SanegeneBio, a clinical‑stage RNAi therapeutics company, announced that China’s National Medical Products Administration (NMPA) approved its Investigational New Drug (IND) application for SGB‑7342, an experimental siRNA medicine targeting Inhibin Beta E (INHBE) for the treatment of obesity. The drug is a GalNAc‑conjugated siRNA designed to suppress INHBE mRNA in hepatocytes, reducing Activin E levels and promoting selective lipolysis while preserving lean body mass.
Regulatory Milestone
Item
Details
Approval Date
16 Dec 2025
Agency
NMPA (China)
Product
SGB‑7342 (INHBE‑targeted siRNA)
Indication
Obesity (metabolic disease)
Mechanism
GalNAc‑conjugated siRNA suppresses INHBE mRNA in liver
Innovation
First RNAi therapy targeting INHBE globally
Development Stage
IND‑ready; Phase 1 initiation expected Q1 2026
Drug Profile & Mechanism of Action
Attribute
SGB‑7342
Scientific Rationale
Target
INHBE mRNA (liver‑expressed)
INHBE loss‑of‑function linked to favorable metabolic profile
Improved composition with preserved lean muscle mass
Safety
Favorable safety and tolerability profile
Differentiation
Targeted metabolic pathway vs. broad appetite suppression
Market Opportunity & Competitive Landscape
Metric
Value
Context
Obesity Prevalence
900 million adults globally; 150 million in China
High unmet need for targeted therapy
Current Standard
GLP‑1/GIP agonists (Wegovy, Zepbound)
Systemic appetite suppression; muscle mass loss common
RNAi Market
$5 billion (2025); projected $15 billion by 2030
Growing interest in hepatic/metabolic RNAi
INHBE Advantage
Selective fat loss with lean mass preservation
Addresses key limitation of current obesity drugs
Peak Sales Potential
¥3‑5 billion (≈ US$420‑700 M) by 2033
10‑15% share of China obesity market if approved
Strategic Implications
For SanegeneBio:First INHBE RNAi globally; GalNAc platform validated for metabolic disease; IND approval enables Phase 1 in Q1 2026; potential for global partnerships given novel mechanism.
For Obesity Treatment:Targeted pathway offers precision vs. systemic GLP‑1 therapy; preserved lean mass critical for long‑term health; single‑dose durability may improve compliance.
For RNAi Market: Demonstrates expansion beyond rare diseases into mass‑market metabolic conditions; SanegeneBio positions as leader in hepatic RNAi; INHBE becomes high‑value target for pharma licensing.
Forward‑Looking Statements This brief contains forward‑looking statements regarding SGB‑7342’s clinical development timeline, market penetration, and competitive positioning. Actual results may differ due to regulatory feedback, clinical risks, or competitive responses.-Fineline Info & Tech
By Fineline Cube 