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On October 1, 2024, Kailera Therapeutics officially announced its establishment. The CEO is Ron Renaud, who previously led CNS leader Cerevel Therapeutics and was acquired by AbbVie for $8.7 billion; he later joined Bain Capital as a senior advisor. He has served as CEO for several biotech companies that were acquired.
HRS9531, licensed by Hengrui Medicine, will be renamed KAI-9531 overseas, with similar changes for other products. Additionally, former Gilead Sciences CEO John Milligan, Ph.D., will serve as the chairman of the board for the new company Kailera.
On May 16, 2024, Hengrui Medicine licensed its GLP-1 product portfolio, which has independent intellectual property rights, to a startup then known as Hercules CM Newco, Inc. (hereinafter referred to as "American Hercules"). American Hercules will obtain exclusive rights to develop, produce, and commercialize the GLP-1 product portfolio globally, except in Greater China.
As part of the licensing deal, Hengrui acquired a 19.9% stake in American Hercules and will receive licensing fees for the GLP-1 product portfolio from the company. The terms of this licensing transaction include a $100 million upfront payment and a $10 million milestone payment after technology transfer; $200 million in development and regulatory milestones; cumulative sales milestones of up to $5.725 billion; totaling approximately $6 billion. Additionally, there will be sales commissions based on actual annual net sales in low single digits to low double-digit percentages.
Hercules CM Newco, Inc. was established in Delaware, USA, in May 2024. The shareholders include Bain Capital Life Sciences, RTW Capital, Atlas, and Lyra Capital, which jointly invested $400 million. A joint management committee was established by Hengrui and American Hercules to coordinate the development and commercialization of licensed products globally, with both parties appointing three representatives to the committee.
The pipeline of American Hercules includes candidate new drugs from the GLP-1 product portfolio:
HRS-7535 Tablets are a novel oral small-molecule glucagon-like peptide-1 receptor (GLP-1R) agonist that promotes insulin secretion and reduces glucagon secretion by activating human GLP-1R, while also enhancing satiety and suppressing appetite through central effects, thereby reducing energy intake. It is intended for the treatment of type 2 diabetes (T2DM) and weight loss. There are currently no oral small-molecule GLP-1R agonists available worldwide. This molecule is expected to hold significant value in the pipeline.
HRS9531 Injection is a dual agonist targeting gastric inhibitory polypeptide receptors (GIPR) and GLP-1 receptors (GLP-1R), developed in-house, that synergistically promotes insulin secretion, suppresses energy intake, and improves insulin sensitivity. By activating GIPR, it effectively accelerates lipid metabolism and reduces gastrointestinal side effects caused by GLP-1, aimed at treating T2DM and aiding weight loss. The GIPR and GLP-1R target drug tirzepatide, marketed as Mounjaro, was approved in the U.S. in May 2022 for treating T2DM. Additionally, two Phase III clinical trials of tirzepatide in obese patients have been successful and have received FDA fast track designation. HRS9531 tablets, featuring HRS9531 as the main active ingredient, represent a novel oral GIPR and GLP-1R dual agonist with global independent intellectual property rights. This formulation enhances the gastrointestinal absorption of HRS9531 for treating T2DM and weight loss. There are currently no comparable oral products available worldwide, making HRS9531 expected to be the most valuable molecule in the pipeline.
HRS-4729 Injection is a next-generation incretin-based product developed in-house, designed to activate multiple targets to protect the pancreas while enhancing insulin secretion and controlling blood glucose levels. It is anticipated to achieve better weight loss effects and treat metabolic dysfunction-related diseases, and it is currently in the preclinical development stage. There are no comparable products available globally.
Hengrui Medicine has invested nearly 40 billion yuan in R&D to date, having launched 16 innovative drugs and 4 Class II new drugs in China, with over 90 self-innovated products currently in clinical development and nearly 300 clinical trials underway both domestically and internationally. In addition to focusing on its traditional strengths in oncology, the company is actively expanding into key chronic disease areas such as autoimmune diseases and metabolic diseases.
In the field of metabolic diseases, after years of accumulation and planning, the company has more than ten products in development. Among them, two Class I innovative antidiabetic drugs, Hengrui Gliclazide and Regaglitin, along with the antidiabetic combination drug Hengrui Gliclazide Metformin Sustained Release Tablets (I)(II), have been approved for launch in China. Two applications for combination diabetes formulations have also been accepted. In addition to focusing on the popular GLP-1 pathway in antidiabetic/weight loss research, the company has also made investments in biopharmaceutical areas such as insulin and insulin/GLP-1 combination formulations.
Data source
[1] https://www.kailera.com/
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