Eli Lilly Raises 2024 Revenue Guidance to $45 Billion Amid Strong GLP-1 Drug Demand

On January 14, 2025, Eli Lilly and Company announced its revenue forecast for 2024 and released the revenue prediction for 2025.

Revenue Forecast for 2024:

Full-year revenue for 2024 is expected to be approximately US$45 billion, which is US$4 billion higher than the financial target initially released at the beginning of the year, representing a year-over-year increase of 32%.

Fourth-quarter revenue is expected to be approximately $13.5 billion, representing a 45% increase year-over-year and a significant rise compared to the fourth quarter of 2023. Of this, Mounjaro® revenue was approximately $3.5 billion, and Zepbound® revenue was approximately $1.9 billion.

Despite a 45% growth in the glucagon-like peptide-1 (GLP-1) market, fourth-quarter revenue was approximately $400 million lower than the estimate released on October 30, due to slower-than-expected market growth and lower-than-expected channel inventory at the end of the year.

Revenue Forecast for 2025:

Revenue for 2025 is expected to be between $58 billion and $61 billion, representing an increase of approximately 32% compared to 2024.

Revenue growth is expected to come from new drugs (such as Jaypirca®, Ebglyss™, Omvoh®, and Kisunla™), the approval of new indications for existing drugs, the launch of Mounjaro in more global markets, and the potential introduction of new drugs (such as imlunestrant).

On 2025-01-13, the NMPA official website showed that the marketing approval for Beijing Gillova Pharmaceutical's "Teicoplanin for Injection - National Medicine Approval No. H20253100" was delivered on 2025-01-08.

Among them, teicoplanin is a glycopeptide antibiotic used to treat infections caused by Gram-positive bacteria and is also utilized for treating MRSA (methicillin-resistant Staphylococcus aureus) infections. Compared with vancomycin, teicoplanin has equivalent efficacy but better tolerability and a lower risk of adverse reactions. A systematic review found that teicoplanin significantly reduces nephrotoxicity and red man syndrome symptoms compared to vancomycin. Teicoplanin is highly bound to plasma albumin and has a long elimination half-life, ranging from 83 to 163 hours. Due to its pharmacokinetic (PK) characteristics, significant variations and fluctuations in teicoplanin concentrations can occur when using fixed-dose regimens.

On January 13, 2025, Bicycle Therapeutics announced the latest data from the Phase 1 clinical trial, Duravelo-1, evaluating its Bicycle® Toxin Conjugate (BTC®) zelenectide pevedotin in combination with pembrolizumab for the treatment of patients with metastatic urothelial carcinoma (mUC), and outlined the company’s strategic priorities and anticipated milestones for 2025.

Data show:

In 22 patients with mUC, the overall response rate (ORR) to zelenectide pevedotin (5 mg/m² weekly) combined with pembrolizumab (200 mg every three weeks) was 65% (13 of 20 evaluable patients), with a confirmed response rate of 50% (10 of 20 patients). Among the 3 patients with unconfirmed responses, 1 was still receiving treatment at the data cutoff.

The median duration of response (mDOR) is not yet mature, with 12 patients still on treatment at the data cutoff.

Safety and tolerability were consistent with previous zelenectide pevedotin monotherapy and combination therapy cohorts. Clinically relevant adverse events (such as peripheral neuropathy, skin reactions, and ocular disorders) were mostly low-grade. All grade 3 treatment-related adverse events (TRAEs) were reversible, and no grade 4 or 5 TRAEs occurred. Notably, no patients discontinued the study due to zelenectide TRAEs.

In addition, Bicycle Therapeutics plans to initiate a Phase 1/2 trial in 2025 targeting breast cancer, lung cancer, and various tumors with NECTIN4 gene amplification. The company also plans to report MT1-MMP human imaging data in the first half of 2025 and the first EphA2 human imaging data in the second half of 2025.

On January 13, 2025, Hengrui Medicine and Kailera Therapeutics announced positive topline data from the 8mg dose group in a Phase 2 obesity trial of their GLP-1/GIP receptor dual agonist HRS9531 (KAI-9531).

Results:

In the treatment of obese or overweight patients, a once-weekly subcutaneous injection of 8mg HRS9531 led to an average weight loss of 22.8% at 36 weeks (21.1% after placebo adjustment), with no plateau in weight loss observed;

59% of participants in the HRS9531 treatment group achieved weight loss of 20% or more.

HRS9531 demonstrated good safety, with most adverse events (AEs) being mild, consistent with GLP-1/GIP receptor dual agonist injectable drugs, and primarily occurring during the dose titration period.

Among them, HRS9531 is a novel injectable GLP-1/GIP receptor dual agonist currently under development for obesity and type 2 diabetes.

On January 13, 2025, Federal Bio registered the Phase II clinical trial of "UBT251 Injection" for the treatment of type 2 diabetes on the China National Drug Clinical Trial Registration and Information Platform (CTR).

Among them, UBT251 Injection, a Class 1 innovative drug independently developed by Federal Biotech, is a long-acting GLP-1/GIP/GCG tri-target receptor agonist mainly used for the treatment of type 2 diabetes, obesity, and related metabolic diseases.

2025-01-15, Attralus announced that the first patient has been enrolled in its Phase 3 clinical trial, the REVEAL study, which aims to evaluate the pan-amyloid PET imaging agent 124I-evuzamitide (AT-01) for the diagnosis of suspected cardiac amyloidosis.

Among them, 124I-evuzamitide is the first non-invasive pan-amyloid PET imaging agent, specifically designed for the diagnosis and management of systemic amyloidosis. This drug has received Breakthrough Therapy Designation (BTD) from the U.S. FDA for PET imaging diagnosis in patients suspected or known to have cardiac amyloidosis. Additionally, 124I-evuzamitide has also been granted Orphan Drug Designation by the FDA and the European Commission for the management of ATTR and AL amyloidosis.

On January 15, 2025, Evaxion Biotech announced that all 16 patients had been dosed in the Phase 2 clinical trial of its personalized cancer vaccine EVX-01.

Among them, EVX-01 is a peptide-based personalized cancer vaccine and Evaxion's leading asset, designed by its AI-Immunology™ platform to treat advanced melanoma (skin cancer). The Phase 2 trial is investigating EVX-01 in combination with Merck's KEYTRUDA® (pembrolizumab) for patients with advanced melanoma. Each patient participating in the trial receives a unique vaccine designed and produced according to their individual biology.

On January 16, 2025, Avacta Therapeutics announced the latest data from the Phase 1 clinical trial of its peptide-drug conjugate (PDC), AVA6000.

Results:

The drug achieved clinically meaningful tumor shrinkage in patients with salivary gland cancer (SGC);

Among the 10 patients receiving treatment at a dose of 250 mg/m² or higher, tumor shrinkage was observed in 5 patients, including 1 case of partial response (PR, with a 45% reduction in tumor size) and 4 cases of minor response (MR, with a 10%-19.5% reduction in tumor size).

Six patients are still undergoing treatment, while two other patients who have reached the maximum treatment cycle are still in follow-up, with a disease control rate (DCR) reaching 90%.

Among them, AVA6000 is the first peptide-drug conjugate in Avacta's pipeline. It consists of doxorubicin conjugated with Avacta's proprietary pre|CISION® peptide, which can be specifically cleaved by fibroblast activation protein α (FAP) in the tumor microenvironment. The safety profile of AVA6000 continues to demonstrate significantly reduced severe hematological and cardiac toxicity, offering advantages over conventionally dosed doxorubicin. Based on the favorable efficacy and safety data observed in the Phase 1a trial, Avacta has initiated three Phase 1b expansion cohorts targeting triple-negative breast cancer, soft tissue sarcoma, and salivary gland cancer patients, with the first patients in the U.S. expected to begin treatment soon.

On January 16, 2025, Hangzhou Zhongmei Huadong, a subsidiary of Huadong Medicine, registered a Phase II clinical study on the CTR platform to evaluate the efficacy and safety of HDM1005 injection in obese non-diabetic subjects.

Among them, DM1005 injection, independently developed by Huadong Medicine with global intellectual property rights, is a long-acting agonist targeting GLP-1/GIP and has shown good efficacy. Preclinical studies have demonstrated that HDM1005 can promote the production of cyclic adenosine monophosphate (cAMP) by activating GLP-1 and GIP receptors, increase insulin secretion, suppress appetite, delay gastric emptying, and improve lipid metabolism, demonstrating effects in lowering blood glucose, reducing weight, and treating MASH. Meanwhile, current data indicate that HDM1005 possesses favorable drug-like properties and safety.

On January 17, 2025, Novo Nordisk announced the latest results of its STEP UP Phase 3b clinical trial.

Results:

Starting from an average baseline weight of 113kg, assuming all participants adhered to the treatment, the 7.2mg semaglutide group experienced a 20.7% weight loss, the 2.4mg semaglutide group had a 17.5% reduction, and the placebo group showed a 2.4% decrease.

Moreover, 33.2% of participants in the 7.2mg semaglutide group achieved weight loss of 25% or more after 72 weeks, compared to 16.7% in the 2.4mg semaglutide group and 0% in the placebo group.

When applying the estimated treatment policy, the 7.2mg semaglutide group experienced an 18.7% weight reduction, the 2.4mg semaglutide group had a 15.6% reduction, and the placebo group showed a 3.9% reduction.

In the trial, 7.2mg semaglutide demonstrated safe and well-tolerated properties. The most common adverse events were gastrointestinal-related, and most were mild to moderate, diminishing over time, consistent with GLP-1 receptor agonist class drugs.

Among them, STEP UP is a 72-week efficacy and safety trial within the global STEP program, studying the efficacy of 7.2mg subcutaneous semaglutide compared with 2.4mg semaglutide and placebo. All treatments are administered once weekly. The trial enrolled 1,407 obese adults, with all treatment groups combined with lifestyle intervention. The trial met its primary endpoint, showing that weight loss in the 7.2mg semaglutide group was significantly superior to the placebo group at week 72.