Xerava^® (eravacycline)

Xerava^® (Eravacycline), is a novel, fully synthetic, fluorocycline intravenous antibiotic for the treatment of infections caused by susceptible gram positive , gram negative and anaerobic pathogens including those multidrug resistant (“MDR”) isolates. Xerava is currently approved for the treatment of complicated intra-abdominal infections (cIAI) in the U.S., E.U., U.K., Singapore and Hong Kong. The medicine is currently under review for cIAI in Taiwan region. In March 2022, National Medical Products Administration (NMPA) of China approved New Drug Application (NDA) for Xerava (eravacycline) for the treatment of complicated intra-abdominal infections (cIAI) in adult patients. Xerava was licensed from Tetraphase Pharmaceuticals, Inc., a wholly owned subsidiary of Innoviva, Inc.

Since 2020, Xerava has been recommended in multiple global treatment guidelines issued by Infectious Disease Society of America's (IDSA) and European Society of Clinical Microbiology and Infectious Diseases (ESCMID) as a treatment choice for multi-drug resistant gram-negative bacterial infections including Carbapenem resistant organisms. In addition, it was included in an expert consensus on the multi-disciplinary management of intra-abdominal infections by the Chinese Society of Surgery of Chinese Medical Association, Infectious Diseases Society for Evidence-based and Translational Medicine of Chinese Research Hospital Association and the Editorial Board of Chinese Journal of Surgery. In Feb. 2023, Xerava was also recommended in the Guidelines for the diagnosis, treatment, prevention and control of infections caused by carbapenem-resistant gram-negative bacilli.

Commercial Rights

Greater China, South Korea, SE Asia

Nefecon

NEFECON (approved in the United States and European Union under other trade names) is an oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism. NEFECON was designed as a 4 mg delayed release capsule and is enteric coated so that it would remain intact until it reaches the ileum. Each capsule contains coated beads of budesonide that target mucosal B-cells present in the ileum, including the Peyer’s patches, which are responsible for the production of galactose-deficient IgA1 antibodies (Gd-IgA1) causing IgA nephropathy. In June 2019, Everest Medicines entered into a license agreement with Calliditas, which gives.

Everest Medicines exclusive rights to develop and commercialize NEFECON in Mainland China, Hong Kong, Macau, Taiwan and Singapore. The agreement was extended in March 2022 to include South Korea as part of Everest Medicine’s territories. The NDA for Nefecon in mainland China is currently under Priority Review and is expected to be approved in the second half of 2023. Nefecon was the first non-oncology medicine to receive Breakthrough Therapy Designation in China. In addition, South Korea’s Ministry of Food and Drug Safety (MFDS) granted Global Innovative product on Fast Track (GIFT) designation to Nefecon in February as the first non-oncology product included in the program. Such inclusion would accelerate regulatory review time by 25% and allow for rolling review. The Taiwan Food and Drug Administration awarded Accelerated Approval Designation (AAD) to Nefecon in November 2022.

Commercial Rights

Greater China, Singapore, South Korea

EVER001

EVER001 (previously known as XNW1011) is a next-generation covalent reversible Bruton’s tyrosine kinase (BTK) inhibitor in development globally for the treatment of renal diseases. BTK is an essential component of the B-cell receptor signaling pathways that regulate the survival, activation, proliferation, and differentiation of B lymphocytes. Targeting BTK with small molecule inhibitors has been demonstrated to be an effective treatment option for B-cell lymphomas and autoimmune diseases. Based in part on results from a completed phase 1 study with healthy subjects conducted by SinoMab in China, EVER001 exhibited high selectivity, excellent pharmacokinetics properties, robust target engagement and a safety profile that supports continued clinical development.

Under an exclusive licensing agreement with Sinovent Pharmaceuticals and SinoMab BioScience, Everest owns the global rights to develop, produce and commercialize EVER001 for the treatment of renal diseases. China National Medical Products Administration (NMPA)’s Center for Drug Evaluation has approved the Investigational New Drug (IND) application for a Phase 1b study of EVER001.

Commercial Rights：

Global rights for renal disease

mRNA platform

mRNA is the world’s leading next-generation biopharmaceutical technology platform and has attracted considerable attention as the leading COVID-19 vaccines globally were developed using mRNA technology. The technology enables rapid iteration and universal manufacturing and bring clear advantages over traditional vaccine technologies.

In September 2021, Everest Medicines reached a comprehensive strategic cooperation agreement with Providence Therapeutics Holdings Inc. (“Providence”) to advance mRNA vaccines and therapies. Everest gained rights to Providence’s mRNA COVID-19 vaccine candidates in Asia emerging markets, including Greater China, Southeast Asia and Pakistan, and establish a broad partnership to develop mRNA products globally leveraging Providence’s clinically validated mRNA technology platform.

Everest Medicines has achieved technology transfer of the mRNA platform, from mRNA sequence design system, LNP delivery systems to industrial-scale manufacturing at our Jiashan factory.

Everest and its partner have developed a monovalent COVID-19 vaccine candidate PTX-COVID19-B which demonstrated statistical non-inferiority in terms of safety and efficacy to Pfizer/BioNTech’s Comirnaty ® in a Phase 2 clinical trial, and an Omicron-based bivalent booster candidate, EVER-COVID19-M1.2. The company will also develop other preventive and therapeutic vaccines against important infectious diseases and cancers by utilizing the technology platform.

Taniborbactam

Taniborbactam is a novel injectable beta-lactamase inhibitor (BLI) that features selective and potent in vitro and in vivo activity against both serine-beta-lactamases (SBLs) and metallo-beta-lactamases (MBLs). In a fixed dose combination with cefepime (a 4th generation cephalosporin), taniborbactam is expected to address unmet medical need for a safe and effective therapy for treatment of diseases due to MDR gram-negative bacteria, particularly extended spectrum beta-lactamase (ESBL) producing organisms, CRE and carbapenem resistant Pseudomonas aeruginosa. Cefepime-taniborbactam has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designation by the U.S. Food and Drug Administration. Everest Medicines is developing cefepime-taniborbactam as a part of the global program in collaboration with Venatorx Pharmaceuticals under an exclusive licensing agreement, and plans to submit an NDA for complicated urinary tract infection in China in 2023.

Commercial Rights

Greater China, South Korea, SE Asia

SPR206

SPR206 is a potentially best-in-class, novel polymyxin derivative that was designed to reduce the toxicity, especially nephrotoxicity, compared to that observed clinically with polymyxin B and colistin. Polymyxins are antibiotics frequently used as a last resort for challenging MDR gram-negative infections, but they are associated with significant neurotoxicity and nephrotoxicity. A series of animal studies, in vitro studies and studies in healthy subjects have been completed to-date that demonstrate a favorable safety profile for SPR206 and in-vitro and in-vivo studies indicate the antibacterial activity of SPR206 is similar or superior to polymyxin B or colistin. Under a licensing agreement with Spero, Everest Medicines has exclusive rights to develop, manufacture and commercialize SPR206 in Greater China, South Korea and certain Southeast Asian countries for the treatment of MDR gram-negative bacterial infections.

Commercial Rights

Greater China, South Korea, SE Asia

Etrasimod

Etrasimod is an oral, once-a-day, selective sphingosine 1-phosphate (S1P) receptor modulator designed for optimized pharmacology and engagement of S1P receptors 1, 4, and 5. It is being investigated for a range of immuno-inflammatory diseases, including ulcerative colitis, Crohn’s disease, atopic dermatitis, eosinophilic esophagitis, and alopecia areata.

ELEVATE UC 52 and ELEVATE UC 12 trials that make up the ELEVATE UC Phase 3 registrational program evaluating etrasimod for the treatment of moderately-to-severely active ulcerative colitis achieved all primary and key secondary endpoints with a safety profile consistent with previous studies, demonstrating etrasimod’s best-in-class potential in ulcerative colitis.

Etrasimod was developed by Arena Pharmaceuticals, which was acquired by Pfizer in 2022. Everest Medicines obtained exclusive rights from Arena to develop, manufacture and commercialize etrasimod in Greater China and South Korea in 2017. Everest Medicines is conducting a phase 3 study for etrasimod in Asia for the treatment of moderately-to-severely active ulcerative colitis and plans to submit NDA in China by the end of 2023.

Commercial Rights

Greater China, South Korea

FGF401

FGF401 is an ATP-competitive, reversible-covalent inhibitor of FGFR4 for which Everest Medicines obtained exclusive global development and commercial rights from Novartis. FGF401 binds in a reversible-covalent manner to the FGFR4 kinase domain and inhibits the activity of FGFR4, which leads to an inhibition of tumor cell proliferation. Everest is developing FGF401 as a potential new treatment for HCC and other solid tumors associated with activation of the FGF19-FGFR4 pathway. FGF401 has undergone a phase 1/2 study in cancer patients that determined the appropriate dose for single agent and demonstrated single agent responses and safety profile in HCC patients.

Commercial Rights

Worldwide