for clinical trial by China Food and Drug Administration (approval number: 2015L05606). |
All press releases naming this drug 9 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | MCV4 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06700148 ↗ |
| Known as | ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197) | “ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197) (MCV4)” NCT06226714 ↗ |
| Known as | Meningococcal Group ACYW135 (Conjugate) (MCV4) | “Meningococcal Group ACYW135 (Conjugate) (MCV4)” NCT07203755 ↗ |
| Modality | Vaccine | “MCV4(quadrivalent meningococcal polysaccharide conjugate” NCT01461980 ↗ |
| Route | Intramuscular | “Intramuscular injection, 0.5ml” NCT06011200 ↗ |