Recently, at Everest Medicines' investor exchange activities, the management led by CEO Luo Yongqing put forward the target of "realizing the marketing of four commercial products in a short time, with a sales peak of CNY 10 billion". 

The main business model of Everest Medicines is to get license-in the same kind of first-in-class or best-in-class drugs in global. In October 2020, Everest Medicines landed in Hong Kong Stock Market successfully. As a company only listing for 3 years, why does it make this sharp goal? It may find the answer from the R&D pipelines of Everest Medicines. 

The product covers the blue ocean market of IgA nephropathy

IgA nephropathy is a kind of glomerular disease characterized by deposition of immune complex mainly composed of IgA in glomerular mesangial region, and a kind of chronic progressive autoimmune nephropathy, with a characteristic of the deposition of immune complex containing IgA in glomerulus, causing inflammatory reaction and injury of cells and tissues, which clinical manifestation is proteinuria and hematuria. About 50% IgA nephropathy patients with high risk of progression will progress to end-stage renal disease within 10-20 years, which needs dialysis or kidney transplantation. According to the Frost & Sullivan report, the total patients with IgA nephropathy in global in 2030 may reach 10.2 million; and more than half of the patients are concentrated in the East Asian region, among which there are about 4~5 million patients in China market alone. 

At present, first-line treatment of IgA nephropathy includes RAS blocker, glucocorticoid, immunosuppressant, etc., which have some limitations in efficacy and safety. However, there is no specific IgA nephropathy therapy approved for marketing in China. 

In 2021, Nefecon (Budesonide Sustained-release Capsule), an etiological therapeutic drug for IgA nephropathy, was accelerated approval for marketing by FDA, becoming the only etiological therapeutic drug for IgA nephropathy in the world, as well as the first targeted therapy drug for IgA nephropathy approved by FDA.

Nefecon, developed by Calliditas Therapeutics, with an active ingredient of Budesonide, is a kind of glucocorticoid, with a strong glucocorticoid activity and weak mineralocorticoid activity, as well as an extreme high first-pass metabolism; Nefecon's original preparation technology can deliver, target and release the drug completely to Peyer patch in the terminal ileum, so as to reduce the Gd-IgA1 which can induce IgA nephropathy to make a precise targeted therapy.

In March 2023, Calliditas Therapeutics announced the Phase III clinical research of Nefecon. Within the 15-month follow-up period, the UPCR of patients in Nefecon group continued to decrease; Its eGFR was improved significantly compared with placebo group, which can last for two years (-2.47 vs -7.52mL/min/1.73m2, p<0.0001). It is noteworthy that Nefecon can effectively improve eGFR regardless of the patient's baseline UPCR level. 

In June 2019, Everest Medicines signed Exclusive Licensing Agreement with Calliditas to get the development and commercialization rights of Nefecon in Greater China and Singapore. In March 2022, the agreement was further expanded to include South Korea in the licensing scope of Everest Medicines.

In November 2022, Everest Medicines submitted Nefecon's marketing application in China, which had got the priority review of NMPA.

Everest Medicines, holding Nefecon's rights and interests in Greater China, Korea and Singapore, covers nearly half of the patients in the world, with a considerable clinical value. 

The second trump card: Etrasimod 

Etrasimod, an oral small molecule selective S1P receptor modulator, can specifically bind with S1P receptor 1, 4 and 5 for treating ulcerative colitis (UC). In addition, it is also developed for a series of immuno-inflammatory diseases such as Crohn's disease, atopic dermatitis and alopecia areata, which was once rated as "Top Ten Potential Important Therapy Expected to Be Approved in 2023" by Evaluate Pharma. 

Etrasimod was developed by Arena. In 2017, Everest Medicines got Etrasimod's rights and interests in Greater China and Korea through authorized cooperation. In 2022, Pfizer acquired Arena and obtained the Etrasimod. 

At present, Pfizer has verified the drug of Etrasimod and good efficacy and safety in the indication for UC through two Phase III clinical researches, and has submitted Etrasimod's NDA in USA and the EU, and Everest Medicines had finished the enrollment work of Phase III clinic in China.

To develop the anti-infective drugs with high barrier

WHO ever issued a warning that the number of deaths due to antibiotic resistance will reach 10 million in 2050 because of the abuse of antibiotics. Thus, Everest Medicines lays out the market of antibiotics for multi-drug resistant gram-negative bacteria with a higher barrier and a larger space, and has a combination of two pipelines: Eravacycline (Xerava) and Taniborbactam.

Eravacycline, a novel and broad-spectrum, tetracycline antibiotics with fluorine, is used to treat for multiple drug fast bacteria infections including common gram-negative bacterial infections and gram-positive bacterial infections. Eravacycline was developed by Tetraphase originally. In February 2018, Everest Medicines cooperated with Tetraphase to introduce Eravacycline. In August and September 2018, Eravacycline was approved by FDA and EMA for treating for adult complicated abdominal infection; In March 2023, Eravacycline was approved for marketing by CDE, with the indication of the treatment for adult complicated abdominal infection. At present, Everest Medicines is developing Eravacycline for treating the CAP. 

And Cefepime/Taniborbactam will be submitted the new drug application for treating complex urinary tract infections this year; Another candidate product, EVER206, is a safer next-generation polymyxin, which has completed Phase I clinical trial.

In addition, Everest Medicines reached a strategic cooperation with Providence in September 2021, introducing its advanced mRNA technology platform, of which the industrial scale technology transfer has been completed. Based on this important technology, Everest Medicines has a large-scale production capacity of mRNA vaccine, which will assist its strategic industrial chain layout integrating independent R&D, clinic, production and commercialization. 

Everest Medicines also reserves a variety of early pipelines and preclinical candidate drugs under research. And the whole pipeline has realized the efficient layout of "step configuration and orderly development". 

Everest Medicines has created a variety of drug combinations that have the potential to become the same kind of first-in-class or best-in-class drugs in global, most of which are in the late stage of clinical trials. Its therapeutic areas have covered nephrology diseases, infectious diseases and autoimmune diseases. For Everest Medicines, 2023 is destined to be a year of great transition and transformation.

Main references: 

1. "Everest Medicines: An Undervalued Enterprise with Global IP of mRNA", Fengshuo Venture Capital, 2021-12-06; 

2. "Three Questions to Everest Medicines: License in, Capital and Team", DeepTech, 2020-11-17; 

3. "As the Darling of Capital but with No Self-developed Patent, Financing CNY 3 Billion in Three Years of Entrepreneurship, Can Everest Medicines Land in Hong Kong Stock Market?", Fengyun Capital, 2020-08-13. 

About the Author:

Xiaobin

Xiaobin holds a Master's degree in Pharmacy and currently work as a public health control staff. Navigating through the intricate and complex data each day and feeling a sense of insignificance of herself. While being happy to witness the golden time of the development of Chinese bio-pharmaceutical industry. Hope to learn and improve together with everyone.