Adocia’s Partner Tonghua Dongbao Receives Clearance to Start Ultra-Rapid Insulin BioChaperone® Lispro Phase 3 Trial to Treat Type 1 and Type 2 Diabetes in China

• This Phase 3 clinical program will enroll over 1,300 people with diabetes and is expected to be pivotal for product registration in China
• First patient in the study will trigger a milestone payment to Adocia
• BC Lispro addresses the Chinese prandial insulin market which is approx. $1.4bn today with double-digit growth

LYON, France--(BUSINESS WIRE)--Regulatory News:

Adocia (Euronext Paris: FR0011184241 – ADOC), a clinical stage biopharmaceutical company focused on diabetes treatments and other metabolic diseases with innovative formulations of proteins and peptides, announced today that its partner Tonghua Dongbao Pharmaceutical Co. Ltd. (Shanghai:600867) received clearance from the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) to conduct the Phase 3 clinical trial of BioChaperone^® Lispro, an Ultra-Rapid Insulin for the treatment of Type 1 and Type 2 diabetes. The first patient enrolled in the program will trigger a milestone payment to Adocia.

“We are delighted to enter into the Phase 3 program for one of the two products licensed to Tonghua Dongbao, the domestic insulin leader in China. ”, commented Gerard Soula, President & CEO of Adocia.

Adocia out-licensed BC Lispro^® to Tonghua Dongbao who is responsible for clinical development, manufacturing, product registration and future commercial operations in China and other Asian territories. The total amount perceived for this agreement could reach $45m (including $10m upfront payment) and double-digit royalties on sales. In parallel, Adocia is looking for other commercial partners in the US and in Europe for BC Lispro^®.

Dr. Chunsheng Leng, CEO of Tonghua Dongbao said, “This is an exciting time for us. Based on the strong positive Phase 1 clinical trial results in Europe, delivered by our partner Adocia, we have been able to apply for and now receive CDE clearance to initiate this Phase 3 program. These studies will be run in parallel with the ongoing Phase 1 trial and will greatly shorten our clinical study time. We hope that BC Lispro, this new generation insulin product, will bring a great value for people with diabetes in China, plus the rest of the world.”

Previous BC Lispro clinical studies demonstrated improved glycemic control compared to Humalog^® (Eli Lilly and Company) characterized by less hyperglycemia and hypoglycemia in meal tests. Hyperglycemia and hypoglycemia are responsible for long-term complications associated with diabetes. BC Lispro has demonstrated good tolerance similar to the standard of care, Humalog and Novolog^®. The primary objective of the Phase 3 program is to demonstrate the non-inferiority of BC Lispro on HbA1c reduction from baseline vs. Humalog ; the secondary objective is superiority of BC Lispro on post-prandial glycemic control.

“I would like to warmly thank our partner Tonghua Dongbao for this fruitful collaboration, leading BC Lispro - the next generation insulin product - to Chinese people with diabetes which represent 1 in 4 in the World.” said Olivier Soula, Deputy CEO of Adocia, “This is a great milestone for Adocia, proving our abilities to develop our products through latest stages together with partners and paving the way to bring this product worldwide.”

In China, the prandial market represents $1.4bn. The fast-acting insulin market segment is the fastest growing with 16% YoY in 2019 (iQVia, May 2021).

About BioChaperone^® Lispro

BioChaperone^® Lispro (BC Lispro) is an ultra-rapid prandial insulin containing insulin lispro and Adocia’s proprietary technology BioChaperone^®. The BioChaperone^® excipient ensures a faster absorption of insulin. BC Lispro has demonstrated a faster action profile and improved performance compared to insulin analog lispro (Humalog^®, Eli Lilly) and insulin analog aspart (Novolog^®, Novo Nordisk), in nine Phase 1 & 2 studies in people with type 1 and type 2 diabetes, administered either by syringes or insulin pumps.

In a study using insulin pumps, BioChaperone Lispro showed a significantly faster-off effect compared to the Novo Nordisk Ultra-Rapid Insulin Fiasp® and similar ultra-rapid onset of action.

For more information on BC Lispro, visit our website: https://www.adocia.com/products/biochaperone-ultra-fast-analog-insulin/

About Adocia & Tonghua Dongbao partnership

Adocia’s partner Tonghua Dongbao is one of leading insulin providers in Asia. Being a domestic player in diabetes innovation, Tonghua Dongbao is well positioned in the Ultra-Rapid Insulin market. Over one in four diabetic patients in the world is in China.

In 2018, Adocia and partner Tonghua Dongbao signed a strategic alliance to develop and commercialize BC Lispro in China and other Asian territories. Tonghua Dongbao also supplies insulin lispro and insulin glargine to Adocia for the worldwide market, except China. This supply allows Adocia to progress its own BC Lispro and BC Combo programs and expand its partnership opportunities. Adocia retains development rights for BC Lispro in many territories such as (but not limited to) : the USA, Europe, Japan and Latin America. BC Lispro is ready for out-licensing in these territories.

About Adocia

Adocia is a clinical-stage biotechnology company that specializes in the development of innovative formulations of therapeutic proteins and peptides for the treatment of diabetes and metabolic diseases. In the diabetes field, Adocia’s portfolio of injectable treatments is among the largest and most differentiated of the industry, featuring six clinical-stage products and several pre-clinical products. The proprietary BioChaperone^® technological platform is designed to enhance the effectiveness and/or safety of therapeutic proteins while making them easier for patients to use. Adocia customizes BioChaperone^® to each protein for a given application.

Adocia’s clinical pipeline includes five novel insulin formulations for the treatment of diabetes: two ultra-rapid formulations of insulin analog lispro (BioChaperone^® Lispro U100 and U200), a combination of basal insulin glargine and rapid acting insulin lispro (BioChaperone^® Combo) and two combinations of a prandial insulin with amylin analog pramlintide (M1Pram and BioChaperone^® LisPram). The clinical pipeline also includes an aqueous formulation of human glucagon (BioChaperone^® Glucagon) for the treatment of hypoglycemia.

Adocia preclinical pipeline includes bi-hormonal combinations for diabetes treatment: a combination of rapid acting insulin analogs and pramlintide (BioChaperone^® AsPram), a combination of insulin glargine with GLP-1 receptor agonists (BioChaperone^® Glargine Liraglutide). In addition, there are two bi-hormonal products for the treatment of obesity: a combination of glucagon and exenatide (BioChaperone^® GluExe) and a combination of pramlintide and exenatide (PramExe).

Adocia recently added a preclinical program to its pipeline with a cell therapy initiative focused on the development of a hydrogel scaffold for use in people with type 1 diabetes. The first patent application supporting this program has been filed.

Disclaimer

This press release contains certain forward-looking statements concerning Adocia and its business. Such forward-looking statements are based on assumptions that Adocia considers as being reasonable. However, there can be no guarantee that the estimates contained in such forward-looking statements will be achieved, as such estimates are subject to numerous risks including those which are set forth in the “Risk Factors” section of the Universal Registration Document that was filed with the French Autorité des marchés financiers on April 20, 2021 (a copy of which is available at www.adocia.com), in particular uncertainties that are linked to research and development, future clinical data, analyses, and the evolution of the economic context, the financial markets and the markets in which Adocia operates.

The forward-looking statements contained in this press release are also subject to risks not yet known to Adocia or not considered as material by Adocia as of this day. The occurrence of all or part of such risks could cause that actual results, financial conditions, performances, or achievements of Adocia be materially different from those mentioned in the forward-looking statements.

This press release and the information contained herein do not constitute an offer to sell or the solicitation of an offer to buy Adocia’s shares in any jurisdiction.

Adocia
Gérard Soula
CEO
contactinvestisseurs@adocia.com
Ph: +33 4 72 610 610
www.adocia.com

MC Services AG
Adocia Press Relations Europe
Raimund Gabriel
Managing Partner
adocia@mc-services.eu
Ph: +49 89 210 228 0

The Ruth Group
Adocia Investor Relations USA
Brett Mermelstein
Senior Account Executive
bmermelstein@theruthgroup.com
Ph.: +1 267 639 0721