DT-20250717-078: A Best-in-Class Oral Small Molecule GLP-1 Receptor Agonist for Type 2 Diabetes and Obesity

2025Year8Month7Recently, Eli Lilly and Company released its Q2 financial report that exceeded expectations and raised its full-year performance guidance. Its core productsTirzepatideExpected to top this year“Medicine King”Throne. However, the market reaction was unexpected: Eli Lilly's stock price plummeted on the same day.14%, with a market value loss of approximately1000billion dollars. This dramatic fluctuation stems from its oral drug under research.GLP-1RSmall Molecule AgonistOrforglipronTheIIIPhase Clinical Data No Match for Semaglutide——Despite the lack of direct head-to-head data, the efficacy gap has been sufficient to raise concerns among investors.This "good performance, sharp drop in stock price" abnormal phenomenon precisely highlights the capital market's concerns about oralGLP-1The market potential of weight-loss drugs is highly anticipated.

With the advantages of convenient administration, low production cost, and wide applicability, OralGLP-1Oral weight-loss drugs have significant commercial value and are expected to cover a vast market that injectables struggle to penetrate, becoming the mainstream choice for metabolic disease treatment in the next phase.

Against this background,Many Chinese innovative pharmaceutical companies are actively deploying oral small molecules.GLP-1Track, and has reached several major licensing deals:

• 2023Year11Month,Eccogene's Oral Small MoleculeGLP-1Receptor AgonistECC5004InUp to20.1Billion US dollarsThe total potential deal value was authorized to AstraZeneca.This product is based on Eli LillyOrforglipronOptimized from the molecular structure, significantly improving oral bioavailability, intended for the treatment of obesity,2Type 2 Diabetes Mellitus and Related Comorbidities.

  
  

• Hansoh Pharma has also made rapid progress with its self-developed oralGLP-1Receptor AgonistHS10535Yu2024Authorized Merck by the end of the year, obtained1.12Hundreds of millions of dollars in upfront payments, future milestone paymentsUp to19Billion US dollars`, highlighting the recognition from international pharmaceutical companies of China's innovative drug R&D capabilities.`

Recently,Chinese companies in oralGLP-1A series of key advancements have also emerged in the field:

• 2025Year7Month15Date, Hengrui Pharma'sGLP-1/GIPDual-Target Receptor AgonistHRS9531Phase III clinical trials were successful, and a new drug application has been submitted (NDA), officially moving towards the commercialization phase. At the same time, Hengrui Pharma is actively expanding into oral small molecules.GLP-1Track, itsSelf-developedHRS-7535Successfully avoided Pfizer's similar drugsdanuglipronPreviously Reported Risk of Hepatotoxicity, which is accelerating the competitive landscape of the global weight-loss drug market.

  
  

• In the same year7Month22Huadong Medicine's wholly-owned subsidiary, Zhongmei Huadong, announced that its self-developed oral small moleculeGLP-1Full AgonistHDM1002Officially Obtain U.S.FDAClinical trial approval for weight management in overweight or obese populations. ChinaIPeriod andIIPhase clinical trial data shows that exceeding800Among the subjects,100mgThe above dose group28Average Weight Loss of Celestial Bodies4.9%~6.8%, and has good safety and tolerability.

  
  

• Following closely, Innovent Biologics' innovative oral small moleculeGLP-1RAgonistIBI3032Yu8Month5Japan Obtains USFDATheINDApproved. The drug achieves highly efficient and specific activation throughGLP-1Receptor, triggering a cascade of signal transduction, therebyDelay gastric emptying, suppress appetite, and promote insulin secretion, thereby effectively treating obesity,2Type 2 diabetes and other metabolic diseases.

In addition, several companies such as Regor Pharma, DRR Intelligence Pharmaceutical, Haisco, Salubris, and Ascletis are also actively deploying in this field, with related products at various clinical stages.

With the global obesity and2The incidence of metabolic diseases such as type 2 diabetes continues to rise.GLP-1Receptor agonists are undergoing an iterative upgrade from injectable to oral formulations. The combination of convenience and efficacy is driving this field towards broader development opportunities, and the growth potential of the Chinese market is promising.

Currently, PharmaTimesBDThe team is working on an oral small molecule with best-in-class weight loss and appetite suppression effects.GLP-1Receptor Agonist Project Seeks Potential Partners.

If your company is interested in this project, please feel free to contact the PharmTimes BD team immediately!

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