By Fineline Cube 
China‑based Chongqing Taiji Industry (Group) Co., Ltd. (Taiji Group, SHA: 600129) announced that its semaglutide injection biosimilar has received approval from the China National Medical Products Administration (NMPA) to initiate clinical trials. The product targets adult patients with type 2 diabetes who remain hyperglycaemic despite diet, exercise, and metformin and/or sulfonylurea therapy, and it also aims to reduce the risk of major adverse cardiovascular events (MACE) in patients with concomitant cardiovascular disease.
About Semaglutide
- Class: Long‑acting human glucagon‑like peptide‑1 (GLP‑1) receptor agonist
- Origins: Developed by Novo Nordisk; approved in China in 2021
- Current Uses:
- Ozempic (or Rybelsus in some markets) – type 2 diabetes
- Wegovy – weight‑loss therapy
Taiji Group’s Biosimilar Edge
- Technology: Yeast high‑efficiency secretory expression system ensures consistent product quality and scalable manufacturing
- Competitive Position: First semaglutide biosimilar to receive regulatory review in China, positioning Taiji Group to capture market share as the original product’s price‑point pressure mounts
- Regulatory Milestone: NMPA clearance for clinical trial initiation—first step toward eventual market approval
What This Means for Stakeholders
| Stakeholder | Impact | Next Step |
|---|---|---|
| Patients | Potential access to a more affordable GLP‑1 therapy | Clinical trial enrollment will begin in Q4 2025 |
| Investors | Adds a high‑potential growth asset to Taiji Group’s portfolio | Monitor trial outcomes and subsequent regulatory filings |
| Healthcare System | May reduce long‑term cardiovascular costs by providing an effective, cost‑competitive option | Integration into diabetes management guidelines pending approval |
Forward‑Looking Statements
Taiji Group will commence Phase I/II trials later this year to assess safety, tolerability, and efficacy. Positive results could pave the way for a domestic and potentially global launch, offering a compelling alternative to Novo Nordisk’s branded semaglutide.-Fineline Info & Tech