First, positive interim analysis results were obtained for the phase 2b clinical trial of up to XW003 (Ecnoglutide) obesity

Hangzhou Xianweida Biotechnology Co.
, Ltd.
, a clinical-stage biotechnology company focused on the research and development of innovative therapies for the treatment of chronic metabolic diseases, today announced the positive interim analysis results
of its ongoing Phase 2b clinical trial of XW003 (Ecnoglutide) obesity.
XW003 is a novel, long-acting glucagon-like peptide-1 (GLP-1) analog in development
for the treatment of type 2 diabetes and obesity.

The ongoing study is a multicenter, open-label, active-controlled Phase 2b clinical trial in subjects
with a body mass index (BMI) of ≥ 30 kg/m2.
The trial was conducted at nine research centres in Australia and New Zealand with a total of 206 participants
.
Participants were randomized to receive a target dose of XW003 (1.
2 mg, 1.
8 mg, or 2.
4 mg once weekly) or liraglutide (Saxenda^®) (3.
0 mg injected once daily) for 26 weeks, with weeks 1 to 14 being a dose-titration escalation phase until the desired target dose
was reached.
An interim analysis
of this trial was performed after approximately 140 participants had completed 18 weeks of treatment.
The mean baseline weight of participants was 99.
6 kg and the BMI was 34.
9 kg/m2
.

After 18 weeks of treatment, subjects who received 2.
4 mg XW003 weekly injections achieved an average weight loss of 11.
1% (10.
9 kg) from baseline, compared to 7.
9% (8.
1 kg) in subjects receiving 3.
0 mg daily injections of liraglutide (P = 0.
009).

。 In the XW003 2.
4 mg dose group, 88.
5% of participants lost ≥5% of their body weight from baseline and 70.
4% in the liraglutide group.
The proportion of XW003 subjects with a weight decrease of ≥ 10% from baseline was 57.
7%, compared with 33.
3%
in the liraglutide group.
Notably, the trend of weight loss in subjects injected with liraglutide began to stabilize after approximately 10 weeks of treatment, while subjects injected with XW003 maintained a sustained trend
of weight loss throughout the 18-week interim analysis period and for the weeks that followed.
In addition to body weight, other measures of efficacy showed good improvement after treatment, including waist circumference, BMI and blood glucose
.

Overall, XW003 was safe, well tolerated, and adverse events (AEs) were similar
to those of other GLP-1 drugs.
During the 18-week dosing period, the proportion of participants reporting any adverse events was similar
in the four trial groups.
The most common adverse events were gastrointestinal adverse effects, including nausea, diarrhoea, constipation and vomiting, and most gastrointestinal adverse events were mild to moderate and occurred briefly during dose escalation
.

"Consistent with our previously announced results, the interim analysis data from this Phase 2b clinical study in obesity further validates the strong efficacy and excellent safety profile of XW003 in the treatment of obesity and other metabolic diseases," said Dr.
Mohammed Junaidi, Vice President of Clinical Research.
It can further increase the effect of
weight loss.
”

"This encouraging research development makes us very much looking forward to initiating a Phase III clinical trial of XW003 for the treatment of obesity and type 2 diabetes in China in the near future and further exploring the global development strategy
of XW003.
" Dr.
Pan Hai, founder and CEO of Xianweida, said, "We will discuss the research data of XW003 with Chinese regulatory authorities, and hope to carry out the pivotal clinical trials
required for registration as soon as possible.
”

The Phase 2b clinical study of obesity is expected to be completed by the end of 2022 and top line results
will be obtained in the first half of 2023.

About XW003

Glucagon-like peptide-1 (GLP-1) receptor agonists have been used clinically to treat type 2 diabetes and obesity and have shown potential for
the treatment of nonalcoholic steatohepatitis (NASH).
XW003 is a novel, biased, long-acting GLP-1 receptor agonist.

XW003 has obtained three clinical approvals in China: type 2 diabetes, weight management, and NASH, of which type 2 diabetes and weight management indications have been rapidly advanced to phase II, and it is expected to enter the pivotal phase III clinical study
by the end of 2022.