By Fineline Cube 
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that its next‑generation small‑interfering RNA (siRNA) drug, HRS‑5635 injection, has been proposed for inclusion in the Breakthrough Therapy Designation (BTD) list by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA). The move could fast‑track the approval of a potentially disease‑modifying therapy for chronic hepatitis B (CHB).
What is HRS‑5635?
- Liver‑targeted siRNA engineered to silence hepatitis B virus (HBV) genes.
- Developed independently by Hengrui Pharma using proprietary delivery technology that enhances hepatic uptake and reduces off‑target effects.
- Phase II data show HRS‑5635 monotherapy may increase the functional cure rate of CHB while maintaining a favorable safety profile.
Why BTD Matters
- BTD status gives the drug priority review, accelerated assessment, and potential for priority marketing approval in China.
- No domestic or international siRNA therapy for HBV has yet received regulatory approval, positioning HRS‑5635 as a first‑in‑class candidate.
- A BTD designation would also signal to global investors and partners a strong regulatory endorsement, potentially opening avenues for international collaboration.
Market Outlook
China alone accounts for > 30 % of the global CHB patient population. If approved, HRS‑5635 could capture a significant share of a market projected to exceed $10 billion by 2030. The drug’s unique mechanism and early‑stage data may also attract interest from U.S. and EU regulators, accelerating its global footprint.
Investor Takeaway
Jiangsu Hengrui’s pursuit of BTD for HRS‑5635 underscores its commitment to innovation in virology and positions the company as a serious contender in the rapidly expanding antiviral therapeutics arena.-Fineline Info & Tech