Lilly's Novel Oral Small Molecule Orforglipron Receives CDE Acceptance for Six Clinical Trials in China

Sep 08, 2025 08:40 CST Updated 08:40

Eli Lilly

Global Pharmaceutical R&D and Production Company

September 5, 2025, Eli Lilly and Company（LLY.US) underSix Clinical Trials of Orforglipron Tablets, an Oral Small Molecule GLP-1 Receptor Agonist, Officially Accepted. Meanwhile, on August 26, 2025,Orforglipron TabletsIn the Phase III clinical trial ATTAIN-2, the primary endpoint and all key secondary endpoints were achieved, not only resulting in significant weight loss and reduction in glycated hemoglobin A1C, but also improving cardiovascular risk factors, with safety consistent with injectable GLP-1RA drugs.

It is reported that,Orforglipron®AsThe first orally administered small-molecule GLP-1 receptor agonist to successfully complete Phase III clinical trials,No food or water restrictions are required when taking the medication.Not only excels in blood sugar control and weight loss, but also demonstrates good safety and tolerability.At the same time, Eli Lilly and Company plans to submit Orforglipron by the end of 2025.®For "weight management" applications, it is expected to submit for "treatment of type 2 diabetes" applications in 2026. However,Pfizer announced on April 14, 2025, the "weight-loss oral version" GLP-1 receptor agonist Danuglipron®Terminated development due to "drug-induced liver injury"。TirzepatideTirzepatideDeveloped by Eli Lilly and CompanyGLP-1/GIP Receptor Dual AgonistThe "glycemic control injectable version" of tirzepatide was approved by the U.S. FDA in May 2022, under the brand name Mounjaro®; the "weight management injectable version" of tirzepatide was approved by the U.S. FDA in November 2023, under the brand name Zepbound®.In China, Eli Lilly and CompanyTirzepatide "Blood Sugar Injection Version"Approved by the National Medical Products Administration on May 21, 2024, under the trade nameMufengda®；Tirzepatide "Weight Loss Injection Version"Approved by the National Medical Products Administration on July 19, 2024, with the trade nameMufengda®In addition to weight loss and diabetes, Eli Lilly is expanding the indications of tirzepatide.Nine chronic disease indications, including cardiovascular disease, chronic kidney disease, and NASH。

About Eli Lilly and Company

Eli Lilly and CompanyEli Lilly, founded in 1876, is headquartered in Indianapolis, Indiana, USA. It is a global pharmaceutical company with a long history, conducting clinical trial research in more than 50 countries worldwide. The company has research and development centers in 8 countries, manufacturing facilities in 13 countries, and its products are marketed in 143 countries and regions globally.

Eli Lilly and CompanyThe business scope covers multiple fields, includingDiabetes, Nervous System, TumorsAnd other fields. The core business is diabetes, mainly includingInsulin products, oral hypoglycemic agentsEtc. Among them, insulin products are the main contributors to this business, including various types of insulin such as long-acting insulin, short-acting insulin, and pre-mixed insulin.

In the endocrine field, Eli Lilly and Novo Nordisk hold leading positions in the insulin market.Tirzepatide was approved later than Semaglutide.Semaglutide, developed by Novo Nordisk, is a GLP-1 receptor agonist., has been approved for controlling type 2 diabetes and weight loss. It primarily reduces appetite by altering hunger and satiety signals in specific neural regions, thereby decreasing calorie intake.

Tizepatide is developed by Eli Lilly and Company.A dual agonist of glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor, capable of producing a synergistic effect on appetite, calorie intake, and metabolic function.As of now, Eli Lilly's tirzepatide (Mounjaro) has been approved in China for both diabetes and weight loss indications.

On August 27, 2024, Eli Lilly and Company announced new prices for the 2.5mg and 5.0mg doses of Zepbound, the weight-loss version of tirzepatide, at $99.75 and $137.25 respectively, representing a price reduction of more than 50%.It is reported that Zepbound is available in six specifications: 2.5mg, 5.0mg, 7.5mg, 10.0mg, 12.5mg, and 15.0mg. The target maintenance doses are 5mg, 10mg, or 15mg, depending on the therapeutic response and tolerability.

On October 11, 2024, Eli Lilly and Company announced an investment of approximately 1.5 billion yuan for the capacity upgrade of its Suzhou plant, expanding the production scale of innovative drugs for type 2 diabetes and obesity.It is reported that Eli Lilly's Suzhou factory was established in 1996. It currently has more than 3,200 employees, covering approximately 400 cities in China. Its drug research spans over 30 diseases, with a total investment of nearly 15 billion RMB.

On October 15, 2024, Eli Lilly and Company announcedEstablishment of the China Medical Innovation Center in Beijing and plans to set up the Eli Lilly Innovation Incubator to promote clinical research and accelerate the drug development process.It is reported that the Lilly Innovation Incubator is dedicated to identifying and supporting high-potential biotechnology companies in the early stages of R&D. By integrating Lilly's professional technical resources, LGL will help drive the next generation of scientific innovation breakthroughs.

On December 4, 2024, Eli Lilly and Company announced that, according toSURMOUNT-5 Phase 3b Clinical Trial Data,At 72 weeks,Weight-Loss Version of TirzepatideZepbound®The reductionWeight loss effect,Compared to Novo Nordisk's weight-loss version of semaglutide, Wegovy®47% higher. Meanwhile, Zepbound®Outperformed Wegovy on the primary endpoint and all five key secondary endpoints.

December 5, 2024Eli Lilly and Company Announces Additional $3 Billion Investment to Expand Its Manufacturing Sites in the U.S.，To increase its diabetes drugsMounjaroAnd the weight-loss drug ZepboundOutput.It is reported that the expanded plant of Eli Lilly and Company, located in Kenosha County, Wisconsin, between Chicago and Milwaukee, has a planned total investment of $4 billion. The expanded facility will add 750 high-skilled jobs to the area, including operators, technicians, engineers, and scientists.

On December 20, 2024, tirzepatide injection, a GIP/GLP-1 receptor dual agonist independently developed by Eli Lilly and CompanyZepbound®Indication for "treating obstructive sleep apnea (OSA)" officially approved by the U.S. FDA, becoming the first approved drug to directly treat this common sleep disorder, which is alsoZepbound®The second approved indication in the United States.

On January 2, 2025, Eli Lilly and Company announced the launch of its self-developed GIP/GLP-1 receptor dual agonist, Mufengda® (tirzepatide) injection.MounjaroOfficially launched in China.It is reported that,Mufengda®Covers the treatment of "Type 2 Diabetes" and "Weight Loss," with these two indications receiving approval from the National Medical Products Administration in May and July 2024, respectively.

On February 6, 2025, Eli Lilly and Company released its 2024 financial report, with annual revenue of $45.043 billion and a net profit of $10.59 billion, representing a year-on-year increase of 102%.Of which, the annual revenue in China was US$1.66 billion, representing a year-on-year increase of 9%.It is reported that the total sales of the tirzepatide series amounted to $16.4458 billion, of which the sales of the diabetes version Mounjaro® were $11.5401 billion, and the weight loss version Zepbound® was $4.9257 billion.

February 25, 2025, Eli Lilly and CompanyCompany Announces Adjustment to U.S. MarketTirzepatideWeight-Loss Version of Zepbound®Price of small vial products.According to reports,Zepbound®The monthly price of 2.5 mg has dropped from $399 to $349; the monthly price of 5 mg has dropped from $549 to $499; 7.5 mg and 10 mg are introduced in vials for the first time, with a monthly price of $499 each.The premise is that the patient must be inReplenish medication within 45 days.

February 26, 2025, Eli Lilly and CompanyAnnounced that it will invest at least $27 billion to build four new production bases in the United States.。It is reported that among the four production bases planned for investment this time, three will focus on producing active pharmaceutical ingredients and further strengthening the supply chain.

May 6, 2025, Eli Lilly and CompanyThe clinical trial of the company's self-developed oral small molecule GLP-1 receptor agonist Orforglipron® capsule has been officially approved by the National Medical Products Administration, with the indication for "treating hypertension in adult patients with obesity or overweight."It is reported that,Orforglipron®As the first orally administered small-molecule GLP-1 receptor agonist to successfully complete Phase III clinical trials, it can be taken without restrictions on food or water intake. It not only demonstrates excellent performance in blood sugar control and weight reduction but also exhibits good safety and tolerability.

May 11, 2025, Eli Lilly and CompanyDetailed Results of a Head-to-Head Comparative Study Between GLP/GLP-1 Dual Receptor Agonist Tirzepatide and GLP-1 Single Receptor Agonist Semaglutide Published in The New England Journal of MedicineData shows that tirzepatide achieved a 1.47-fold relative weight loss compared to semaglutide.

June 3, 2025, Eli Lilly and CompanyEli Lilly and Company has signed an $870 million licensing and development agreement with Camurus to jointly develop long-acting insulinotropic drugs for the treatment of obesity, diabetes, and other metabolic diseases based on Camurus' FluidCrystal technology.。It is reported that the agreement allows Eli Lilly and Company to develop up to four proprietary drug compounds, includingGIP/GLP-1 receptor agonists, GIP/glucagon/GLP-1 receptor agonists, and options including amylin receptor agonists.