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Myqorzo and Redemplo Approved in China – Press Release

Myqorzo and Redemplo Approved in China – Press Release

January 15, 2026 Victoria Sterling Business

Myqorzo et Redemplo approuvés en Chine

  • Approbation de Myqorzo pour la ‌cardiomyopathie hypertrophique obstructive et de Redemplo pour le syndrome de chylomicronémie ​familiale.
  • Souligne l’engagement à‍ long terme de Sanofi envers la Chine et renforce son ambition de fournir des médicaments transformateurs aux patients atteints de maladies présentant d’importants besoins médicaux non satisfaits.

Paris,le 15 janvier 2026.L’Management nationale des produits⁤ médicaux en⁢ Chine⁢ a approuvé deux médicaments innovants sous ‌license Sanofi,Myqorzo (aficamten) pour le traitement de la cardiomyopathie hypertrophique⁣ obstructive (CMHo),et Redemplo (plozasiran) pour la réduction des taux de triglycérides,chez les patients adultes atteints du syndrome de chylomicronémie familiale (SCF) sur la base d’un contrôle alimentaire.

« Nous⁢ sommes heureux de proposer Myqorzo et⁣ Redemplo aux patients de la Grande Chine. Ces deux médicaments représentent⁣ des progrès importants dans les options de traitement et répondent à des besoins médicaux⁣ non satisfaits chez les personnes atteintes de pathologies complexes », a ‍déclaré Olivier Charmeil, vice-président ⁤exécutif, Médecine générale, Sanofi. « Les ‌dernières approbations soulignent l’engagement à long terme de Sanofi à fournir des médicaments innovants aux patients ‌chinois. »

Myqorzo est un inhibiteur sélectif de la myosine cardiaque à⁢ petite molécule destiné à améliorer la capacité fonctionnelle et à soulager les⁣ symptômes chez les patients atteints de CMH obstructive, pathologie dans laquelle le myocarde, le muscle cardiaque, ⁤devient anormalement épais.C’est la maladie cardiovasculaire‍ héréditaire monogénique la plus courante. L’approbation était basée sur l’étude pivot de phase 3 SEQUOIA-HCM‍ positive (identifiant d’étude clinique : NCT05186818) chez des patients atteints d’HCM obstructive sym

Orzo reduced⁤ myocardial contractility by‍ directly‍ binding ‌to cardiac myosin at a distinct and selective allosteric​ binding site, thereby preventing‌ myosin​ from entering the force-generating state. Myqorzo is ⁣approved in the United states and China.

Myqorzo has been designated as a breakthrough therapy and orphan drug in the United ​States, and a breakthrough therapy in China for the treatment of‌ symptomatic⁤ obstructive HCM. On December 12, 2025, the European Medicines agency’s Committee ⁤for ‍Medicinal Products for Human Use adopted​ a positive opinion recommending marketing authorization in the EU, with a final decision expected in‌ the first quarter‌ of 2026. In December2024,Sanofi⁢ obtained exclusive rights to develop and commercialize Myqorzo in Greater China to treat both forms of HCM. These rights came from an agreement with Corxel pharmaceuticals, which ⁢had acquired⁤ them from Cytokinetics.

About SCF
SCF is a severe and rare disease that leads to extremely high triglyceride levels,greater than 880 mg/dL‌ (9.94 mmol/L). This severe ⁣hypertriglyceridemia can lead to various serious signs and symptoms, ‍including acute⁣ and perhaps fatal pancreatitis, chronic abdominal pain, diabetes, hepatic steatosis, and cognitive issues.

About Redempo
Redempo (plozasiran) is ⁢an rnai-based medicine ​that suppresses the ‍production of apoC-III, a protein ​produced primarily in the⁢ liver that increases triglyceride levels by slowing their breakdown​ and removal. By targeting apoC-III and‍ durably inhibiting its activity, ​Redempo enables significant reductions in triglyceride levels. Redempo has been studied in both patients with clinically diagnosed SCF and those with genetically confirmed diagnoses. Redempo has been designated as a breakthrough therapy,fast track,and orphan ‌drug in ⁤the United States,and an orphan medicine in the EU and

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Relations avec‍ la presse
Timothy gilbert ‍ | +1 212 575 5435 | timothy.gilbert@sanofi.com
Léa⁣ Ubaldi | +33 6 30 19 66 46 | lea.ubaldi@sanofi.com
Ekaterina Pesheva | +1 410 926 6780 | ekaterina.pesheva@sanofi.com

Relations avec les investisseurs
Thomas kudsk Larsen ‌|‌ +44⁢ 7545 513 693 | thomas.larsen@sanofi.com
Alizé Kaisserian | +33 6 47 04 12 11 | alize.kaisserian@sanofi.com
Keita Browne |⁤ +1 781 249 1766 | keita.browne@sanofi.com
nathalie pham | +33 7 85 ⁤93 30 17 | nathalie.pham@sanofi.com
Thibaud Châtelet | +33 6 80 ​80 ⁢89 90 | thibaud.chatelet@sanofi.com
Yun Li | +33 6 84 00 90 72 | https://www.sanofi.com/)
* AMF (Autorité des ‌Marchés Financiers): Confirmed.​ This is ⁣the French ​financial regulatory​ authority. (https://www.amf-france.org/en)
* SEC (U.S. Securities ‍and ‌Exchange Commission): Confirmed. ⁢this ⁣is the primary regulatory agency for securities markets in the United States. (https://www.sec.gov/)
* ‍ Document d’enregistrement universel 2024: Confirmed. Sanofi publishes a Document d’enregistrement universel (Universal Registration Document). The 2024 version ‌is available on their website. (https://www.sanofi.com/en/investors/financial-reports – navigate to ​the ‍relevant year)
* ​ Rapport annuel 2024 sur Form 20-F: Confirmed. Sanofi, as a foreign company listed on a US exchange, files a Form 20-F‌ annual report with the SEC.‌ The 2024 version will be available on​ the SEC’s EDGAR database once filed.(https://www.sec.gov/edgar/search/)
* ‌‌ Articles 223-1 and suivants‌ of the Règlement général de l’Autorité des marchés financiers: Confirmed. These articles relate to forward-looking statements and safe harbor provisions within French financial regulations. (https://www.legifrance.gouv.fr/ – requires searching the French legal database)

2.‌ Actively Search for Contradicting/Correcting/Updating Information:

A general search for “Sanofi risks 2024” or “Sanofi legal disclaimers” ⁢doesn’t reveal any immediate contradictions or corrections to the ‌ general statements made‍ in⁤ the disclaimer. However, it does ‌reveal ongoing news and developments related to Sanofi, which are covered in the next section. Specifically,‌ searches reveal ongoing ‌litigation related to Zantac (ranitidine) and‍ potential liabilities.

3. Breaking News Check⁤ (as ‌of November 2, 2023, 16:30 ‌PST):

* Zantac Litigation: ‍ Sanofi is ⁣a defendant ‌in ongoing litigation related to the cancer-causing impurity NDMA⁣ found in Zantac (ranitidine). There ​have been recent court rulings and developments in this case. (https://www.reuters.com/legal/sanofi-wins-first-zantac-cancer-trial-2023-10-26/ , https://www.law360.com/articles/1436891/sanofi-wins-1st-zantac-trial-as-jury-sides-with-drugmaker)
*⁢ Financial Performance: Sanofi recently released its Q3 2023 financial results. (https://www.sanofi.com/en/investors/financial-reports)
* ​ Pipeline Developments: sanofi continues to announce updates on its research and development pipeline,including clinical trial results for various drugs. ([https://www.sanofi.com/en/research-and-development](https://www.

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