CMS through
its wholly-owned subsidiary signed a License,
Collaboration and Supply Agreement (the “License Agreement”) with
Gelesis Inc. (“Gelesis”) for its product PLENITY® (Gelesis100) (the “Product”) on 18 June 2020. In accordance with the License Agreement, the Group through its
wholly-owned subsidiary
will gain an exclusive license under Gelesis intellectual property and applicable regulatory approvals to
develop, import, register, make and have made, manufacture and commercialise
the Product in Mainland China, Hong Kong Special Administrative Region, Macao
Special Administrative Region, Taiwan, Singapore and the United Arab Emirates (the
“Territory”). The term of the License Agreement is 20 years from the
date of signing. Upon the expiration of the aforementioned term, the License
Agreement may be renewable for every single period of three years thereafter as
per certain conditions defined in it. At the same time, the Group through its
wholly-owned subsidiary signed a Stock Purchase Agreement with Gelesis to
invest in its equity.
Through
this collaboration, the Group’s product portfolio will be further enriched and
extended upon occurrence of the perspective commercialisation of the Product in
the Territory.
About the Product
PLENITY® (Class II Medical
Device cleared by the U.S. Food and Drug Administration (FDA))
PLENITY®,
the first product based on Gelesis’ proprietary hydrogel technology platform,
is an orally-administered, non-systemic and non-stimulant aid for weight
management. It is administered in the form of capsules taken with water before
lunch and dinner. The capsules release thousands of particles that rapidly
absorb water in the stomach, creating small individual gel pieces with the
elasticity and firmness of plant-based foods (e.g., vegetables) without caloric
value. The gel contributes to a feeling of fullness and induces satiety, which
can help with weight loss. This novel treatment has been shown in clinical
studies to be effective and well-tolerated. PLENITY® was cleared by
the U.S. FDA as an aid for weight management in adults with a Body Mass Index
(BMI) of 25–40 kg/m2, when used in conjunction with diet and exercise. PLENITY® also received a CE mark, which allows Gelesis to market it
in European Economic Area.
Based on data from a 6-month, randomized,
double-blind, placebo-controlled pivotal clinical trial, PLENITY® was cleared by the
U.S.
FDA in 2019. The trial was
conducted
on 436
patients with overweight or obesity (BMI of 27–40 kg/m2) with at least one comorbidity. Nearly 60% patients treated
with PLENITY® achieved at least 5% weight loss (an average of 10%
weight loss, or 10kg) and 26% achieved at least 10% (an average of 14% weight loss, or 13kg) after
6 months of treatment. Meanwhile, PLENITY® demonstrated
a highly favorable safety profile: no difference in overall incidence of adverse events
(AEs) compared
with placebo; the most common AEs were gastrointestinal AEs and 95% of AEs
were mild or moderate in intensity.
China
has one of the world’s biggest population of obese adults.
Statistics show that in 2015,
overweight and
obesity accounted for 23% and 5% of adult population respectively.
Currently, the commonly used weight loss and weight
maintenance drugs have different degrees of adverse reactions; whilst, other
products in the healthcare market have not been fully validated by
evidence-based medicine in terms of effectiveness and safety. Generally, there
is significant unmet need in the market; the introduction of PLENITY® would meet the market demand and provide patients with effective and safe
treatment option.
PLENITY®’s core patents (namely formulation/use and preparation method patents) have been granted in Mainland China and are valid up to the year of 2032. Additional several patent
applications in Mainland China are in
different stages of prosecution.
About Gelesis
Gelesis is developing a novel
hydrogel platform technology to treat overweight, obesity, and chronic diseases
related to the GI pathway. Gelesis’ proprietary approach is designed to act
mechanically in the GI pathway to potentially alter the course of certain
chronic diseases. In April 2019, Gelesis received the U.S. FDA clearance for
its lead product candidate, PLENITY®, as an aid for weight management in overweight and obese
adults with a Body Mass Index (BMI) of 25-40 kg/m2, when used in
conjunction with diet and exercise. PLENITY® was also granted a CE mark, which
allows Gelesis to market it in the European Economic Area. Additionally, Gelesis is developing its second
investigational candidate, Gelesis200, a hydrogel optimized for glycemic
control in patients with type 2 diabetes and prediabetes. Novel hydrogel mechanotherapeutics
based on the Gelesis platform technology are also being advanced in other GI
inflammatory conditions, such as non-alcoholic steatohepatitis (NASH) and
Chronic Idiopathic Constipation (CIC). For more information
about Gelesis, please visit gelesis.com.