Lilly Reports 2023 Financial Results: Tirzepatide Surpasses $5 Billion in Sales

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On February 6, 2024, Eli Lilly and Company announced its 2023 financial report, with total annual revenue of $34.124 billion, representing a 20% year-over-year increase; R&D investment reached $9.313 billion, marking a 30% year-over-year increase. Revenue in China amounted to $1.540 billion, reflecting an 11% year-over-year increase.

Among them, tirzepatide brought nearly $500 million in revenue to Eli Lilly in its first year of approval, with rapid growth. As the diabetes market gradually penetrates, the sales of tirzepatide (Mounjaro) reached $5.163 billion in 2023 (+970%), far exceeding the initial performance of semaglutide (with $286 million in 2018 and $1.686 billion in 2019, +490%). At the end of last year, tirzepatide (Zepbound) successfully obtained an obesity indication based on outstanding weight loss data, generating $175.8 million in revenue within less than two months of its launch. With strong demand in the obesity market, there is no doubt that its total sales will surpass dulaglutide in 2024.

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Recently, OKYO Pharma received FDA approval for the IND of OK-101 in treating neuropathic corneal pain. Notably, the initial IND submission to the FDA proposed an open-label design for the clinical trial. Based on positive feedback from the FDA, the Phase II study is now designed as a double-blind, randomized, 12-week placebo-controlled trial comparing OK-101 with a placebo in NCP patients. The study plans to enroll 54 patients with NCP confirmed via confocal microscopy. The primary endpoint will be measured using the VAS pain relief score. These protocol changes will enable a statistically valid demonstration of the true drug effect of OK-101 on NCP symptoms. OKYO Pharma plans to initiate this trial in Q2 2024.

Among them, OK-101 is a long-acting esterified Chemerin peptide analog developed using novel Membrane-Anchored Peptide (MAP) technology. It consists of a peptide sequence containing 10 amino acids (derived from Chemerin), a linker component, and an anchoring lipid domain. The peptide sequence in OK-101 can bind to ChemR23 on ocular immune cells, exerting an anti-inflammatory effect.

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On February 7, 2023, Johnson & Johnson announced the results of the Phase II clinical FRONTIER 1 trial for JNJ-2113. The primary endpoint of the study was at least a 75% reduction from baseline in the Psoriasis Area and Severity Index score (PASI 75 response) at week 16. The study results showed that, compared to patients receiving placebo, adult patients treated with JNJ-2113 demonstrated a significant dose-response in PASI 75 at week 16, with 79% of patients in the highest tested dose group achieving a PASI 75 response.

Among them, JNJ-2113 is the first and only investigational targeted oral peptide inhibitor designed to block the IL-23 receptor. IL-23 plays a key role in the pathogenic T-cell activation in moderate to severe plaque psoriasis (PsO) and supports the inflammatory response in PsO and other dermatological and gastrointestinal diseases mediated by IL-23.

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2024-2-6, Scholar Rock announced preclinical data for its pipeline candidate SRK-439, showing the potential of SRK-439 as part of a healthy weight loss regimen in maintaining lean body mass and improving metabolic health. The data indicated that when SRK-439 was used in combination with GLP-1 receptor agonists (GLP-1 RA; in separate experiments with semaglutide and liraglutide), it helped maintain lean body mass and improved fat reduction in diet-induced obesity (DIO) mice. Treatment with SRK-439 also led to a gradual reduction in fasting blood glucose levels, surpassing the effects of semaglutide alone. 2024-1, Scholar Rock announced that the FDA approved the company’s Investigational New Drug (IND) application for a Phase II proof-of-concept trial of apitegromab for treating obesity in patients taking GLP-1 RA.

Among them, SRK-439 is a novel preclinical investigational myostatin inhibitor with high in vitro affinity for both mature myostatin and latent myostatin, maintaining myostatin specificity (i.e., no GDF11 or Activin-A binding), and was initially developed for the treatment of obesity.

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Recently, Amgen's research and development team published the preclinical studies and Phase I clinical trial results of the investigational weight-loss therapy AMG 133 in the Nature Metabolism, a subsidiary journal of Nature. Clinical trial results showed that obese patients only need one injection per month, and after 85 days of treatment with a high dose of AMG 133, body weight can be reduced by 14.5% (approximately 26 jin). Notably, these patients were still able to maintain a 11.2% reduction in body weight 150 days after discontinuation of the drug. Amgen is currently conducting Phase II clinical trials to explore maintaining weight loss with a lower dose of AMG 133 or less frequent dosing after using a high dose of AMG 133 to reduce patient weight.

Among them, AMG 133 is a potential "first-in-class" investigational antibody-peptide conjugate (antibody-peptide conjugate) that conjugates two glucagon-like peptide-1 (GLP-1) analogs at specific sites of a monoclonal antibody targeting the gastric inhibitory polypeptide receptor (GIPR), activating GLP-1 receptors while inhibiting GIPR. Activation of GLP-1 receptors can delay gastric emptying and suppress appetite, thereby achieving weight loss effects. On the other hand, many genetic epidemiological studies have shown that decreases in body mass index (BMI) across individuals of different ethnic backgrounds are all associated with low expression levels of GIPR.