Two siRNA Therapies for Hepatitis B Nominated for Breakthrough Therapy Designation on the Same Day

September 15Day,CDE official website shows,Two siRNA Therapies Proposed for Inclusion in Breakthrough Treatment Category, includingHengrui PharmaHRS-5635 InjectionAndHepa Thera HT-101 Injection, the former is suitableShouldSymptom isChronic hepatitis B, the latter isCompared with HT-102(Hepatitis B Virus Surface Antigen Neutralizing Antibody)Combination therapy for the treatment of chronic hepatitis B virus infection.

 Hengrui Pharma: HRS-5635

HRS-5635 is a self-developed product by Hengrui Pharma.A New Generation of Liver-Targeted siRNA Drug for Hepatitis B Virus，GlobalNo similar products have been approved for marketing.。

HRS-5635 for Chronic Hepatitis B Advances to Phase II Clinical Trials(Registration Number:NCT06425341、CTR20241805）The study plans to enroll 303 subjects, and has currently enrolled 278 subjects.

BesidesIn addition to HRS-5635, Hengrui Pharma has also laid out siRNA therapies for hyperlipidemia (HRS-7249), obesity (HRS-5817), and hypertension (HRS-9563).

 Hepa Thera:HT-101

HT-101 is aGalNAc-Conjugated siRNA Innovative Drug, through highly specific liver targeting, silences HBV mRNA, blocks the synthesis of multiple viral proteins, and achieves anti-HBV effects. Its clinical advantages are significant. Currently, it is in Phase II clinical trials for hepatitis B.

Phase Ib clinical trial results showed that hepatitis B surface antigen levels decreased in all dose groups after two administrations.（HBsAg）The level continued to decline, with some patients in the high-dose group achieving HBsAg clearance. Preliminary data from Phase II furtherIndicates that HT-101 is superior to similar competing products both domestically and internationally in terms of onset time and S antigen clearance rate.

Early this July, the product was used as a single drug forChronic Hepatitis B Virus Infection Included in Breakthrough Therapy Designation.

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Disclaimer:This article is for information sharing only and does not represent the position or viewpoint of Insight. It does not recommend or introduce any treatment plans. If needed, please consult and contact正规医疗机构.

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