CMS Signs License Agreement of the Product PLENITY and a Stock Purchase Agreement with Gelesis
2020-06-18 20:47

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¨C40 kg/m?, 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¨C40 kg/m?) 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.