Chinese company Menova has successfully developed probiotics that secrete GLP - 1

#1

Recently, a single-center, open, self-controlled human trial sponsored by Ningbo Menohua Tiankang Pharmaceutical Co., Ltd. evaluated the weight loss effect and safety of probiotic (JH389) capsule products.

The results showed that taking the product for 8 weeks could significantly improve the subjects’ weight, body fat and obesity-related indicators, help to comprehensively improve the quality of life, help to positively regulate the structure of intestinal flora, and have no adverse effects on glucose and lipid metabolism and various safety indicators.

Experimental design

project

content

Research title

Study on the effectiveness and safety of probiotic capsule products to help control body fat (without replacing staple foods)

Research Design

Single-center, open, self-controlled human trial

test cycle

8 weeks

sample size

28 cases were enrolled and 28 cases were completed, with a dropout rate of 0%.

intervention measures

Take 2 capsules (250mg/capsule) once a day for 8 weeks

study population

People with simple obesity, adult BMI ≥ 28, or total fat percentage > 25% in men and > 30% in women

Main research indicators

body weight, total body fat, fat proportion, subcutaneous fat thickness, body mass index (BMI), super-severe, blood sugar-related indicators, four blood lipids, quality of life survey scale (SF-36), fecal intestinal flora 16SrDNA detection, etc

test result

  1. Core results

After taking the probiotic capsules for 8 weeks, the subjects’ weight level was significantly reduced, body fat was significantly reduced, subcutaneous fat thickness was significantly reduced, and BMI improved simultaneously with super-heavy. Core data include:

The average weight loss was 2.5kg (77.2 ± 15.16kg → 74.8 ± 14.77kg), the degree of improvement was 3.20%, p

The average fat loss was 2.2kg (31.2 ± 8.52kg → 29.0 ± 8.15kg), the degree of improvement was 7.07%, p

The thickness of subcutaneous fat was reduced by 3.9mm (30.6 ± 4.95mm → 26.6 ± 4.02mm) on average, and the improvement degree was 12.86%, p

The proportion of fat decreased by an average of 1.7% (40.2 ± 6.16% → 38.5 ± 6.33%), and the degree of improvement was 4.19%, p

The average BMI decreased by 0.9 kg/m ² (29.2 ± 4.50kg/m ² → 28.2 ± 4.31kg/m ²), and the improvement degree was 3.22%, p

The average overseverity was reduced by 2.5% (21.1 ± 11.98% → 18.6 ± 11.49%), and the degree of improvement was 11.72%, p

  1. Results analysis

Overweight people (BMI 24-28) had better results (4.26% weight loss):

According to the clinical results, baseline BMI was more favorable for weight loss: mean weight loss of 2.64kg, weight loss ratio of 4.26% (higher than 3.20% of the overall subjects), of which 75% (6/8) of the subjects lost more than 2% and 37.5% (3/8) of the subjects lost more than 5%.

Transformation of gut microbiota to “metabolically friendly”:

16SrDNA testing revealed that after the intervention:

Bacteroides: (4.97% → 9.09%, p

Segatella: 5.95% → 10.41%, showing an upward trend - this bacteria is involved in the degradation of dietary fiber and polysaccharides

Megamonas: 3.39% → 8.77% on the rise - this species ferments complex carbohydrates to produce short URL fatty acids

Blautia: 12.41% → 8.74%, showing a downward trend - the abundance of this bacteria is positively correlated with energy absorption

The proportion of three “metabolically friendly” bacteria (Segatella, Bacteroides, Megamonas) doubled from 14.31% in the group to 28.27% in the group. The abundance of the flora associated with energy overabsorption (Blautia) decreased significantly.

  1. Safety and quality of life

Good security:

There were no adverse reactions related to the product in the whole clinical trial of 28 subjects. Fasting blood glucose, insulin, and blood lipids (triglycerides, total cholesterol, etc.) were maintained in the normal range throughout the trial period, and there was no fluctuation of clinical significance. There were no abnormalities in blood routine, liver and kidney function, and urine routine. This fully proves that probiotic capsules have good safety performance under the current study design.

Overall improvement in quality of life:

The 28 subjects also showed significant improvement in their living conditions within 8 weeks of the clinical trial. The results of the SF-36 Quality of Life Scale (an internationally accepted health-related quality of life questionnaire) showed that:

Vitality: 69.8 → 82.1 points, with an average increase of 12.3 points (p = 0.0004) - significantly improved energy

Mental health: 74.0 → 82.3, with an average improvement of 8.3 points (p = 0.0404) - improved emotional state

Somatic pain: 70.0 → 75.4 points, average improvement of 5.4 points (p = 0.0371) - pain distress reduced

Clinical results suggest that improved gut microbiota not only affects body weight, but may also affect mental status and quality of life through the “gut-brain axis.”

About JH389

The company and the University of Michigan (“University of Michigan”) signed a “Strategic Service Agreement Of GLP-1 Delivery System” on April 12, 2024 to cooperate in the development of a new delivery system for glucagon-like peptide-1 (GLP-1) related targets.

#2

Introduction to the JH389 Project

1. Market Background

  • According to the 2025 World Obesity Report, the global trend of overweight is intensifying. By 2030, it is estimated that 50% of adults will have a high BMI (BMI ≥ 25, exceeding 2.9 billion people), among whom approximately 1.1 billion will be obese (BMI ≥ 30).
  • Middle- and high-income groups are the main population with high BMI: in 2015, there were 1.38 billion middle- and high-income people with high BMI, and this number is expected to reach 1.88 billion by 2030.
    (Source: 2025 World Obesity Report)

2. Product Positioning

JH389 is positioned as a safe and effective non-pharmaceutical GLP-1 product, which can be categorized as a dietary supplement, health product, functional food, or novel food. Its target groups include:

  • Patients who experience weight rebound after discontinuing GLP-1 drugs;
  • Overweight individuals who are reluctant to take injections or oral medications;
  • Early adopters interested in weight loss products.

This “health-anxious population” has a large global base and strong willingness to pay. Key advantages of the non-pharmaceutical positioning include:

  • Greater flexibility in pricing and distribution channels;
  • Differentiated competition with traditional pharmaceutical companies;
  • Complementarity with pharmaceutical products to cover most consumer needs.

3. R&D Progress

  • Mouse studies have shown that the product’s blood concentration levels are comparable to those of mainstream GLP-1 analogs;
  • Preliminary small-scale human feedback indicates favorable weight loss effects and good tolerance;
  • In June 2025, positive data were obtained from a high-fat diet (HFD) animal model, and the results were presented at CHINAGUT;
  • In the same year, a cooperation agreement was reached with a leading Italian probiotic company to conduct product registration, formula optimization, and necessary research activities (sales regions are limited to Italy, San Marino, and Vatican City). The product’s efficacy has been recognized by the partner; the trial is currently in the final stage, and complete materials will be submitted to the European Food Safety Authority (EFSA) once prepared;
  • A small-scale 8-week human food trial has been conducted in China.

4. Human Food Trial

【JH389 Trial Design】

  • Study Title: A Study on the Efficacy and Safety of Probiotic Capsules in Aiding Body Fat Control (Without Replacing Staple Foods)
  • Study Design: Single-center, open-label, self-controlled human food trial
  • Trial Duration: 8 weeks
  • Sample Size: 28 subjects were enrolled, 28 completed the trial, with a dropout rate of 0%.
  • Intervention: 2 capsules (250mg per capsule) taken once daily for 8 consecutive weeks.
  • Study Population: Adults with simple obesity, defined as BMI ≥ 28, or total body fat percentage ≥ 25% for males and ≥ 30% for females.
  • Primary Outcome Measures: Body weight, total body fat, body fat percentage, subcutaneous fat thickness, body mass index (BMI), degree of overweight, blood glucose-related indicators, four lipid profiles, SF-36 Quality of Life Scale, 16S rDNA detection of fecal intestinal flora, etc.

【Trial Results】Core Findings

After 8 weeks of taking the probiotic capsules, subjects showed significant reductions in body weight, body fat, and subcutaneous fat thickness, with simultaneous improvements in BMI and degree of overweight. Key data are as follows:

  • Average weight loss: 2.5kg (from 77.2±15.16kg to 74.8±14.77kg), improvement rate: 3.20%, p<0.0001;
  • Average fat loss: 2.2kg (from 31.2±8.52kg to 29.0±8.15kg), improvement rate: 7.07%, p<0.0001;
  • Average reduction in subcutaneous fat thickness: 3.9mm (from 30.6±4.95mm to 26.6±4.02mm), improvement rate: 12.86%, p<0.0001;
  • Average decrease in body fat percentage: 1.7% (from 40.2±6.16% to 38.5±6.33%), improvement rate: 4.19%, p<0.0001;
  • Average decrease in BMI: 0.9 kg/m² (from 29.2±4.50kg/m² to 28.2±4.31kg/m²), improvement rate: 3.22%, p<0.0001;
  • Average reduction in degree of overweight: 2.5% (from 21.1±11.98% to 18.6±11.49%), improvement rate: 11.72%, p<0.0001.

【Trial Results】Result Analysis

  • Better efficacy in overweight 人群 (BMI 24~28): According to clinical results, subjects with baseline BMI < 28 (8 people, accounting for 28.6%) showed superior weight loss effects: average weight loss of 2.64kg (improvement rate: 4.26%, higher than the 3.20% of all subjects). Among them, 75% (6/8) of subjects lost >2% of their body weight, and 37.5% (3/8) lost >5%.
  • Shift of intestinal flora to “metabolically friendly”: 16S rDNA detection showed the following changes after intervention:
    • Bacteroides: Significantly increased from 4.97% to 9.09% (p<0.05) — this genus degrades polysaccharides and mucins, and participates in the production of short-chain fatty acids (SCFAs) and secondary bile acids;
    • Segatella: Increased from 5.95% to 10.41% — this genus is involved in the degradation of dietary fiber and polysaccharides;
    • Megamonas: Increased from 3.39% to 8.77% — this genus ferments complex carbohydrates to produce SCFAs;
    • Blautia: Decreased from 12.41% to 8.74% — the abundance of this genus is positively correlated with energy absorption.

The total proportion of the three “metabolically friendly” genera (Segatella, Bacteroides, Megamonas) doubled from 14.31% at enrollment to 28.27% at the end of the trial, while the abundance of Blautia (a genus associated with excessive energy absorption) decreased significantly.

【Trial Results】Safety and Quality of Life

  • Good safety profile: No product-related adverse reactions were reported in any of the 28 subjects throughout the clinical trial. Fasting blood glucose, insulin, and four lipid profiles (triglycerides, total cholesterol, etc.) remained within the normal range during the entire trial period, with no clinically significant fluctuations. Routine blood tests, liver/kidney function tests, and urine routine tests all showed no abnormalities. These results fully confirm the good safety of the probiotic capsules under the current study design.
  • Comprehensive improvement in quality of life: During the 8-week clinical trial, the 28 subjects also showed significant improvements in their living conditions. Results from the SF-36 Quality of Life Scale (an internationally recognized health-related quality of life questionnaire) indicated:
    • Vitality: Increased from 69.8 to 82.1 points (average increase: 12.3 points, p=0.0004) — significant improvement in energy levels;
    • Mental Health: Increased from 74.0 to 82.3 points (average increase: 8.3 points, p=0.0404) — improved emotional state;
    • Bodily Pain: Increased from 70.0 to 75.4 points (average increase: 5.4 points, p=0.0371) — reduced pain distress.

Clinical results suggest that improvements in intestinal flora not only affect body weight but may also influence mental state and quality of life through the “gut-brain axis.”

5. Commercialization

  • Non-pharmaceutical attribute: As a health product/food, it can be sold in pharmacies, supermarkets, and online channels. For the European market, approval from the EFSA is required (jointly promoted with the Italian partner); for the U.S. market, GRAS (Generally Recognized as Safe) certification is needed.
  • Business model: Dual-track approach of B2C and B2B (building its own brand + collaborating with platforms/local partners). Contacts have been established with Google, Amazon, TikTok, Alibaba International, etc.
  • Product flexibility: The formula can be integrated into other products as needed.
  • Pricing strategy: Referencing the price of GLP-1 drugs, with adjustments based on local purchasing power to maintain competitiveness.

6. Future Plans

  • Consider dose-escalation trials after the completion of human safety trials in Europe;
  • Conduct larger-scale clinical trials if necessary;
  • Expand global patent 布局: European patents have been filed, with plans to expand applications this year.
#3

Q&A on JH389 Project

Q: What procedures must be completed for JH389 to launch on the market?

A: To launch in Europe and the United States, relevant certifications are required: approval from the European Food Safety Authority (EFSA) for the European market, and Generally Recognized as Safe (GRAS) certification for the U.S. market. Currently, safety trials are being jointly advanced with the Italian partner and have entered the final stage. We are awaiting the completion of the trials to compile a comprehensive safety report, which will then be used for registration processes in regions including Europe and the United States.

Q: What is JH389’s subsequent commercialization strategy?

A: JH389 is positioned as a safe, effective, and long-term administrable non-pharmaceutical product, adopting a strategy of differentiated competition and complementary advantages. Pharmaceutical products typically compete fiercely on efficacy; however, our analysis shows that the non-pharmaceutical positioning allows JH389 to cover a broader population, including:

  • Patients who experience weight rebound after discontinuing GLP-1 drugs (or those who need long-term, intermittent administration to maintain effects post-discontinuation);
  • Overweight individuals who fear injections or oral medications;
  • Early adopters interested in weight loss products.

This “health-anxious population” has a huge global scale (a significant portion does not even fall into the conventionally recognized overweight group) and strong willingness to pay. Meanwhile, the non-pharmaceutical route provides greater flexibility in pricing and distribution channels. The product can also be combined with other ingredients/products to form various product combinations, enabling faster access to target consumers.

Based on the above strategy, we plan to pursue a dual-track approach of B2C (building our own brand) and B2B (collaborating with platforms/local partners). Contacts have been established with Google, Amazon, TikTok, Alibaba International, and other parties. We aim to achieve differentiated competition with traditional pharmaceutical companies, complement existing products, expand the market size, capture non-pharmaceutical market share, and build a brand effect.

Q: How to maintain the first-mover advantage?

A: We will first adopt differentiated cooperation strategies in different markets and conduct multi-dimensional market penetration with local partners to maximize product exposure and market share. Subsequently, we will maintain and even expand the first-mover advantage through a comprehensive set of strategies, including:

  • Ongoing patent layout (European patents have been filed, with plans to expand to a global scale this year);
  • Launch of new products (different efficacy based on the same technology platform);
  • Product iteration (for the same efficacy);
  • Optimization of channel selection;
  • In-depth collaboration with high-quality partners.

Q: Did a plateau period occur after the 8-week trial? What about the effects of continuous administration?

A: Currently, we cannot answer questions about the situation beyond 8 weeks, as this trial only lasted 8 weeks and no larger-scale, longer-duration trials have been conducted yet. During this trial, we observed an acceleration in weight loss efficiency between Days 0–28 and Days 28–56. Since we did not adjust the dosage, no plateau period occurred within the 8-week timeframe.

Probiotics work similarly to a sustained-release mechanism: after administration, they continuously secrete the target peptide until excreted from the body. Therefore, there will be no significant subjective sensory changes caused by rapid increases or sharp drops in concentration. Even if occasional missed doses occur during continuous administration, the overall effect will not be significantly affected.

Q: What is JH389’s pricing plan? What about cooperation models in regions other than Italy? Will the subsequent cooperation model involve the company providing APIs while partners handle sales?

A: The expected overseas pricing of JH389 will reference the prices of GLP-1 drugs, with specific pricing strategies varying based on the final product form and target market. JH389 can be added to other products as needed to form a daily nutritional combination formula, which increases the overall product value-added—thus enabling highly flexible pricing strategies.

The cooperation model is also flexible. Given our overall dual-track (B2C + B2B) approach, we will develop cooperation plans and promote products based on the strengths of local partners in different regions. Cooperation models will be determined on a case-by-case basis for each region.

Q: JH389 is not a pharmaceutical product—why conduct clinical trials? What about subsequent dosage selection?

A: First, it is true that we could skip any efficacy-related clinical trials, as they are not mandatory for market launch. For non-pharmaceutical products, the approval standards in Europe and the United States focus on safety rather than efficacy. However, we have our own principles: we hope to demonstrate Menova’s rigorous and responsible approach, as well as the potential of the JH389 project, to partners, investors, and consumers through these trials. Of course, these trial data will also serve as important support for JH389’s commercial promotion in the future.

Currently, dosage studies are being conducted in Europe, with a primary focus on safety. The current dosage was designed based on multiple safety assessments and experimental measurements, with reference to the administration standards of low-dose oral GLP-1 analogs. The efficacy has met and slightly exceeded expectations. After the completion of human safety trials in Europe, we will consider conducting dose-escalation trials. Higher doses showed corresponding benefits in animal experiments, so there is potential to achieve greater benefits by increasing the dosage—but this requires verification through relevant trials.

#4

Well over 90% of studies there fake their data dude

#5

Genetically modifying probiotics is not a difficult task.