Pfizer Announces FDA Approval of Etrasimod (VELSIPITY™) for Moderately to Severely Active Ulcerative Colitis in Adults

Shanghai, ChinaOctober 16, 2023 PR Newswire -- Everest Medicines (HKEX 1952.HK) Authorized partner Pfizer (New York Stock Exchange ticker symbol:PFE ) AnnounceU.S. Food and Drug Administration (FDA) has approved a once-daily oral selective sphingosine-1-Phosphoric Acid (S1P）Receptor Modulator Itrumod（VELSIPITY™, etrasimod) for the treatment of moderate to severe active ulcerative colitis (UC) adult patients.Everest Medicines is conducting trials for Itrumod (etrasimod) Multicenter3Phase clinical research, striving to submit its New Drug Application (NDA) within the authorized scope of Everest Medicines as soon as possible (NDA）。

Everest Medicines CEO Yongqing Luo said: "Congratulations to our partner on reaching this significant milestone, which will provide ulcerative colitis patients with an innovative, effective, and convenient treatment option that they urgently need."Itrumod is a clinically validated effective treatment method with good clinical benefits and safety, compared to other S1P Unlike other modulators, Itrumod does not require dose adjustment during the induction phase. Meanwhile, our partner is also conducting clinical trials for various indications such as Crohn's disease, atopic dermatitis, eosinophilic esophagitis, and alopecia areata. Itrumod is expected to become a blockbuster drug for a broad spectrum of autoimmune diseases.In recent years, the incidence of ulcerative colitis and other autoimmune diseases in China has risen rapidly. We look forward to advancing progress in Asia as soon as possible.3Phase clinical research, and achieve registration and market launch in China and other Asian countries and regions as soon as possible."

Itrumod (etrasimod) The leading investigator of the Asia-Pacific clinical trial, standing director of the World Gastroenterology Organization, vice chairman of the Digestive Disease Branch of the Chinese Medical Association, and Professor Wu Kaichun from Xijing Hospital, Fourth Military Medical University of the Chinese People's Liberation Army, stated：“EtrasimodIn the United StatesFDAApproval is a very important milestone that provides a new treatment option for patients with moderate to severe active ulcerative colitis.Patients with this disease often try different treatment methods, and some patients have concerns about using injectable therapies (such as biologics).EtrasimodWith good benefits-Risk Characteristics, This New GenerationS1PThe modulator can achieve hormone-free remission through an oral, once-daily treatment regimen, offering patients a more advanced and convenient treatment option.Patient recruitment for the Asia-Pacific clinical trial has been completed. We look forward to the早日 approval in China and other Asian countries, benefiting more patients."

To2030In 2023, the number of patients with ulcerative colitis in China is expected to increase compared to2019Increase more than doubled year by year, reaching approximately100Ten thousand people, indicating a huge unmet demand in the Chinese market for innovative therapies for this disease. Itrumod (etrasimod) byArena PharmaceuticalsDeveloped by the company, Pfizer2022Completed inArena PharmaceuticalsThe acquisition, while Everest Medicines as early as2017Year has passed fromArenaGained the rights to develop, manufacture, and commercialize Itrumod (in Greater China and South Korea.etrasimod) exclusive rights.

This time in the United StatesFDAThe approval is based onELEVATE UC 3Pivotal registrational study (ELEVATE UC 52AndELEVATE UC 12) results, which aimed to evaluate prior treatment with at least one conventional therapy, biologic agent, orJAKPatients with ulcerative colitis who have failed or are intolerant to inhibitor therapy, take once daily2mg etrasimodSafety and efficacy. Both randomized, double-blind, placebo-controlled studies met all primary and key secondary endpoints, with a safety profile consistent with previous studies.

InELEVATE UC 52In the study, the12Weeks, receiving Itrumod (etrasimod) The clinical remission rate of patients treated with27.0%, while the clinical remission rate in the placebo control group was7.0%(Difference is20.0%，P=<.001); The52At the same time, Iztromod (etrasimod) The clinical remission rate of patients treated with32.0%, while the clinical remission rate in the placebo control group was7.0%(Difference is26.0%，P=<.001）。InELEVATE UC 12In the study, patients received Itrumod (etrasimod) The clinical remission rate of patients treated with26.0%, while the clinical remission rate in the placebo control group was15.0%(Difference is11.0%，P=<.05). All key secondary endpoints were met at Week12Zhou reached, including endoscopic improvement and mucosal healing. Itrumod (etrasimod) The safety profile was consistent with previous studies, with the most common adverse reactions being headache and dizziness (incidence rate ≥5%）。

About Itrumo德 (etrasimod）

Itrumod (etrasimod) is a once-daily oral selective sphingosine-1-Phosphoric Acid (S1P) receptor modulator, utilizing optimized pharmacological design, withS1PReceptor1、4And5Combination.

Itrumod's new drug application for the treatment of ulcerative colitis has been submitted in multiple countries, including Canada, Australia, Mexico, Russia, Switzerland, and Singapore. European Medicines Agency (EMA) Has accepted its new drug marketing application (MAA), is expected to 2024 A decision was made at the beginning of the year.

AboutELEVATE UC 52AndELEVATE UC 12

ELEVATE UC 52AndELEVATE UC 12YesELEVATE UC 3 Pivotal trial in the registration study.

ELEVATE UC 52It is a randomized, double-blind, placebo-controlled trial, including12Weeks of induction period and40Week of maintenance. From the12At the start of the week, all patients could continue to receive their randomized treatment; patients whose disease had not improved or had worsened compared to baseline could discontinue treatment, and eligible patients could enroll in the open-label extension study. The primary objective of the trial was to evaluate once-daily dosing.2mg Itrumod (etrasimod) In12Zhou He52Safety and efficacy in achieving clinical remission after weeks of treatment. The primary endpoint is clinical remission, defined as based on the Mayo score.3Improvement in individual items, including the single-item score for bowel movement frequency0(Or for1And the reduction from baseline is at least1Score, Hematochezia Single Item Score0, Endoscopic Single Item Score<=1 (Exclude fragile). InELEVATE UC 52In, the12At the same time, Iztromod (etrasimod) The clinical remission rates for patients treated with and patients receiving placebo were27.0%And7.0%（20.0%Difference,P˂.001), the52At weeks, respectively32.0%And7.0%（26.0%Difference,P˂.001). All key secondary endpoints (including the12Zhou and Di 52 Endoscopic improvement and mucosal healing at week52Weeks of hormone-free remission and sustained clinical remission) both achieved statistically significant improvement.

ELEVATE UC 12It is a randomized, double-blind, placebo-controlled trial designed to evaluate once-daily dosing in patients with moderate to severe active ulcerative colitis.2mg Itrumod (etrasimod) efficacy and safety. The main purpose of this trial is to evaluate Itrumod (etrasimod) In12Safety and efficacy in achieving clinical remission after weeks of treatment, evaluated based onFDARequired3The modified Mayo score for sub-items. InELEVATE UC 12In China,26.0%Receiving Itrumod (etrasimod) Patients treated with15%Patients receiving placebo experienced relief of clinical symptoms (11.0%Difference,P <.05). The12All key secondary endpoints, including endoscopic improvement and mucosal healing, were met at the same time.

InELEVATE UC 12In China, Itrumod (etrasimod） 2mgTreatment-emergent adverse events occurred in the treatment group and the placebo treatment group (AE) was similar among patients, while inELEVATE UC 52In China,etrasimod 2 mgThis proportion in the group was higher than that in the placebo group. The proportion of patients experiencing serious adverse events was similar between the treatment groups in both trials. In both trials, as of...52Week, Itrumo (etrasimod) The incidence rate in the treatment group was3%The most common treatment-emergent adverse events at and above this level, which were higher than those in the placebo group, were headache,UCAggravate,COVID-19Infections, dizziness, fever, joint pain, abdominal pain, and nausea. No serious adverse events of bradycardia or atrioventricular block were reported. The trial data indicates that initiationetrasimodTreatment does not require a complex upward titration regimen.

InELEVATE UC 52AndELEVATE UC 12In China, nearly two-thirds of the patients had never previously received biologics orJAKInhibitor therapy.

About Everest Medicines

Everest Medicines is a biopharmaceutical company focused on the development, manufacturing, and commercialization of innovative drugs and vaccines, dedicated to addressing unmet medical needs in the Asian market. The management team of Everest Medicines has extensive experience in high-quality clinical development, regulatory affairs, and chemistry, manufacturing, and control (CMC) in China and leading global pharmaceutical enterprises.CMC), business development and operations, with deep expertise and extensive experience. Everest Medicines has built a portfolio of potential first-in-class or best-in-class drugs globally, most of which are already in the late stages of clinical trials. The company's therapeutic areas include renal diseases, infectious and communicable diseases, and autoimmune diseases. For more information, please visit the company’s website: www.everestmedicines.com。

Forward-Looking Statements:

The information contained in this press release may include certain forward-looking statements based on the Company’s or management's current views, beliefs, and expectations regarding the Company’s business operations and financial condition at the time of making such statements. These statements may be expressed using terms such as "will," "expect," "forecast," "anticipate," "intend," "plan," "believe," "estimate," "confident," and similar expressions. These forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties, and other factors, some of which are beyond the Company's control and are difficult to predict. Therefore, actual results may differ materially from the information contained in these forward-looking statements due to various factors and assumptions, including changes and developments in our business, competitive environment, political, economic, legal, and social conditions. Neither the Company nor its subsidiaries, directors, officers, advisors, or agents have any obligation, nor do they assume any obligation, to update the forward-looking statements contained in this press release to reflect new information, future events, or circumstances after the date of this press release, except as required by law.