Science & research

Drug discovery, development and manufacturing

Our proprietary recombinant-protein platform connects molecular design and candidate screening with preclinical research, clinical development and manufacturing processes. Efsubaglutide alfa is the first marketed medicine developed through this work.

Ribbon rendering of human IgG2 Fc: the Fc component, not the complete efsubaglutide alfa fusion protein.
Human IgG2 FcThe colours distinguish the two Fc protein chains. This reference structure does not show the complete efsubaglutide alfa fusion protein.Structure · 4HAF ↗

Our recombinant fusion-protein platform

The platform behind our first medicine

Native GLP-1 is rapidly degraded in the body. Innogen’s GLP-1/IgG2 Fc fusion design aims to preserve GLP-1 receptor activity while extending its duration of action.

Efsubaglutide alfa

A long-acting GLP-1 receptor agonist

The recombinant fusion protein efsubaglutide alfa: two human GLP-1 units joined through hinge regions to the paired CH2 and CH3 domains of human IgG2 Fc.HumanGLP-1Hinge regionsHumanIgG2 FcCH2 + CH3

Simplified fusion-protein schematic; not to scale. Published schematic ↗

GLP-1 receptor activity

GLP-1 receptor activation promotes glucose-dependent insulin secretion and suppresses glucagon release.

Fusion with human IgG2 Fc

The fusion design aims to reduce enzymatic breakdown and kidney clearance, and to prolong circulation through FcRn-mediated recycling.

Foundational research · 2010

Observing uptake into cells

Rat insulinoma INS-1 cells

At 0 minutes, the red signal is mainly at the cell surface. After 10 minutes at 37°C, the authors observed more signal inside the cells, supporting uptake of the bound fusion protein.

0 min
Original Figure 3A: INS-1 cells after 0 minutes at 37°C. Red shows GLP-1/hIgG2 staining; blue shows nuclei.
10 min
Original Figure 3A: INS-1 cells after 10 minutes at 37°C. Red shows GLP-1/hIgG2 staining; blue shows nuclei.
20 min
Original Figure 3A: INS-1 cells after 20 minutes at 37°C. Red shows GLP-1/hIgG2 staining; blue shows nuclei.
60 min
Original Figure 3A: INS-1 cells after 60 minutes at 37°C. Red shows GLP-1/hIgG2 staining; blue shows nuclei.

Red: GLP-1/hIgG2 staining · Blue: nuclei

Each timepoint shows separately fixed cells, rather than the same cells followed over time. This experiment examines cell uptake; it does not measure duration of action in the body or effects in people.

Experiment details

As described in the Figure 3 caption, INS-1 cells were incubated with 1 μM GLP-1/hIgG2 at 4°C for 30 minutes, then moved to 37°C. Cells were fixed and stained at 0, 10, 20 and 60 minutes and imaged by confocal microscopy. All four panels from Figure 3A are shown here.

View full Figure 3 (A & B) ↗Wang et al., PLOS ONE, 2010 ↗© 2010 Wang et al. · Figure 3A, detail · CC BY

Longer action in mice

A 2010 cell and mouse study tested whether GLP-1/IgG2 fusion could retain receptor activity and extend its action. Improved glucose tolerance was still observed in mice one week after a single injection. The study predates Innogen; the company identifies continuing work on this approach as part of the scientific foundation for its later drug development.

Development and manufacturing

Efsubaglutide alfa progressed from molecular design and process development through clinical studies to commercial manufacturing.

  1. Drug design
  2. Screening
  3. Lead identification
  4. Preclinical studiesToxicology and pharmacology
  5. Pilot production
  6. Clinical trials
  7. Production and launch
Two people in protective clothing working with equipment, from Innogen’s published platform illustration.
Production operations

Original platform illustration

500 L bioreactor
Purification equipment
Formulation

View illustration ↗

Clinical evidence

Clinical studies of efsubaglutide alfa

Efsubaglutide alfa is approved for adult type 2 diabetes in mainland China and Macao. The studies below examine monotherapy, treatment added to metformin, dosing intervals, weight management and glucose control after treatment stops; further uses and regimens remain investigational.

SUPER 2Nature Communications · 2026

A randomised trial of efsubaglutide alfa added to metformin

The randomised, double-blind, placebo-controlled Phase IIb/III trial enrolled adults with type 2 diabetes inadequately controlled on metformin. The Phase III stage randomised 344 new participants to efsubaglutide alfa 3 mg weekly or placebo, both added to metformin.

The Phase IIb stage compared doses before 3 mg was selected for Phase III. At week 24, mixed-meal testing found lower glucose responses and higher insulin and C-peptide responses with efsubaglutide alfa than with placebo, consistent with improved β-cell secretory function during treatment.

Read the full study ↗

Primary endpoint · week 24

Reduction in HbA1c from baseline

Percentage points

Efsubaglutide alfa + metformin
1.80
Placebo + metformin
0.74

Estimated treatment difference: −1.06 percentage points (95% CI −1.37 to −0.74).

Common adverse events were gastrointestinal, mostly mild to moderate. The comparator was placebo; the study does not establish comparative efficacy or safety against another active medicine. See the paper for full methods, results and safety data.

Clinical research questions

One molecule, different clinical questions

SUPER 1 and SUPER 2 examine monotherapy and add-on treatment. Further studies explore dosing intervals, weight management and disease status after treatment. The study settings are outlined below; current development status is shown in the pipeline.

  1. SUPER 1

    Glycaemic control · Monotherapy

    People with type 2 diabetes who had not previously received glucose-lowering medicines.

    Examines glycaemic control after 24 weeks of once-weekly monotherapy, alongside safety and tolerability.

    A randomised, double-blind, placebo-controlled phase 2b/3 trial, published online in Diabetologia in November 2025. It examines monotherapy, unlike SUPER 2’s metformin background therapy.

  2. SUPER 2

    Glycaemic control · Add-on to metformin

    People with type 2 diabetes whose glycaemia remained inadequately controlled on metformin.

    Compares efsubaglutide alfa with placebo alongside metformin, assessing HbA1c and post-meal glucose, insulin and C-peptide responses.

    Randomised, double-blind, two-stage adaptive phase 2b/3 trial, published in Nature Communications in 2026.

  3. SUPER Q2W

    Dosing interval · Every two weeks

    59 adults with type 2 diabetes inadequately controlled by lifestyle intervention.

    After a one-week 1 mg run-in, compares 12 weeks of 3 mg every two weeks with 1 mg weekly using HbA1c and continuous glucose monitoring.

    Published in November 2025, this multicentre, randomised, open-label study found similar glycaemic improvements. Its small sample, short follow-up and descriptive statistical comparisons do not establish equivalence between regimens. Current regulatory progress is shown in the pipeline.

  4. LIGHT 1 → ENLIGHT

    Weight management · Dose and regimen research

    People with overweight or obesity; ENLIGHT enrolled adults without diabetes.

    Moves from LIGHT 1 phase 2a dose exploration to ENLIGHT phase 2b weekly and every-two-week regimens, assessing weight, body composition and safety.

    The randomised, double-blind, placebo-controlled LIGHT 1 phase 2a paper was published in January 2026. ENLIGHT phase 2b results were reported as an ADA 2026 poster abstract. Weight management remains investigational.

  5. Diabetes-remission follow-up

    Glucose control after treatment stops

    29 participants entered follow-up after completing 52 weeks of weekly treatment in SUPER 1 with HbA1c ≤7.0%. They had not used glucose-lowering medicines before SUPER 1.

    Follows participants for 52 weeks without glucose-lowering medicines, defining remission as HbA1c <6.5% measured at least three months after treatment stops.

    The observational follow-up, published in January 2026, reported remission in 12 of 20 participants included in the three-month analysis (60%). This small, selected group of treatment responders cannot establish a remission rate for all patients. It is separate from SUPER 2’s functional assessments during treatment.

Adult type 2 diabetes

Approved and commercially launched in mainland China and Macao. Mainland approval includes monotherapy or treatment with metformin.

Obesity and overweight

Adult Phase III research in China, Phase II in Australia and adolescent Phase Ib research in China are distinct programs. These uses remain investigational.

Longer dosing intervals

A supplemental application for dosing every two weeks in adult type 2 diabetes was accepted in July 2026. Acceptance is not approval; formulation research is listed separately among early programs.

Development status: interim results announcement, 25 August 2026. Original disclosure ↗

Development pipeline

Pipeline source · 2026-08-25 ↗

Innogen develops its pipeline independently and reports global commercial rights for every disclosed program. Development status is listed by indication, territory and dosing regimen.

18 development entries

Efsubaglutide alfaGLP-1

Innogen’s first marketed medicine, with further research into new uses, patient groups and dosing schedules.

Adult type 2 diabetes

Chinese mainland

Marketed

Approved and commercially launched for adult type 2 diabetes, as monotherapy or with metformin; included in the NRDL from 1 January 2026.

Macao, China

Marketed

Approved in June 2025; commercially launched in September 2025.

Brazil

Submission or acceptance is not marketing approval.

Biologics licence application submitted in September 2025.

Adult type 2 diabetes: dosing every two weeks

Chinese mainland

Supplemental application accepted

Submission or acceptance is not marketing approval.

Once every two weeks; proposed supplemental regimen

A supplemental application for dosing once every two weeks was accepted in July 2026.

Adult obesity and overweight

Chinese mainland

Phase III

Weekly and every-two-week dosing under investigation

Phase III; 30-week follow-up for the primary efficacy endpoint completed in July 2026.

Australia

Phase II

Weekly, every-two-week and every-four-week dosing under investigation

Phase II; database locked in July 2026.

Adolescent obesity

Chinese mainland

Phase Ib

Phase Ib; first participant enrolled and dosed on 28 July 2026.

Metabolic dysfunction-associated steatohepatitis (MASH)

China and United States

IND clearance

Permits a clinical trial; not marketing approval.

The FDA cleared an IND for a Phase IIa study in March 2023; NMPA IND approval for the same indication followed in March 2025. The Group reports that it is prioritising selected next-generation early-stage programs, including differentiated fusion proteins intended to address broader disease mechanisms in MASH.

Next-generation programs

Early research in weight management, MASH, type 1 diabetes and Alzheimer’s disease, alongside long-acting formulation technology.

YN203

GCGRi/GLP-1

GCGRi: Glucagon receptor inhibitor

Obesity and overweight

Development territory not disclosed

Preclinical research

YN308

Apelin/GLP-1

Obesity and overweight

Development territory not disclosed

Preclinical research

YN202

GHS-Ri

GHS-Ri: Growth hormone secretagogue receptor inhibitor

Obesity and overweight

Development territory not disclosed

Preclinical research

YN302

Ultra-long-acting formulation

Long-acting formulation technology

Development territory not disclosed

Preclinical research

YN209

Myokine/GLP-1

MASH

Development territory not disclosed

Preclinical research

YN205

FGF21/GLP-1

FGF21: Fibroblast growth factor 21

MASH

Development territory not disclosed

Preclinical research

YN014

Neuron–microglia-specific target

Alzheimer’s disease

Development territory not disclosed

IND-enabling

YN401

β-cell-specific target

Type 1 diabetes

Development territory not disclosed

IND-enabling

Companion-animal medicines

Studies of efsubaglutide alfa in feline type 2 diabetes and obesity.

Efsubaglutide alfa

GLP-1

Feline type 2 diabetes

China

Phase I study

Phase I; clinical studies ongoing.

Feline obesity

China

Phase I study

Phase I; clinical studies ongoing.

Reading the development status

A medicine can be studied in different populations, indications and dosing regimens. The pipeline shows progress by program and territory, with approved uses distinguished from investigational uses.

Entries distinguish indications, dosing regimens and territories. IND clearance permits a clinical trial; submission or acceptance of an application is not marketing approval.

Commercial rights and regulatory status are shown separately. Global commercial rights do not mean a medicine has marketing approval in every territory. 2026 interim results announcement ↗

Further research

New molecules and delivery technologies

Recombinant protein engineering underpins Innogen’s research. Work on longer-acting delivery, computational modelling and experimental validation extends that foundation into drug development.

01

Fusion-protein design

We design and screen candidate molecules addressing GLP-1 and other metabolic pathways. Early programs include Apelin/GLP-1, FGF21/GLP-1 and Myokine/GLP-1 approaches.

02

Long-acting formulation and delivery

Injectable hydrogel research explores longer dosing intervals. Published work uses cell and animal models and does not establish a human dosing interval or approved regimen.

Read about the hydrogel research →
03

Computational and experimental research

In its 2026 interim results, Innogen described work on an AI-enabled discovery platform connecting target identification and validation, computational molecular design and laboratory evaluation. The intended scope runs from early discovery to preclinical candidate selection, including fusion proteins and peptides.

2026 interim results: technology platform ↗

Platform and early-program source: 2026 interim results ↗

Research library

Published studies and reviews

Early GLP-1 fusion-protein studies, clinical trials and emerging delivery technologies.

Randomised phase 2b/3 trial

SUPER 1: monotherapy in newly diagnosed type 2 diabetes

Diabetologia

Study summary and limitations

Can weekly efsubaglutide alfa improve glucose control in adults who have not taken glucose-lowering medicines and remain inadequately controlled with diet and exercise?

This two-stage study enrolled adults with newly diagnosed type 2 diabetes who had not used glucose-lowering medicines. Following phase 2b dose selection, phase 3 randomised 297 participants to weekly 1 mg, 3 mg or placebo. Both doses reduced HbA1c more than placebo at week 24. Adverse events were mainly mild-to-moderate gastrointestinal events.

Placebo-controlled results in previously untreated participants do not establish superiority over other glucose-lowering medicines. Figure 2d has been corrected in the linked article.

Randomised phase 2b/3 trial

SUPER 2: glucose control alongside metformin

Nature Communications

Study summary and limitations

How does adding efsubaglutide alfa affect glucose control and post-meal insulin secretion when metformin alone is insufficient?

Adults with type 2 diabetes inadequately controlled on metformin received weekly 3 mg or placebo in phase 3; both groups continued metformin. At week 24, HbA1c fell by 1.80 versus 0.74 percentage points. Mixed-meal testing at week 24 found lower glucose responses and higher insulin and C-peptide responses with efsubaglutide alfa than with placebo, consistent with improved β-cell secretory function during treatment. Adverse events were mainly mild-to-moderate gastrointestinal events.

The study included a 24-week placebo-controlled period and a 28-week open-label extension, with metformin as background treatment. Follow-up cannot fully establish rare-event safety or long-term efficacy.

Randomised open-label trial

Q2W: comparing dosing every two weeks with weekly treatment

Diabetes, Obesity and Metabolism

Study summary and limitations

How does short-term glucose control differ between 3 mg every two weeks and 1 mg weekly in adults with type 2 diabetes?

This multicentre study enrolled 59 adults whose glucose remained inadequately controlled with lifestyle intervention. After a one-week 1 mg run-in, the groups received either 3 mg every two weeks or 1 mg weekly for 12 weeks. HbA1c reductions and continuous glucose monitoring measures were similar between groups. Adverse events were mainly mild-to-moderate gastrointestinal events.

The trial was small, short and open-label; its descriptive statistics do not establish equivalence between regimens. Every-two-week dosing remains investigational, and acceptance of a supplemental application is not approval.

Phase 2a ascending-dose trial

LIGHT 1: exploring doses and tolerability for weight management

Diabetes, Obesity and Metabolism

Study summary and limitations

How does increasing the weekly dose affect weight and tolerability in adults with overweight or obesity?

This randomised, double-blind, placebo-controlled phase 2a study enrolled 50 adults with overweight or obesity who had not responded adequately to lifestyle intervention. It explored weekly target doses of 5, 7.5, 10, 15 and 20 mg, with escalation every two weeks followed by four weeks at the target dose. Greater weight reduction was observed with efsubaglutide alfa. Gastrointestinal events were mainly mild to moderate and occurred primarily during escalation.

This small, early dose-finding study cannot establish long-term weight loss or safety. Both fat and lean mass decreased, so it does not establish muscle preservation. Obesity remains an investigational use.

Phase 2b trial · conference abstract

ENLIGHT: studying weekly and fortnightly weight-management regimens

Diabetes · ADA 2026, 2636-P

Study summary and limitations

How do the studied weekly and every-two-week dose regimens affect weight in adults with overweight or obesity?

This randomised, double-blind, placebo-controlled study assessed 18 weeks of treatment, including dose escalation. Weight changed by −10.58% with 20 mg weekly, −9.70% with 20 mg every two weeks and −3.61% with placebo. Results were presented as a poster abstract at ADA 2026.

This is a conference abstract, rather than a complete clinical paper. Obesity and the studied regimens remain investigational.

Observational follow-up

After SUPER 1: diabetes remission following treatment withdrawal

Advances in Therapy

Study summary and limitations

Can selected participants who achieved glucose control during treatment meet diabetes-remission criteria after stopping glucose-lowering medicines?

The study enrolled 29 SUPER 1 participants who had been drug-naive before treatment, completed 52 weeks of efsubaglutide alfa and reached HbA1c ≤7.0%. They stopped all glucose-lowering medicines and entered a 52-week follow-up. In the three-month analysis, 12 of 20 participants met the remission criterion: HbA1c <6.5% measured at least three months after the last dose.

This was a small, selected observational cohort. The three-month result uses a denominator of 20, not all 29 enrollees; it does not establish the likelihood of remission for all patients or show that diabetes has been cured.

Hydrogel study illustration showing the fusion protein, temperature-responsive gel formation and sustained-release experiments in diabetic mice.
Original Theranostics illustration · Animal research
Formulation research · rodent models

A temperature-responsive hydrogel for sustained drug release

Theranostics · 16(4):1833–1854

Can a hydrogel depot extend efsubaglutide alfa’s action further in animal models?

Innogen and Fudan University researchers incorporated efsubaglutide alfa into a biodegradable, temperature-responsive hydrogel. A single subcutaneous injection maintained glucose control for about three weeks in diabetic mice, with improvements in islet function, lipid metabolism and related tissue measures.

These findings come from animal research. Whether this hydrogel formulation could support monthly dosing in people still requires larger-animal and clinical studies.

Preclinical study · mouse model

MASH: examining liver fat and collagen changes

Diabetes, Obesity and Metabolism

How does efsubaglutide alfa affect liver fat, inflammation and fibrosis-related measures in a mouse model of MASH?

A 42-day mouse study used a high-fat diet and carbon tetrachloride to model MASH. Groups received vehicle, obeticholic acid, semaglutide or different efsubaglutide alfa doses. Efsubaglutide alfa improved liver steatosis, liver enzymes and selected collagen-imaging measures.

Sirius Red fibrosis area and scores did not differ significantly between treatment groups; collagen-imaging findings require longer studies.

Mechanistic review

Klotho: research directions from the biology of ageing

Cells · 15(6):507

What does existing research suggest about the links between Klotho, ageing, chronic inflammation and tissue injury?

Gérald J. Prud’homme and Qinghua Wang review links between Klotho and the hallmarks of ageing, including inflammation, mitochondrial function, cellular senescence and injury across organs. They examine pathways including NF-κB and NLRP3 and identify directions for translational research.

The review synthesises existing research and reports no new clinical-trial data. The authors identify a lack of clinical investigation of direct Klotho therapy.

Foundational research · cells and mice

GLP-1/IgG2 fusion: early evidence for longer action

PLOS ONE · 5(9):e12734

Can IgG2 Fc fusion extend GLP-1’s action while retaining receptor activity?

Qinghua Wang and colleagues showed receptor binding and insulin secretion in cells. Mice retained improved glucose tolerance one week after a single injection, providing early experimental support for a long-acting GLP-1 fusion protein.

Published before Innogen’s 2014 founding, this is cell and animal evidence rather than clinical efficacy data for the marketed medicine.

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